Phase 3
Completed N=153
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
Source: ClinicalTrials.gov NCT01910636 ↗Enrolled (actual)
153
Serious AEs
1.3%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 97.8; 95.2 percentage of participants
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
97.8; 95.2 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
— | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
98.9; 95.2; 97.8; 95.2 | — |
| SECONDARY Percentage of Participants Experiencing Viral Breakthrough |
0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
2.2; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic genotype 2 HCV-infection
- Male or female, age ≥ 20 years
- Body weight ≥ 40 kg
- HCV RNA ≥ 10, 000 IU/mL at screening
Exclusion Criteria
- Current or prior history of clinically significant illness other than HCV
- Pregnant or nursing female or male with pregnant female partner
- Chronic liver disease of a non-HCV etiology
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT01910636). 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.