Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir; Drug: RBV

• 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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-29
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2015-03
• Results First Submitted: 2015-03-13
• Results First Submitted QC: 2015-03-13
• Last Update Submitted: 2015-03-13
• Results First Posted: 2015-03-24
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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)

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.