Hepatitis C Virus
Conditions
Brief summary
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Detailed description
US National Institutes of Health Division of AIDs (DAIDS)
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subject chronically infected with HCV genotype 1 (GT-1) * Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A) * HCV RNA ≥ 10,000 IU/mL at screening * Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.) * Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Exclusion criteria
* Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair; * Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening; * Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed); * Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort | Post treatment Week 12 | Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment) | Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24). |
| Percentage of Participants Who Achieved HCV RNA < LLOQ TND | On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment) | Percentage of treated participants with HCV RNA \< LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24. |
| Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | Up to post treatment week 4 | SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect. |
| Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline | Up to post treatment week 4 | Anemia was defined as hemoglobin \< 10 g/dL on-treatment for subjects who had hemoglobin \>= 10 g/dL at baseline. |
| Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b | Post treatment week 12 | Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported. |
| Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort | Post treatment Week 12 | Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA \< LLOQ target detected or target not detected (LLOQ TD/TND). |
| Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 | Post treatment Week 12 | Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported. |
| Number of Participants With Selected Grade 3/4 Laboratory Abnormalities | Post treatment week 4 | Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated |
| Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs | Up to post treatment week 4 | Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted. |
| Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Up to post treatment week 4 | Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted. |
| Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) | Post treatment Week 12 | Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported. |
Countries
Russia, South Korea, Taiwan
Participant flow
Pre-assignment details
Total of 169 subjects were treated; 138 treatment-naive and 31 treatment-experienced; 3 participants did not complete the treatment period (1 was lost to follow-up and 2 had withdrawn)
Participants by arm
| Arm | Count |
|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 Daclatasvir (DCV) 30 mg/ Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks | 138 |
| Treatment-Experianced: Daclatasvir (DCV) 30 mg / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks | 31 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Treatment-Naive: DCV/ASV/BMS-791325 | Treatment-Experianced: | Total |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 11.78 | 53.0 years STANDARD_DEVIATION 12.64 | 52.2 years STANDARD_DEVIATION 11.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 128 Participants | 31 Participants | 159 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 0 Participants | 10 Participants |
| Region of Enrollment Asia | 128 Participants | 31 Participants | 159 Participants |
| Region of Enrollment Europe | 10 Participants | 0 Participants | 10 Participants |
| Sex: Female, Male Female | 70 Participants | 11 Participants | 81 Participants |
| Sex: Female, Male Male | 68 Participants | 20 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 138 | 0 / 31 |
| other Total, other adverse events | 62 / 138 | 20 / 31 |
| serious Total, serious adverse events | 2 / 138 | 0 / 31 |
Outcome results
Primary
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Time frame: Post treatment Week 12
Population: Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach. (Exact binomial confidence interval reported)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort | 98.6 Percentage of Participants |
Secondary
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Time frame: Up to post treatment week 4
Population: Safety analysis population included participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | Serious Adverse Events | 2 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | AEs Leading to Discontinuation | 2 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | Deaths | 0 Participants |
| Treatment-Experianced: | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | Serious Adverse Events | 0 Participants |
| Treatment-Experianced: | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | AEs Leading to Discontinuation | 2 Participants |
| Treatment-Experianced: | Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment | Deaths | 0 Participants |
Secondary
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Time frame: Post treatment week 4
Population: Safety analysis population included participants who received at least 1 dose of study therapy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With Selected Grade 3/4 Laboratory Abnormalities | 16 Participants |
| Treatment-Experianced: | Number of Participants With Selected Grade 3/4 Laboratory Abnormalities | 5 Participants |
Secondary
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Time frame: Up to post treatment week 4
Population: Subgroup analysis set included participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs | Serious AEs | 0 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs | AEs leading to Discontinuation | 1 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs | Serious AEs | 2 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs | AEs leading to Discontinuation | 3 Participants |
Secondary
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Time frame: Up to post treatment week 4
Population: Subgroup analysis set included participants who received at least 1 dose of study therapy.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Aspartate Aminotransferase | 1 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Hemoglobin | 0 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Lymphocytes | 0 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Platelets | 1 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Lipase | 2 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | International Normalized Ratio | 1 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Neutrophils | 1 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Serum Glucose | 0 Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Alanine Aminotransferase | 1 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Serum Glucose | 1 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Alanine Aminotransferase | 6 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Aspartate Aminotransferase | 4 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Lipase | 2 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Lymphocytes | 3 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Neutrophils | 1 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Hemoglobin | 1 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | Platelets | 0 Participants |
| Treatment-Experianced: | Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities | International Normalized Ratio | 0 Participants |
Secondary
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Population: Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 8 | 99.3 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 4 | 97.8 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 6 | 100.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 8 | 98.6 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 12 | 100.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 24 | 96.4 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 4 | 99.3 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 1 | 44.2 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | End of Treatment | 100.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 2 | 87.7 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | End of Treatment | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 4 | 93.5 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 6 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 8 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 12 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 2 | 80.6 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 4 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 8 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Follow-Up Week 24 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND | Week 1 | 29.0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Percentage of treated participants with HCV RNA \< LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Population: Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 6 | 98.6 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | End of Treatment | 97.8 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 4 | 93.5 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 4 | 97.1 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 8 | 99.3 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 8 | 98.6 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 2 | 42.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 12 | 98.6 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 12 | 97.8 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 24 | 96.4 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 1 | 11.6 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 24 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 1 | 0.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 2 | 25.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 4 | 90.3 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 6 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 8 | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Week 12 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | End of Treatment | 100.0 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 4 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 8 | 96.8 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved HCV RNA < LLOQ TND | Follow-Up Week 12 | 100.0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Time frame: Post treatment week 12
Population: It included enrolled participants who received at least 1 dose of study therapy. Here, N signifies number of participants evaluable for the outcome measure, 'n' signifies number of participants analysed for specific category. SVR12 is based on Next Value Carried Backwards approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b | Genotype - 1a | 88.9 Percentage of participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b | Genotype - 1b | 100.0 Percentage of participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b | Genotype - 1a | 100.0 Percentage of participants |
| Treatment-Experianced: | Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b | Genotype - 1b | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Anemia was defined as hemoglobin \< 10 g/dL on-treatment for subjects who had hemoglobin \>= 10 g/dL at baseline.
Time frame: Up to post treatment week 4
Population: Analysis population included enrolled participants who received at least 1 dose of study therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline | 1.4 Percentage of Participants |
| Treatment-Experianced: | Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA \< LLOQ target detected or target not detected (LLOQ TD/TND).
Time frame: Post treatment Week 12
Population: Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort | 100.0 Percentage of Participants |
Secondary
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Time frame: Post treatment Week 12
Population: It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 | Cirrhotic | 100.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 | Noncirrhotic | 98.4 Percentage of Participants |
| Treatment-Experianced: | Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 | Cirrhotic | 100.0 Percentage of Participants |
| Treatment-Experianced: | Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12 | Noncirrhotic | 100.0 Percentage of Participants |
Secondary
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Time frame: Post treatment Week 12
Population: It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-Naive: DCV/ASV/BMS-791325 | Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) | CC genotype | 99.0 Percentage of Participants |
| Treatment-Naive: DCV/ASV/BMS-791325 | Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) | Non-CC Genotype | 97.4 Percentage of Participants |
| Treatment-Experianced: | Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) | CC genotype | 100.0 Percentage of Participants |
| Treatment-Experianced: | Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype) | Non-CC Genotype | 100.0 Percentage of Participants |