Hepatitis C, Chronic
Conditions
Keywords
Genotype 4, GSK2336805, pegylated interferon, telaprevir, Genotype 1, chronic hepatitis C, ribavirin, NS5A inhibitor, hepatitis C virus (HCV) infection
Brief summary
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection. In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.
Detailed description
Subjects with chronic genotype 1 hepatitis C virus (HCV) infection will be randomly assigned on a 2:2:1 basis to 1 of 3 treatment arms: T40 (GSK2336805 40 mg and PEG + RIBA) or T60 (GSK2336805 60 mg and PEG + RIBA) or PEG + RIBA and telaprevir (PRT). Randomization will be stratified by interleukin 28B (IL28B) rs12979860 status (C/C versus carriage of the T allele), HCV genotype (1a vs. 1b), and plasma HCV Ribonucleic Acid (RNA) (\<800,000 IU/mL versus ≥800,000 IU/mL). An additional nonrandomized single-arm cohort of subjects with chronic genotype 4 HCV infection will be enrolled in parallel. A maximum of 15 genotype 4 subjects will receive GSK2336805 60 mg and PEG + RIBA. The purpose of this cohort is to further characterize the antiviral activity of GSK2336805 in subjects with chronic genotype 4 HCV infection. The schedule of assessments for the genotype 4 subjects will be the same as for the genotype 1 subjects. Recruitment of the genotype 4 subjects may be terminated when the target sample of genotype 1 subjects have been randomized. Subjects in a GSK2336805 treatment arm who achieve extended rapid virologic response (eRVR) will receive a total of 24 weeks of therapy (12 weeks GSK2336805 in combination with PEG + RIBA followed by 12 weeks PEG + RIBA). Subjects who are HCV detectable at Week 4 and then undetectable at Week 12 will receive a total of 48 weeks of therapy (12 weeks GSK2336805 in combination with PEG + RIBA followed by 36 weeks PEG + RIBA). Subjects in the telaprevir treatment control arm will be managed according to the current product label for treatment-naïve subjects. Subjects who complete treatment will undergo follow-up monitoring for 24 weeks after completion of therapy. At the end of the 24-week follow-up visit, subjects will have completed their participation in the study. The total duration of the study will be 48 weeks for subjects who achieve eRVR at Week 12 and up to 72 weeks for subjects who do not achieve eRVR at Week 12.
Interventions
DRUGGSK2336805 40 mg
20 mg tablet, round, 10-mm diameter, white to off-white, no markings
DRUGGSK2336805 60 mg
30 mg tablet, round, 10-mm diameter, white to off-white, no markings
180 microgram per 0.5 mL prefilled syringe for single use
DRUGRibavirin
200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with 200 on 1 side and the logo 3RP on the other side
DRUGTelaprevir
375 mg film-coated tablet
Sponsors
PPD Development, LP
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female aged 18 to 70 years of age, inclusive, at Screening. * Genotype 1 or genotype 4 hepatitis C virus (HCV) infection as assessed by Versant HCV Genotype assay 2.0 (LiPA). * Chronic HCV infection documented by at least 1 measurement of serum HCV RNA greater than or equal to 100,000 IU/mL measured during Screening by the COBAS High Pure/COBAS TaqMan HCV Test v2.0 and at least one of the following: * A positive anti-HCV antibody, HCV RNA, or HCV genotype test at least 6 months prior to Baseline (Day 1) together with positive HCV RNA and anti-HCV antibody tests at the time of Screening; or * A positive HCV RNA test and anti-HCV antibody test at the time of Screening together with either a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis). * Naïve to all HCV antiviral treatment(s), including, but not limited to, immunomodulatory and nucleoside/nucleotide treatments for chronic HCV infection. * Agree to interleukin 28B (IL28B) genotyping. * A subject, who, in the opinion of the investigator, is an appropriate candidate for pegylated interferon alpha-2a (PEG)/ribavirin (RIBA)/protease inhibitor combination therapy for genotype 1 subjects and PEG/RIBA combination therapy for genotype 4 subjects. * Body mass index \>18 kg/m2 but not exceeding 36 kg/m2. * A liver biopsy obtained within 3 years (36 calendar months) prior to the Day 1 visit, with a fibrosis classification of noncirrhotic as judged by a local pathologist (defined as Knodell less than or equal to 3, Metavir less than or equal to 2, Ishak less than or equal to 4, or Batts and Ludwig less than or equal to 2). Both incomplete and transition to cirrhosis (e.g., Metavir score 3) are considered as cirrhosis. If no recent (\<36 months) liver biopsy is available, a study-qualifying biopsy must be performed prior to Baseline (Day 1). * All fertile males and females must use 2 forms of effective contraception between them during treatment and during the 24 weeks after treatment ends. * Females, is eligible to enter and participate in the study if of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) and includes any female who has had a hysterectomy or has had a bilateral oophorectomy (ovariectomy) or has had a bilateral tubal ligation or is postmenopausal (demonstrate total cessation of menses for greater than 1 year). * Females, is eligible to enter and participate in the study if of childbearing potential and has a negative urine or serum pregnancy test at Screening and within the 24-hour period prior to the first dose of study medication and completely abstains from intercourse for 2 weeks before exposure to the study medication, throughout the clinical study, and for 24 weeks after completion or premature discontinuation from this study or uses 2 of the following acceptable methods of contraception throughout the clinical study and for 24 weeks after completion or premature discontinuation from this study: * Any intrauterine device with a documented failure rate of \<1% per year * Double-barrier contraception (condom, diaphragm, or cervical cap used with spermicidal jelly) * Male partner who is sterile prior to the female subject's study entry and is the sole sexual partner for that female * Any other contraceptive method with a documented failure rate of \<1% per year * Otherwise healthy as determined by the medical history, physical examination, ECG findings, and clinical laboratory measurements performed at Screening.
Exclusion criteria
* Positive test at Screening visit for hepatitis B surface antigen (HBsAg) or antihuman immunodeficiency virus antibody * History of any other clinically significant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, 1-antitrypsin deficiency, alcoholic liver disease, \>Grade 1 nonalcoholic steatohepatitis, and toxin exposures). Subjects with Gilbert's syndrome who otherwise meet all inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving eRVR | Week 4 and Week 12 | eRVR is defined as plasma HCV ribonucleic acid (RNA) \<lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders. |
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | From the start of study treatment up to Week 12 | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | Baseline (Week 0) up to 12-week treatment period | Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12 | Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12 | Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Baseline (Week 0), Weeks 2 and 12 | Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1 and 12 | The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Baseline (Week 0) and Weeks 1 and 12 | The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12. |
| Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed. |
| Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status | Week 4 and Week 12 | Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status | Week 4 and Week 12 | Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status | Week 4 | Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status | Week 4 | Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status | Week 4 and Week 12 | Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Number of Participants With Any AEs and Any SAEs After Week 12 | From Week 12 up to PT Week 24 FU | An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
| Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2 | Day 2 | Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available. |
| Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | From the start of the treatment up to PT FU Week 24 | Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA \<LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA \<LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR. |
| Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1, Day 2, Week 4, and Week 12 | Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour \[h\]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose \[20-28h\]), Week 4 (Predose \[20-28h\], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose \[20-28h\]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. |
| Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 | Week 4 (24 h post dose) | Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose. |
| Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4 | Week 4 (24 h post dose) | Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose. |
| Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4 | Week 4 (24 h post dose) | Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. |
| Apparent Clearance (CL/F) at Week 4 | Week 4 (24 h post dose) | Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau). |
| Apparent Volume of Distribution (Vz/F) at Week 4 | Week 4 (24 h post dose) | Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC\[0-tau\] lambda z) where lambda z is the terminal phase rate constant. |
| Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. |
| Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12 | Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4 | Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12. |
Countries
Belgium, Bulgaria, France, Germany, Puerto Rico, United States
Participant flow
Recruitment details
This study was conducted across 29 centers in 6 countries (United States, Puerto Rico, Germany, Belgium, France, and Bulgaria) from 15 August 2012 to 16 July 2014.
Pre-assignment details
Participants with treatment-naïve(TN) chronic genotype1(G1) hepatitis C virus (HCV) infection were randomly allocated on 2:2:1 basis to 2 dose levels of GSK2336805 or telaprevir. In a nonrandomized single-arm cohort, participants with TN genotype4(G4) chronic HCV infection were enrolled in parallel at dose level of 60 milligrams (mg) of GSK2336805.
Participants by arm
| Arm | Count |
|---|---|
| GSK2336805 40 mg, Genotype 1 HCV Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken in 2 divided doses with food. | 41 |
| GSK2336805 60 mg, Genotype 1 HCV Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food. | 40 |
| Telaprevir, Genotype 1 HCV Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food. | 17 |
| GSK2336805 60 mg, Genotype 4 HCV Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was \<75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was \>=75 kg) taken orally in 2 divided doses with food. | 13 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 2 | 0 |
| Overall Study | Lack of Efficacy | 4 | 7 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 3 | 2 |
Baseline characteristics
| Characteristic | GSK2336805 40 mg, Genotype 1 HCV | Total | GSK2336805 60 mg, Genotype 4 HCV | Telaprevir, Genotype 1 HCV | GSK2336805 60 mg, Genotype 1 HCV |
|---|---|---|---|---|---|
| Age, Continuous | 43.7 Years STANDARD_DEVIATION 13.23 | 42.2 Years STANDARD_DEVIATION 11.73 | 45.3 Years STANDARD_DEVIATION 11.46 | 39.4 Years STANDARD_DEVIATION 12.02 | 40.8 Years STANDARD_DEVIATION 9.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 17 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 91 Participants | 9 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Female | 13 Participants | 38 Participants | 3 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Male | 28 Participants | 73 Participants | 10 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 41 / 41 | 38 / 40 | 17 / 17 | 13 / 13 |
| serious Total, serious adverse events | 2 / 41 | 2 / 40 | 3 / 17 | 1 / 13 |
Outcome results
Primary
Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week1; n=40, 39, 15, 13 | -0.6 Grams per liter | Standard Deviation 2.67 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week2; n=41, 38, 14, 13 | -1.3 Grams per liter | Standard Deviation 2.98 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week4; n=41, 39, 14, 13 | -1.9 Grams per liter | Standard Deviation 2.48 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week6; n=41, 38, 13, 13 | -2.2 Grams per liter | Standard Deviation 2.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week8; n=40, 39, 13, 13 | -2.6 Grams per liter | Standard Deviation 2.99 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week12; n=37, 35, 12, 13 | -2.1 Grams per liter | Standard Deviation 3.03 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week12; n=37, 35, 12, 13 | -1.3 Grams per liter | Standard Deviation 2.84 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week6; n=41, 38, 13, 13 | -1.5 Grams per liter | Standard Deviation 2.27 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week1; n=40, 39, 15, 13 | -0.3 Grams per liter | Standard Deviation 2.46 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week4; n=41, 39, 14, 13 | -1.5 Grams per liter | Standard Deviation 2.52 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week2; n=41, 38, 14, 13 | -1.5 Grams per liter | Standard Deviation 2.68 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week8; n=40, 39, 13, 13 | -1.7 Grams per liter | Standard Deviation 2 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week2; n=41, 38, 14, 13 | -2 Grams per liter | Standard Deviation 2.6 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week4; n=41, 39, 14, 13 | -3 Grams per liter | Standard Deviation 3.21 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week6; n=41, 38, 13, 13 | -3.5 Grams per liter | Standard Deviation 3.36 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week12; n=37, 35, 12, 13 | -3.3 Grams per liter | Standard Deviation 3.02 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week8; n=40, 39, 13, 13 | -3.7 Grams per liter | Standard Deviation 4.71 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week1; n=40, 39, 15, 13 | -1.1 Grams per liter | Standard Deviation 1.6 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week8; n=40, 39, 13, 13 | -1.5 Grams per liter | Standard Deviation 1.94 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week12; n=37, 35, 12, 13 | -1.6 Grams per liter | Standard Deviation 2.1 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week2; n=41, 38, 14, 13 | -0.2 Grams per liter | Standard Deviation 2.39 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week6; n=41, 38, 13, 13 | -2.1 Grams per liter | Standard Deviation 2.22 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week1; n=40, 39, 15, 13 | -1 Grams per liter | Standard Deviation 1.87 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12 | Albumin; Week4; n=41, 39, 14, 13 | -1.2 Grams per liter | Standard Deviation 1.46 |
Primary
Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week4; n=41, 39, 14, 13 | -24.5 International units per liter | Standard Deviation 52.93 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week6; n=41, 38, 13, 13 | -36 International units per liter | Standard Deviation 49.77 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week8; n=40, 39, 13, 13 | 6.9 International units per liter | Standard Deviation 15.59 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week6; n=41, 38, 13, 13 | -13.8 International units per liter | Standard Deviation 21.56 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week1; n=40, 39, 15, 13 | 0 International units per liter | Standard Deviation 7.73 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week4; n=41, 39, 14, 13 | -32.5 International units per liter | Standard Deviation 44.5 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week8; n=40, 39, 13, 13 | -32.1 International units per liter | Standard Deviation 70.41 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week8; n=40, 39, 13, 13 | -13.1 International units per liter | Standard Deviation 26.01 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week6; n=41, 38, 13, 13 | -28.1 International units per liter | Standard Deviation 67.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week8; n=40, 39, 13, 13 | -21.3 International units per liter | Standard Deviation 95.03 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week6; n=41, 38, 13, 13 | 9.1 International units per liter | Standard Deviation 13.73 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week12; n=37, 35, 12, 13 | -14.4 International units per liter | Standard Deviation 25.58 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week12; n=37, 35, 12, 13 | -38.9 International units per liter | Standard Deviation 59.7 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week12; n=37, 35, 12, 13 | -29.7 International units per liter | Standard Deviation 80.2 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week1; n=40, 39, 15, 13 | -12.3 International units per liter | Standard Deviation 16.28 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week1; n=40, 39, 15, 13 | 18.2 International units per liter | Standard Deviation 82.13 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week2; n=41, 38, 14, 13 | -11.7 International units per liter | Standard Deviation 33.78 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week8; n=40, 39, 13, 13 | -36.8 International units per liter | Standard Deviation 55.75 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week4; n=41, 39, 14, 13 | 8.6 International units per liter | Standard Deviation 11.12 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week2; n=41, 38, 14, 13 | -0.7 International units per liter | Standard Deviation 53.87 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week1; n=40, 39, 15, 13 | -26.8 International units per liter | Standard Deviation 31.64 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week12; n=37, 35, 12, 13 | 6.7 International units per liter | Standard Deviation 15.56 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week2; n=41, 38, 14, 13 | -10 International units per liter | Standard Deviation 20.84 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week4; n=41, 39, 14, 13 | 4.5 International units per liter | Standard Deviation 141.46 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week12; n=37, 35, 12, 13 | -36.3 International units per liter | Standard Deviation 75.56 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week2; n=41, 38, 14, 13 | 4.6 International units per liter | Standard Deviation 9.26 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week6; n=41, 38, 13, 13 | -26 International units per liter | Standard Deviation 63.11 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week2; n=41, 38, 14, 13 | -28.2 International units per liter | Standard Deviation 40.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week1; n=40, 39, 15, 13 | -3.7 International units per liter | Standard Deviation 20.79 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week4; n=41, 39, 14, 13 | -12.8 International units per liter | Standard Deviation 21.45 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week8; n=40, 39, 13, 13 | -33.2 International units per liter | Standard Deviation 65.96 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week12; n=37, 35, 12, 13 | -33.9 International units per liter | Standard Deviation 47.72 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week12; n=37, 35, 12, 13 | -20.7 International units per liter | Standard Deviation 73.43 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week1; n=40, 39, 15, 13 | -2 International units per liter | Standard Deviation 16.83 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week2; n=41, 38, 14, 13 | -17.1 International units per liter | Standard Deviation 45.23 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week12; n=37, 35, 12, 13 | -23.5 International units per liter | Standard Deviation 59.69 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week8; n=40, 39, 13, 13 | -27.2 International units per liter | Standard Deviation 80.33 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week4; n=41, 39, 14, 13 | -25.5 International units per liter | Standard Deviation 59.64 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week6; n=41, 38, 13, 13 | -30.5 International units per liter | Standard Deviation 72.27 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week12; n=37, 35, 12, 13 | 6.4 International units per liter | Standard Deviation 20.78 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week1; n=40, 39, 15, 13 | -15.2 International units per liter | Standard Deviation 21.55 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week4; n=41, 39, 14, 13 | -25.3 International units per liter | Standard Deviation 50.87 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week2; n=41, 38, 14, 13 | -11.6 International units per liter | Standard Deviation 26.3 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week8; n=40, 39, 13, 13 | 6.5 International units per liter | Standard Deviation 15.91 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week4; n=41, 39, 14, 13 | -10.6 International units per liter | Standard Deviation 27.4 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week6; n=41, 38, 13, 13 | -13.8 International units per liter | Standard Deviation 25.01 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week6; n=41, 38, 13, 13 | -30.3 International units per liter | Standard Deviation 50.74 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week6; n=41, 38, 13, 13 | 7.2 International units per liter | Standard Deviation 17.1 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week8; n=40, 39, 13, 13 | -7.6 International units per liter | Standard Deviation 38.38 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week12; n=37, 35, 12, 13 | -6.5 International units per liter | Standard Deviation 36.17 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week1; n=40, 39, 15, 13 | -24.4 International units per liter | Standard Deviation 32.39 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week4; n=41, 39, 14, 13 | 7.1 International units per liter | Standard Deviation 13.76 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week1; n=40, 39, 15, 13 | -10.9 International units per liter | Standard Deviation 103.31 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week2; n=41, 38, 14, 13 | -22.6 International units per liter | Standard Deviation 77.26 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week8; n=40, 39, 13, 13 | -25.4 International units per liter | Standard Deviation 55.92 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week2; n=41, 38, 14, 13 | 3.8 International units per liter | Standard Deviation 16.22 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week4; n=41, 39, 14, 13 | -32.1 International units per liter | Standard Deviation 59.61 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week6; n=41, 38, 13, 13 | 56.1 International units per liter | Standard Deviation 566.79 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week1; n=40, 39, 15, 13 | 1.5 International units per liter | Standard Deviation 10.21 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week2; n=41, 38, 14, 13 | -24.9 International units per liter | Standard Deviation 47.49 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week6; n=41, 38, 13, 13 | 16.6 International units per liter | Standard Deviation 31.03 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week4; n=41, 39, 14, 13 | -14.4 International units per liter | Standard Deviation 22.06 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week6; n=41, 38, 13, 13 | -21.5 International units per liter | Standard Deviation 48.49 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week2; n=41, 38, 14, 13 | -35.4 International units per liter | Standard Deviation 36.38 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week6; n=41, 38, 13, 13 | -40.8 International units per liter | Standard Deviation 41.51 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week8; n=40, 39, 13, 13 | -39.9 International units per liter | Standard Deviation 40.27 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week12; n=37, 35, 12, 13 | -43.7 International units per liter | Standard Deviation 40.45 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week1; n=40, 39, 15, 13 | -18.1 International units per liter | Standard Deviation 21.77 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week2; n=41, 38, 14, 13 | -18.4 International units per liter | Standard Deviation 23.52 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week4; n=41, 39, 14, 13 | -20.9 International units per liter | Standard Deviation 25.86 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week6; n=41, 38, 13, 13 | -21.6 International units per liter | Standard Deviation 28.43 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week8; n=40, 39, 13, 13 | -21.8 International units per liter | Standard Deviation 26.38 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week12; n=37, 35, 12, 13 | -25.7 International units per liter | Standard Deviation 27.32 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week1; n=40, 39, 15, 13 | -3.3 International units per liter | Standard Deviation 32.1 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week2; n=41, 38, 14, 13 | -9.6 International units per liter | Standard Deviation 36.26 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week8; n=40, 39, 13, 13 | -30.3 International units per liter | Standard Deviation 51.17 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week12; n=37, 35, 12, 13 | -20.9 International units per liter | Standard Deviation 59.82 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week1; n=40, 39, 15, 13 | -10.3 International units per liter | Standard Deviation 19.38 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week2; n=41, 38, 14, 13 | -19.9 International units per liter | Standard Deviation 29.59 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week4; n=41, 39, 14, 13 | -27.7 International units per liter | Standard Deviation 36.64 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week6; n=41, 38, 13, 13 | -30.5 International units per liter | Standard Deviation 44.3 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week8; n=40, 39, 13, 13 | -30.5 International units per liter | Standard Deviation 45.05 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week12; n=37, 35, 12, 13 | -33.6 International units per liter | Standard Deviation 49.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week1; n=40, 39, 15, 13 | 3.9 International units per liter | Standard Deviation 19.36 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week2; n=41, 38, 14, 13 | 9.4 International units per liter | Standard Deviation 21.15 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week4; n=41, 39, 14, 13 | 11.7 International units per liter | Standard Deviation 26.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week4; n=41, 39, 14, 13 | -40.4 International units per liter | Standard Deviation 38.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week8; n=40, 39, 13, 13 | 15.5 International units per liter | Standard Deviation 25.83 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week12; n=37, 35, 12, 13 | 11.7 International units per liter | Standard Deviation 25.09 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week1; n=40, 39, 15, 13 | -30.7 International units per liter | Standard Deviation 30.1 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week8; n=40, 39, 13, 13 | -66.8 International units per liter | Standard Deviation 107.3 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week6; n=41, 38, 13, 13 | -64.5 International units per liter | Standard Deviation 110.82 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week12; n=37, 35, 12, 13 | 7.3 International units per liter | Standard Deviation 18.33 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week1; n=40, 39, 15, 13 | -0.2 International units per liter | Standard Deviation 17.45 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week4; n=41, 39, 14, 13 | -47.7 International units per liter | Standard Deviation 59.52 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week2; n=41, 38, 14, 13 | -28.5 International units per liter | Standard Deviation 54.43 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week8; n=40, 39, 13, 13 | -39.5 International units per liter | Standard Deviation 29.92 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week2; n=41, 38, 14, 13 | 3.8 International units per liter | Standard Deviation 12.43 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week1; n=40, 39, 15, 13 | -43.5 International units per liter | Standard Deviation 82.73 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week12; n=37, 35, 12, 13 | -17.3 International units per liter | Standard Deviation 12.68 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week6; n=41, 38, 13, 13 | -38.4 International units per liter | Standard Deviation 29.11 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week4; n=41, 39, 14, 13 | 7.2 International units per liter | Standard Deviation 15.3 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week8; n=40, 39, 13, 13 | -18.6 International units per liter | Standard Deviation 12.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week6; n=41, 38, 13, 13 | -19.5 International units per liter | Standard Deviation 12.99 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week2; n=41, 38, 14, 13 | -26.8 International units per liter | Standard Deviation 24.25 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week6; n=41, 38, 13, 13 | 6.6 International units per liter | Standard Deviation 16.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week4; n=41, 39, 14, 13 | -15.8 International units per liter | Standard Deviation 11.92 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week2; n=41, 38, 14, 13 | -10.2 International units per liter | Standard Deviation 12.56 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week1; n=40, 39, 15, 13 | -25.6 International units per liter | Standard Deviation 20.74 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALP; Week8; n=40, 39, 13, 13 | 5.6 International units per liter | Standard Deviation 14.72 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | AST; Week1; n=40, 39, 15, 13 | -13.9 International units per liter | Standard Deviation 10.52 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week6; n=41, 38, 13, 13 | -23.8 International units per liter | Standard Deviation 39.91 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week4; n=41, 39, 14, 13 | -16.2 International units per liter | Standard Deviation 36.59 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week2; n=41, 38, 14, 13 | -7.2 International units per liter | Standard Deviation 29.11 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week12; n=37, 35, 12, 13 | -36.8 International units per liter | Standard Deviation 24.75 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week8; n=40, 39, 13, 13 | -28.5 International units per liter | Standard Deviation 45.5 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week1; n=40, 39, 15, 13 | -6.4 International units per liter | Standard Deviation 23.77 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | CK; Week12; n=37, 35, 12, 13 | -48.5 International units per liter | Standard Deviation 61.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | ALT; Week4; n=41, 39, 14, 13 | -33 International units per liter | Standard Deviation 28.79 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12 | GGT; Week12; n=37, 35, 12, 13 | -30 International units per liter | Standard Deviation 53.44 |
Primary
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week8; n=38, 39, 13, 13 | -0.229 Giga cells per liter | Standard Deviation 0.167 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week6; n=41, 37, 12, 12 | -0.117 Giga cells per liter | Standard Deviation 0.0929 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week2; n=40, 38, 14, 10 | -0.08 Giga cells per liter | Standard Deviation 0.1004 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week6; n=41, 37, 12, 12 | -0.182 Giga cells per liter | Standard Deviation 0.1664 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week8; n=38, 39, 13, 13 | -0.121 Giga cells per liter | Standard Deviation 0.0897 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week1; n=38, 38, 14, 11 | -2.83 Giga cells per liter | Standard Deviation 1.705 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week4; n=41, 38, 14, 13 | -0.151 Giga cells per liter | Standard Deviation 0.1771 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week2; n=40, 38, 14, 10 | -0.122 Giga cells per liter | Standard Deviation 0.227 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week12; n=37, 36, 12, 12 | -0.118 Giga cells per liter | Standard Deviation 0.0916 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week12; n=38, 34, 12, 12 | -73.4 Giga cells per liter | Standard Deviation 45.3 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week1; n=38, 38, 14, 11 | -0.103 Giga cells per liter | Standard Deviation 0.1418 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week12; n=37, 36, 12, 12 | -1.118 Giga cells per liter | Standard Deviation 0.5139 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week1; n=38, 38, 14, 11 | -0.319 Giga cells per liter | Standard Deviation 0.5006 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week8; n=39, 39, 13, 13 | -74.9 Giga cells per liter | Standard Deviation 42.31 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week8; n=38, 39, 13, 13 | -0.953 Giga cells per liter | Standard Deviation 0.4624 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week6; n=41, 37, 12, 12 | -0.963 Giga cells per liter | Standard Deviation 0.5313 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week6; n=41, 38, 12, 13 | -66.8 Giga cells per liter | Standard Deviation 50.43 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week2; n=40, 38, 14, 10 | -0.448 Giga cells per liter | Standard Deviation 0.5385 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week6; n=41, 37, 12, 12 | -0.015 Giga cells per liter | Standard Deviation 0.021 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week4; n=41, 38, 14, 13 | -0.787 Giga cells per liter | Standard Deviation 0.5055 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week12; n=37, 36, 12, 12 | -4.33 Giga cells per liter | Standard Deviation 2.149 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week1; n=38, 38, 14, 11 | -0.011 Giga cells per liter | Standard Deviation 0.0191 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week6; n=41, 37, 12, 12 | -3.78 Giga cells per liter | Standard Deviation 2.051 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week4; n=41, 38, 14, 13 | -54.4 Giga cells per liter | Standard Deviation 49.18 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week2; n=41, 38, 14, 11 | -58 Giga cells per liter | Standard Deviation 43.92 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week4; n=41, 38, 14, 13 | -0.017 Giga cells per liter | Standard Deviation 0.0184 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week1; n=38, 39, 14, 11 | -58.5 Giga cells per liter | Standard Deviation 36.23 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week4; n=41, 38, 14, 13 | -3.55 Giga cells per liter | Standard Deviation 2.183 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week12; n=37, 36, 12, 12 | -2.894 Giga cells per liter | Standard Deviation 1.8124 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week8; n=38, 39, 13, 13 | -2.706 Giga cells per liter | Standard Deviation 1.7553 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week8; n=38, 39, 13, 13 | -0.019 Giga cells per liter | Standard Deviation 0.0155 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week6; n=41, 37, 12, 12 | -2.51 Giga cells per liter | Standard Deviation 1.8144 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week12; n=37, 36, 12, 12 | -0.018 Giga cells per liter | Standard Deviation 0.0184 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week2; n=40, 38, 14, 10 | -2.77 Giga cells per liter | Standard Deviation 2.178 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week2; n=40, 38, 14, 10 | -0.014 Giga cells per liter | Standard Deviation 0.0175 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week4; n=41, 38, 14, 13 | -2.487 Giga cells per liter | Standard Deviation 1.9145 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week 2; n=40, 38, 14, 10 | -2.114 Giga cells per liter | Standard Deviation 1.9189 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week1; n=38, 38, 14, 11 | -0.051 Giga cells per liter | Standard Deviation 0.0874 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week1; n=38, 38, 14, 11 | -2.338 Giga cells per liter | Standard Deviation 1.4959 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week12; n=37, 36, 12, 12 | -0.185 Giga cells per liter | Standard Deviation 0.1715 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week4; n=41, 38, 14, 13 | -0.105 Giga cells per liter | Standard Deviation 0.0872 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week8; n=38, 39, 13, 13 | -4.03 Giga cells per liter | Standard Deviation 2.028 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week4; n=41, 38, 14, 13 | -2.333 Giga cells per liter | Standard Deviation 1.5497 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week6; n=41, 37, 12, 12 | -0.013 Giga cells per liter | Standard Deviation 0.0205 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week8; n=38, 39, 13, 13 | -0.016 Giga cells per liter | Standard Deviation 0.018 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week1; n=38, 38, 14, 11 | -0.075 Giga cells per liter | Standard Deviation 0.106 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week2; n=40, 38, 14, 10 | -0.603 Giga cells per liter | Standard Deviation 0.5921 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week4; n=41, 38, 14, 13 | -0.854 Giga cells per liter | Standard Deviation 0.5114 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week1; n=38, 38, 14, 11 | -0.011 Giga cells per liter | Standard Deviation 0.0193 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week2; n=40, 38, 14, 10 | -0.01 Giga cells per liter | Standard Deviation 0.0192 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week4; n=41, 38, 14, 13 | -0.012 Giga cells per liter | Standard Deviation 0.0187 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week12; n=37, 36, 12, 12 | -0.013 Giga cells per liter | Standard Deviation 0.0187 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week2; n=40, 38, 14, 10 | -0.111 Giga cells per liter | Standard Deviation 0.0912 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week4; n=41, 38, 14, 13 | -0.132 Giga cells per liter | Standard Deviation 0.1057 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week6; n=41, 37, 12, 12 | -0.134 Giga cells per liter | Standard Deviation 0.1182 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week8; n=38, 39, 13, 13 | -0.134 Giga cells per liter | Standard Deviation 0.1061 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week12; n=37, 36, 12, 12 | -0.112 Giga cells per liter | Standard Deviation 0.1594 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week1; n=38, 38, 14, 11 | -0.282 Giga cells per liter | Standard Deviation 0.5698 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week6; n=41, 37, 12, 12 | -1.043 Giga cells per liter | Standard Deviation 0.5928 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week8; n=38, 39, 13, 13 | -1.061 Giga cells per liter | Standard Deviation 0.6021 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week12; n=37, 36, 12, 12 | -1.074 Giga cells per liter | Standard Deviation 0.5883 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week1; n=38, 38, 14, 11 | -0.056 Giga cells per liter | Standard Deviation 0.145 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week2; n=40, 38, 14, 10 | -0.061 Giga cells per liter | Standard Deviation 0.1785 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week4; n=41, 38, 14, 13 | -0.129 Giga cells per liter | Standard Deviation 0.158 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week6; n=41, 37, 12, 12 | -0.171 Giga cells per liter | Standard Deviation 0.1326 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week8; n=38, 39, 13, 13 | -0.165 Giga cells per liter | Standard Deviation 0.1779 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week12; n=37, 36, 12, 12 | -0.183 Giga cells per liter | Standard Deviation 0.1438 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week1; n=38, 38, 14, 11 | -1.871 Giga cells per liter | Standard Deviation 1.5089 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week 2; n=40, 38, 14, 10 | -2.121 Giga cells per liter | Standard Deviation 1.6445 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week6; n=41, 37, 12, 12 | -2.247 Giga cells per liter | Standard Deviation 1.5132 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week8; n=38, 39, 13, 13 | -2.168 Giga cells per liter | Standard Deviation 1.6902 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week12; n=37, 36, 12, 12 | -2.188 Giga cells per liter | Standard Deviation 1.7297 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week1; n=38, 39, 14, 11 | -51.4 Giga cells per liter | Standard Deviation 36.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week2; n=41, 38, 14, 11 | -57.8 Giga cells per liter | Standard Deviation 44.02 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week4; n=41, 38, 14, 13 | -55.9 Giga cells per liter | Standard Deviation 47.19 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week6; n=41, 38, 12, 13 | -71.9 Giga cells per liter | Standard Deviation 38.6 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week8; n=39, 39, 13, 13 | -75.7 Giga cells per liter | Standard Deviation 45.82 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week12; n=38, 34, 12, 12 | -85.3 Giga cells per liter | Standard Deviation 40.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week1; n=38, 38, 14, 11 | -2.3 Giga cells per liter | Standard Deviation 1.872 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week2; n=40, 38, 14, 10 | -2.92 Giga cells per liter | Standard Deviation 1.81 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week4; n=41, 38, 14, 13 | -3.47 Giga cells per liter | Standard Deviation 1.712 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week6; n=41, 37, 12, 12 | -3.62 Giga cells per liter | Standard Deviation 1.682 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week8; n=38, 39, 13, 13 | -3.55 Giga cells per liter | Standard Deviation 1.896 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week12; n=37, 36, 12, 12 | -3.58 Giga cells per liter | Standard Deviation 1.934 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week1; n=38, 38, 14, 11 | -0.059 Giga cells per liter | Standard Deviation 0.0578 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week12; n=37, 36, 12, 12 | -0.011 Giga cells per liter | Standard Deviation 0.0124 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week6; n=41, 37, 12, 12 | -0.245 Giga cells per liter | Standard Deviation 0.1786 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week8; n=38, 39, 13, 13 | -0.185 Giga cells per liter | Standard Deviation 0.1344 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week2; n=40, 38, 14, 10 | -2.01 Giga cells per liter | Standard Deviation 1.869 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week12; n=37, 36, 12, 12 | -0.219 Giga cells per liter | Standard Deviation 0.1493 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week2; n=40, 38, 14, 10 | -0.059 Giga cells per liter | Standard Deviation 0.104 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week1; n=38, 38, 14, 11 | -1.158 Giga cells per liter | Standard Deviation 1.2688 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week 2; n=40, 38, 14, 10 | -1.186 Giga cells per liter | Standard Deviation 1.3343 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week4; n=41, 38, 14, 13 | -1.412 Giga cells per liter | Standard Deviation 1.5704 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week8; n=38, 39, 13, 13 | -0.009 Giga cells per liter | Standard Deviation 0.0132 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week2; n=40, 38, 14, 10 | -0.009 Giga cells per liter | Standard Deviation 0.0107 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week6; n=41, 37, 12, 12 | -1.413 Giga cells per liter | Standard Deviation 1.4303 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week4; n=41, 38, 14, 13 | -2.61 Giga cells per liter | Standard Deviation 2.055 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week8; n=38, 39, 13, 13 | -1.222 Giga cells per liter | Standard Deviation 1.3481 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week4; n=41, 38, 14, 13 | -0.01 Giga cells per liter | Standard Deviation 0.0118 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week12; n=37, 36, 12, 12 | -1.649 Giga cells per liter | Standard Deviation 0.8749 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week6; n=41, 37, 12, 12 | -0.013 Giga cells per liter | Standard Deviation 0.0114 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week1; n=38, 39, 14, 11 | -59.5 Giga cells per liter | Standard Deviation 36.29 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week2; n=41, 38, 14, 11 | -41.4 Giga cells per liter | Standard Deviation 37.44 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week1; n=38, 38, 14, 11 | -0.012 Giga cells per liter | Standard Deviation 0.0105 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week6; n=41, 37, 12, 12 | -3.09 Giga cells per liter | Standard Deviation 1.69 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week4; n=41, 38, 14, 13 | -56.2 Giga cells per liter | Standard Deviation 50.99 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week6; n=41, 38, 12, 13 | -71.3 Giga cells per liter | Standard Deviation 47.07 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week1; n=38, 38, 14, 11 | -0.608 Giga cells per liter | Standard Deviation 0.5466 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week8; n=39, 39, 13, 13 | -60.1 Giga cells per liter | Standard Deviation 43.26 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week6; n=41, 37, 12, 12 | -0.113 Giga cells per liter | Standard Deviation 0.0607 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week12; n=37, 36, 12, 12 | -3.42 Giga cells per liter | Standard Deviation 1.104 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week4; n=41, 38, 14, 13 | -0.989 Giga cells per liter | Standard Deviation 0.5293 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week12; n=38, 34, 12, 12 | -58.8 Giga cells per liter | Standard Deviation 58.77 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week6; n=41, 37, 12, 12 | -1.334 Giga cells per liter | Standard Deviation 0.4906 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week2; n=40, 38, 14, 10 | -0.675 Giga cells per liter | Standard Deviation 0.5639 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week8; n=38, 39, 13, 13 | -1.256 Giga cells per liter | Standard Deviation 0.3509 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week4; n=41, 38, 14, 13 | -0.079 Giga cells per liter | Standard Deviation 0.1089 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week12; n=37, 36, 12, 12 | -1.438 Giga cells per liter | Standard Deviation 0.4773 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week12; n=37, 36, 12, 12 | -0.106 Giga cells per liter | Standard Deviation 0.1152 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week8; n=38, 39, 13, 13 | -2.8 Giga cells per liter | Standard Deviation 1.477 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week1; n=38, 38, 14, 11 | 0.034 Giga cells per liter | Standard Deviation 0.1502 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week1; n=38, 38, 14, 11 | -1.81 Giga cells per liter | Standard Deviation 1.516 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week2; n=40, 38, 14, 10 | -0.091 Giga cells per liter | Standard Deviation 0.1562 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week8; n=38, 39, 13, 13 | -0.13 Giga cells per liter | Standard Deviation 0.0965 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week4; n=41, 38, 14, 13 | -0.126 Giga cells per liter | Standard Deviation 0.1471 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week12; n=37, 36, 12, 12 | -1.048 Giga cells per liter | Standard Deviation 0.6612 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week2; n=41, 38, 14, 11 | -34.4 Giga cells per liter | Standard Deviation 41.74 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week4; n=41, 38, 14, 13 | -0.055 Giga cells per liter | Standard Deviation 0.2103 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week6; n=41, 37, 12, 12 | -0.135 Giga cells per liter | Standard Deviation 0.1088 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week4; n=41, 38, 14, 13 | -0.108 Giga cells per liter | Standard Deviation 0.0923 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week8; n=38, 39, 13, 13 | -2.8 Giga cells per liter | Standard Deviation 1.04 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week6; n=41, 37, 12, 12 | -0.93 Giga cells per liter | Standard Deviation 0.4955 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week8; n=38, 39, 13, 13 | -0.124 Giga cells per liter | Standard Deviation 0.2164 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week2; n=40, 38, 14, 10 | -0.114 Giga cells per liter | Standard Deviation 0.1247 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week1; n=38, 38, 14, 11 | -1.87 Giga cells per liter | Standard Deviation 0.508 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week4; n=41, 38, 14, 13 | -33.8 Giga cells per liter | Standard Deviation 61.79 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week12; n=37, 36, 12, 12 | -0.133 Giga cells per liter | Standard Deviation 0.2048 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week1; n=38, 38, 14, 11 | -0.371 Giga cells per liter | Standard Deviation 0.4332 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week2; n=40, 38, 14, 10 | -2.17 Giga cells per liter | Standard Deviation 0.886 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week6; n=41, 37, 12, 12 | -2.85 Giga cells per liter | Standard Deviation 0.923 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week1; n=38, 38, 14, 11 | -1.378 Giga cells per liter | Standard Deviation 0.598 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week1; n=38, 38, 14, 11 | -0.085 Giga cells per liter | Standard Deviation 0.1052 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week8; n=38, 39, 13, 13 | -0.012 Giga cells per liter | Standard Deviation 0.0142 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week12; n=38, 34, 12, 12 | -53 Giga cells per liter | Standard Deviation 39.49 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week 2; n=40, 38, 14, 10 | -1.468 Giga cells per liter | Standard Deviation 0.584 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week6; n=41, 37, 12, 12 | -0.109 Giga cells per liter | Standard Deviation 0.1208 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week12; n=37, 36, 12, 12 | -0.012 Giga cells per liter | Standard Deviation 0.0153 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week6; n=41, 38, 12, 13 | -46 Giga cells per liter | Standard Deviation 46.05 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week4; n=41, 38, 14, 13 | -1.603 Giga cells per liter | Standard Deviation 0.5953 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week2; n=40, 38, 14, 10 | -0.034 Giga cells per liter | Standard Deviation 0.1687 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week4; n=41, 38, 14, 13 | -0.015 Giga cells per liter | Standard Deviation 0.0113 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week8; n=38, 39, 13, 13 | -0.964 Giga cells per liter | Standard Deviation 0.5098 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week6; n=41, 37, 12, 12 | -1.683 Giga cells per liter | Standard Deviation 0.661 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week6; n=41, 37, 12, 12 | -0.013 Giga cells per liter | Standard Deviation 0.0106 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week8; n=39, 39, 13, 13 | -52.6 Giga cells per liter | Standard Deviation 43.54 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week12; n=37, 36, 12, 12 | -0.102 Giga cells per liter | Standard Deviation 0.1428 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week8; n=38, 39, 13, 13 | -1.613 Giga cells per liter | Standard Deviation 0.6882 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Monocytes; Week1; n=38, 38, 14, 11 | -0.025 Giga cells per liter | Standard Deviation 0.0808 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week4; n=41, 38, 14, 13 | -2.55 Giga cells per liter | Standard Deviation 0.919 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Eosinophils; Week8; n=38, 39, 13, 13 | -0.104 Giga cells per liter | Standard Deviation 0.0916 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Total Neutrophils; Week12; n=37, 36, 12, 12 | -1.483 Giga cells per liter | Standard Deviation 0.5873 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week2; n=40, 38, 14, 10 | -0.009 Giga cells per liter | Standard Deviation 0.0179 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week4; n=41, 38, 14, 13 | -0.773 Giga cells per liter | Standard Deviation 0.4104 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Lymphocytes; Week2; n=40, 38, 14, 10 | -0.553 Giga cells per liter | Standard Deviation 0.4346 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Platelet Count; Week1; n=38, 39, 14, 11 | -33.1 Giga cells per liter | Standard Deviation 33.32 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | Basophils; Week1; n=38, 38, 14, 11 | -0.013 Giga cells per liter | Standard Deviation 0.0119 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12 | White Blood Cell count; Week12; n=37, 36, 12, 12 | -2.77 Giga cells per liter | Standard Deviation 0.963 |
Primary
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week8; n=40, 39, 13, 13 | -0.7 Millimoles per liter | Standard Deviation 2.41 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week4; n=41, 39, 14, 13 | 1.7 Millimoles per liter | Standard Deviation 2.31 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week8; n=40, 39, 13, 13 | -0.11 Millimoles per liter | Standard Deviation 0.49 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week6; n=41, 38, 13, 13 | -0.15 Millimoles per liter | Standard Deviation 0.483 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week12; n=37, 35, 12, 13 | -0.6 Millimoles per liter | Standard Deviation 2.42 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week1; n=40, 39, 15, 13 | -0.37 Millimoles per liter | Standard Deviation 1.485 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week4; n=41, 39, 14, 13 | -0.16 Millimoles per liter | Standard Deviation 0.411 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week2; n=41, 38, 14, 13 | -0.1 Millimoles per liter | Standard Deviation 0.428 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week1; n=40, 39, 15, 13 | -0.02 Millimoles per liter | Standard Deviation 0.392 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week12; n=38, 35, 12, 13 | -0.3 Millimoles per liter | Standard Deviation 1.877 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week2; n=41, 38, 14, 13 | -0.22 Millimoles per liter | Standard Deviation 1.467 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week2; n=41, 38, 14, 13 | 0.2 Millimoles per liter | Standard Deviation 1.012 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week8; n=40, 39, 13, 13 | -0.05 Millimoles per liter | Standard Deviation 1.165 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week6; n=41, 38, 13, 13 | -0.15 Millimoles per liter | Standard Deviation 1.315 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week4; n=41, 39, 14, 13 | -0.03 Millimoles per liter | Standard Deviation 1.162 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week1; n=40, 39, 15, 13 | 0.24 Millimoles per liter | Standard Deviation 0.996 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week6; n=41, 38, 13, 13 | 1.6 Millimoles per liter | Standard Deviation 2.62 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week12; n=37, 35, 12, 13 | -0.08 Millimoles per liter | Standard Deviation 1.164 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week12; n=37,35,12,13 | -0.172 Millimoles per liter | Standard Deviation 0.1708 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week8; n=40,39,13,13 | -0.169 Millimoles per liter | Standard Deviation 0.2025 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week8; n=40, 39, 13, 13 | 2 Millimoles per liter | Standard Deviation 3.49 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week8; n=40, 39, 13, 13 | -0.16 Millimoles per liter | Standard Deviation 1.088 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week6; n=41,38,13,13 | -0.171 Millimoles per liter | Standard Deviation 0.1939 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week4; n=41,39,14,13 | -0.151 Millimoles per liter | Standard Deviation 0.1666 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week12; n=37, 35, 12, 13 | 1.5 Millimoles per liter | Standard Deviation 2.36 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week2; n=41, 38, 14, 13 | 0.7 Millimoles per liter | Standard Deviation 2.37 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week2; n=41,38,14,13 | -0.141 Millimoles per liter | Standard Deviation 0.181 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week1; n=40, 39, 15, 13 | -0.13 Millimoles per liter | Standard Deviation 0.1599 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week1; n=40, 39, 15, 13 | 0 Millimoles per liter | Standard Deviation 3.05 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week1; n=40, 39, 15, 13 | 0.5 Millimoles per liter | Standard Deviation 2.1 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week12; n=37, 35, 12, 13 | 0.1 Millimoles per liter | Standard Deviation 1.91 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week8; n=40, 39, 13, 13 | 0.3 Millimoles per liter | Standard Deviation 3.28 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week2; n=41, 38, 14, 13 | -0.3 Millimoles per liter | Standard Deviation 2.2 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week6; n=41, 38, 13, 13 | -0.04 Millimoles per liter | Standard Deviation 1.09 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week6; n=41, 38, 13, 13 | 0.2 Millimoles per liter | Standard Deviation 2.39 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week4; n=41, 39, 14, 13 | -0.9 Millimoles per liter | Standard Deviation 1.91 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week4; n=41, 39, 14, 13 | 0.03 Millimoles per liter | Standard Deviation 1.145 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week4; n=41, 39, 14, 13 | 0.1 Millimoles per liter | Standard Deviation 2.16 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week2; n=41, 38, 14, 13 | -0.1 Millimoles per liter | Standard Deviation 2.15 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week6; n=41, 38, 13, 13 | -0.4 Millimoles per liter | Standard Deviation 2 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week1; n=40, 39, 15, 13 | -0.4 Millimoles per liter | Standard Deviation 1.85 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week12; n=37, 35, 12, 13 | -0.15 Millimoles per liter | Standard Deviation 0.394 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week4; n=41, 39, 14, 13 | -0.1 Millimoles per liter | Standard Deviation 2.2 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week6; n=41, 38, 13, 13 | -0.7 Millimoles per liter | Standard Deviation 2.23 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week1; n=40, 39, 15, 13 | -0.34 Millimoles per liter | Standard Deviation 0.761 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week1; n=40, 39, 15, 13 | -0.4 Millimoles per liter | Standard Deviation 2.03 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week2; n=41, 38, 14, 13 | 0.1 Millimoles per liter | Standard Deviation 1.9 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week4; n=41, 39, 14, 13 | 1 Millimoles per liter | Standard Deviation 2.46 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week6; n=41, 38, 13, 13 | 0.8 Millimoles per liter | Standard Deviation 2.57 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week8; n=40, 39, 13, 13 | 0.7 Millimoles per liter | Standard Deviation 2.36 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week12; n=37, 35, 12, 13 | 0.1 Millimoles per liter | Standard Deviation 3.35 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week1; n=40, 39, 15, 13 | -0.9 Millimoles per liter | Standard Deviation 2.57 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week2; n=41, 38, 14, 13 | -0.8 Millimoles per liter | Standard Deviation 3.1 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week4; n=41, 39, 14, 13 | -0.8 Millimoles per liter | Standard Deviation 2.55 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week8; n=40, 39, 13, 13 | -0.8 Millimoles per liter | Standard Deviation 2.35 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week12; n=37, 35, 12, 13 | -0.9 Millimoles per liter | Standard Deviation 2.37 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week2; n=41, 38, 14, 13 | -0.17 Millimoles per liter | Standard Deviation 0.791 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week4; n=41, 39, 14, 13 | 0.02 Millimoles per liter | Standard Deviation 1.054 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week6; n=41, 38, 13, 13 | -0.18 Millimoles per liter | Standard Deviation 1.154 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week8; n=40, 39, 13, 13 | -0.06 Millimoles per liter | Standard Deviation 0.835 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week12; n=38, 35, 12, 13 | -0.39 Millimoles per liter | Standard Deviation 1.047 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week1; n=40, 39, 15, 13 | -0.06 Millimoles per liter | Standard Deviation 0.339 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week2; n=41, 38, 14, 13 | -0.12 Millimoles per liter | Standard Deviation 0.453 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week4; n=41, 39, 14, 13 | -0.11 Millimoles per liter | Standard Deviation 0.455 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week6; n=41, 38, 13, 13 | -0.16 Millimoles per liter | Standard Deviation 0.387 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week8; n=40, 39, 13, 13 | -0.19 Millimoles per liter | Standard Deviation 0.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week12; n=37, 35, 12, 13 | -0.21 Millimoles per liter | Standard Deviation 0.362 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week1; n=40, 39, 15, 13 | -0.8 Millimoles per liter | Standard Deviation 1.76 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week2; n=41, 38, 14, 13 | -0.6 Millimoles per liter | Standard Deviation 1.81 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week6; n=41, 38, 13, 13 | -0.3 Millimoles per liter | Standard Deviation 2.39 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week8; n=40, 39, 13, 13 | -0.6 Millimoles per liter | Standard Deviation 2.24 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week12; n=37, 35, 12, 13 | -0.3 Millimoles per liter | Standard Deviation 2.36 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week1; n=40, 39, 15, 13 | -0.086 Millimoles per liter | Standard Deviation 0.1415 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week2; n=41,38,14,13 | -0.108 Millimoles per liter | Standard Deviation 0.1754 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week4; n=41,39,14,13 | -0.125 Millimoles per liter | Standard Deviation 0.1421 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week6; n=41,38,13,13 | -0.181 Millimoles per liter | Standard Deviation 0.1823 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week8; n=40,39,13,13 | -0.23 Millimoles per liter | Standard Deviation 0.1937 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week12; n=37,35,12,13 | -0.168 Millimoles per liter | Standard Deviation 0.2047 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week1; n=40, 39, 15, 13 | 0.04 Millimoles per liter | Standard Deviation 1.002 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week2; n=41, 38, 14, 13 | -0.13 Millimoles per liter | Standard Deviation 1.05 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week4; n=41, 39, 14, 13 | -0.4 Millimoles per liter | Standard Deviation 1.047 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week6; n=41, 38, 13, 13 | -0.29 Millimoles per liter | Standard Deviation 1.13 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week8; n=40, 39, 13, 13 | -0.46 Millimoles per liter | Standard Deviation 1.337 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week12; n=37, 35, 12, 13 | -0.31 Millimoles per liter | Standard Deviation 1.276 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week4; n=41, 39, 14, 13 | -1.4 Millimoles per liter | Standard Deviation 1.86 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week4; n=41, 39, 14, 13 | 1.6 Millimoles per liter | Standard Deviation 2.21 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week6; n=41, 38, 13, 13 | -0.45 Millimoles per liter | Standard Deviation 0.355 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week8; n=40, 39, 13, 13 | -1.2 Millimoles per liter | Standard Deviation 2.19 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week8; n=40, 39, 13, 13 | -0.51 Millimoles per liter | Standard Deviation 0.348 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week2; n=41, 38, 14, 13 | 0.08 Millimoles per liter | Standard Deviation 1.309 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week12; n=37, 35, 12, 13 | -0.38 Millimoles per liter | Standard Deviation 0.447 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week6; n=41, 38, 13, 13 | -1.5 Millimoles per liter | Standard Deviation 2.18 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week1; n=40, 39, 15, 13 | -0.2 Millimoles per liter | Standard Deviation 2.46 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week2; n=41, 38, 14, 13 | 0 Millimoles per liter | Standard Deviation 1.8 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week4; n=41, 39, 14, 13 | 0.4 Millimoles per liter | Standard Deviation 1.78 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week2; n=41, 38, 14, 13 | -1.5 Millimoles per liter | Standard Deviation 2.98 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week1; n=40, 39, 15, 13 | 0.6 Millimoles per liter | Standard Deviation 2.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week6; n=41, 38, 13, 13 | 0.2 Millimoles per liter | Standard Deviation 2.91 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week4; n=41, 39, 14, 13 | 0.11 Millimoles per liter | Standard Deviation 1.436 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week8; n=40, 39, 13, 13 | 1.1 Millimoles per liter | Standard Deviation 2.18 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week1; n=40, 39, 15, 13 | -1.2 Millimoles per liter | Standard Deviation 2.54 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week12; n=37, 35, 12, 13 | 0.8 Millimoles per liter | Standard Deviation 2.66 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week2; n=41, 38, 14, 13 | 0.5 Millimoles per liter | Standard Deviation 1.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week1; n=40, 39, 15, 13 | -0.122 Millimoles per liter | Standard Deviation 0.1353 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week12; n=37, 35, 12, 13 | 1.9 Millimoles per liter | Standard Deviation 2.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week2; n=41,38,14,13 | -0.081 Millimoles per liter | Standard Deviation 0.1194 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week6; n=41, 38, 13, 13 | -0.39 Millimoles per liter | Standard Deviation 0.883 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week4; n=41,39,14,13 | -0.077 Millimoles per liter | Standard Deviation 0.1669 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week8; n=40, 39, 13, 13 | 2.2 Millimoles per liter | Standard Deviation 3 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week6; n=41,38,13,13 | -0.121 Millimoles per liter | Standard Deviation 0.1549 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week8; n=40,39,13,13 | -0.112 Millimoles per liter | Standard Deviation 0.1563 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week6; n=41, 38, 13, 13 | 0.8 Millimoles per liter | Standard Deviation 2.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week12; n=37, 35, 12, 13 | -0.11 Millimoles per liter | Standard Deviation 1.272 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week4; n=41, 39, 14, 13 | -0.11 Millimoles per liter | Standard Deviation 0.601 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week12; n=37,35,12,13 | -0.117 Millimoles per liter | Standard Deviation 0.1123 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week6; n=41, 38, 13, 13 | 0.18 Millimoles per liter | Standard Deviation 0.772 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week2; n=41, 38, 14, 13 | 0.11 Millimoles per liter | Standard Deviation 0.52 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week8; n=40, 39, 13, 13 | 0.04 Millimoles per liter | Standard Deviation 0.675 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week12; n=38, 35, 12, 13 | -0.23 Millimoles per liter | Standard Deviation 0.757 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week1; n=40, 39, 15, 13 | -0.03 Millimoles per liter | Standard Deviation 0.616 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week8; n=40, 39, 13, 13 | -0.07 Millimoles per liter | Standard Deviation 1.206 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week1; n=40, 39, 15, 13 | -0.11 Millimoles per liter | Standard Deviation 0.376 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week1; n=40, 39, 15, 13 | 0.19 Millimoles per liter | Standard Deviation 1.287 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week2; n=41, 38, 14, 13 | -0.39 Millimoles per liter | Standard Deviation 0.417 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week12; n=37, 35, 12, 13 | -1.1 Millimoles per liter | Standard Deviation 2.23 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week4; n=41, 39, 14, 13 | -0.34 Millimoles per liter | Standard Deviation 0.497 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week6; n=41, 38, 13, 13 | -0.55 Millimoles per liter | Standard Deviation 0.755 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week2; n=41,38,14,13 | -0.105 Millimoles per liter | Standard Deviation 0.1159 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week8; n=40, 39, 13, 13 | -0.8 Millimoles per liter | Standard Deviation 2.77 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week6; n=41, 38, 13, 13 | -0.21 Millimoles per liter | Standard Deviation 0.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week2; n=41, 38, 14, 13 | -0.02 Millimoles per liter | Standard Deviation 0.316 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week8; n=40, 39, 13, 13 | -0.85 Millimoles per liter | Standard Deviation 1.067 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week12; n=37,35,12,13 | -0.136 Millimoles per liter | Standard Deviation 0.1943 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week8; n=40, 39, 13, 13 | -0.14 Millimoles per liter | Standard Deviation 0.348 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week6; n=41, 38, 13, 13 | 0.6 Millimoles per liter | Standard Deviation 2.6 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week4; n=41,39,14,13 | -0.078 Millimoles per liter | Standard Deviation 0.1871 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week1; n=40, 39, 15, 13 | -0.02 Millimoles per liter | Standard Deviation 0.313 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week12; n=37, 35, 12, 13 | -0.1 Millimoles per liter | Standard Deviation 0.428 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week6; n=41, 38, 13, 13 | -1.02 Millimoles per liter | Standard Deviation 0.667 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week2; n=41, 38, 14, 13 | -0.12 Millimoles per liter | Standard Deviation 1.244 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week8; n=40, 39, 13, 13 | -0.36 Millimoles per liter | Standard Deviation 1.191 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week1; n=40, 39, 15, 13 | -0.8 Millimoles per liter | Standard Deviation 2.08 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week4; n=41, 39, 14, 13 | -0.5 Millimoles per liter | Standard Deviation 2.67 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week2; n=41, 38, 14, 13 | -0.7 Millimoles per liter | Standard Deviation 2.21 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week6; n=41,38,13,13 | -0.159 Millimoles per liter | Standard Deviation 0.121 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week2; n=41, 38, 14, 13 | -1.3 Millimoles per liter | Standard Deviation 2.25 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week8; n=40, 39, 13, 13 | 0 Millimoles per liter | Standard Deviation 2.2 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week2; n=41, 38, 14, 13 | -0.2 Millimoles per liter | Standard Deviation 3.65 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week6; n=41, 38, 13, 13 | -0.1 Millimoles per liter | Standard Deviation 1.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week4; n=41, 39, 14, 13 | -0.8 Millimoles per liter | Standard Deviation 1.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week1; n=40, 39, 15, 13 | -0.2 Millimoles per liter | Standard Deviation 1.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week1; n=40, 39, 15, 13 | 0.36 Millimoles per liter | Standard Deviation 1.619 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week8; n=40,39,13,13 | -0.14 Millimoles per liter | Standard Deviation 0.167 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week6; n=41, 38, 13, 13 | 0 Millimoles per liter | Standard Deviation 2 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week1; n=40, 39, 15, 13 | -0.7 Millimoles per liter | Standard Deviation 2.56 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week4; n=41, 39, 14, 13 | 0.1 Millimoles per liter | Standard Deviation 2.5 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Bicarbonate; Week12; n=37, 35, 12, 13 | -0.5 Millimoles per liter | Standard Deviation 2.76 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week8; n=40, 39, 13, 13 | -0.6 Millimoles per liter | Standard Deviation 2.22 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week12; n=38, 35, 12, 13 | -0.45 Millimoles per liter | Standard Deviation 1.063 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week4; n=41, 39, 14, 13 | -0.88 Millimoles per liter | Standard Deviation 1.137 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week4; n=41, 39, 14, 13 | -0.48 Millimoles per liter | Standard Deviation 0.832 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Sodium; Week12; n=37, 35, 12, 13 | 0.5 Millimoles per liter | Standard Deviation 2.18 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Chloride; Week12; n=37, 35, 12, 13 | 1.2 Millimoles per liter | Standard Deviation 2.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Glucose; Week2; n=41, 38, 14, 13 | 0.13 Millimoles per liter | Standard Deviation 1.765 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Potassium; Week4; n=41, 39, 14, 13 | -0.05 Millimoles per liter | Standard Deviation 0.499 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Inorganic Phosphorus; Week1; n=40, 39, 15, 13 | -0.087 Millimoles per liter | Standard Deviation 0.1489 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week1; n=40, 39, 15, 13 | -0.01 Millimoles per liter | Standard Deviation 1.188 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12 | Urea/BUN; Week12; n=37, 35, 12, 13 | -0.64 Millimoles per liter | Standard Deviation 1.81 |
Primary
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week8; n=40, 39,13,13 | 1.9 Milliliter per minute (mL/min) | Standard Deviation 10.49 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week2; n=41, 38,14,13 | 3.3 Milliliter per minute (mL/min) | Standard Deviation 13.48 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week12; n=38,35,12,13 | -0.2 Milliliter per minute (mL/min) | Standard Deviation 15.06 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week6; n=41, 38,13,13 | 2.7 Milliliter per minute (mL/min) | Standard Deviation 11.93 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week4; n=41, 39,14,13 | 5 Milliliter per minute (mL/min) | Standard Deviation 12.45 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week1; n=40, 39, 15, 13 | 1.5 Milliliter per minute (mL/min) | Standard Deviation 9.79 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week12; n=38,35,12,13 | 2.2 Milliliter per minute (mL/min) | Standard Deviation 17.27 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week1; n=40, 39, 15, 13 | -2.1 Milliliter per minute (mL/min) | Standard Deviation 19.51 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week2; n=41, 38,14,13 | 4.7 Milliliter per minute (mL/min) | Standard Deviation 11.33 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week4; n=41, 39,14,13 | 1.9 Milliliter per minute (mL/min) | Standard Deviation 14.72 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week6; n=41, 38,13,13 | -0.7 Milliliter per minute (mL/min) | Standard Deviation 16.25 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week8; n=40, 39,13,13 | 3.4 Milliliter per minute (mL/min) | Standard Deviation 19.94 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week2; n=41, 38,14,13 | -9 Milliliter per minute (mL/min) | Standard Deviation 12.55 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week4; n=41, 39,14,13 | -9.1 Milliliter per minute (mL/min) | Standard Deviation 13.42 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week12; n=38,35,12,13 | -14.3 Milliliter per minute (mL/min) | Standard Deviation 16.99 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week6; n=41, 38,13,13 | -19.1 Milliliter per minute (mL/min) | Standard Deviation 20.54 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week1; n=40, 39, 15, 13 | -9.5 Milliliter per minute (mL/min) | Standard Deviation 10.09 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week8; n=40, 39,13,13 | -17.8 Milliliter per minute (mL/min) | Standard Deviation 16.1 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week2; n=41, 38,14,13 | -1.8 Milliliter per minute (mL/min) | Standard Deviation 15.27 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week8; n=40, 39,13,13 | -3 Milliliter per minute (mL/min) | Standard Deviation 14.54 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week6; n=41, 38,13,13 | 1.5 Milliliter per minute (mL/min) | Standard Deviation 13.12 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week4; n=41, 39,14,13 | 4.5 Milliliter per minute (mL/min) | Standard Deviation 16.19 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week12; n=38,35,12,13 | 1.2 Milliliter per minute (mL/min) | Standard Deviation 20.49 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12 | Creatinine Clearance; Week1; n=40, 39, 15, 13 | 5.7 Milliliter per minute (mL/min) | Standard Deviation 10.18 |
Primary
Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week8; n=40, 39, 13, 13 | 1.4 Micromoles per liter | Standard Deviation 4.63 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week2; n=41, 38, 14, 13 | 5.8 Micromoles per liter | Standard Deviation 6.62 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week4; n=41, 39, 14, 13 | 2.2 Micromoles per liter | Standard Deviation 5.03 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week6; n=41, 38, 13, 13 | 1.5 Micromoles per liter | Standard Deviation 4.14 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week1; n=40, 39, 15, 13 | 6.9 Micromoles per liter | Standard Deviation 8.74 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week12; n=37, 35, 12, 13 | 0.4 Micromoles per liter | Standard Deviation 4.46 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week1; n=1, 1, 1, 1 | 0 Micromoles per liter | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week2; n=1, 1, 1, 1 | 0 Micromoles per liter | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week4; n=1, 1, 0, 0 | 0 Micromoles per liter | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week6; n=1, 1, 0, 0 | 0 Micromoles per liter | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week1; n=40, 39, 15, 13 | -1.41 Micromoles per liter | Standard Deviation 5.983 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week2; n=41, 38, 14, 13 | -2.47 Micromoles per liter | Standard Deviation 7.966 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week4; n=41, 39, 14, 13 | -3.4 Micromoles per liter | Standard Deviation 5.894 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week6; n=41, 38, 13, 13 | -2.15 Micromoles per liter | Standard Deviation 6.18 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week8; n=40, 39, 13, 13 | -1.88 Micromoles per liter | Standard Deviation 5.724 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week12; n=38, 35, 12, 13 | -1.49 Micromoles per liter | Standard Deviation 8.411 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week12; n=37, 35, 12, 13 | 1.4 Micromoles per liter | Standard Deviation 5.61 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week4; n=1, 1, 0, 0 | 2 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week12; n=38, 35, 12, 13 | -1.99 Micromoles per liter | Standard Deviation 8.704 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week2; n=41, 38, 14, 13 | -2.78 Micromoles per liter | Standard Deviation 5.725 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week8; n=40, 39, 13, 13 | -0.51 Micromoles per liter | Standard Deviation 5.425 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week6; n=1, 1, 0, 0 | 0 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week4; n=41, 39, 14, 13 | 2.9 Micromoles per liter | Standard Deviation 3.52 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week1; n=40, 39, 15, 13 | 0.23 Micromoles per liter | Standard Deviation 5.446 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week8; n=40, 39, 13, 13 | 2.3 Micromoles per liter | Standard Deviation 4.93 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week1; n=1, 1, 1, 1 | 2 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week6; n=41, 38, 13, 13 | 2.7 Micromoles per liter | Standard Deviation 3.97 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week2; n=41, 38, 14, 13 | 5.5 Micromoles per liter | Standard Deviation 6.84 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week4; n=41, 39, 14, 13 | -1.33 Micromoles per liter | Standard Deviation 6.403 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week2; n=1, 1, 1, 1 | 0 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week6; n=41, 38, 13, 13 | -0.34 Micromoles per liter | Standard Deviation 7.667 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week1; n=40, 39, 15, 13 | 6.7 Micromoles per liter | Standard Deviation 8.93 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week12; n=37, 35, 12, 13 | -2.8 Micromoles per liter | Standard Deviation 10.04 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week8; n=40, 39, 13, 13 | -0.3 Micromoles per liter | Standard Deviation 9.83 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week6; n=41, 38, 13, 13 | 7.1 Micromoles per liter | Standard Deviation 7.905 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week1; n=1, 1, 1, 1 | -8 Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week2; n=1, 1, 1, 1 | -14 Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week12; n=38, 35, 12, 13 | 6.85 Micromoles per liter | Standard Deviation 10.363 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week4; n=1, 1, 0, 0 | NA Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week6; n=1, 1, 0, 0 | NA Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week8; n=40, 39, 13, 13 | 9.43 Micromoles per liter | Standard Deviation 10.839 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week1; n=40, 39, 15, 13 | 5.12 Micromoles per liter | Standard Deviation 7.883 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week2; n=41, 38, 14, 13 | 4.13 Micromoles per liter | Standard Deviation 6.518 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week1; n=40, 39, 15, 13 | 8.1 Micromoles per liter | Standard Deviation 11.81 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week2; n=41, 38, 14, 13 | 5.6 Micromoles per liter | Standard Deviation 9.8 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week4; n=41, 39, 14, 13 | 5.35 Micromoles per liter | Standard Deviation 10.16 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week4; n=41, 39, 14, 13 | 0.7 Micromoles per liter | Standard Deviation 8.94 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week6; n=41, 38, 13, 13 | -0.5 Micromoles per liter | Standard Deviation 9.09 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week12; n=38, 35, 12, 13 | -2.41 Micromoles per liter | Standard Deviation 12.239 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week2; n=1, 1, 1, 1 | 1 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week4; n=41, 39, 14, 13 | 2.5 Micromoles per liter | Standard Deviation 5.97 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week1; n=40, 39, 15, 13 | 4.2 Micromoles per liter | Standard Deviation 8.36 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week6; n=41, 38, 13, 13 | -2.05 Micromoles per liter | Standard Deviation 9.365 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week1; n=1, 1, 1, 1 | -1 Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week4; n=41, 39, 14, 13 | -3.57 Micromoles per liter | Standard Deviation 9.599 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week2; n=41, 38, 14, 13 | 6.5 Micromoles per liter | Standard Deviation 9.34 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week8; n=40, 39, 13, 13 | 1.8 Micromoles per liter | Standard Deviation 6.39 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week6; n=1, 1, 0, 0 | NA Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week12; n=37, 35, 12, 13 | 1.2 Micromoles per liter | Standard Deviation 5.31 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week1; n=40, 39, 15, 13 | -3.85 Micromoles per liter | Standard Deviation 5.868 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week8; n=40, 39, 13, 13 | -0.08 Micromoles per liter | Standard Deviation 10.23 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Direct Bilirubin; Week4; n=1, 1, 0, 0 | NA Micromoles per liter | — |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Total Bilirubin; Week6; n=41, 38, 13, 13 | 2.1 Micromoles per liter | Standard Deviation 6.87 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12 | Creatinine; Week2; n=41, 38, 14, 13 | -1.17 Micromoles per liter | Standard Deviation 7.692 |
Primary
Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12
The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 1, n=41, 40, 15, 12 | 3.3 Beats per minute | Standard Deviation 8.28 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 12, n=38, 35, 12, 13 | 8.3 Beats per minute | Standard Deviation 8.37 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 12, n=38, 35, 12, 13 | 5.1 Beats per minute | Standard Deviation 10.86 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 1, n=41, 40, 15, 12 | 0.8 Beats per minute | Standard Deviation 8.49 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 1, n=41, 40, 15, 12 | 4.1 Beats per minute | Standard Deviation 9.52 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 12, n=38, 35, 12, 13 | 9.3 Beats per minute | Standard Deviation 10.15 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 12, n=38, 35, 12, 13 | 8.5 Beats per minute | Standard Deviation 8 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12 | Week 1, n=41, 40, 15, 12 | 4.8 Beats per minute | Standard Deviation 10.62 |
Primary
Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12
Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Day2; n=41, 40, 17, 13 | 6.5 Beats per minute | Standard Deviation 8.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week8; n=41, 39, 13, 13 | 4.7 Beats per minute | Standard Deviation 9.91 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week12; n=38, 35, 12, 13 | 7 Beats per minute | Standard Deviation 9.2 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week1; n=41, 39, 15, 13 | 1.5 Beats per minute | Standard Deviation 8.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week2; n=41, 39, 14, 13 | 3.8 Beats per minute | Standard Deviation 9.02 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week4; n=41, 39, 14, 13 | 6.8 Beats per minute | Standard Deviation 9.42 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week6; n=41, 39, 13, 13 | 8 Beats per minute | Standard Deviation 10.15 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week6; n=41, 39, 13, 13 | 5 Beats per minute | Standard Deviation 10.98 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Day2; n=41, 40, 17, 13 | 5.4 Beats per minute | Standard Deviation 9.96 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week2; n=41, 39, 14, 13 | 4.2 Beats per minute | Standard Deviation 12.14 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week1; n=41, 39, 15, 13 | 3.1 Beats per minute | Standard Deviation 8.75 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week12; n=38, 35, 12, 13 | 5.3 Beats per minute | Standard Deviation 12.1 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week8; n=41, 39, 13, 13 | 6.8 Beats per minute | Standard Deviation 12.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week4; n=41, 39, 14, 13 | 4.2 Beats per minute | Standard Deviation 11.78 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week6; n=41, 39, 13, 13 | 13.8 Beats per minute | Standard Deviation 9.75 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week2; n=41, 39, 14, 13 | 8.7 Beats per minute | Standard Deviation 8.17 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week12; n=38, 35, 12, 13 | 11 Beats per minute | Standard Deviation 8.02 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week8; n=41, 39, 13, 13 | 14.2 Beats per minute | Standard Deviation 10.36 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week1; n=41, 39, 15, 13 | 8.1 Beats per minute | Standard Deviation 6.32 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week4; n=41, 39, 14, 13 | 10.7 Beats per minute | Standard Deviation 11.39 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Day2; n=41, 40, 17, 13 | 9.3 Beats per minute | Standard Deviation 11.74 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week4; n=41, 39, 14, 13 | 5.5 Beats per minute | Standard Deviation 8.35 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week8; n=41, 39, 13, 13 | 12.8 Beats per minute | Standard Deviation 12.27 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week6; n=41, 39, 13, 13 | 10.2 Beats per minute | Standard Deviation 8.2 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Day2; n=41, 40, 17, 13 | 3.8 Beats per minute | Standard Deviation 5.79 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week12; n=38, 35, 12, 13 | 8.4 Beats per minute | Standard Deviation 9.47 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week1; n=41, 39, 15, 13 | 7.7 Beats per minute | Standard Deviation 10.11 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12 | Heart Rate; Week2; n=41, 39, 14, 13 | 7.8 Beats per minute | Standard Deviation 8.6 |
Primary
Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week1; n=38, 39, 14, 12 | -0.0196 Ratio | Standard Deviation 0.02345 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week2; n=41, 38, 14, 12 | -0.0539 Ratio | Standard Deviation 0.03653 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week4; n=41, 38, 14, 13 | -0.0848 Ratio | Standard Deviation 0.04576 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week6; n=41, 38, 12, 13 | -0.0859 Ratio | Standard Deviation 0.0411 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week8; n=39, 39, 13, 13 | -0.0838 Ratio | Standard Deviation 0.03955 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week12; n=38, 36, 12, 12 | -0.0843 Ratio | Standard Deviation 0.04038 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week12; n=38, 36, 12, 12 | -0.0589 Ratio | Standard Deviation 0.03648 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week6; n=41, 38, 12, 13 | -0.0685 Ratio | Standard Deviation 0.04487 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week1; n=38, 39, 14, 12 | -0.0069 Ratio | Standard Deviation 0.02751 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week4; n=41, 38, 14, 13 | -0.0621 Ratio | Standard Deviation 0.05468 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week2; n=41, 38, 14, 12 | -0.0465 Ratio | Standard Deviation 0.04738 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week8; n=39, 39, 13, 13 | -0.0663 Ratio | Standard Deviation 0.04144 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week2; n=41, 38, 14, 12 | -0.0609 Ratio | Standard Deviation 0.03007 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week4; n=41, 38, 14, 13 | -0.0999 Ratio | Standard Deviation 0.03967 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week6; n=41, 38, 12, 13 | -0.1203 Ratio | Standard Deviation 0.04463 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week12; n=38, 36, 12, 12 | -0.1318 Ratio | Standard Deviation 0.03847 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week8; n=39, 39, 13, 13 | -0.1235 Ratio | Standard Deviation 0.03288 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week1; n=38, 39, 14, 12 | -0.0201 Ratio | Standard Deviation 0.01921 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week8; n=39, 39, 13, 13 | -0.07 Ratio | Standard Deviation 0.02758 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week12; n=38, 36, 12, 12 | -0.0688 Ratio | Standard Deviation 0.03298 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week2; n=41, 38, 14, 12 | -0.0335 Ratio | Standard Deviation 0.03625 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week6; n=41, 38, 12, 13 | -0.074 Ratio | Standard Deviation 0.03316 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week1; n=38, 39, 14, 12 | -0.0166 Ratio | Standard Deviation 0.0298 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12 | Hematocrit; Week4; n=41, 38, 14, 13 | -0.0668 Ratio | Standard Deviation 0.04445 |
Primary
Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week1; n=38, 39, 14, 12 | -5.2 Grams per liter | Standard Deviation 6.98 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week2; n=41, 38, 14, 12 | -16.7 Grams per liter | Standard Deviation 12.54 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week4; n=41, 38, 14, 13 | -28.6 Grams per liter | Standard Deviation 15.38 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week6; n=41, 38, 12, 13 | -30.1 Grams per liter | Standard Deviation 14.54 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week8; n=39, 39, 13, 13 | -30.5 Grams per liter | Standard Deviation 13.29 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week12; n=38, 36, 12, 12 | -33 Grams per liter | Standard Deviation 12.88 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week12; n=38, 36, 12, 12 | -24.1 Grams per liter | Standard Deviation 13.41 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week6; n=41, 38, 12, 13 | -24.7 Grams per liter | Standard Deviation 16 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week1; n=38, 39, 14, 12 | -2.3 Grams per liter | Standard Deviation 9.38 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week4; n=41, 38, 14, 13 | -22.1 Grams per liter | Standard Deviation 18.98 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week2; n=41, 38, 14, 12 | -14.9 Grams per liter | Standard Deviation 16.21 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week8; n=39, 39, 13, 13 | -25.5 Grams per liter | Standard Deviation 14.22 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week2; n=41, 38, 14, 12 | -20.5 Grams per liter | Standard Deviation 10.66 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week4; n=41, 38, 14, 13 | -34.4 Grams per liter | Standard Deviation 13.55 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week6; n=41, 38, 12, 13 | -40.8 Grams per liter | Standard Deviation 14.11 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week12; n=38, 36, 12, 12 | -47.4 Grams per liter | Standard Deviation 14.12 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week8; n=39, 39, 13, 13 | -44.9 Grams per liter | Standard Deviation 11.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week1; n=38, 39, 14, 12 | -6.6 Grams per liter | Standard Deviation 5.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week8; n=39, 39, 13, 13 | -25.2 Grams per liter | Standard Deviation 8.66 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week12; n=38, 36, 12, 12 | -27.6 Grams per liter | Standard Deviation 12.05 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week2; n=41, 38, 14, 12 | -9.9 Grams per liter | Standard Deviation 11.5 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week6; n=41, 38, 12, 13 | -25.2 Grams per liter | Standard Deviation 12.28 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week1; n=38, 39, 14, 12 | -5.3 Grams per liter | Standard Deviation 8.85 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12 | Hemoglobin; Week4; n=41, 38, 14, 13 | -22.5 Grams per liter | Standard Deviation 14.89 |
Primary
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week1; n=38, 39, 14, 12 | -1.1 Femtoliters | Standard Deviation 1.21 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week2; n=41, 38, 14, 12 | -2 Femtoliters | Standard Deviation 1.84 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week4; n=41, 38, 14, 13 | 0.3 Femtoliters | Standard Deviation 3.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week6; n=41, 38, 12, 13 | 2.3 Femtoliters | Standard Deviation 4.76 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week8; n=39, 39, 13, 13 | 3.8 Femtoliters | Standard Deviation 5.39 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week12; n=38, 34, 12, 12 | 5.7 Femtoliters | Standard Deviation 6 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week12; n=38, 34, 12, 12 | 4.2 Femtoliters | Standard Deviation 6.3 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week6; n=41, 38, 12, 13 | 1.8 Femtoliters | Standard Deviation 4.67 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week1; n=38, 39, 14, 12 | -0.8 Femtoliters | Standard Deviation 1.37 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week4; n=41, 38, 14, 13 | 0.2 Femtoliters | Standard Deviation 3.4 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week2; n=41, 38, 14, 12 | -1.4 Femtoliters | Standard Deviation 1.59 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week8; n=39, 39, 13, 13 | 3 Femtoliters | Standard Deviation 5.2 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week2; n=41, 38, 14, 12 | -1.4 Femtoliters | Standard Deviation 1.09 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week4; n=41, 38, 14, 13 | -0.8 Femtoliters | Standard Deviation 1.58 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week6; n=41, 38, 12, 13 | -0.2 Femtoliters | Standard Deviation 2.37 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week12; n=38, 34, 12, 12 | 5.3 Femtoliters | Standard Deviation 4.14 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week8; n=39, 39, 13, 13 | 3.1 Femtoliters | Standard Deviation 2.78 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week1; n=38, 39, 14, 12 | -0.4 Femtoliters | Standard Deviation 1.15 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week8; n=39, 39, 13, 13 | 2.2 Femtoliters | Standard Deviation 3.75 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week12; n=38, 34, 12, 12 | 3.8 Femtoliters | Standard Deviation 4.28 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week2; n=41, 38, 14, 12 | -1.5 Femtoliters | Standard Deviation 1.45 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week6; n=41, 38, 12, 13 | 1.4 Femtoliters | Standard Deviation 4.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week1; n=38, 39, 14, 12 | -0.7 Femtoliters | Standard Deviation 1.37 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12 | Mean corpuscle volume; Week4; n=41, 38, 14, 13 | -0.2 Femtoliters | Standard Deviation 2.94 |
Primary
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12
The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT interval, Week 12,n=38,35,12,13 | -11.8 Milliseconds | Standard Deviation 31.28 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 12,n=38,35,12,13 | 11.5512 Milliseconds | Standard Deviation 26.5644 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 1, n=41,40,15,12 | 7.7087 Milliseconds | Standard Deviation 25.63001 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 12, n=38, 35, 12, 13 | 2.9 Milliseconds | Standard Deviation 13.36 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 1, n=41, 40, 15, 12 | 0.5 Milliseconds | Standard Deviation 19.43 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 12,n=38,35,12,13 | 3.3516 Milliseconds | Standard Deviation 26.34546 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 1, n=41, 40, 15,12 | -6.6 Milliseconds | Standard Deviation 50.28 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 12, n=38, 35, 12,13 | -8.2 Milliseconds | Standard Deviation 51.69 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 1, n=41,40,15,12 | 4.1995 Milliseconds | Standard Deviation 23.18239 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT Interval, Week 1, n=41,40,15,12 | -2.3 Milliseconds | Standard Deviation 27.29 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 12,n=38,35,12,13 | 1.7615 Milliseconds | Standard Deviation 20.3859 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT interval, Week 12,n=38,35,12,13 | -12 Milliseconds | Standard Deviation 25.22 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 12,n=38,35,12,13 | -3.1442 Milliseconds | Standard Deviation 17.38368 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 1, n=41, 40, 15,12 | 0.4 Milliseconds | Standard Deviation 7.69 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 1, n=41,40,15,12 | -0.7151 Milliseconds | Standard Deviation 19.69091 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 1, n=41,40,15,12 | 0.2491 Milliseconds | Standard Deviation 22.90285 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT Interval, Week 1, n=41,40,15,12 | -2.6 Milliseconds | Standard Deviation 22.29 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 12, n=38, 35, 12, 13 | 3.2 Milliseconds | Standard Deviation 12.07 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 12, n=38, 35, 12,13 | -1.8 Milliseconds | Standard Deviation 6.44 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 1, n=41, 40, 15, 12 | 1.2 Milliseconds | Standard Deviation 13.57 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 1, n=41, 40, 15,12 | 2.9 Milliseconds | Standard Deviation 6.61 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 1, n=41, 40, 15, 12 | 2.7 Milliseconds | Standard Deviation 7.27 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 12, n=38, 35, 12, 13 | 5.5 Milliseconds | Standard Deviation 8.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 12, n=38, 35, 12,13 | 0.4 Milliseconds | Standard Deviation 7.54 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT Interval, Week 1, n=41,40,15,12 | -2.1 Milliseconds | Standard Deviation 22.39 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT interval, Week 12,n=38,35,12,13 | -17 Milliseconds | Standard Deviation 18.01 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 1, n=41,40,15,12 | 9.8112 Milliseconds | Standard Deviation 20.6771 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 12,n=38,35,12,13 | 11.2801 Milliseconds | Standard Deviation 25.54652 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 1, n=41,40,15,12 | 5.7676 Milliseconds | Standard Deviation 17.06472 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 12,n=38,35,12,13 | 1.6147 Milliseconds | Standard Deviation 18.38188 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 1, n=41, 40, 15, 12 | -1.6 Milliseconds | Standard Deviation 20.92 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 12,n=38,35,12,13 | 18.9943 Milliseconds | Standard Deviation 16.76576 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 12, n=38, 35, 12,13 | -2 Milliseconds | Standard Deviation 4.4 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QRS duration, Week 1, n=41, 40, 15,12 | 0.4 Milliseconds | Standard Deviation 4.03 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 12,n=38,35,12,13 | 10.7637 Milliseconds | Standard Deviation 17.07259 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcF interval, Week 1, n=41,40,15,12 | 14.9187 Milliseconds | Standard Deviation 32.2737 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | PR interval, Week 12, n=38, 35, 12, 13 | 0.2 Milliseconds | Standard Deviation 14.68 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | QTcB interval, Week 1, n=41,40,15,12 | 19.8879 Milliseconds | Standard Deviation 40.13504 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT interval, Week 12,n=38,35,12,13 | -4.6 Milliseconds | Standard Deviation 23.36 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12 | Uncorrected QT Interval, Week 1, n=41,40,15,12 | 5.9 Milliseconds | Standard Deviation 25.68 |
Primary
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12
Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week1; n=38, 39, 14, 12 | -0.15 Trillion cells per liter | Standard Deviation 0.226 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week2; n=41, 38, 14, 12 | -0.48 Trillion cells per liter | Standard Deviation 0.376 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week4; n=41, 38, 14, 13 | -0.88 Trillion cells per liter | Standard Deviation 0.507 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week6; n=41, 38, 12, 13 | -0.97 Trillion cells per liter | Standard Deviation 0.504 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week8; n=39, 39, 13, 13 | -1.01 Trillion cells per liter | Standard Deviation 0.506 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week12; n=38, 36, 12, 12 | -1.08 Trillion cells per liter | Standard Deviation 0.48 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week12; n=38, 36, 12, 12 | -0.79 Trillion cells per liter | Standard Deviation 0.56 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week6; n=41, 38, 12, 13 | -0.78 Trillion cells per liter | Standard Deviation 0.563 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week1; n=38, 39, 14, 12 | -0.04 Trillion cells per liter | Standard Deviation 0.279 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week4; n=41, 38, 14, 13 | -0.64 Trillion cells per liter | Standard Deviation 0.623 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week2; n=41, 38, 14, 12 | -0.44 Trillion cells per liter | Standard Deviation 0.508 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week8; n=39, 39, 13, 13 | -0.82 Trillion cells per liter | Standard Deviation 0.534 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week2; n=41, 38, 14, 12 | -0.57 Trillion cells per liter | Standard Deviation 0.312 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week4; n=41, 38, 14, 13 | -1.03 Trillion cells per liter | Standard Deviation 0.441 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week6; n=41, 38, 12, 13 | -1.28 Trillion cells per liter | Standard Deviation 0.49 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week12; n=38, 36, 12, 12 | -1.61 Trillion cells per liter | Standard Deviation 0.464 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week8; n=39, 39, 13, 13 | -1.45 Trillion cells per liter | Standard Deviation 0.357 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week1; n=38, 39, 14, 12 | -0.18 Trillion cells per liter | Standard Deviation 0.212 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week8; n=39, 39, 13, 13 | -0.85 Trillion cells per liter | Standard Deviation 0.412 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week12; n=38, 36, 12, 12 | -0.92 Trillion cells per liter | Standard Deviation 0.459 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week2; n=41, 38, 14, 12 | -0.28 Trillion cells per liter | Standard Deviation 0.361 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week6; n=41, 38, 12, 13 | -0.86 Trillion cells per liter | Standard Deviation 0.52 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week1; n=38, 39, 14, 12 | -0.13 Trillion cells per liter | Standard Deviation 0.303 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12 | Red Blood Cell count; Week4; n=41, 38, 14, 13 | -0.72 Trillion cells per liter | Standard Deviation 0.559 |
Primary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12
Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) up to 12-week treatment period
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week12; n=38, 35, 12, 13 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 8.48 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week4; n=41, 39, 14, 13 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 7.73 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week2; n=41, 39, 14, 13 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 10.41 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week4; n=41, 39, 14, 13 | -3.6 Millimeters of mercury (mmHg) | Standard Deviation 11.56 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Day2; n=41, 40, 17, 13 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week1; n=41, 39, 15, 13 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 12.99 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Day2; n=41, 40, 17, 13 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 6.63 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week6; n=41, 39, 13, 13 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 7.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week8; n=41, 39, 13, 13 | -2.1 Millimeters of mercury (mmHg) | Standard Deviation 10 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week2; n=41, 39, 14, 13 | -2 Millimeters of mercury (mmHg) | Standard Deviation 10.57 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week1; n=41, 39, 15, 13 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 7.98 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week8; n=41, 39, 13, 13 | -3.7 Millimeters of mercury (mmHg) | Standard Deviation 12.15 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week12; n=38, 35, 12, 13 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 13.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week6; n=41, 39, 13, 13 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 14.47 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week1; n=41, 39, 15, 13 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 9.13 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week8; n=41, 39, 13, 13 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 12.64 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Day2; n=41, 40, 17, 13 | -1 Millimeters of mercury (mmHg) | Standard Deviation 7.03 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week8; n=41, 39, 13, 13 | -2.9 Millimeters of mercury (mmHg) | Standard Deviation 9.11 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Day2; n=41, 40, 17, 13 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 12.85 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week6; n=41, 39, 13, 13 | -4.8 Millimeters of mercury (mmHg) | Standard Deviation 9.86 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week12; n=38, 35, 12, 13 | -4.4 Millimeters of mercury (mmHg) | Standard Deviation 10.24 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week4; n=41, 39, 14, 13 | -4.4 Millimeters of mercury (mmHg) | Standard Deviation 9.78 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week1; n=41, 39, 15, 13 | -3 Millimeters of mercury (mmHg) | Standard Deviation 11.24 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week2; n=41, 39, 14, 13 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 11.67 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week4; n=41, 39, 14, 13 | -4.2 Millimeters of mercury (mmHg) | Standard Deviation 16.2 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week6; n=41, 39, 13, 13 | -3.8 Millimeters of mercury (mmHg) | Standard Deviation 13.28 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week12; n=38, 35, 12, 13 | -1.4 Millimeters of mercury (mmHg) | Standard Deviation 11.72 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week2; n=41, 39, 14, 13 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 9.52 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week1; n=41, 39, 15, 13 | -4.5 Millimeters of mercury (mmHg) | Standard Deviation 12.67 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week1; n=41, 39, 15, 13 | 1 Millimeters of mercury (mmHg) | Standard Deviation 10.54 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week4; n=41, 39, 14, 13 | -3.9 Millimeters of mercury (mmHg) | Standard Deviation 9.74 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week6; n=41, 39, 13, 13 | -5.9 Millimeters of mercury (mmHg) | Standard Deviation 7.82 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week8; n=41, 39, 13, 13 | -4.4 Millimeters of mercury (mmHg) | Standard Deviation 7.63 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week12; n=38, 35, 12, 13 | -3.5 Millimeters of mercury (mmHg) | Standard Deviation 9.2 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Day2; n=41, 40, 17, 13 | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 10.46 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week12; n=38, 35, 12, 13 | -5.2 Millimeters of mercury (mmHg) | Standard Deviation 5.81 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week2; n=41, 39, 14, 13 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 8.8 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Day2; n=41, 40, 17, 13 | -3 Millimeters of mercury (mmHg) | Standard Deviation 9.03 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week2; n=41, 39, 14, 13 | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 12.67 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week4; n=41, 39, 14, 13 | -3.8 Millimeters of mercury (mmHg) | Standard Deviation 9.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week6; n=41, 39, 13, 13 | -5.9 Millimeters of mercury (mmHg) | Standard Deviation 11.39 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week8; n=41, 39, 13, 13 | -2.9 Millimeters of mercury (mmHg) | Standard Deviation 10.36 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week4; n=41, 39, 14, 13 | -5.2 Millimeters of mercury (mmHg) | Standard Deviation 15.3 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week1; n=41, 39, 15, 13 | -2.6 Millimeters of mercury (mmHg) | Standard Deviation 11.84 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week12; n=38, 35, 12, 13 | -2.6 Millimeters of mercury (mmHg) | Standard Deviation 19.16 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week2; n=41, 39, 14, 13 | -4.2 Millimeters of mercury (mmHg) | Standard Deviation 17.35 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week12; n=38, 35, 12, 13 | -1 Millimeters of mercury (mmHg) | Standard Deviation 9.11 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week8; n=41, 39, 13, 13 | -4.2 Millimeters of mercury (mmHg) | Standard Deviation 12.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week8; n=41, 39, 13, 13 | -2.4 Millimeters of mercury (mmHg) | Standard Deviation 9.02 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week1; n=41, 39, 15, 13 | -1 Millimeters of mercury (mmHg) | Standard Deviation 7.99 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Week6; n=41, 39, 13, 13 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 14.47 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | SBP; Day2; n=41, 40, 17, 13 | -1.3 Millimeters of mercury (mmHg) | Standard Deviation 13.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week6; n=41, 39, 13, 13 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 10.1 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week2; n=41, 39, 14, 13 | -2.8 Millimeters of mercury (mmHg) | Standard Deviation 11.09 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Week4; n=41, 39, 14, 13 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 9.92 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12 | DBP; Day2; n=41, 40, 17, 13 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 10.45 |
Primary
Number of Participants Achieving eRVR
eRVR is defined as plasma HCV ribonucleic acid (RNA) \<lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.
Time frame: Week 4 and Week 12
Population: Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving eRVR | 23 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving eRVR | 21 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving eRVR | 9 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving eRVR | 9 Participants |
Primary
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time frame: From the start of study treatment up to Week 12
Population: Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any SAE | 0 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any AE | 39 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any SAE | 2 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any AE | 37 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any AE | 17 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any SAE | 3 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any SAE | 1 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12 | Any AE | 13 Participants |
Primary
Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12
Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0), Weeks 2 and 12
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2 | 4 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2 | 4 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL NL, n=37,34,12,13 | 36 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, USG, BL NL to PBL NL, n=1, 0,0,0 | 1 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL NL, n=37,34,12,13 | 37 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL ANL,n=37,34,12,13 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL NL, n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL NL, n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0 | 1 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL ANL,n=37,34,12,13 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2 | 5 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13 | 34 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, USG, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2 | 5 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2 | 2 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2 | 2 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, USG, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL ANL,n=37,34,12,13 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL NL, n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL NL, n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13 | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UPH, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMWBC, BL MIS to PBL MIS, n=4,5,2,2 | 2 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL NL, n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UBIL, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL NL, n=37,34,12,13 | 12 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMRBC, BL MIS to PBL MIS,n=4,5,2,2 | 2 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UMBT, BL MIS to PBL MIS,n=1,1,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UBIL, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UPH, BL NL to PBL ANL, n=37,34,12,13 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, ULET, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UKET, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UGLU, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, USG, BL NL to PBL ANL,n=37,34,12,13 | 1 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UOB, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UNIT, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, USG, BL NL to PBL NL, n=1, 0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, ULET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UOB, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UKET, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 2, UNIT, BL MIS to PBL MIS, n=1,0,0,0 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12 | Week 12, UGLU, BL MIS to PBL MIS,n=37,34,12,13 | 13 Participants |
Secondary
Apparent Clearance (CL/F) at Week 4
Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).
Time frame: Week 4 (24 h post dose)
Population: Intensive PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Apparent Clearance (CL/F) at Week 4 | 14.63 Liter per hour (L/hr) | Geometric Coefficient of Variation 82 |
| GSK2336805 60 mg, Genotype 1 HCV | Apparent Clearance (CL/F) at Week 4 | 12.13 Liter per hour (L/hr) | Geometric Coefficient of Variation 66.3 |
Secondary
Apparent Volume of Distribution (Vz/F) at Week 4
Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC\[0-tau\] lambda z) where lambda z is the terminal phase rate constant.
Time frame: Week 4 (24 h post dose)
Population: Intensive PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Apparent Volume of Distribution (Vz/F) at Week 4 | 172.81 Liter per hour (L/hr) | Geometric Coefficient of Variation 76.6 |
| GSK2336805 60 mg, Genotype 1 HCV | Apparent Volume of Distribution (Vz/F) at Week 4 | 125.09 Liter per hour (L/hr) | Geometric Coefficient of Variation 67.9 |
Secondary
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4
Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.
Time frame: Week 4 (24 h post dose)
Population: Intensive PK Summary Population
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4 | 2733.34 hour*nanogram per milliliter(hr*ng/mL) | Geometric Coefficient of Variation 82 |
| GSK2336805 60 mg, Genotype 1 HCV | Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4 | 4948.23 hour*nanogram per milliliter(hr*ng/mL) | Geometric Coefficient of Variation 66.3 |
Secondary
Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2
Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Day 2
Population: PK/PD Analysis Population
Secondary
Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status
Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Week 4 and Week 12
Population: PK/PD Analysis Population
Secondary
Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status
Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Week 4 and Week 12
Population: Intensive PK Population
Secondary
Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status
Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Week 4
Population: Intensive PK Population
Secondary
Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status
Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA \<LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Week 4 and Week 12
Population: Intensive PK Population
Secondary
Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status
Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.
Time frame: Week 4
Population: Intensive PK Population
Secondary
Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4
Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.
Time frame: Week 4 (24 h post dose)
Population: Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 | Cmax, n=11, 10 | 335.35 ng/mL | Geometric Coefficient of Variation 69.4 |
| GSK2336805 40 mg, Genotype 1 HCV | Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 | Ctau, n=11, 10 | 31.37 ng/mL | Geometric Coefficient of Variation 135.9 |
| GSK2336805 60 mg, Genotype 1 HCV | Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 | Cmax, n=11, 10 | 618.75 ng/mL | Geometric Coefficient of Variation 46.1 |
| GSK2336805 60 mg, Genotype 1 HCV | Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4 | Ctau, n=11, 10 | 49.31 ng/mL | Geometric Coefficient of Variation 97.6 |
Secondary
Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 48; n=6, 6, 0, 2 | -1.3 Grams per liter | Standard Deviation 3.61 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 42; n=9, 6, 1, 2 | -1.3 Grams per liter | Standard Deviation 2.5 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; PT Week 4; n=33, 34, 11, 11 | -0.7 Grams per liter | Standard Deviation 3.93 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 24; n=35, 33, 12, 11 | -2.1 Grams per liter | Standard Deviation 3.08 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 18; n=38, 34, 13, 12 | -2.3 Grams per liter | Standard Deviation 2.78 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 30; n=13, 10, 3, 2 | -1.8 Grams per liter | Standard Deviation 2.09 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 36; n=10, 7, 2, 2 | -1.7 Grams per liter | Standard Deviation 3.92 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 42; n=9, 6, 1, 2 | -1.3 Grams per liter | Standard Deviation 1.63 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 30; n=13, 10, 3, 2 | -0.7 Grams per liter | Standard Deviation 4.22 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 18; n=38, 34, 13, 12 | -1.4 Grams per liter | Standard Deviation 2.65 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 48; n=6, 6, 0, 2 | -0.3 Grams per liter | Standard Deviation 2.16 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 36; n=10, 7, 2, 2 | -1.1 Grams per liter | Standard Deviation 2.85 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; PT Week 4; n=33, 34, 11, 11 | -0.2 Grams per liter | Standard Deviation 2.84 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 24; n=35, 33, 12, 11 | -1.6 Grams per liter | Standard Deviation 2.82 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 36; n=10, 7, 2, 2 | 2 Grams per liter | Standard Deviation 1.41 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 24; n=35, 33, 12, 11 | -2.3 Grams per liter | Standard Deviation 2.81 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 42; n=9, 6, 1, 2 | -1 Grams per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 18; n=38, 34, 13, 12 | -1.8 Grams per liter | Standard Deviation 2.86 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 48; n=6, 6, 0, 2 | NA Grams per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 30; n=13, 10, 3, 2 | -3 Grams per liter | Standard Deviation 2.65 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; PT Week 4; n=33, 34, 11, 11 | 0.5 Grams per liter | Standard Deviation 2.3 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; PT Week 4; n=33, 34, 11, 11 | -0.7 Grams per liter | Standard Deviation 1.79 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 18; n=38, 34, 13, 12 | -1 Grams per liter | Standard Deviation 2.89 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 24; n=35, 33, 12, 11 | -1.1 Grams per liter | Standard Deviation 2.81 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 30; n=13, 10, 3, 2 | -4.5 Grams per liter | Standard Deviation 0.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 42; n=9, 6, 1, 2 | -3 Grams per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 48; n=6, 6, 0, 2 | -4 Grams per liter | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12 | Albumin; Week 36; n=10, 7, 2, 2 | -2 Grams per liter | Standard Deviation 0 |
Secondary
Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 18; n=38, 34, 13, 12 | -44 International units per liter | Standard Deviation 55.77 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 48; n=6, 6, 0, 2 | 10.5 International units per liter | Standard Deviation 71.39 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 42; n=9, 6, 1, 2 | -14.2 International units per liter | Standard Deviation 16.81 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 42; n=9, 6, 1, 2 | 5.3 International units per liter | Standard Deviation 13.4 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 48; n=6, 6, 0, 2 | -12.8 International units per liter | Standard Deviation 18.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 42; n=9, 6, 1, 2 | -0.2 International units per liter | Standard Deviation 51.5 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; PT Week 4; n=33, 34, 11, 11 | -19.5 International units per liter | Standard Deviation 26.41 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 36; n=10, 7, 2, 2 | -11.8 International units per liter | Standard Deviation 13.81 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 42; n=9, 6, 1, 2 | -44.6 International units per liter | Standard Deviation 46.61 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 24; n=35, 33, 12, 11 | -34.5 International units per liter | Standard Deviation 66.48 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 48; n=6, 6, 0, 2 | 9.8 International units per liter | Standard Deviation 17.36 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 30; n=13, 10, 3, 2 | -33 International units per liter | Standard Deviation 83.25 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 24; n=35, 33, 12, 11 | -16.5 International units per liter | Standard Deviation 26.86 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; PT Week 4; n=33, 34, 11, 11 | -4.9 International units per liter | Standard Deviation 19.71 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; PT Week 4; n=33, 34, 11, 11 | -43.4 International units per liter | Standard Deviation 78.29 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 36; n=10, 7, 2, 2 | -51.5 International units per liter | Standard Deviation 45.03 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 18; n=38, 34, 13, 12 | -38.9 International units per liter | Standard Deviation 61.39 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 24; n=35, 33, 12, 11 | 0.8 International units per liter | Standard Deviation 19.71 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 30; n=13, 10, 3, 2 | 1.8 International units per liter | Standard Deviation 15.79 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 24; n=35, 33, 12, 11 | -43.9 International units per liter | Standard Deviation 62.25 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 30; n=13, 10, 3, 2 | -34.8 International units per liter | Standard Deviation 30.82 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 36; n=10, 7, 2, 2 | -18.9 International units per liter | Standard Deviation 34.18 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 30; n=13, 10, 3, 2 | -44.2 International units per liter | Standard Deviation 41.3 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 36; n=10, 7, 2, 2 | -30.2 International units per liter | Standard Deviation 28.15 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 42; n=9, 6, 1, 2 | -34.3 International units per liter | Standard Deviation 35.15 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 24; n=35, 33, 12, 11 | -38.3 International units per liter | Standard Deviation 72.79 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 48; n=6, 6, 0, 2 | -38.8 International units per liter | Standard Deviation 42.1 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; PT Week 4; n=33, 34, 11, 11 | -45.5 International units per liter | Standard Deviation 62.76 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 48; n=6, 6, 0, 2 | -37.8 International units per liter | Standard Deviation 28.74 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 18; n=38, 34, 13, 12 | -37.3 International units per liter | Standard Deviation 71.19 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 18; n=38, 34, 13, 12 | -13.1 International units per liter | Standard Deviation 27.49 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 36; n=10, 7, 2, 2 | 2 International units per liter | Standard Deviation 17.49 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; PT Week 4; n=33, 34, 11, 11 | -17.9 International units per liter | Standard Deviation 48.82 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 30; n=13, 10, 3, 2 | -15.1 International units per liter | Standard Deviation 17.35 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 18; n=38, 34, 13, 12 | 2.5 International units per liter | Standard Deviation 17.25 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 18; n=38, 34, 13, 12 | -12.3 International units per liter | Standard Deviation 60.35 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 36; n=10, 7, 2, 2 | -7.3 International units per liter | Standard Deviation 9.5 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 42; n=9, 6, 1, 2 | -19.7 International units per liter | Standard Deviation 25.06 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 24; n=35, 33, 12, 11 | -31.3 International units per liter | Standard Deviation 56.12 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 24; n=35, 33, 12, 11 | 3.3 International units per liter | Standard Deviation 18.83 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 42; n=9, 6, 1, 2 | -5.8 International units per liter | Standard Deviation 10.03 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 30; n=13, 10, 3, 2 | -32.8 International units per liter | Standard Deviation 31.81 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 42; n=9, 6, 1, 2 | -29.7 International units per liter | Standard Deviation 43.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; PT Week 4; n=33, 34, 11, 11 | -26.4 International units per liter | Standard Deviation 49.42 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 48; n=6, 6, 0, 2 | -2.2 International units per liter | Standard Deviation 13.61 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 42; n=9, 6, 1, 2 | 3.3 International units per liter | Standard Deviation 8.45 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 30; n=13, 10, 3, 2 | -45.1 International units per liter | Standard Deviation 95.76 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; PT Week 4; n=33, 34, 11, 11 | -33.3 International units per liter | Standard Deviation 56.81 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; PT Week 4; n=33, 34, 11, 11 | -15.6 International units per liter | Standard Deviation 34.38 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 18; n=38, 34, 13, 12 | 1.1 International units per liter | Standard Deviation 16.95 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 36; n=10, 7, 2, 2 | -26.7 International units per liter | Standard Deviation 32.22 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 24; n=35, 33, 12, 11 | -11.8 International units per liter | Standard Deviation 30.51 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 18; n=38, 34, 13, 12 | -28.3 International units per liter | Standard Deviation 36.59 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 36; n=10, 7, 2, 2 | 2.7 International units per liter | Standard Deviation 9.45 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 30; n=13, 10, 3, 2 | -15.8 International units per liter | Standard Deviation 51.92 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 36; n=10, 7, 2, 2 | -16.6 International units per liter | Standard Deviation 13.7 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 24; n=35, 33, 12, 11 | -18.7 International units per liter | Standard Deviation 77.24 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 48; n=6, 6, 0, 2 | -16.8 International units per liter | Standard Deviation 24.38 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 24; n=35, 33, 12, 11 | -12.5 International units per liter | Standard Deviation 86.73 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 48; n=6, 6, 0, 2 | 4.2 International units per liter | Standard Deviation 9.62 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 30; n=13, 10, 3, 2 | -18.7 International units per liter | Standard Deviation 43.89 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 36; n=10, 7, 2, 2 | -19.7 International units per liter | Standard Deviation 24.52 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 42; n=9, 6, 1, 2 | -14.3 International units per liter | Standard Deviation 20.07 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; PT Week 4; n=33, 34, 11, 11 | -6.3 International units per liter | Standard Deviation 17.88 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 30; n=13, 10, 3, 2 | -6.4 International units per liter | Standard Deviation 18.62 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 18; n=38, 34, 13, 12 | -3.5 International units per liter | Standard Deviation 37.25 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 48; n=6, 6, 0, 2 | 22.3 International units per liter | Standard Deviation 77.32 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 18; n=38, 34, 13, 12 | -22.9 International units per liter | Standard Deviation 61.65 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 48; n=6, 6, 0, 2 | -10.8 International units per liter | Standard Deviation 27.11 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; PT Week 4; n=33, 34, 11, 11 | -17.7 International units per liter | Standard Deviation 78.22 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 30; n=13, 10, 3, 2 | -38.7 International units per liter | Standard Deviation 36.02 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 18; n=38, 34, 13, 12 | 2.2 International units per liter | Standard Deviation 21.77 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 24; n=35, 33, 12, 11 | 2.1 International units per liter | Standard Deviation 20.24 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 30; n=13, 10, 3, 2 | -8 International units per liter | Standard Deviation 8.54 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 36; n=10, 7, 2, 2 | 2.5 International units per liter | Standard Deviation 0.71 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 42; n=9, 6, 1, 2 | -2 International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 48; n=6, 6, 0, 2 | NA International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; PT Week 4; n=33, 34, 11, 11 | -7 International units per liter | Standard Deviation 17.93 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 18; n=38, 34, 13, 12 | -38.6 International units per liter | Standard Deviation 40.89 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 24; n=35, 33, 12, 11 | -39.7 International units per liter | Standard Deviation 38.19 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 30; n=13, 10, 3, 2 | -57.7 International units per liter | Standard Deviation 58.31 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 36; n=10, 7, 2, 2 | -69 International units per liter | Standard Deviation 74.95 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 42; n=9, 6, 1, 2 | -122 International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 48; n=6, 6, 0, 2 | NA International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; PT Week 4; n=33, 34, 11, 11 | -31.5 International units per liter | Standard Deviation 22.68 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 18; n=38, 34, 13, 12 | -18.8 International units per liter | Standard Deviation 27.32 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 24; n=35, 33, 12, 11 | -23.8 International units per liter | Standard Deviation 26.91 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 30; n=13, 10, 3, 2 | -27.7 International units per liter | Standard Deviation 20.13 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 36; n=10, 7, 2, 2 | -27.5 International units per liter | Standard Deviation 31.82 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 42; n=9, 6, 1, 2 | -54 International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 48; n=6, 6, 0, 2 | NA International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; PT Week 4; n=33, 34, 11, 11 | -17.7 International units per liter | Standard Deviation 14.67 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 18; n=38, 34, 13, 12 | -38.7 International units per liter | Standard Deviation 45.46 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 24; n=35, 33, 12, 11 | -39 International units per liter | Standard Deviation 36.68 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 30; n=13, 10, 3, 2 | -30 International units per liter | Standard Deviation 24.27 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 36; n=10, 7, 2, 2 | -37.5 International units per liter | Standard Deviation 6.36 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 42; n=9, 6, 1, 2 | -32 International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 48; n=6, 6, 0, 2 | NA International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; PT Week 4; n=33, 34, 11, 11 | -21.7 International units per liter | Standard Deviation 42.62 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 18; n=38, 34, 13, 12 | -30.2 International units per liter | Standard Deviation 42.04 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 24; n=35, 33, 12, 11 | -37.4 International units per liter | Standard Deviation 45.44 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 36; n=10, 7, 2, 2 | -40.5 International units per liter | Standard Deviation 33.23 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 42; n=9, 6, 1, 2 | -17 International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 48; n=6, 6, 0, 2 | NA International units per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; PT Week 4; n=33, 34, 11, 11 | -30.7 International units per liter | Standard Deviation 41.91 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 36; n=10, 7, 2, 2 | -2.5 International units per liter | Standard Deviation 2.12 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 30; n=13, 10, 3, 2 | -6.5 International units per liter | Standard Deviation 7.78 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 30; n=13, 10, 3, 2 | 22.5 International units per liter | Standard Deviation 14.85 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 48; n=6, 6, 0, 2 | -82.5 International units per liter | Standard Deviation 70 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 24; n=35, 33, 12, 11 | -15.7 International units per liter | Standard Deviation 18.91 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 18; n=38, 34, 13, 12 | -16.3 International units per liter | Standard Deviation 15.11 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 24; n=35, 33, 12, 11 | 4.5 International units per liter | Standard Deviation 22.82 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; PT Week 4; n=33, 34, 11, 11 | 258.7 International units per liter | Standard Deviation 994.88 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; PT Week 4; n=33, 34, 11, 11 | -43.9 International units per liter | Standard Deviation 27.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 48; n=6, 6, 0, 2 | -26.5 International units per liter | Standard Deviation 26.16 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; PT Week 4; n=33, 34, 11, 11 | -41.4 International units per liter | Standard Deviation 61.06 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 42; n=9, 6, 1, 2 | -28 International units per liter | Standard Deviation 25.46 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 36; n=10, 7, 2, 2 | -20.5 International units per liter | Standard Deviation 16.26 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 48; n=6, 6, 0, 2 | -9.5 International units per liter | Standard Deviation 6.36 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 24; n=35, 33, 12, 11 | -35.7 International units per liter | Standard Deviation 59.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 30; n=13, 10, 3, 2 | -26 International units per liter | Standard Deviation 22.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 24; n=35, 33, 12, 11 | -41.7 International units per liter | Standard Deviation 28.32 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALT; Week 18; n=38, 34, 13, 12 | -38.4 International units per liter | Standard Deviation 32.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 30; n=13, 10, 3, 2 | -12 International units per liter | Standard Deviation 4.24 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; PT Week 4; n=33, 34, 11, 11 | -3.9 International units per liter | Standard Deviation 22.15 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 48; n=6, 6, 0, 2 | 30 International units per liter | Standard Deviation 24.04 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 18; n=38, 34, 13, 12 | 6.4 International units per liter | Standard Deviation 20.08 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 36; n=10, 7, 2, 2 | -10 International units per liter | Standard Deviation 4.24 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 42; n=9, 6, 1, 2 | 17.5 International units per liter | Standard Deviation 2.12 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 24; n=35, 33, 12, 11 | 60.1 International units per liter | Standard Deviation 475.39 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 18; n=38, 34, 13, 12 | -60.7 International units per liter | Standard Deviation 75.8 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | ALP; Week 36; n=10, 7, 2, 2 | 18 International units per liter | Standard Deviation 7.07 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 30; n=13, 10, 3, 2 | -78.5 International units per liter | Standard Deviation 55.86 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; PT Week 4; n=33, 34, 11, 11 | -16 International units per liter | Standard Deviation 31.8 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 18; n=38, 34, 13, 12 | -34.2 International units per liter | Standard Deviation 56.52 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 36; n=10, 7, 2, 2 | -69 International units per liter | Standard Deviation 53.74 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 48; n=6, 6, 0, 2 | -6.5 International units per liter | Standard Deviation 9.19 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | AST; Week 42; n=9, 6, 1, 2 | -9 International units per liter | Standard Deviation 7.07 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | GGT; Week 42; n=9, 6, 1, 2 | -9 International units per liter | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12 | CK; Week 42; n=9, 6, 1, 2 | -81 International units per liter | Standard Deviation 57.98 |
Secondary
Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week24; n=34, 32, 12,11 | -1.181 Giga cells per liter | Standard Deviation 0.4795 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week18; n=37, 33, 13,12 | -1.081 Giga cells per liter | Standard Deviation 0.5533 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week42; n=10, 6, 2, 2 | -0.015 Giga cells per liter | Standard Deviation 0.0242 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week24; n=34,32,12,11 | -4.06 Giga cells per liter | Standard Deviation 2.251 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; PT Week4; n=32, 34, 11,11 | -0.069 Giga cells per liter | Standard Deviation 0.0925 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week48; n=8, 6, 1, 2 | -0.071 Giga cells per liter | Standard Deviation 0.0889 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week48; n=7, 6, 1, 2 | -0.007 Giga cells per liter | Standard Deviation 0.0214 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; PT Week4; n=32, 34,11,11 | -20.4 Giga cells per liter | Standard Deviation 44.37 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week42; n=10, 6, 2, 2 | -0.105 Giga cells per liter | Standard Deviation 0.074 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week36; n=12, 7, 1, 2 | -0.081 Giga cells per liter | Standard Deviation 0.1459 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; PT Week4; n=32, 34, 11, 11 | -0.007 Giga cells per liter | Standard Deviation 0.0162 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; PT Week4; n=32, 34,11,11 | -1.158 Giga cells per liter | Standard Deviation 1.8855 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week30; n=13, 10, 2, 2 | -0.124 Giga cells per liter | Standard Deviation 0.0982 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week24; n=34, 32, 12, 11 | -0.128 Giga cells per liter | Standard Deviation 0.101 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week18; n=37, 33, 13, 12 | -0.119 Giga cells per liter | Standard Deviation 0.1006 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week48; n=7, 6, 1, 2 | -1.129 Giga cells per liter | Standard Deviation 2.2597 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week30; n=13,10,2,2 | -3.92 Giga cells per liter | Standard Deviation 2.258 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week48; n=9, 6, 1, 2 | -37.7 Giga cells per liter | Standard Deviation 66.18 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week42; n=10, 6, 2,2 | -2.23 Giga cells per liter | Standard Deviation 2.0311 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week36; n=12, 7, 1,2 | -2.503 Giga cells per liter | Standard Deviation 1.6709 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week36; n=12,7,1,2 | -4.13 Giga cells per liter | Standard Deviation 2.188 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week36; n=12, 7, 1, 2 | -64.1 Giga cells per liter | Standard Deviation 41.52 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week30; n=13, 10,2,2 | -2.402 Giga cells per liter | Standard Deviation 1.7954 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week24; n=34, 32,12,11 | -2.527 Giga cells per liter | Standard Deviation 1.9492 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week42; n=10,6,2,2 | -3.67 Giga cells per liter | Standard Deviation 2.807 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week30; n=13, 10, 1, 2 | -70 Giga cells per liter | Standard Deviation 60.5 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week18; n=37, 33,13,12 | -2.702 Giga cells per liter | Standard Deviation 1.9136 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; PT Week4; n=32, 34, 11,11 | -0.047 Giga cells per liter | Standard Deviation 0.1773 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week48; n=7,6,1,2 | -2.09 Giga cells per liter | Standard Deviation 3.304 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week18; n=37,33,13,12 | -4.1 Giga cells per liter | Standard Deviation 2.258 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week48; n=7, 6, 1, 2 | -0.066 Giga cells per liter | Standard Deviation 0.1744 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week42; n=10, 6, 2, 2 | -0.184 Giga cells per liter | Standard Deviation 0.234 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; PT Week4;n=32,34,11,11 | -1.97 Giga cells per liter | Standard Deviation 1.938 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week36; n=12, 7, 1, 2 | -0.255 Giga cells per liter | Standard Deviation 0.1474 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week30; n=13, 10, 2, 2 | -0.151 Giga cells per liter | Standard Deviation 0.1655 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week18; n=37, 33, 13, 12 | -0.019 Giga cells per liter | Standard Deviation 0.0178 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week42; n=10, 6, 2, 2 | -56.1 Giga cells per liter | Standard Deviation 53.01 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week24; n=34, 32, 12, 11 | -0.206 Giga cells per liter | Standard Deviation 0.1692 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week18; n=37, 33, 13, 12 | -0.186 Giga cells per liter | Standard Deviation 0.1588 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week24; n=34, 32, 12, 11 | -0.018 Giga cells per liter | Standard Deviation 0.0177 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week24; n=35, 33, 12,11 | -67.5 Giga cells per liter | Standard Deviation 43.22 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; PT Week4; n=32, 34, 11,11 | -0.681 Giga cells per liter | Standard Deviation 0.4594 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week48; n=7, 6, 1, 2 | -0.779 Giga cells per liter | Standard Deviation 1.0639 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week30; n=13, 10, 2, 2 | -0.018 Giga cells per liter | Standard Deviation 0.0142 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week18; n=38, 34, 13,12 | -73.7 Giga cells per liter | Standard Deviation 43.93 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week42; n=10, 6, 2, 2 | -1.135 Giga cells per liter | Standard Deviation 0.8657 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week36; n=12, 7, 1, 2 | -1.267 Giga cells per liter | Standard Deviation 0.6828 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week36; n=12, 7, 1, 2 | -0.02 Giga cells per liter | Standard Deviation 0.0165 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week30; n=13, 10, 2, 2 | -1.225 Giga cells per liter | Standard Deviation 0.7588 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week36; n=12, 7, 1, 2 | -0.006 Giga cells per liter | Standard Deviation 0.019 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; PT Week4;n=32,34,11,11 | -1.64 Giga cells per liter | Standard Deviation 1.907 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; PT Week4; n=32, 34,11,11 | -28.9 Giga cells per liter | Standard Deviation 45.92 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week18; n=37,33,13,12 | -3.81 Giga cells per liter | Standard Deviation 1.884 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week24; n=34,32,12,11 | -3.58 Giga cells per liter | Standard Deviation 1.977 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week30; n=13,10,2,2 | -3.59 Giga cells per liter | Standard Deviation 3.051 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week36; n=12,7,1,2 | -4.39 Giga cells per liter | Standard Deviation 3.168 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week42; n=10,6,2,2 | -4.52 Giga cells per liter | Standard Deviation 3.68 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week48; n=7,6,1,2 | -4.17 Giga cells per liter | Standard Deviation 4.172 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week18; n=37, 33, 13, 12 | -0.01 Giga cells per liter | Standard Deviation 0.0194 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week24; n=34, 32, 12, 11 | -0.01 Giga cells per liter | Standard Deviation 0.0166 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week30; n=13, 10, 2, 2 | -0.012 Giga cells per liter | Standard Deviation 0.0148 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week42; n=10, 6, 2, 2 | -0.005 Giga cells per liter | Standard Deviation 0.0187 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week48; n=7, 6, 1, 2 | -0.007 Giga cells per liter | Standard Deviation 0.0197 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; PT Week4; n=32, 34, 11, 11 | -0.003 Giga cells per liter | Standard Deviation 0.0189 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week18; n=37, 33, 13, 12 | -0.127 Giga cells per liter | Standard Deviation 0.1207 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week24; n=34, 32, 12, 11 | -0.131 Giga cells per liter | Standard Deviation 0.1103 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week30; n=13, 10, 2, 2 | -0.116 Giga cells per liter | Standard Deviation 0.1117 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week36; n=12, 7, 1, 2 | -0.123 Giga cells per liter | Standard Deviation 0.1003 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week42; n=10, 6, 2, 2 | -0.1 Giga cells per liter | Standard Deviation 0.12 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week48; n=8, 6, 1, 2 | -0.11 Giga cells per liter | Standard Deviation 0.1223 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; PT Week4; n=32, 34, 11,11 | -0.085 Giga cells per liter | Standard Deviation 0.1208 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week18; n=37, 33, 13,12 | -1.157 Giga cells per liter | Standard Deviation 0.5373 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week24; n=34, 32, 12,11 | -1.092 Giga cells per liter | Standard Deviation 0.5598 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week30; n=13, 10, 2, 2 | -1.085 Giga cells per liter | Standard Deviation 0.798 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week36; n=12, 7, 1, 2 | -1.286 Giga cells per liter | Standard Deviation 0.8983 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week42; n=10, 6, 2, 2 | -1.22 Giga cells per liter | Standard Deviation 0.9909 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week48; n=7, 6, 1, 2 | -1.4 Giga cells per liter | Standard Deviation 1.0384 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; PT Week4; n=32, 34, 11,11 | -0.7 Giga cells per liter | Standard Deviation 0.6163 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week18; n=37, 33, 13, 12 | -0.141 Giga cells per liter | Standard Deviation 0.1339 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week24; n=34, 32, 12, 11 | -0.156 Giga cells per liter | Standard Deviation 0.1574 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week30; n=13, 10, 2, 2 | -0.135 Giga cells per liter | Standard Deviation 0.091 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week36; n=12, 7, 1, 2 | -0.18 Giga cells per liter | Standard Deviation 0.0987 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week42; n=10, 6, 2, 2 | -0.093 Giga cells per liter | Standard Deviation 0.1743 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week48; n=7, 6, 1, 2 | -0.147 Giga cells per liter | Standard Deviation 0.088 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; PT Week4; n=32, 34, 11,11 | -0.031 Giga cells per liter | Standard Deviation 0.165 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week18; n=37, 33,13,12 | -2.378 Giga cells per liter | Standard Deviation 1.6735 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week24; n=34, 32,12,11 | -2.187 Giga cells per liter | Standard Deviation 1.7758 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week30; n=13, 10,2,2 | -2.252 Giga cells per liter | Standard Deviation 2.3658 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week36; n=12, 7, 1,2 | -2.777 Giga cells per liter | Standard Deviation 2.4215 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week42; n=10, 6, 2,2 | -3.085 Giga cells per liter | Standard Deviation 2.7313 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week48; n=7, 6, 1, 2 | -2.488 Giga cells per liter | Standard Deviation 3.397 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; PT Week4; n=32, 34,11,11 | -0.808 Giga cells per liter | Standard Deviation 1.6104 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week18; n=38, 34, 13,12 | -87.5 Giga cells per liter | Standard Deviation 38.4 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week24; n=35, 33, 12,11 | -78.8 Giga cells per liter | Standard Deviation 44.15 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week30; n=13, 10, 1, 2 | -71.9 Giga cells per liter | Standard Deviation 59.35 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week36; n=12, 7, 1, 2 | -75.7 Giga cells per liter | Standard Deviation 65.89 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week42; n=10, 6, 2, 2 | -67.3 Giga cells per liter | Standard Deviation 62.09 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week48; n=9, 6, 1, 2 | -68.8 Giga cells per liter | Standard Deviation 65.74 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week42; n=10,6,2,2 | -1.75 Giga cells per liter | Standard Deviation 2.051 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week42; n=10, 6, 2, 2 | -112 Giga cells per liter | Standard Deviation 0 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week18; n=37, 33,13,12 | -1.652 Giga cells per liter | Standard Deviation 0.852 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week24; n=34, 32, 12, 11 | -0.151 Giga cells per liter | Standard Deviation 0.1474 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; PT Week4; n=32, 34,11,11 | -0.744 Giga cells per liter | Standard Deviation 1.1276 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week30; n=13, 10, 1, 2 | -112 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week24; n=34, 32,12,11 | -1.308 Giga cells per liter | Standard Deviation 0.7148 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week24; n=34, 32, 12, 11 | -0.013 Giga cells per liter | Standard Deviation 0.0129 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week36; n=12,7,1,2 | -3.9 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week18; n=37,33,13,12 | -2.84 Giga cells per liter | Standard Deviation 0.961 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week30; n=13, 10,2,2 | -2.24 Giga cells per liter | Standard Deviation 1.2869 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week30; n=13, 10, 2, 2 | -0.4 Giga cells per liter | Standard Deviation 0.3111 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week42; n=10, 6, 2, 2 | -1.125 Giga cells per liter | Standard Deviation 1.0253 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; PT Week4; n=32, 34,11,11 | -12.4 Giga cells per liter | Standard Deviation 34.3 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week36; n=12, 7, 1,2 | -1.61 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; PT Week4;n=32,34,11,11 | -1.54 Giga cells per liter | Standard Deviation 1.638 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week18; n=37, 33, 13, 12 | -0.087 Giga cells per liter | Standard Deviation 0.0507 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week48; n=9, 6, 1, 2 | 33 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week36; n=12, 7, 1, 2 | -0.2 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week30; n=13,10,2,2 | -4.7 Giga cells per liter | Standard Deviation 1.838 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week24; n=34, 32, 12, 11 | -0.118 Giga cells per liter | Standard Deviation 0.0612 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; PT Week4; n=32, 34, 11,11 | -0.756 Giga cells per liter | Standard Deviation 0.5874 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; PT Week4; n=32, 34, 11, 11 | -0.001 Giga cells per liter | Standard Deviation 0.0181 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week36; n=12, 7, 1, 2 | -1.97 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week30; n=13, 10, 2, 2 | -0.13 Giga cells per liter | Standard Deviation 0.0849 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week24; n=35, 33, 12,11 | -60.3 Giga cells per liter | Standard Deviation 56.5 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week42; n=10, 6, 2, 2 | -0.025 Giga cells per liter | Standard Deviation 0.2192 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week42; n=10, 6, 2,2 | -0.565 Giga cells per liter | Standard Deviation 0.7849 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week36; n=12, 7, 1, 2 | -0.06 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week30; n=13, 10, 2, 2 | -1.905 Giga cells per liter | Standard Deviation 0.1768 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week48; n=7, 6, 1, 2 | 0.02 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week48; n=7,6,1,2 | 0.2 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week42; n=10, 6, 2, 2 | -0.02 Giga cells per liter | Standard Deviation 0.0424 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week18; n=38, 34, 13,12 | -55.7 Giga cells per liter | Standard Deviation 56.96 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week48; n=7, 6, 1, 2 | 0.02 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week18; n=37, 33, 13, 12 | -0.088 Giga cells per liter | Standard Deviation 0.1663 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week48; n=8, 6, 1, 2 | 0.13 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week30; n=13, 10, 2, 2 | -0.02 Giga cells per liter | Standard Deviation 0 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week42; n=10, 6, 2, 2 | 0 Giga cells per liter | Standard Deviation 0.0424 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week36; n=12, 7, 1, 2 | -115 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; PT Week4; n=32, 34, 11,11 | -0.07 Giga cells per liter | Standard Deviation 0.0694 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week18; n=37, 33, 13, 12 | -0.014 Giga cells per liter | Standard Deviation 0.0112 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; PT Week4; n=32, 34, 11,11 | 0.032 Giga cells per liter | Standard Deviation 0.1543 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week48; n=7, 6, 1, 2 | 0.02 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week18; n=37, 33, 13,12 | -0.999 Giga cells per liter | Standard Deviation 0.4672 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week48; n=7, 6, 1, 2 | 0.09 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week36; n=12, 7, 1, 2 | -0.02 Giga cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week24; n=34,32,12,11 | -3 Giga cells per liter | Standard Deviation 1.047 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week24; n=34, 32, 12,11 | -1.405 Giga cells per liter | Standard Deviation 0.5912 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week30; n=13,10,2,2 | -4.05 Giga cells per liter | Standard Deviation 0.495 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week48; n=7, 6, 1, 2 | -1.445 Giga cells per liter | Standard Deviation 0.4596 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week36; n=12, 7, 1, 2 | -34 Giga cells per liter | Standard Deviation 52.33 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week30; n=13, 10, 2, 2 | -1.845 Giga cells per liter | Standard Deviation 0.2899 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week30; n=13, 10, 2, 2 | -0.02 Giga cells per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week36; n=12, 7, 1, 2 | -1.92 Giga cells per liter | Standard Deviation 0.4808 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; PT Week4; n=32, 34,11,11 | -0.671 Giga cells per liter | Standard Deviation 0.8001 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week42; n=10, 6, 2, 2 | -1.93 Giga cells per liter | Standard Deviation 0.1414 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week24; n=34, 32, 12, 11 | -0.013 Giga cells per liter | Standard Deviation 0.011 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week18; n=37,33,13,12 | -2.65 Giga cells per liter | Standard Deviation 0.923 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week48; n=7, 6, 1, 2 | -2.2 Giga cells per liter | Standard Deviation 0.0424 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week48; n=9, 6, 1, 2 | -14 Giga cells per liter | Standard Deviation 22.63 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; PT Week4; n=32, 34, 11,11 | -0.737 Giga cells per liter | Standard Deviation 0.5666 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week18; n=37, 33, 13, 12 | -0.012 Giga cells per liter | Standard Deviation 0.0119 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week18; n=37, 33, 13, 12 | -0.143 Giga cells per liter | Standard Deviation 0.1776 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week18; n=38, 34, 13,12 | -52.1 Giga cells per liter | Standard Deviation 39.87 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week24; n=34, 32, 12, 11 | -0.121 Giga cells per liter | Standard Deviation 0.1902 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; PT Week4;n=32,34,11,11 | -1.45 Giga cells per liter | Standard Deviation 0.884 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week30; n=13, 10, 2, 2 | -0.06 Giga cells per liter | Standard Deviation 0.0141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week36; n=12, 7, 1, 2 | 0.015 Giga cells per liter | Standard Deviation 0.1061 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count; Week48; n=7,6,1,2 | -3.8 Giga cells per liter | Standard Deviation 0.141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week42; n=10, 6, 2, 2 | -0.01 Giga cells per liter | Standard Deviation 0.099 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week24; n=35, 33, 12,11 | -51.9 Giga cells per liter | Standard Deviation 44.19 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; Week48; n=7, 6, 1, 2 | -0.085 Giga cells per liter | Standard Deviation 0.1909 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week42; n=10,6,2,2 | -3.8 Giga cells per liter | Standard Deviation 0.707 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; PT Week4; n=32, 34,11,11 | -12.9 Giga cells per liter | Standard Deviation 42.3 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Monocytes; PT Week4; n=32, 34, 11,11 | -0.053 Giga cells per liter | Standard Deviation 0.1536 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week18; n=37, 33,13,12 | -1.463 Giga cells per liter | Standard Deviation 0.7174 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week36; n=12,7,1,2 | -3.55 Giga cells per liter | Standard Deviation 0.919 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week24; n=34, 32,12,11 | -1.3 Giga cells per liter | Standard Deviation 0.9956 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week30; n=13, 10, 1, 2 | -36.5 Giga cells per liter | Standard Deviation 47.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week30; n=13, 10,2,2 | -2.085 Giga cells per liter | Standard Deviation 0.1909 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week24; n=34, 32, 12,11 | -1.057 Giga cells per liter | Standard Deviation 0.4832 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week36; n=12, 7, 1,2 | -1.63 Giga cells per liter | Standard Deviation 0.297 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week18; n=37, 33, 13, 12 | -0.068 Giga cells per liter | Standard Deviation 0.0746 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; PT Week4; n=32, 34, 11, 11 | -0.003 Giga cells per liter | Standard Deviation 0.0119 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week24; n=34, 32, 12, 11 | -0.041 Giga cells per liter | Standard Deviation 0.1003 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Platelet Count; Week42; n=10, 6, 2, 2 | -22 Giga cells per liter | Standard Deviation 52.33 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week30; n=13, 10, 2, 2 | -0.04 Giga cells per liter | Standard Deviation 0.0141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week48; n=7, 6, 1, 2 | 0.005 Giga cells per liter | Standard Deviation 0.0071 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week36; n=12, 7, 1, 2 | -0.05 Giga cells per liter | Standard Deviation 0.0141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Total Neutrophils; Week42; n=10, 6, 2,2 | -1.815 Giga cells per liter | Standard Deviation 0.4455 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week42; n=10, 6, 2, 2 | -0.04 Giga cells per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week42; n=10, 6, 2, 2 | -0.015 Giga cells per liter | Standard Deviation 0.0071 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | White Blood Cell count ; Week24; n=34,32,12,11 | -2.52 Giga cells per liter | Standard Deviation 1.272 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; Week48; n=8, 6, 1, 2 | -0.05 Giga cells per liter | Standard Deviation 0.0141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Eosinophils; PT Week4; n=32, 34, 11,11 | -0.018 Giga cells per liter | Standard Deviation 0.0808 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Basophils; Week36; n=12, 7, 1, 2 | -0.01 Giga cells per liter | Standard Deviation 0.0141 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12 | Lymphocytes; Week18; n=37, 33, 13,12 | -0.973 Giga cells per liter | Standard Deviation 0.5328 |
Secondary
Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 30; n=13, 10, 3, 2 | 0.03 Millimoles per liter | Standard Deviation 1.383 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; PT Week 4; n=33, 34, 11, 11 | -0.1 Millimoles per liter | Standard Deviation 2.3 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 30; n=13, 10, 3, 2 | -0.03 Millimoles per liter | Standard Deviation 0.48 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 36; n=10, 7, 2, 2 | 0.24 Millimoles per liter | Standard Deviation 0.599 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 48; n=6, 6, 0, 2 | -0.2 Millimoles per liter | Standard Deviation 2.14 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 42; n=9, 6, 1, 2 | -0.1 Millimoles per liter | Standard Deviation 0.555 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 42; n=9, 6, 1, 2 | 1.3 Millimoles per liter | Standard Deviation 2.78 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 48; n=6, 6, 0, 2 | 0.1 Millimoles per liter | Standard Deviation 0.566 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 42; n=9, 6, 1, 2 | 0.4 Millimoles per liter | Standard Deviation 2.07 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; PT Week 4; n=33, 34, 11,11 | -0.16 Millimoles per liter | Standard Deviation 0.382 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 48; n=6, 6, 0, 2 | 0.67 Millimoles per liter | Standard Deviation 1.353 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 18; n=38, 34, 13, 12 | 0.7 Millimoles per liter | Standard Deviation 2.04 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 36; n=10, 7, 2, 2 | 0.4 Millimoles per liter | Standard Deviation 2.67 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 24; n=35, 33, 12, 11 | 0.4 Millimoles per liter | Standard Deviation 1.86 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 48; n=6, 6, 0, 2 | 1.3 Millimoles per liter | Standard Deviation 2.34 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 30; n=13, 10, 3, 2 | 1.1 Millimoles per liter | Standard Deviation 3.25 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 24; n=35, 33, 12, 11 | -0.22 Millimoles per liter | Standard Deviation 1.263 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 18; n=38, 34, 13, 12 | -0.19 Millimoles per liter | Standard Deviation 1.166 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; PT Week 4; n=33, 34, 11, 11 | 0.5 Millimoles per liter | Standard Deviation 2.69 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 30; n=13, 10, 3, 2 | 0.69 Millimoles per liter | Standard Deviation 1.107 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 18; n=38, 34, 13,12 | -0.3 Millimoles per liter | Standard Deviation 2.18 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 24; n=35, 33, 12,11 | -1 Millimoles per liter | Standard Deviation 2.41 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 42; n=9, 6, 1, 2 | 0.34 Millimoles per liter | Standard Deviation 1.65 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; PT Week 4;n=33,34,11,11 | -0.084 Millimoles per liter | Standard Deviation 0.2375 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 30; n=13, 10, 3, 2 | 0.4 Millimoles per liter | Standard Deviation 2.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 48; n=6,6,0,2 | -0.167 Millimoles per liter | Standard Deviation 0.1715 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 36; n=10, 7, 2, 2 | -0.9 Millimoles per liter | Standard Deviation 2.92 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 18; n=38, 34, 13, 12 | 1.9 Millimoles per liter | Standard Deviation 2.75 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 42; n=9, 6, 1, 2 | -0.7 Millimoles per liter | Standard Deviation 1.73 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 42; n=9,6,1,2 | -0.08 Millimoles per liter | Standard Deviation 0.2248 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 48; n=6, 6, 0, 2 | -1 Millimoles per liter | Standard Deviation 1.67 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; PT Week 4; n=33, 34, 11,11 | -0.7 Millimoles per liter | Standard Deviation 2.1 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 24; n=35, 33, 12, 11 | 2 Millimoles per liter | Standard Deviation 2.33 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 18; n=38, 34, 13, 12 | -0.28 Millimoles per liter | Standard Deviation 1.326 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 36; n=10,7,2,2 | -0.121 Millimoles per liter | Standard Deviation 0.2564 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 24; n=35, 33, 12, 11 | -0.33 Millimoles per liter | Standard Deviation 1.552 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; PT Week 4; n=33, 34, 11,11 | 0.35 Millimoles per liter | Standard Deviation 1.284 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 30; n=13,10,3,2 | -0.156 Millimoles per liter | Standard Deviation 0.1644 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 36; n=10, 7, 2, 2 | -0.38 Millimoles per liter | Standard Deviation 0.758 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 30; n=13, 10, 3, 2 | 1.9 Millimoles per liter | Standard Deviation 2.72 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 42; n=9, 6, 1, 2 | -0.28 Millimoles per liter | Standard Deviation 1.663 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 24; n=35,33,12,11 | -0.139 Millimoles per liter | Standard Deviation 0.2268 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 48; n=6, 6, 0, 2 | 0.25 Millimoles per liter | Standard Deviation 1.358 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; PT Week 4; n=33, 34, 11, 11 | 0.24 Millimoles per liter | Standard Deviation 3.122 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 36; n=10, 7, 2, 2 | 0.65 Millimoles per liter | Standard Deviation 1.775 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 18; n=38,34,13,12 | -0.161 Millimoles per liter | Standard Deviation 0.1971 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 18; n=38, 34, 13, 12 | -0.19 Millimoles per liter | Standard Deviation 0.399 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 36; n=10, 7, 2, 2 | 1.3 Millimoles per liter | Standard Deviation 2.11 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 24; n=35, 33, 12, 11 | -0.13 Millimoles per liter | Standard Deviation 0.452 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 30; n=13, 10, 3, 2 | -0.26 Millimoles per liter | Standard Deviation 0.587 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 36; n=10, 7, 2, 2 | 0.04 Millimoles per liter | Standard Deviation 1.172 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 36; n=10, 7, 2, 2 | 0.1 Millimoles per liter | Standard Deviation 1.86 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 30; n=13, 10, 3, 2 | -0.23 Millimoles per liter | Standard Deviation 0.377 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 48; n=6, 6, 0, 2 | 0.4 Millimoles per liter | Standard Deviation 1.607 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 48; n=6, 6, 0, 2 | -1.2 Millimoles per liter | Standard Deviation 2.79 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 42; n=9, 6, 1, 2 | 0.5 Millimoles per liter | Standard Deviation 1.239 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 36; n=10, 7, 2, 2 | -0.1 Millimoles per liter | Standard Deviation 0.365 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 30; n=13, 10, 3, 2 | -0.16 Millimoles per liter | Standard Deviation 1.027 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 42; n=9,6,1,2 | -0.108 Millimoles per liter | Standard Deviation 0.0794 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 18; n=38,34,13,12 | -0.13 Millimoles per liter | Standard Deviation 0.1928 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 42; n=9, 6, 1, 2 | -0.2 Millimoles per liter | Standard Deviation 0.415 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 42; n=9, 6, 1, 2 | -0.2 Millimoles per liter | Standard Deviation 2.04 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 42; n=9, 6, 1, 2 | -0.5 Millimoles per liter | Standard Deviation 1.38 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 18; n=38, 34, 13, 12 | 1 Millimoles per liter | Standard Deviation 2.5 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 48; n=6, 6, 0, 2 | -0.3 Millimoles per liter | Standard Deviation 0.322 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 42; n=9, 6, 1, 2 | 0 Millimoles per liter | Standard Deviation 2 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 36; n=10, 7, 2, 2 | -0.37 Millimoles per liter | Standard Deviation 1.09 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; PT Week 4; n=33, 34, 11, 11 | 0.1 Millimoles per liter | Standard Deviation 2.45 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; PT Week 4; n=33, 34, 11,11 | -0.13 Millimoles per liter | Standard Deviation 0.398 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 48; n=6, 6, 0, 2 | -1.3 Millimoles per liter | Standard Deviation 2.66 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 36; n=10, 7, 2, 2 | -0.7 Millimoles per liter | Standard Deviation 1.98 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 48; n=6, 6, 0, 2 | -0.3 Millimoles per liter | Standard Deviation 0.867 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 18; n=38, 34, 13, 12 | 0.1 Millimoles per liter | Standard Deviation 2.27 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 18; n=38, 34, 13, 12 | -0.23 Millimoles per liter | Standard Deviation 1.403 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 36; n=10,7,2,2 | -0.167 Millimoles per liter | Standard Deviation 0.1906 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 24; n=35,33,12,11 | -0.13 Millimoles per liter | Standard Deviation 0.2354 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 24; n=35, 33, 12, 11 | -0.1 Millimoles per liter | Standard Deviation 2.61 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; PT Week 4; n=33, 34, 11,11 | -0.5 Millimoles per liter | Standard Deviation 2.46 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 30; n=13, 10, 3, 2 | -1.4 Millimoles per liter | Standard Deviation 2.72 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; PT Week 4; n=33, 34, 11, 11 | 0.18 Millimoles per liter | Standard Deviation 0.684 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 48; n=6, 6, 0, 2 | -1 Millimoles per liter | Standard Deviation 3.16 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 42; n=9, 6, 1, 2 | -0.12 Millimoles per liter | Standard Deviation 0.794 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 18; n=38, 34, 13, 12 | -0.13 Millimoles per liter | Standard Deviation 1.188 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 24; n=35, 33, 12, 11 | 0.7 Millimoles per liter | Standard Deviation 2.73 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; PT Week 4; n=33, 34, 11, 11 | 0.2 Millimoles per liter | Standard Deviation 2.54 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 24; n=35, 33, 12, 11 | -0.55 Millimoles per liter | Standard Deviation 1.252 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 30; n=13, 10, 3, 2 | 0.3 Millimoles per liter | Standard Deviation 2.87 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 18; n=38, 34, 13, 12 | -0.24 Millimoles per liter | Standard Deviation 0.376 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 18; n=38, 34, 13,12 | -1 Millimoles per liter | Standard Deviation 2.16 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; PT Week 4; n=33, 34, 11,11 | -0.19 Millimoles per liter | Standard Deviation 1.311 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; PT Week 4;n=33,34,11,11 | -0.003 Millimoles per liter | Standard Deviation 0.2162 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 24; n=35, 33, 12, 11 | 0.27 Millimoles per liter | Standard Deviation 2.986 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 24; n=35, 33, 12,11 | -1.2 Millimoles per liter | Standard Deviation 2.21 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 24; n=35, 33, 12, 11 | -0.12 Millimoles per liter | Standard Deviation 0.459 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 30; n=13,10,3,2 | -0.118 Millimoles per liter | Standard Deviation 0.2071 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 36; n=10, 7, 2, 2 | -0.1 Millimoles per liter | Standard Deviation 2.54 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 30; n=13, 10, 3, 2 | -2.2 Millimoles per liter | Standard Deviation 4.02 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 48; n=6,6,0,2 | -0.108 Millimoles per liter | Standard Deviation 0.1665 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 30; n=13, 10, 3, 2 | -1.3 Millimoles per liter | Standard Deviation 1.53 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 24; n=35, 33, 12, 11 | -0.43 Millimoles per liter | Standard Deviation 1.106 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 18; n=38, 34, 13, 12 | 1.8 Millimoles per liter | Standard Deviation 2.41 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 24; n=35, 33, 12, 11 | 2.9 Millimoles per liter | Standard Deviation 2.81 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 30; n=13, 10, 3, 2 | 5.3 Millimoles per liter | Standard Deviation 3.21 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 36; n=10, 7, 2, 2 | 4.5 Millimoles per liter | Standard Deviation 6.36 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 42; n=9, 6, 1, 2 | 10 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; PT Week 4; n=33, 34, 11, 11 | 0.6 Millimoles per liter | Standard Deviation 2.29 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 18; n=38, 34, 13,12 | -1.2 Millimoles per liter | Standard Deviation 2.27 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 24; n=35, 33, 12,11 | -1.8 Millimoles per liter | Standard Deviation 2.41 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 36; n=10, 7, 2, 2 | -2.5 Millimoles per liter | Standard Deviation 2.12 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 42; n=9, 6, 1, 2 | -4 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; PT Week 4; n=33, 34, 11,11 | -0.9 Millimoles per liter | Standard Deviation 2.43 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 18; n=38, 34, 13, 12 | -0.06 Millimoles per liter | Standard Deviation 0.702 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 24; n=35, 33, 12, 11 | -0.23 Millimoles per liter | Standard Deviation 0.672 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 30; n=13, 10, 3, 2 | -0.13 Millimoles per liter | Standard Deviation 0.252 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 36; n=10, 7, 2, 2 | -0.1 Millimoles per liter | Standard Deviation 0.99 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 42; n=9, 6, 1, 2 | 0.4 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; PT Week 4; n=33, 34, 11, 11 | -0.12 Millimoles per liter | Standard Deviation 0.735 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 18; n=38, 34, 13, 12 | -0.41 Millimoles per liter | Standard Deviation 0.236 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 24; n=35, 33, 12, 11 | -0.34 Millimoles per liter | Standard Deviation 0.403 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 30; n=13, 10, 3, 2 | -0.1 Millimoles per liter | Standard Deviation 0.2 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 36; n=10, 7, 2, 2 | 0.15 Millimoles per liter | Standard Deviation 0.071 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 42; n=9, 6, 1, 2 | -0.1 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; PT Week 4; n=33, 34, 11,11 | -0.25 Millimoles per liter | Standard Deviation 0.532 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 18; n=38, 34, 13, 12 | 0.7 Millimoles per liter | Standard Deviation 2.32 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 24; n=35, 33, 12, 11 | 1.5 Millimoles per liter | Standard Deviation 2.24 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 30; n=13, 10, 3, 2 | 1.3 Millimoles per liter | Standard Deviation 1.53 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 36; n=10, 7, 2, 2 | 2 Millimoles per liter | Standard Deviation 2.83 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 42; n=9, 6, 1, 2 | 3 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; PT Week 4; n=33, 34, 11, 11 | 1.1 Millimoles per liter | Standard Deviation 2.47 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 18; n=38,34,13,12 | -0.092 Millimoles per liter | Standard Deviation 0.1537 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 24; n=35,33,12,11 | -0.119 Millimoles per liter | Standard Deviation 0.1991 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 30; n=13,10,3,2 | -0.267 Millimoles per liter | Standard Deviation 0.2023 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 36; n=10,7,2,2 | -0.195 Millimoles per liter | Standard Deviation 0.0495 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 42; n=9,6,1,2 | -0.15 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 48; n=6,6,0,2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; PT Week 4;n=33,34,11,11 | 0.009 Millimoles per liter | Standard Deviation 0.0798 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 18; n=38, 34, 13, 12 | -0.49 Millimoles per liter | Standard Deviation 1.233 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 30; n=13, 10, 3, 2 | -0.5 Millimoles per liter | Standard Deviation 1.082 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 36; n=10, 7, 2, 2 | -0.15 Millimoles per liter | Standard Deviation 0.636 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 42; n=9, 6, 1, 2 | 0.5 Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 48; n=6, 6, 0, 2 | NA Millimoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; PT Week 4; n=33, 34, 11,11 | -0.62 Millimoles per liter | Standard Deviation 1.012 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; PT Week 4; n=33, 34, 11, 11 | -0.5 Millimoles per liter | Standard Deviation 2.7 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; PT Week 4; n=33, 34, 11, 11 | -0.07 Millimoles per liter | Standard Deviation 1.234 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 48; n=6, 6, 0, 2 | 4.55 Millimoles per liter | Standard Deviation 4.596 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 24; n=35, 33, 12, 11 | -0.2 Millimoles per liter | Standard Deviation 3.52 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 18; n=38,34,13,12 | -0.111 Millimoles per liter | Standard Deviation 0.2648 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 42; n=9, 6, 1, 2 | -0.15 Millimoles per liter | Standard Deviation 0.919 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 36; n=10, 7, 2, 2 | -0.7 Millimoles per liter | Standard Deviation 0.283 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 42; n=9,6,1,2 | -0.1 Millimoles per liter | Standard Deviation 0.3536 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 24; n=35,33,12,11 | -0.107 Millimoles per liter | Standard Deviation 0.2205 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 30; n=13, 10, 3, 2 | 0.9 Millimoles per liter | Standard Deviation 0.707 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 24; n=35, 33, 12, 11 | -0.22 Millimoles per liter | Standard Deviation 1.349 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 36; n=10, 7, 2, 2 | -0.25 Millimoles per liter | Standard Deviation 1.061 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 30; n=13,10,3,2 | -0.225 Millimoles per liter | Standard Deviation 0.1768 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Glucose; Week 18; n=38, 34, 13, 12 | -0.23 Millimoles per liter | Standard Deviation 2.134 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 48; n=6, 6, 0, 2 | -0.5 Millimoles per liter | Standard Deviation 3.54 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 24; n=35, 33, 12, 11 | 0.02 Millimoles per liter | Standard Deviation 2.007 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 36; n=10,7,2,2 | -0.125 Millimoles per liter | Standard Deviation 0.2475 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 42; n=9, 6, 1, 2 | -1 Millimoles per liter | Standard Deviation 2.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 36; n=10, 7, 2, 2 | -1.5 Millimoles per liter | Standard Deviation 2.12 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; PT Week 4; n=33, 34, 11,11 | 1 Millimoles per liter | Standard Deviation 3.07 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 30; n=13, 10, 3, 2 | -2 Millimoles per liter | Standard Deviation 2.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 18; n=38, 34, 13, 12 | 0.5 Millimoles per liter | Standard Deviation 2.94 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 42; n=9, 6, 1, 2 | -0.5 Millimoles per liter | Standard Deviation 1.414 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; Week 48; n=6,6,0,2 | -0.35 Millimoles per liter | Standard Deviation 0.0707 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 24; n=35, 33, 12,11 | -0.4 Millimoles per liter | Standard Deviation 3.35 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Bicarbonate; Week 18; n=38, 34, 13,12 | 0 Millimoles per liter | Standard Deviation 2.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 18; n=38, 34, 13, 12 | -0.25 Millimoles per liter | Standard Deviation 1.688 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; PT Week 4; n=33, 34, 11, 11 | -1.5 Millimoles per liter | Standard Deviation 2.25 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Inorganic phosphorus; PT Week 4;n=33,34,11,11 | -0.085 Millimoles per liter | Standard Deviation 0.2247 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 48; n=6, 6, 0, 2 | 0 Millimoles per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 42; n=9, 6, 1, 2 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 24; n=35, 33, 12, 11 | 0.4 Millimoles per liter | Standard Deviation 3.53 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; PT Week 4; n=33, 34, 11,11 | -0.47 Millimoles per liter | Standard Deviation 0.969 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 30; n=13, 10, 3, 2 | 0 Millimoles per liter | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 18; n=38, 34, 13, 12 | 0.4 Millimoles per liter | Standard Deviation 3.37 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; PT Week 4; n=33, 34, 11,11 | -0.1 Millimoles per liter | Standard Deviation 0.316 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 36; n=10, 7, 2, 2 | 1 Millimoles per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 36; n=10, 7, 2, 2 | -0.5 Millimoles per liter | Standard Deviation 0.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 48; n=6, 6, 0, 2 | 0.05 Millimoles per liter | Standard Deviation 0.495 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 42; n=9, 6, 1, 2 | 0.1 Millimoles per liter | Standard Deviation 0.566 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 48; n=6, 6, 0, 2 | -0.5 Millimoles per liter | Standard Deviation 0.707 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 42; n=9, 6, 1, 2 | -1.5 Millimoles per liter | Standard Deviation 0.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 36; n=10, 7, 2, 2 | 0.2 Millimoles per liter | Standard Deviation 0.424 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 30; n=13, 10, 3, 2 | -0.1 Millimoles per liter | Standard Deviation 0.424 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Urea/BUN; Week 30; n=13, 10, 3, 2 | -0.5 Millimoles per liter | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Sodium; Week 48; n=6, 6, 0, 2 | -2.5 Millimoles per liter | Standard Deviation 3.54 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 24; n=35, 33, 12, 11 | -0.32 Millimoles per liter | Standard Deviation 0.494 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Potassium; Week 18; n=38, 34, 13, 12 | -0.2 Millimoles per liter | Standard Deviation 0.424 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12 | Chloride; Week 30; n=13, 10, 3, 2 | 3 Millimoles per liter | Standard Deviation 0 |
Secondary
Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 42; n=9, 6,1,2 | -6.1 mL/min | Standard Deviation 16.86 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 30; n=13,10,3,2 | -4.8 mL/min | Standard Deviation 13.91 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; PT Week 4; n=33,34,11,11 | -1.5 mL/min | Standard Deviation 34.53 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 36; n=10,7,2,2 | -11 mL/min | Standard Deviation 23.3 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 48; n=6, 6,0,2 | 3.2 mL/min | Standard Deviation 10.23 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 18; n=38, 34, 13, 12 | -0.1 mL/min | Standard Deviation 17.36 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 24; n=35, 33, 12, 11 | -1.9 mL/min | Standard Deviation 16.77 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 48; n=6, 6,0,2 | -15.8 mL/min | Standard Deviation 16.18 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; PT Week 4; n=33,34,11,11 | -1.3 mL/min | Standard Deviation 23.85 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 24; n=35, 33, 12, 11 | -1 mL/min | Standard Deviation 18.53 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 30; n=13,10,3,2 | -10.4 mL/min | Standard Deviation 14.41 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 18; n=38, 34, 13, 12 | -1.1 mL/min | Standard Deviation 20.69 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 36; n=10,7,2,2 | -8.1 mL/min | Standard Deviation 13.28 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 42; n=9, 6,1,2 | -13.3 mL/min | Standard Deviation 16.13 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 36; n=10,7,2,2 | -1 mL/min | Standard Deviation 29.7 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 18; n=38, 34, 13, 12 | -2.5 mL/min | Standard Deviation 16.25 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 24; n=35, 33, 12, 11 | -4.1 mL/min | Standard Deviation 15.11 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 48; n=6, 6,0,2 | NA mL/min | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 42; n=9, 6,1,2 | 9 mL/min | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 30; n=13,10,3,2 | -3.7 mL/min | Standard Deviation 13.58 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; PT Week 4; n=33,34,11,11 | -2.7 mL/min | Standard Deviation 11.38 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; PT Week 4; n=33,34,11,11 | -5.3 mL/min | Standard Deviation 13.95 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 18; n=38, 34, 13, 12 | -4.3 mL/min | Standard Deviation 19.37 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 30; n=13,10,3,2 | 7 mL/min | Standard Deviation 0 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 36; n=10,7,2,2 | 1.5 mL/min | Standard Deviation 9.19 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 42; n=9, 6,1,2 | -1.5 mL/min | Standard Deviation 0.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 48; n=6, 6,0,2 | -4 mL/min | Standard Deviation 11.31 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12 | Creatinine clearance; Week 24; n=35, 33, 12, 11 | -6.1 mL/min | Standard Deviation 19.05 |
Secondary
Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12
The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population
Secondary
Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12
Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population
Secondary
Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 24; n=35, 33, 12, 11 | -0.0782 Ratio | Standard Deviation 0.04021 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 30; n=13, 10, 2, 2 | -0.0713 Ratio | Standard Deviation 0.0486 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 48; n=9, 6, 1, 2 | -0.0624 Ratio | Standard Deviation 0.06203 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 42; n=10, 6, 2, 2 | -0.0623 Ratio | Standard Deviation 0.05449 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; PT Week 4; n=32, 34, 11,11 | -0.0293 Ratio | Standard Deviation 0.03575 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 18; n=38, 34, 13, 12 | -0.083 Ratio | Standard Deviation 0.03831 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 36; n=12, 7, 1, 2 | -0.0567 Ratio | Standard Deviation 0.05031 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 36; n=12, 7, 1, 2 | -0.069 Ratio | Standard Deviation 0.04724 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 48; n=9, 6, 1, 2 | -0.0753 Ratio | Standard Deviation 0.05285 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 18; n=38, 34, 13, 12 | -0.0622 Ratio | Standard Deviation 0.04289 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; PT Week 4; n=32, 34, 11,11 | -0.0135 Ratio | Standard Deviation 0.03178 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 42; n=10, 6, 2, 2 | -0.0802 Ratio | Standard Deviation 0.0562 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 30; n=13, 10, 2, 2 | -0.0397 Ratio | Standard Deviation 0.05793 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 24; n=35, 33, 12, 11 | -0.0635 Ratio | Standard Deviation 0.03499 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 30; n=13, 10, 2, 2 | -0.0955 Ratio | Standard Deviation 0.03323 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 24; n=35, 33, 12, 11 | -0.0808 Ratio | Standard Deviation 0.03543 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 48; n=9, 6, 1, 2 | -0.047 Ratio | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 36; n=12, 7, 1, 2 | -0.087 Ratio | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 18; n=38, 34, 13, 12 | -0.0776 Ratio | Standard Deviation 0.04313 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 42; n=10, 6, 2, 2 | -0.0535 Ratio | Standard Deviation 0.07 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; PT Week 4; n=32, 34, 11,11 | -0.0362 Ratio | Standard Deviation 0.02907 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 30; n=13, 10, 2, 2 | -0.1125 Ratio | Standard Deviation 0.00636 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 36; n=12, 7, 1, 2 | -0.0895 Ratio | Standard Deviation 0.00354 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 42; n=10, 6, 2, 2 | -0.111 Ratio | Standard Deviation 0.00566 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 48; n=9, 6, 1, 2 | -0.1095 Ratio | Standard Deviation 0.03041 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; PT Week 4; n=32, 34, 11,11 | -0.0354 Ratio | Standard Deviation 0.0358 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 18; n=38, 34, 13, 12 | -0.0699 Ratio | Standard Deviation 0.02801 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12 | Hematocrit; Week 24; n=35, 33, 12, 11 | -0.0823 Ratio | Standard Deviation 0.03968 |
Secondary
Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 42; n=10, 6, 2, 2 | -27.1 Grams per liter | Standard Deviation 18.51 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; PT Week 4; n=32, 34, 11,11 | -16.5 Grams per liter | Standard Deviation 11.43 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 18; n=38, 34, 13, 12 | -33.6 Grams per liter | Standard Deviation 12.34 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 30; n=13, 10, 2, 2 | -30.2 Grams per liter | Standard Deviation 16.13 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 48; n=9, 6, 1, 2 | -25.9 Grams per liter | Standard Deviation 21.47 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 36; n=12, 7, 1, 2 | -26.7 Grams per liter | Standard Deviation 18.86 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 24; n=35, 33, 12,11 | -33.4 Grams per liter | Standard Deviation 12.16 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 36; n=12, 7, 1, 2 | -30 Grams per liter | Standard Deviation 16.37 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 42; n=10, 6, 2, 2 | -31.7 Grams per liter | Standard Deviation 19.82 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 24; n=35, 33, 12,11 | -28 Grams per liter | Standard Deviation 12.44 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 18; n=38, 34, 13, 12 | -26.7 Grams per liter | Standard Deviation 14.65 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; PT Week 4; n=32, 34, 11,11 | -11.7 Grams per liter | Standard Deviation 9.57 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 30; n=13, 10, 2, 2 | -21 Grams per liter | Standard Deviation 20.02 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 48; n=9, 6, 1, 2 | -29.3 Grams per liter | Standard Deviation 20.33 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 36; n=12, 7, 1, 2 | -37 Grams per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 30; n=13, 10, 2, 2 | -40 Grams per liter | Standard Deviation 12.73 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 18; n=38, 34, 13, 12 | -35 Grams per liter | Standard Deviation 16.38 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 24; n=35, 33, 12,11 | -35.6 Grams per liter | Standard Deviation 13.48 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 42; n=10, 6, 2, 2 | -25 Grams per liter | Standard Deviation 22.63 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 48; n=9, 6, 1, 2 | -18 Grams per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; PT Week 4; n=32, 34, 11,11 | -21.4 Grams per liter | Standard Deviation 8.59 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 30; n=13, 10, 2, 2 | -40 Grams per liter | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; PT Week 4; n=32, 34, 11,11 | -16.8 Grams per liter | Standard Deviation 11.99 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 48; n=9, 6, 1, 2 | -41 Grams per liter | Standard Deviation 8.49 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 18; n=38, 34, 13, 12 | -29 Grams per liter | Standard Deviation 10.61 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 24; n=35, 33, 12,11 | -32.3 Grams per liter | Standard Deviation 14.98 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 42; n=10, 6, 2, 2 | -40 Grams per liter | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12 | Hemoglobin; Week 36; n=12, 7, 1, 2 | -35 Grams per liter | Standard Deviation 1.41 |
Secondary
Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 42;n=10,6,2,2 | 6.9 Femtoliters | Standard Deviation 5.7 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume; PT Week 4; n=32,34,11,11 | 6.1 Femtoliters | Standard Deviation 5.56 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 30; n=13,10,2,2 | 7.8 Femtoliters | Standard Deviation 7.24 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 18;n=38,34,13,12 | 7.5 Femtoliters | Standard Deviation 6.37 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 24;n=35,33,12,11 | 8.5 Femtoliters | Standard Deviation 6.14 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 36; n=12,7,1,2 | 8.1 Femtoliters | Standard Deviation 5.92 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 48;n=9,6,1,2 | 5.2 Femtoliters | Standard Deviation 5.76 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 36; n=12,7,1,2 | 11.4 Femtoliters | Standard Deviation 13.6 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 42;n=10,6,2,2 | 10.7 Femtoliters | Standard Deviation 14.47 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume; PT Week 4; n=32,34,11,11 | 5.1 Femtoliters | Standard Deviation 4.86 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 24;n=35,33,12,11 | 7.5 Femtoliters | Standard Deviation 8.89 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 18;n=38,34,13,12 | 6.2 Femtoliters | Standard Deviation 8.19 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 48;n=9,6,1,2 | 9 Femtoliters | Standard Deviation 14.04 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 30; n=13,10,2,2 | 9.5 Femtoliters | Standard Deviation 12.02 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 36; n=12,7,1,2 | 2 Femtoliters | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 18;n=38,34,13,12 | 8.5 Femtoliters | Standard Deviation 5.78 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 24;n=35,33,12,11 | 7.6 Femtoliters | Standard Deviation 5.9 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 30; n=13,10,2,2 | 11.5 Femtoliters | Standard Deviation 7.78 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 42;n=10,6,2,2 | 1 Femtoliters | Standard Deviation 2.83 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 48;n=9,6,1,2 | -1 Femtoliters | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume; PT Week 4; n=32,34,11,11 | 5.8 Femtoliters | Standard Deviation 3.79 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 30; n=13,10,2,2 | 3 Femtoliters | Standard Deviation 2.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume; PT Week 4; n=32,34,11,11 | 5.3 Femtoliters | Standard Deviation 5.1 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 48;n=9,6,1,2 | 5 Femtoliters | Standard Deviation 1.41 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 24;n=35,33,12,11 | 5.8 Femtoliters | Standard Deviation 5.08 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 18;n=38,34,13,12 | 5.3 Femtoliters | Standard Deviation 5.28 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 42;n=10,6,2,2 | 4 Femtoliters | Standard Deviation 2.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12 | Mean Corpuscle Volume ; Week 36; n=12,7,1,2 | 5.5 Femtoliters | Standard Deviation 2.12 |
Secondary
Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12
The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population
Secondary
Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 36; n=12,7,1,2 | -0.88 Trillion cells per liter | Standard Deviation 0.67 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 48; n=9, 6,1,2 | -0.83 Trillion cells per liter | Standard Deviation 0.791 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 42; n=10,6,2,2 | -0.91 Trillion cells per liter | Standard Deviation 0.674 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; PT Week 4; n=32,34,11,11 | -0.57 Trillion cells per liter | Standard Deviation 0.435 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 24; n=35, 33, 12, 11 | -1.13 Trillion cells per liter | Standard Deviation 0.482 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 18; n=38, 34, 13, 12 | -1.13 Trillion cells per liter | Standard Deviation 0.494 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 30; n=13,10,2,2 | -1.05 Trillion cells per liter | Standard Deviation 0.511 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 30; n=13,10,2,2 | -0.75 Trillion cells per liter | Standard Deviation 0.809 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 36; n=12,7,1,2 | -1.06 Trillion cells per liter | Standard Deviation 0.761 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; PT Week 4; n=32,34,11,11 | -0.37 Trillion cells per liter | Standard Deviation 0.353 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 24; n=35, 33, 12, 11 | -0.94 Trillion cells per liter | Standard Deviation 0.513 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 18; n=38, 34, 13, 12 | -0.88 Trillion cells per liter | Standard Deviation 0.591 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 42; n=10,6,2,2 | -1.17 Trillion cells per liter | Standard Deviation 0.769 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 48; n=9, 6,1,2 | -1.03 Trillion cells per liter | Standard Deviation 0.794 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 42; n=10,6,2,2 | -0.55 Trillion cells per liter | Standard Deviation 0.636 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; PT Week 4; n=32,34,11,11 | -0.66 Trillion cells per liter | Standard Deviation 0.437 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 18; n=38, 34, 13, 12 | -1.19 Trillion cells per liter | Standard Deviation 0.638 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 24; n=35, 33, 12, 11 | -1.19 Trillion cells per liter | Standard Deviation 0.552 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 30; n=13,10,2,2 | -1.45 Trillion cells per liter | Standard Deviation 0.071 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 36; n=12,7,1,2 | -1 Trillion cells per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 48; n=9, 6,1,2 | -0.4 Trillion cells per liter | — |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 36; n=12,7,1,2 | -1.3 Trillion cells per liter | Standard Deviation 0.283 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 30; n=13,10,2,2 | -1.45 Trillion cells per liter | Standard Deviation 0.354 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; PT Week 4; n=32,34,11,11 | -0.65 Trillion cells per liter | Standard Deviation 0.474 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 48; n=9, 6,1,2 | -1.5 Trillion cells per liter | Standard Deviation 0.566 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 18; n=38, 34, 13, 12 | -0.99 Trillion cells per liter | Standard Deviation 0.498 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 24; n=35, 33, 12, 11 | -1.14 Trillion cells per liter | Standard Deviation 0.528 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12 | Red Blood Cell count; Week 42; n=10,6,2,2 | -1.45 Trillion cells per liter | Standard Deviation 0.354 |
Secondary
Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12
Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population
Secondary
Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12
Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.
Time frame: Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 18; n=38, 34, 13, 12 | 0.5 Micromoles per liter | Standard Deviation 5.01 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 24; n=35, 33, 12, 11 | -1.55 Micromoles per liter | Standard Deviation 9.507 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin PT Week 4; n=33, 34, 11,11 | -4.6 Micromoles per liter | Standard Deviation 3.57 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 42; n=9, 6, 1, 2 | 0.1 Micromoles per liter | Standard Deviation 5.11 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 24; n=35, 33, 12,11 | -0.1 Micromoles per liter | Standard Deviation 5.73 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 48; n=6, 6, 0, 2 | -0.7 Micromoles per liter | Standard Deviation 4.72 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; PT Week 4; n=33, 34, 11,11 | 1.23 Micromoles per liter | Standard Deviation 8.22 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 42; n=9, 6, 1, 2 | 1.23 Micromoles per liter | Standard Deviation 10.32 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 36; n=10, 7, 2, 2 | 2.33 Micromoles per liter | Standard Deviation 11.096 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 30; n=13, 10, 3, 2 | -0.2 Micromoles per liter | Standard Deviation 5.99 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 48; n=6, 6, 0, 2 | -2.35 Micromoles per liter | Standard Deviation 4.222 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 30; n=13, 10, 3, 2 | 0.66 Micromoles per liter | Standard Deviation 4.603 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 18; n=38, 34, 13, 12 | -2.24 Micromoles per liter | Standard Deviation 9.186 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 36; n=10, 7, 2, 2 | 0 Micromoles per liter | Standard Deviation 4.29 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 36; n=10, 7, 2, 2 | 1.9 Micromoles per liter | Standard Deviation 4.95 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 42; n=9, 6, 1, 2 | 4.97 Micromoles per liter | Standard Deviation 11.697 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 18; n=38, 34, 13, 12 | 1.7 Micromoles per liter | Standard Deviation 5.32 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 24; n=35, 33, 12,11 | 1 Micromoles per liter | Standard Deviation 4.08 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 30; n=13, 10, 3, 2 | 0.8 Micromoles per liter | Standard Deviation 4.76 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 42; n=9, 6, 1, 2 | 1.5 Micromoles per liter | Standard Deviation 5.79 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 48; n=6, 6, 0, 2 | 3.5 Micromoles per liter | Standard Deviation 7.2 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin PT Week 4; n=33, 34, 11,11 | -2.4 Micromoles per liter | Standard Deviation 3.3 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 24; n=35, 33, 12, 11 | -2.4 Micromoles per liter | Standard Deviation 8.413 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 18; n=38, 34, 13, 12 | -1.97 Micromoles per liter | Standard Deviation 9.65 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 30; n=13, 10, 3, 2 | 2.82 Micromoles per liter | Standard Deviation 8.123 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 36; n=10, 7, 2, 2 | 2.99 Micromoles per liter | Standard Deviation 8.179 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 48; n=6, 6, 0, 2 | 10.07 Micromoles per liter | Standard Deviation 17.173 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; PT Week 4; n=33, 34, 11,11 | -0.34 Micromoles per liter | Standard Deviation 7.624 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 18; n=38, 34, 13, 12 | -1.75 Micromoles per liter | Standard Deviation 9.874 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 36; n=10, 7, 2, 2 | -5.5 Micromoles per liter | Standard Deviation 16.829 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 36; n=10, 7, 2, 2 | -3 Micromoles per liter | Standard Deviation 11.31 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 24; n=35, 33, 12,11 | -1.3 Micromoles per liter | Standard Deviation 11.9 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 42; n=9, 6, 1, 2 | -14.3 Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 30; n=13, 10, 3, 2 | -2.3 Micromoles per liter | Standard Deviation 9.29 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 18; n=38, 34, 13, 12 | -1.4 Micromoles per liter | Standard Deviation 11.37 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 42; n=9, 6, 1, 2 | -14 Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 30; n=13, 10, 3, 2 | -8.47 Micromoles per liter | Standard Deviation 8.693 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 48; n=6, 6, 0, 2 | NA Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 48; n=6, 6, 0, 2 | NA Micromoles per liter | — |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 24; n=35, 33, 12, 11 | -3.12 Micromoles per liter | Standard Deviation 9.408 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; PT Week 4; n=33, 34, 11,11 | -1.7 Micromoles per liter | Standard Deviation 6.897 |
| Telaprevir, Genotype 1 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin PT Week 4; n=33, 34, 11,11 | -0.4 Micromoles per liter | Standard Deviation 5.68 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; PT Week 4; n=33, 34, 11,11 | -1.25 Micromoles per liter | Standard Deviation 6.228 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 24; n=35, 33, 12, 11 | 1.31 Micromoles per liter | Standard Deviation 10.377 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 30; n=13, 10, 3, 2 | -4 Micromoles per liter | Standard Deviation 5.66 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 48; n=6, 6, 0, 2 | -7.1 Micromoles per liter | Standard Deviation 1.273 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 18; n=38, 34, 13, 12 | 0.09 Micromoles per liter | Standard Deviation 10.668 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 30; n=13, 10, 3, 2 | -8.85 Micromoles per liter | Standard Deviation 3.748 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 24; n=35, 33, 12,11 | 1.3 Micromoles per liter | Standard Deviation 6.26 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin PT Week 4; n=33, 34, 11,11 | -2.2 Micromoles per liter | Standard Deviation 2.71 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 36; n=10, 7, 2, 2 | -8 Micromoles per liter | Standard Deviation 1.273 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Creatinine; Week 42; n=9, 6, 1, 2 | -7.55 Micromoles per liter | Standard Deviation 5.586 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 42; n=9, 6, 1, 2 | -4 Micromoles per liter | Standard Deviation 5.66 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 18; n=38, 34, 13, 12 | 0.6 Micromoles per liter | Standard Deviation 6.49 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 48; n=6, 6, 0, 2 | -4 Micromoles per liter | Standard Deviation 2.83 |
| GSK2336805 60 mg, Genotype 4 HCV | Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12 | Total bilirubin; Week 36; n=10, 7, 2, 2 | -3 Micromoles per liter | Standard Deviation 7.07 |
Secondary
Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12
Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour \[h\]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose \[20-28h\]), Week 4 (Predose \[20-28h\], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose \[20-28h\]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.
Time frame: Day 1, Day 2, Week 4, and Week 12
Population: PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (0h-1h), n=1, 3 | NA nanograms per milliliter (ng/mL) | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (1h-4h), n=35, 42 | 290.39 nanograms per milliliter (ng/mL) | Standard Deviation 241.05 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (4h-8h), n=0, 3 | NA nanograms per milliliter (ng/mL) | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (8h-20h), n=0, 1 | NA nanograms per milliliter (ng/mL) | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 2 Predose (20-28h), n=36, 43 | 53.79 nanograms per milliliter (ng/mL) | Standard Deviation 52.629 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 Predose (20-28h), n=33, 42 | 81.18 nanograms per milliliter (ng/mL) | Standard Deviation 153.462 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (0h-1h), n=2, 6 | 198.4 nanograms per milliliter (ng/mL) | Standard Deviation 242.679 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (1h-4h), n=46, 52 | 392.78 nanograms per milliliter (ng/mL) | Standard Deviation 275.504 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (4h-8h), n=22, 19 | 215.55 nanograms per milliliter (ng/mL) | Standard Deviation 127.737 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (8h-20h), n=1, 2 | NA nanograms per milliliter (ng/mL) | — |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (20h-28h), n=11, 10 | 51.24 nanograms per milliliter (ng/mL) | Standard Deviation 57.261 |
| GSK2336805 40 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 12 (Predose [20-28h]), n=26, 35 | 45.99 nanograms per milliliter (ng/mL) | Standard Deviation 42.034 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (20h-28h), n=11, 10 | 66.29 nanograms per milliliter (ng/mL) | Standard Deviation 53.604 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (0h-1h), n=1, 3 | 604 nanograms per milliliter (ng/mL) | Standard Deviation 392.763 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (0h-1h), n=2, 6 | 553 nanograms per milliliter (ng/mL) | Standard Deviation 536.451 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (1h-4h), n=35, 42 | 445.18 nanograms per milliliter (ng/mL) | Standard Deviation 314.624 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (8h-20h), n=1, 2 | 192.5 nanograms per milliliter (ng/mL) | Standard Deviation 94.045 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (4h-8h), n=0, 3 | 221.33 nanograms per milliliter (ng/mL) | Standard Deviation 191.996 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (1h-4h), n=46, 52 | 591.07 nanograms per milliliter (ng/mL) | Standard Deviation 402.442 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 1 (8h-20h), n=0, 1 | NA nanograms per milliliter (ng/mL) | — |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 12 (Predose [20-28h]), n=26, 35 | 142.59 nanograms per milliliter (ng/mL) | Standard Deviation 178.252 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Day 2 Predose (20-28h), n=36, 43 | 123.89 nanograms per milliliter (ng/mL) | Standard Deviation 257.575 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 (4h-8h), n=22, 19 | 411.68 nanograms per milliliter (ng/mL) | Standard Deviation 251.604 |
| GSK2336805 60 mg, Genotype 1 HCV | Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12 | Week 4 Predose (20-28h), n=33, 42 | 146.85 nanograms per milliliter (ng/mL) | Standard Deviation 243.331 |
Secondary
Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)
Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA \<LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA \<LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA \<LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA \<LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.
Time frame: From the start of the treatment up to PT FU Week 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | RVR | 23 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 with RGT | 17 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | cEVR | 33 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 | 27 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR12 | 30 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | vRVR | 8 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 | 25 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 with RGT | 17 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | RVR | 23 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | cEVR | 30 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR12 | 26 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | vRVR | 12 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 with RGT | 9 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | vRVR | 8 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR12 | 10 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | RVR | 10 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 | 10 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | cEVR | 11 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 with RGT | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | vRVR | 6 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | cEVR | 13 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR12 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | SVR24 | 0 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT) | RVR | 9 Participants |
Secondary
Number of Participants With Any AEs and Any SAEs After Week 12
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
Time frame: From Week 12 up to PT Week 24 FU
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any SAE | 2 Participants |
| GSK2336805 40 mg, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any AE | 21 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any SAE | 1 Participants |
| GSK2336805 60 mg, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any AE | 22 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any SAE | 0 Participants |
| Telaprevir, Genotype 1 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any AE | 8 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any AE | 9 Participants |
| GSK2336805 60 mg, Genotype 4 HCV | Number of Participants With Any AEs and Any SAEs After Week 12 | Any SAE | 0 Participants |
Secondary
Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4
Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.
Time frame: Week 4 (24 h post dose)
Population: Intensive PK Summary Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GSK2336805 40 mg, Genotype 1 HCV | Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4 | 2 hour |
| GSK2336805 60 mg, Genotype 1 HCV | Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4 | 2 hour |