Phase 3
Completed N=117
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Chronic HCV Infection
Source: ClinicalTrials.gov NCT02074514 ↗
Enrolled (actual)
117
Serious AEs
1.7%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 90; 96.4; 100.0; 93.3 percentage of participants
◆ Published Evidence
Emerging
18citations · ~2 / year
Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.
Linked Publications
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Sofosbuvir plus ribavirin in treatment-naïve patients with chronic hepatitis C virus genotype 1 or 3 infection in India.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
90; 96.4; 100.0; 93.3 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 3.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
90.0; 96.4; 100.0; 96.7; 90.0; 96.4 | — |
| SECONDARY Percentage of Participants With Virologic Failure and Viral Relapse |
10.0; 3.6; 0; 3.3; 10.0; 3.6 | — |
Eligibility Criteria
Inclusion Criteria
- HCV RNA ≥10^4 IU/mL at screening
- Confirmed chronic HCV genotype 1 or 3 infection
- HCV treatment naive
- Approximately 30% of individuals may have compensated cirrhosis at screening
Exclusion Criteria
- Any other chronic liver disease
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Current or prior history of clinical hepatic de-compensation
- Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
- Chronic use of systemically administered immunosuppressive agents
- History of solid organ transplantation
Data sourced from ClinicalTrials.gov (NCT02074514) and the linked publication. 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.