Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
- Registration Number
- NCT01910636
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- Chronic genotype 2 HCV-infection
- Male or female, age ≥ 20 years
- Body weight ≥ 40 kg
- HCV RNA ≥ 10,000 IU/mL at screening
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sofosbuvir+RBV 12 weeks Sofosbuvir Participants will receive sofosbuvir+RBV for 12 weeks. Sofosbuvir+RBV 12 weeks RBV Participants will receive sofosbuvir+RBV for 12 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) 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) Up to 12 weeks The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Experiencing Viral Breakthrough Up to 12 weeks Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants Experiencing Viral Relapse Up to Posttreatment Week 24 Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR.