A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 153
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Intervention: Sofosbuvir (Drug)
Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Intervention: RBV (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time Frame: Up to 12 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Secondary Outcomes
- Percentage of Participants Experiencing Viral Breakthrough(Up to 12 weeks)
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)