Phase 3
Completed N=50
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
Source: ClinicalTrials.gov NCT02319031 ↗Enrolled (actual)
50
Serious AEs
10.0%
Results posted
Jan 2017
Primary outcomePrimary: Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) — 87.5; 92.3 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) |
87.5; 92.3 | — |
| SECONDARY Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) |
87.5; 96.2; 87.5; 92.3 | — |
| SECONDARY Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities |
1; 0; 2; 3; 0; 0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Must have Genotype 3 Chronic HCV
- Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
- HCV RNA Viral load ≥ 10, 000 IU/mL
- HCV Treatment naive or treatment-experienced
Exclusion Criteria
- Non Genotype 3 or mixed genotypes
- Non advanced fibrosis or compensated cirrhosis
- Any prior treatment with NS5A inhibitors
Data sourced from ClinicalTrials.gov (NCT02319031). 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.