Phase 3
Completed N=602
Study Comparing Daclatasvir (BMS-790052) With Telaprevir Combined With Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT01492426 ↗Enrolled (actual)
602
Serious AEs
7.6%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) — 85.1; 81.3 Percentage of participants
Summary
The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
85.1; 81.3 | — |
| SECONDARY Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4 |
77.2; 79.1 | — |
| SECONDARY Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12 |
75.0; 73.1 | — |
| SECONDARY Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR) |
90.7; 90.03 | — |
| SECONDARY Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24) |
84.3; 80.6 | — |
| SECONDARY Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) |
64.9; 69.7 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participants chronically infected with hepatitis C virus (HCV) genotype 1a or 1b
- HCV RNA viral load ≥10,000 IU/mL
- No prior treatment including but not limited to interferon, ribavirin, and direct-acting antivirals
- No history of cirrhosis liver biopsy within 3 years or Fibroscan® within 1 year
- Body mass index of 18 to 35 kg/m^2
- Negative for HIV and hepatitis B virus
Key Exclusion Criteria
- Evidence of decompensated liver disease
- Evidence of medical condition other than HCV contributing to chronic liver disease
Data sourced from ClinicalTrials.gov (NCT01492426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.