Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

Phase 3

Completed

• Conditions: Chronic HCV Infection
• Interventions: Drug: Sofosbuvir; Drug: RBV

• Registration Number: NCT02074514
• Lead Sponsor: Gilead Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-28
• Study Start: 2014-03
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2016-09
• Results First Submitted: 2016-09-02
• Results First Submitted QC: 2016-09-02
• Last Update Submitted: 2016-09-02
• Results First Posted: 2016-10-25
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sofosbuvir+RBV 16 weeks	Sofosbuvir	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Sofosbuvir+RBV 16 weeks	RBV	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Sofosbuvir+RBV 24 weeks	Sofosbuvir	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.
Sofosbuvir+RBV 24 weeks	RBV	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	Posttreatment Week 12	SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic Failure and Viral Relapse	Up to Posttreatment Week 24	Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or; * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.