Hepatitis C, Chronic
Conditions
Keywords
hepatitis C, ribavirin, Hepatitis C-related thrombocytopenia, thrombopoietin, peginterferon alfa-2b, platelets
Brief summary
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).
Interventions
DRUGeltrombopag
double-blind active treatment daily oral administation at dose of 25, 50, 75, or 100 mg
DRUGplacebo
double-blind matched placebo control daily oral administration
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female subjects, \>18 years Evidence of chronic hepatitis C virus (HCV) infection Subjects who are appropriate candidates for peginterferon (pegIFN) and ribavirin antiviral therapy A platelet count of \<75,000/mcL Haemoglobin \>11.0g/dL for men or \>10.0g/dL for women Absolute neutrophil count (ANC) \>750/mm3 and no history of infections associated with neutropenia Creatinine clearance \>50mL/minute All fertile males and females must use two forms of effective contraception between them during treatment and during the 24 weeks after treatment end Subject is able to understand, consent and comply with protocol requirements and instructions and is likely to complete the study as planned
Exclusion criteria
Non-responders to previous treatment with pegIFN and ribavirin who failed to achieve a sustained virologic response (SVR) for reasons other than thrombocytopenia, despite an optimal course (dose and duration) of combination therapy with pegIFN and ribavirin Decompensated liver disease, e.g. Child-Pugh score \>6 or history of ascites or hepatic encephalopathy or current evidence of ascites Known hypersensitivity, intolerance or allergy to interferon (IFN), ribavirin, eltrombopag or any of their ingredients Serious cardiac, cerebrovascular, or pulmonary disease that would preclude treatment with pegIFN and ribavirin Subjects with a history of any one of the following: Suicide attempt or hospitalisation for depression in the past 5 years Any current severe or poorly controlled psychiatric disorder The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional: * Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago * Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk of thromboembolic events, or corrected QT interval (QTc) \>450 msec Evidence of hepatocellular carcinoma Laboratory evidence of infection with human immunodeficiency virus (HIV) or active Hepatitis B Virus (HBV) infection Any disease condition associated with active bleeding or requiring anticoagulation with heparin or warfarin Therapy with any anti-neoplastic or immuno-modulatory treatment \<6 months prior to the first dose of eltrombopag. Subjects who have had a malignancy diagnosed and/or treated within the past 5 years, except for subjects with localised basal or squamous cell carcinoma treated by local excision or subjects with malignancies who have been adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival Pregnant or nursing women Males with a female partner who is pregnant History of alcohol/drug abuse or dependence within 6 months of the study start (unless participating in a controlled rehabilitation programme) Treatment with an investigational drug or IFN within 30 days or 5 half-lives (whichever is longer) of the screening visit History of platelet clumping that prevents reliable measurement of platelet counts History of major organ transplantation with an existing functional graft Thyroid dysfunction not adequately controlled Subjects planning to have cataract surgery Evidence of portal vein thrombosis on abdominal imaging within 3 months of the baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | From Baseline up to Week 9 in the OL Phase | Participants were assessed for a shift from a baseline platelet count of \<75 Gi/L to a count \>=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw. |
| Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | From Baseline up to Week 9 in the OL Phase | In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<100 Gi/L. Participants who achieved platelet counts \>=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase. |
| Median Platelet Count at the Indicated Time Points During the OL Phase | OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82) | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. |
| Median Platelet Count at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. |
| Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L. |
| Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12. |
| Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment. |
| Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment. |
| Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin. |
| Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction. |
| Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved. |
| Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3. |
| Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0. |
| Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening. |
| Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral. |
| Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72) | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. |
| Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment (up to Week 52); and 24-week FU (up to Week 72) | Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
| Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. |
Countries
Australia, Belgium, Brazil, Canada, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Pakistan, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Taiwan, Ukraine, United States
Participant flow
Pre-assignment details
The number of enrolled participants in the protocol record (n=759) reflects the number of participants randomized to double-blind treatment after completing the Open-label Phase.
Participants by arm
| Arm | Count |
|---|---|
| Placebo+Antiviral Therapy: DB Phase Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). | 253 |
| Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3). | 506 |
| Total | 759 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-bilnd Antiviral Treatment Phase | Adverse Event | 0 | 10 | 27 |
| Double-bilnd Antiviral Treatment Phase | Lost to Follow-up | 0 | 15 | 48 |
| Double-bilnd Antiviral Treatment Phase | Physician Decision | 0 | 5 | 8 |
| Double-bilnd Antiviral Treatment Phase | Protocol Violation | 0 | 1 | 0 |
| Double-bilnd Antiviral Treatment Phase | Withdrawal by Subject | 0 | 17 | 19 |
| Open-label Pre-Antiviral Treatment Phase | Adverse Event | 5 | 0 | 0 |
| Open-label Pre-Antiviral Treatment Phase | Insufficient Platelet Response | 13 | 0 | 0 |
| Open-label Pre-Antiviral Treatment Phase | Lost to Follow-up | 12 | 0 | 0 |
| Open-label Pre-Antiviral Treatment Phase | Physician Decision | 8 | 0 | 0 |
| Open-label Pre-Antiviral Treatment Phase | Protocol Violation | 5 | 0 | 0 |
| Open-label Pre-Antiviral Treatment Phase | Withdrawal by Subject | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo+Antiviral Therapy: DB Phase | Eltrombopag+Antiviral Therapy: DB Phase | Total |
|---|---|---|---|
| Age Continuous | 52.0 Years STANDARD_DEVIATION 9.15 | 52.4 Years STANDARD_DEVIATION 8.61 | 52.3 Years STANDARD_DEVIATION 8.79 |
| Baseline HCV Ribonucleic Acid (RNA) | 1656788.0 International Units per milliliter STANDARD_DEVIATION 2564763.45 | 1702729.6 International Units per milliliter STANDARD_DEVIATION 3066411.11 | 1687415.8 International Units per milliliter STANDARD_DEVIATION 2907191.97 |
| Baseline Platelet Count | 56.56 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.571 | 56.85 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.311 | 56.75 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.39 |
| Number of participants categorized into the indicated Child-Pugh (CP) Class Class A | 242 participants | 487 participants | 729 participants |
| Number of participants categorized into the indicated Child-Pugh (CP) Class Class B | 11 participants | 17 participants | 28 participants |
| Number of participants categorized into the indicated Child-Pugh (CP) Class Class C | 0 participants | 0 participants | 0 participants |
| Number of participants categorized into the indicated Child-Pugh (CP) Class Missing | 0 participants | 2 participants | 2 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 1 | 160 participants | 320 participants | 480 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 2 | 28 participants | 40 participants | 68 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 3 | 47 participants | 113 participants | 160 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 4 | 17 participants | 30 participants | 47 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 5 | 0 participants | 0 participants | 0 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 6 | 0 participants | 1 participants | 1 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 7 | 0 participants | 0 participants | 0 participants |
| Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Missing | 1 participants | 2 participants | 3 participants |
| Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT) Elevated | 204 participants | 393 participants | 597 participants |
| Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT) Normal | 49 participants | 113 participants | 162 participants |
| Number of participants with or without previous interferon (IFN) use Experienced | 71 participants | 159 participants | 230 participants |
| Number of participants with or without previous interferon (IFN) use Naïve | 182 participants | 347 participants | 529 participants |
| Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Missing | 35 participants | 55 participants | 90 participants |
| Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Score: F0/F1/F2 | 19 participants | 46 participants | 65 participants |
| Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Score: F3/F4 | 199 participants | 405 participants | 604 participants |
| Race/Ethnicity, Customized African A/African and A Indian/Alaska Native and W | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized African American (A)/African | 4 participants | 8 participants | 12 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native and White | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Central/South Asian | 16 participants | 43 participants | 59 participants |
| Race/Ethnicity, Customized Japanese/East Asian /South East Asian | 45 participants | 64 participants | 109 participants |
| Race/Ethnicity, Customized White (W) | 188 participants | 388 participants | 576 participants |
| Sex: Female, Male Female | 93 Participants | 185 Participants | 278 Participants |
| Sex: Female, Male Male | 160 Participants | 321 Participants | 481 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 805 | 226 / 252 | 459 / 506 |
| serious Total, serious adverse events | 9 / 805 | 49 / 252 | 119 / 506 |
Outcome results
Primary
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase
Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | 32 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | 97 participants |
p-value: 0.020295% CI: [1.2, 10.9]Cochran-Mantel-Haenszel
Secondary
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase
The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | End of Treatment, n=240, 468 | -1.16 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.553 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 1, n=248, 490 | -0.23 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.771 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 2, n=244, 493 | -0.31 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.691 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 4, n=229, 486 | -0.46 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.823 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 6, n=207, 474 | -0.50 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.871 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 8, n=191, 471 | -0.66 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.967 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 12, n=175, 451 | -0.77 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.055 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 16, n=145, 404 | -0.85 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.158 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 20, n=134, 376 | -1.11 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.324 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 24, n=99, 264 | -1.46 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.509 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 28, n=74, 211 | -1.67 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.731 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 32, n=67, 199 | -1.64 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.586 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 36, n=63, 187 | -1.65 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.703 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 40, n=59, 173 | -1.81 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.671 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 44, n=59, 167 | -1.73 Kilograms per meters squared (kg/m^2) | Standard Deviation 2.007 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 4-week FU, n=223, 423 | -0.98 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.519 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 12-week FU, n=210, 432 | -0.70 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.434 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 24-week FU, n=205, 399 | -0.47 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.544 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 40, n=59, 173 | -2.09 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.953 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | End of Treatment, n=240, 468 | -1.64 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.783 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 24, n=99, 264 | -1.66 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.624 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 1, n=248, 490 | -0.23 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.713 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 24-week FU, n=205, 399 | -0.53 Kilograms per meters squared (kg/m^2) | Standard Deviation 2.736 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 2, n=244, 493 | -0.36 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.921 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 28, n=74, 211 | -1.79 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.733 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 4, n=229, 486 | -0.45 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.855 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 44, n=59, 167 | -2.09 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.942 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 6, n=207, 474 | -0.58 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.893 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 32, n=67, 199 | -1.94 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.844 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 8, n=191, 471 | -0.73 Kilograms per meters squared (kg/m^2) | Standard Deviation 0.955 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 12-week FU, n=210, 432 | -1.06 Kilograms per meters squared (kg/m^2) | Standard Deviation 2.055 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 12, n=175, 451 | -0.97 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.167 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 36, n=63, 187 | -1.89 Kilograms per meters squared (kg/m^2) | Standard Deviation 2.651 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 16, n=145, 404 | -1.15 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.285 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | 4-week FU, n=223, 423 | -1.35 Kilograms per meters squared (kg/m^2) | Standard Deviation 2.306 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase | Week 20, n=134, 376 | -1.39 Kilograms per meters squared (kg/m^2) | Standard Deviation 1.377 |
Secondary
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase
Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 1, n=244, 490 | 1.16 beats per minute | Standard Deviation 8.358 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 2, n=242, 490 | 1.89 beats per minute | Standard Deviation 8.51 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 4, n=227, 483 | 2.47 beats per minute | Standard Deviation 9.464 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 6, n=205, 470 | 3.23 beats per minute | Standard Deviation 9.158 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 8, n=190, 472 | 2.91 beats per minute | Standard Deviation 9.751 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 12, n=174, 450 | 4.28 beats per minute | Standard Deviation 10.188 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 16, n=143, 403 | 5.87 beats per minute | Standard Deviation 9.975 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 20, n=132, 371 | 5.73 beats per minute | Standard Deviation 9.688 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 24, n=99, 262 | 3.77 beats per minute | Standard Deviation 9.912 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 28, n=74, 211 | 2.72 beats per minute | Standard Deviation 10.038 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 32, n=67, 196 | 4.28 beats per minute | Standard Deviation 8.281 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 36, n=62, 186 | 5.42 beats per minute | Standard Deviation 10.109 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 40, n=59, 171 | 4.83 beats per minute | Standard Deviation 8.919 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 44, n=59, 165 | 5.53 beats per minute | Standard Deviation 11.005 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | End of Treatment, n=237, 467 | 4.01 beats per minute | Standard Deviation 10.606 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 4-week FU, n=220, 422 | 4.27 beats per minute | Standard Deviation 10.432 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 12-week FU, n=206, 429 | 1.73 beats per minute | Standard Deviation 9.707 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 24-week FU, n=202, 395 | 0.14 beats per minute | Standard Deviation 9.803 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 44, n=59, 165 | 1.16 beats per minute | Standard Deviation 8.846 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 1, n=244, 490 | -0.43 beats per minute | Standard Deviation 8.629 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 28, n=74, 211 | 1.64 beats per minute | Standard Deviation 10.328 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 2, n=242, 490 | 0.78 beats per minute | Standard Deviation 9.644 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 24-week FU, n=202, 395 | -1.90 beats per minute | Standard Deviation 9.176 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 4, n=227, 483 | 1.50 beats per minute | Standard Deviation 9.739 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 32, n=67, 196 | 1.62 beats per minute | Standard Deviation 9.676 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 6, n=205, 470 | 1.19 beats per minute | Standard Deviation 8.708 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | End of Treatment, n=237, 467 | 2.89 beats per minute | Standard Deviation 11.134 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 8, n=190, 472 | 1.78 beats per minute | Standard Deviation 9.227 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 36, n=62, 186 | 2.11 beats per minute | Standard Deviation 10.205 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 12, n=174, 450 | 2.02 beats per minute | Standard Deviation 9.539 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 12-week FU, n=206, 429 | 0.74 beats per minute | Standard Deviation 9.955 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 16, n=143, 403 | 2.38 beats per minute | Standard Deviation 10.419 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 40, n=59, 171 | 0.78 beats per minute | Standard Deviation 9.895 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 20, n=132, 371 | 2.10 beats per minute | Standard Deviation 9.53 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | 4-week FU, n=220, 422 | 2.11 beats per minute | Standard Deviation 10.113 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase | Week 24, n=99, 262 | 2.03 beats per minute | Standard Deviation 9.399 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase
Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 1, n=246, 491 | -1.43 Millimeters of mercury (mmHg) | Standard Deviation 9.235 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 8, n=190, 472 | -2.72 Millimeters of mercury (mmHg) | Standard Deviation 14.073 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 2, n=242, 493 | -1.55 Millimeters of mercury (mmHg) | Standard Deviation 9.217 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 28, n=74, 211 | -0.69 Millimeters of mercury (mmHg) | Standard Deviation 14.663 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 4, n=228, 485 | -1.84 Millimeters of mercury (mmHg) | Standard Deviation 9.726 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 4, n=228, 485 | -3.75 Millimeters of mercury (mmHg) | Standard Deviation 13.781 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 6, n=206, 471 | -2.16 Millimeters of mercury (mmHg) | Standard Deviation 8.939 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 32, n=67, 197 | -1.46 Millimeters of mercury (mmHg) | Standard Deviation 13.904 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 8, n=190, 472 | -1.24 Millimeters of mercury (mmHg) | Standard Deviation 9.517 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 12, n=175, 452 | -2.16 Millimeters of mercury (mmHg) | Standard Deviation 15.297 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 12, n=175, 452 | -1.31 Millimeters of mercury (mmHg) | Standard Deviation 8.781 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 36, n=62, 186 | -1.31 Millimeters of mercury (mmHg) | Standard Deviation 13.803 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 16, n=143, 403 | -1.54 Millimeters of mercury (mmHg) | Standard Deviation 9.684 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 2, n=242, 494 | -3.25 Millimeters of mercury (mmHg) | Standard Deviation 13.8 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 20, n=133, 374 | -0.93 Millimeters of mercury (mmHg) | Standard Deviation 10.582 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 40, n=59, 173 | 0.10 Millimeters of mercury (mmHg) | Standard Deviation 13.605 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 24, n=99, 263 | -1.66 Millimeters of mercury (mmHg) | Standard Deviation 10.207 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 16, n=143, 403 | -3.16 Millimeters of mercury (mmHg) | Standard Deviation 15.426 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 28, n=74, 211 | -1.23 Millimeters of mercury (mmHg) | Standard Deviation 9.538 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 44, n=59, 167 | 0.56 Millimeters of mercury (mmHg) | Standard Deviation 11.689 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 32, n=67, 197 | -0.54 Millimeters of mercury (mmHg) | Standard Deviation 10.445 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 6, n=206, 471 | -3.36 Millimeters of mercury (mmHg) | Standard Deviation 14.405 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 36, n=62, 186 | -0.74 Millimeters of mercury (mmHg) | Standard Deviation 9.559 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, End of Treatment, n=238, 468 | -2.03 Millimeters of mercury (mmHg) | Standard Deviation 13.259 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 40, n=59, 173 | 0.34 Millimeters of mercury (mmHg) | Standard Deviation 9.343 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 20, n=133, 374 | -2.50 Millimeters of mercury (mmHg) | Standard Deviation 14.387 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 44, n=59, 167 | 0.92 Millimeters of mercury (mmHg) | Standard Deviation 9.033 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 12-week FU, n=207, 432 | -0.11 Millimeters of mercury (mmHg) | Standard Deviation 14.113 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, End of Treatment, n=238, 468 | -1.55 Millimeters of mercury (mmHg) | Standard Deviation 9.174 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 4-week FU, n=221, 426 | -1.14 Millimeters of mercury (mmHg) | Standard Deviation 14.095 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 4-week FU, n=221, 426 | -0.83 Millimeters of mercury (mmHg) | Standard Deviation 9.102 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 24-week FU, n=203, 398 | 1.10 Millimeters of mercury (mmHg) | Standard Deviation 14.545 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 12-week FU, n=207, 432 | -0.78 Millimeters of mercury (mmHg) | Standard Deviation 10.253 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 24, n=99, 263 | -1.97 Millimeters of mercury (mmHg) | Standard Deviation 14.82 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 24-week FU, n=203, 398 | 0.03 Millimeters of mercury (mmHg) | Standard Deviation 9.814 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 1, n=246, 491 | -3.00 Millimeters of mercury (mmHg) | Standard Deviation 13.541 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 24-week FU, n=203, 398 | -1.61 Millimeters of mercury (mmHg) | Standard Deviation 9.339 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 4-week FU, n=221, 426 | -1.65 Millimeters of mercury (mmHg) | Standard Deviation 15.122 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 1, n=246, 491 | -2.36 Millimeters of mercury (mmHg) | Standard Deviation 12.296 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 2, n=242, 494 | -3.74 Millimeters of mercury (mmHg) | Standard Deviation 13.122 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 4, n=228, 485 | -3.91 Millimeters of mercury (mmHg) | Standard Deviation 13.78 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 6, n=206, 471 | -3.85 Millimeters of mercury (mmHg) | Standard Deviation 14.624 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 8, n=190, 472 | -4.33 Millimeters of mercury (mmHg) | Standard Deviation 14.401 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 12, n=175, 452 | -4.30 Millimeters of mercury (mmHg) | Standard Deviation 14.377 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 16, n=143, 403 | -4.59 Millimeters of mercury (mmHg) | Standard Deviation 13.579 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 20, n=133, 374 | -4.12 Millimeters of mercury (mmHg) | Standard Deviation 14.908 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 24, n=99, 263 | -3.94 Millimeters of mercury (mmHg) | Standard Deviation 14.917 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 28, n=74, 211 | -4.99 Millimeters of mercury (mmHg) | Standard Deviation 14.557 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 32, n=67, 197 | -5.61 Millimeters of mercury (mmHg) | Standard Deviation 13.523 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 36, n=62, 186 | -4.40 Millimeters of mercury (mmHg) | Standard Deviation 14.842 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 40, n=59, 173 | -4.31 Millimeters of mercury (mmHg) | Standard Deviation 13.941 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, Week 44, n=59, 167 | -4.54 Millimeters of mercury (mmHg) | Standard Deviation 13.794 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, End of Treatment, n=238, 468 | -3.98 Millimeters of mercury (mmHg) | Standard Deviation 15.318 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 12-week FU, n=207, 432 | -0.86 Millimeters of mercury (mmHg) | Standard Deviation 14.806 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | SBP, 24-week FU, n=203, 398 | 0.25 Millimeters of mercury (mmHg) | Standard Deviation 14.518 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 1, n=246, 491 | -1.37 Millimeters of mercury (mmHg) | Standard Deviation 8.224 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 2, n=242, 493 | -1.86 Millimeters of mercury (mmHg) | Standard Deviation 8.946 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 4, n=228, 485 | -2.72 Millimeters of mercury (mmHg) | Standard Deviation 9.467 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 6, n=206, 471 | -2.95 Millimeters of mercury (mmHg) | Standard Deviation 9.859 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 8, n=190, 472 | -2.68 Millimeters of mercury (mmHg) | Standard Deviation 9.901 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 12, n=175, 452 | -3.23 Millimeters of mercury (mmHg) | Standard Deviation 10.025 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 16, n=143, 403 | -3.31 Millimeters of mercury (mmHg) | Standard Deviation 9.899 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 20, n=133, 374 | -3.08 Millimeters of mercury (mmHg) | Standard Deviation 9.606 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 24, n=99, 263 | -3.54 Millimeters of mercury (mmHg) | Standard Deviation 9.313 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 28, n=74, 211 | -3.42 Millimeters of mercury (mmHg) | Standard Deviation 10.502 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 32, n=67, 197 | -3.76 Millimeters of mercury (mmHg) | Standard Deviation 9.527 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 36, n=62, 186 | -3.59 Millimeters of mercury (mmHg) | Standard Deviation 9.211 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 40, n=59, 173 | -3.32 Millimeters of mercury (mmHg) | Standard Deviation 9.517 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, Week 44, n=59, 167 | -3.77 Millimeters of mercury (mmHg) | Standard Deviation 10.134 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, End of Treatment, n=238, 468 | -3.59 Millimeters of mercury (mmHg) | Standard Deviation 10.254 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 4-week FU, n=221, 426 | -2.20 Millimeters of mercury (mmHg) | Standard Deviation 9.824 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DBP, 12-week FU, n=207, 432 | -1.76 Millimeters of mercury (mmHg) | Standard Deviation 9.903 |
Secondary
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase
The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.
Time frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 16, n=145, 406 | -2.37 Kilograms (kg) | Standard Deviation 3.247 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 1, n=248, 492 | -0.65 Kilograms (kg) | Standard Deviation 2.201 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 2, n=244, 495 | -0.88 Kilograms (kg) | Standard Deviation 1.983 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 4, n=229, 488 | -1.30 Kilograms (kg) | Standard Deviation 2.374 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 6, n=207, 476 | -1.42 Kilograms (kg) | Standard Deviation 2.464 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 8, n=191, 473 | -1.89 Kilograms (kg) | Standard Deviation 2.793 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 12, n=175, 453 | -2.18 Kilograms (kg) | Standard Deviation 2.985 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 20, n=134, 378 | -3.08 Kilograms (kg) | Standard Deviation 3.684 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 24, n=99, 265 | -4.04 Kilograms (kg) | Standard Deviation 4.148 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 28, n=74, 212 | -4.57 Kilograms (kg) | Standard Deviation 4.749 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 32, n=67, 200 | -4.50 Kilograms (kg) | Standard Deviation 4.397 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 36, n=63, 188 | -4.54 Kilograms (kg) | Standard Deviation 4.739 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 40, n=59, 174 | -4.99 Kilograms (kg) | Standard Deviation 4.612 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 44, n=59, 168 | -4.79 Kilograms (kg) | Standard Deviation 5.475 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | End of Treatment, n=240, 470 | -3.28 Kilograms (kg) | Standard Deviation 4.361 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 4-week FU, n=223, 425 | -2.78 Kilograms (kg) | Standard Deviation 4.318 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 12-week FU, n=210, 434 | -1.98 Kilograms (kg) | Standard Deviation 4.088 |
| Placebo+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 24-week FU, n=205, 401 | -1.36 Kilograms (kg) | Standard Deviation 4.568 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 44, n=59, 168 | -5.89 Kilograms (kg) | Standard Deviation 5.661 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 28, n=74, 212 | -5.09 Kilograms (kg) | Standard Deviation 5.016 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 1, n=248, 492 | -0.68 Kilograms (kg) | Standard Deviation 2.062 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 24-week FU, n=205, 401 | -1.51 Kilograms (kg) | Standard Deviation 7.683 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 2, n=244, 495 | -1.06 Kilograms (kg) | Standard Deviation 2.809 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 32, n=67, 200 | -5.52 Kilograms (kg) | Standard Deviation 5.369 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 4, n=229, 488 | -1.30 Kilograms (kg) | Standard Deviation 2.488 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | End of Treatment, n=240, 470 | -4.69 Kilograms (kg) | Standard Deviation 5.18 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 6, n=207, 476 | -1.68 Kilograms (kg) | Standard Deviation 2.652 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 36, n=63, 188 | -5.39 Kilograms (kg) | Standard Deviation 7.476 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 8, n=191, 473 | -2.11 Kilograms (kg) | Standard Deviation 2.81 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 12-week FU, n=210, 434 | -2.99 Kilograms (kg) | Standard Deviation 5.999 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 12, n=175, 453 | -2.83 Kilograms (kg) | Standard Deviation 3.44 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 16, n=145, 406 | -3.32 Kilograms (kg) | Standard Deviation 3.798 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 40, n=59, 174 | -5.87 Kilograms (kg) | Standard Deviation 5.571 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 20, n=134, 378 | -3.99 Kilograms (kg) | Standard Deviation 4.04 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | 4-week FU, n=223, 425 | -3.84 Kilograms (kg) | Standard Deviation 6.381 |
| Eltrombopag+Antiviral Therapy: DB Phase | Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase | Week 24, n=99, 265 | -4.75 Kilograms (kg) | Standard Deviation 4.175 |
Secondary
Median Platelet Count at the Indicated Time Points During the DB Phase
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
Time frame: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)
Population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 40, n=58, 174 | 53.7 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 1, n=247, 494 | 120.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Last on Treatment, n=253, 505 | 50.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 2, n=244, 492 | 89.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 36, n=63, 185 | 50.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 4, n=228, 487 | 51.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 4 week follow up, n=221, 424 | 63.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 6, n=206, 473 | 49.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 44, n=59, 168 | 53.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 8, n=192, 473 | 50.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 12 week follow up, n=209, 430 | 57.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 16, n=145, 405 | 48.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 20, n=134, 378 | 50.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 24 week follow up, n=201, 395 | 57.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 24, n=99, 263 | 49.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | End of Treatment/Withdrawal, n=240, 468 | 51.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 28, n=74, 212 | 52.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Baseline, n=238, 460 | 140.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 32, n=67, 199 | 49.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 12, n=176, 451 | 49.7 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 32, n=67, 199 | 107.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 12, n=176, 451 | 104.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 36, n=63, 185 | 106.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 40, n=58, 174 | 106.5 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 44, n=59, 168 | 108.7 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | End of Treatment/Withdrawal, n=240, 468 | 106.5 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Last on Treatment, n=253, 505 | 105.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 4 week follow up, n=221, 424 | 89.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 12 week follow up, n=209, 430 | 62.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | 24 week follow up, n=201, 395 | 59.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Baseline, n=238, 460 | 136.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 1, n=247, 494 | 116.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 2, n=244, 492 | 124.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 4, n=228, 487 | 105 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 6, n=206, 473 | 100.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 8, n=192, 473 | 100.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 16, n=145, 405 | 102.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 20, n=134, 378 | 103.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 24, n=99, 263 | 102.0 Gi/L |
| Eltrombopag+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the DB Phase | Week 28, n=74, 212 | 102.0 Gi/L |
Secondary
Median Platelet Count at the Indicated Time Points During the OL Phase
Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.
Time frame: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)
Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Baseline, n=797 | 59.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Day 1, n=714 | 58.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 1, n=791 | 77.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 2, n=530 | 93.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 3, n=288 | 89.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 4, n=161 | 90.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 5, n=98 | 92.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 8, n=24 | 87.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 9, n=4 | 85.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Antiviral Baseline, n=48 | 131.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | End of Treatment/Withdrawal, n=22 | 76.5 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Last on Treatment, n=39 | 87.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 4 Follow-Up, n=20 | 42.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 12 Follow-Up, n=15 | 43.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 24 Follow-Up, n=14 | 41.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 6, n=55 | 86.0 Gi/L |
| Placebo+Antiviral Therapy: DB Phase | Median Platelet Count at the Indicated Time Points During the OL Phase | Week 7, n=35 | 78.0 Gi/L |
Secondary
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.
Time frame: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Normal, n=252, 505 | 113 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Abnormal - NCS, n=218, 428 | 62 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Abnormal - CS, n=218, 428 | 22 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Normal, n=194, 383 | 123 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Abnormal - NCS, n=194, 383 | 49 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Abnormal - CS, n=194, 383 | 22 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Abnormal - NCS, n=252, 505 | 91 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Abnormal - CS, n=252, 505 | 48 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Normal, n=232, 478 | 147 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Abnormal - NCS, n=232, 478 | 63 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Abnormal - CS, n=232, 478 | 22 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Normal, n=218, 428 | 134 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Normal, n=252, 505 | 233 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Normal, n=218, 428 | 291 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Normal, n=232, 478 | 332 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Abnormal - NCS, n=218, 428 | 103 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Abnormal - NCS, n=252, 505 | 171 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | End of Treatment, Abnormal - CS, n=218, 428 | 34 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Abnormal - CS, n=232, 478 | 43 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Normal, n=194, 383 | 238 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Worst ECG post-BL, Abnormal - CS, n=252, 505 | 101 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Abnormal - NCS, n=194, 383 | 107 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | Antiviral BL, Abnormal - NCS, n=232, 478 | 103 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | 24-week FU, Abnormal - CS, n=194, 383 | 38 participants |
Secondary
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3)
There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CC), R; n=12, 50 | 10 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CC), NR; n=105, 205 | 24 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CT), R; n=12, 50 | 2 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (TT), R; n=12, 50 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (TT), NR; n=105, 205 | 21 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (TT), NR; n=105, 205 | 48 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GT), R; n=12, 50 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GT), NR; n=105, 205 | 51 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GG), R; n=12, 50 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GG), NR; n=105, 205 | 6 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CT), R; n=11, 33 | 5 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (TT), R; n=11, 33 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (TT), R, n=11, 33 | 9 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (TT), NR; n=106, 222 | 50 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GT), NR; n=106, 222 | 50 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GG), R; n=11, 33 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GG), R; n=106, 222 | 6 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CT), NR; n=105, 205 | 60 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (TT), R; n=12, 50 | 11 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CC), R; n=11, 33 | 6 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CC), NR; n=106, 222 | 28 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CT), NR; n=106, 222 | 57 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (TT), NR; n=106, 222 | 21 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GT), R; n=11, 33 | 2 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CT), NR; n=106, 222 | 118 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CC), R; n=12, 50 | 28 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GG), R; n=11, 33 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CC), NR; n=105, 205 | 58 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (TT), R; n=11, 33 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CT), R; n=12, 50 | 18 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (CT), NR; n=105, 205 | 111 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (TT), NR; n=106, 222 | 39 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (TT), R; n=12, 50 | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CC), NR; n=106, 222 | 65 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs12979860 (TT), NR; n=105, 205 | 36 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (TT), R; n=12, 50 | 36 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (TT), R, n=11, 33 | 28 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (TT), NR; n=105, 205 | 89 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GG), R; n=106, 222 | 18 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GT), R; n=12, 50 | 13 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (TT), NR; n=106, 222 | 97 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GT), NR; n=105, 205 | 99 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CC), R; n=11, 33 | 21 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GG), R; n=12, 50 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GT), NR; n=106, 222 | 107 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | SVR, rs8099917 (GG), NR; n=105, 205 | 17 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs8099917 (GT), R; n=11, 33 | 5 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) | RVR, rs12979860 (CT), R; n=11, 33 | 11 participants |
Secondary
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase
Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 2 | 40 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 1 | 76 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 3 | 34 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | >3 | 35 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 0 | 68 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | >3 | 52 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 0 | 231 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 3 | 47 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 1 | 101 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | 2 | 75 participants |
Secondary
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication
Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: Safety DB Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral CP, Genotype 2/3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral CP, Non-genotype 2/3 | 4 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral CP, Genotype 2/3 | 3 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral CP, Non-genotype 2/3 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral IP, Genotype 2/3 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral IP, Non-genotype 2/3 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral IP, Genotype 2/3 | 3 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral IP, Non-genotype 2/3 | 3 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral IP, Non-genotype 2/3 | 10 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral CP, Genotype 2/3 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral IP, Genotype 2/3 | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral CP, Non-genotype 2/3 | 6 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral IP, Genotype 2/3 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral CP, Genotype 2/3 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Unilateral IP, Non-genotype 2/3 | 6 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication | Bilateral CP, Non-genotype 2/3 | 7 participants |
Secondary
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy
The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | <25 Gi/L | 34 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=25 to <50 Gi/L | 159 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=50 to <90 Gi/L | 49 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=90 to <150 Gi/L | 10 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=150 to <200 Gi/L | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=200 to <400 Gi/L | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=400 Gi/L | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | Missing | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | Missing | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | <25 Gi/L | 20 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=150 to <200 Gi/L | 8 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=25 to <50 Gi/L | 76 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=400 Gi/L | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=50 to <90 Gi/L | 263 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=200 to <400 Gi/L | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | >=90 to <150 Gi/L | 135 participants |
Secondary
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase
In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<100 Gi/L. Participants who achieved platelet counts \>=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.
Time frame: From Baseline up to Week 9 in the OL Phase
Population: Safety Population. Participants with a platelet count \>=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | 25 mg | 443 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | 50 mg | 208 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | 75 mg | 77 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | 100 mg | 31 participants |
Secondary
Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase
The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | 164 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | 242 participants |
Secondary
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase
Participants were assessed for a shift from a baseline platelet count of \<75 Gi/L to a count \>=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.
Time frame: From Baseline up to Week 9 in the OL Phase
Population: Safety Population: all participants who had received study drug in the OL Phase
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | 773 participants |
Secondary
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase
Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. Not applicable indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.
Time frame: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)
Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, CS change from BL, n=218, 428 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | 24-week FU, CS change from BL, n=194, 383 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, NCS change from BL, n=218, 428 | 218 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | 24-week FU, NCS change from BL, n=194, 383 | 193 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, Not applicable, n=218, 428 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | 24-week FU, NCS change from BL, n=194, 383 | 379 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, NCS change from BL, n=218, 428 | 420 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, Not applicable, n=218, 428 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | 24-week FU, CS change from BL, n=194, 383 | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment, CS change from BL, n=218, 428 | 7 participants |
Secondary
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase
EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | EVR | 103 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | cEVR | 57 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | EVR | 313 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | cEVR | 174 participants |
Secondary
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase
ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | SVR12 | 29 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | ETR | 59 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | ETR | 190 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | SVR12 | 106 participants |
Secondary
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase
RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | RVR | 34 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | eRVR | 27 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | RVR | 78 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | eRVR | 69 participants |
Secondary
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase
The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population. One participant could have had more than one dose reduction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | <=25% | 44 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >25% to <=34% | 33 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >34% to <=50% | 115 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >50% | 33 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >50% | 30 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | <=25% | 89 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >34% to <=50% | 112 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | >25% to <=34% | 35 participants |
Secondary
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS)
Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: Safety DB Population: all randomized participants who had received study drug in the DB Phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G1 | 17 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G1 | 140 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G2 | 42 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G3 | 2 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G1 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G2 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Any Grade Increase | 31 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Any Grade Increase | 184 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G2 | 10 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G3 | 4 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G1 | 31 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G2 | 77 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G3 | 19 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G4 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Any Grade Increase | 3 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G1 | 2 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G2 | 1 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Any Grade Increase | 53 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G1 | 48 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Any Grade Increase | 14 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G1 | 14 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G2 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G4 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Any Grade Increase | 72 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G1 | 69 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G3 | 0 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Any Grade Increase | 2 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Any Grade Increase | 128 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G2 | 5 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G2 | 3 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G4 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G2 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Any Grade Increase | 374 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G2 | 3 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G1 | 246 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G3 | 44 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G3 | 2 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G3 | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G3 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G4 | 2 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Any Grade Increase | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G4 | 3 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G1 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G3 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G2 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Any Grade Increase | 74 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G3 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G4 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypercalcemia), Increase to G4 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G1 | 66 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Any Grade Increase | 90 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G2 | 6 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G1 | 45 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G4 | 1 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G2 | 31 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G3 | 2 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G3 | 9 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Any Grade Increase | 128 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hypoglycemia), Increase to G4 | 5 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Any Grade Increase | 277 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hypokalemia), Increase to G4 | 0 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G1 | 68 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Calcium (hypocalcemia), Increase to G2 | 122 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G2 | 161 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Any Grade Increase | 21 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G1 | 118 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Glu. (hyperglycemia), Increase to G4 | 4 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hypernatremia), Increase to G1 | 20 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Any Grade Increase | 15 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Sod. (hyponatremia), Increase to G2 | 8 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) | Pot. (hyperkalemia), Increase to G1 | 7 participants |
Secondary
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS
Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: Safety DB Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Any Grade Increase | 161 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G1 | 46 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G2 | 64 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G3 | 48 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G4 | 3 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Any Grade Increase | 136 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G1 | 16 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G2 | 38 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G3 | 48 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G4 | 34 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Any Grade Increase | 208 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G1 | 50 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G2 | 53 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G3 | 73 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G4 | 32 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Any Grade Increase | 191 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G1 | 56 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G2 | 69 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G3 | 58 participants |
| Placebo+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G4 | 8 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G2 | 145 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Any Grade Increase | 361 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Any Grade Increase | 394 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G1 | 112 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Any Grade Increase | 391 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G2 | 129 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G1 | 106 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G3 | 114 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G4 | 23 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Hemoglobin (anemia), Increase to G4 | 6 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G2 | 113 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Any Grade Increase | 346 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G1 | 113 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G1 | 43 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G3 | 128 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G2 | 80 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | WBC (leukocytopenia), Increase to G3 | 110 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G3 | 109 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Tot Neu. (neutropenia), Increase to G4 | 47 participants |
| Eltrombopag+Antiviral Therapy: DB Phase | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS | Lym. (lymphocytopenia), Increase to G4 | 114 participants |
Secondary
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase
Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.
Time frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)
Population: ITT Population. Only those participants with dose reductions were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo+Antiviral Therapy: DB Phase | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Peginterferon alfa-2a dose reduction, n=171, 208 | 6.58 weeks | Standard Deviation 7.336 |
| Placebo+Antiviral Therapy: DB Phase | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Ribavirin dose reduction, n=79, 189 | 12.43 weeks | Standard Deviation 9.681 |
| Eltrombopag+Antiviral Therapy: DB Phase | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Peginterferon alfa-2a dose reduction, n=171, 208 | 10.64 weeks | Standard Deviation 9.305 |
| Eltrombopag+Antiviral Therapy: DB Phase | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | Ribavirin dose reduction, n=79, 189 | 10.99 weeks | Standard Deviation 8.984 |