A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection
Overview
- Phase
- Phase 2
- Intervention
- SOF
- Conditions
- Hepatitis C
- Sponsor
- Gilead Sciences
- Enrollment
- 323
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) ≥ 18 kg/m\^2
- •HCV RNA ≥ 10000 IU/mL at screening
- •Prior treatment failure to a regimen including interferon with or without RBV
- •HCV genotype 1 or 3
- •Chronic HCV infection
- •Cirrhosis determination
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- •Current or prior history of clinically significant illness other than HCV
- •Screening ECG with clinically significant abnormalities
- •Prior exposure to HCV specific direct acting antiviral agent
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of non-HCV etiology
- •Hepatitis B
- •Active drug abuse
- •Use of any prohibited concomitant medications
Arms & Interventions
SOF+VEL 25 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Intervention: SOF
SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: VEL
SOF+VEL 25mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: RBV
SOF+VEL 100 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT3) without cirrhosis
Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: RBV
SOF+VEL 25 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Intervention: SOF
SOF+VEL 25 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.
Intervention: VEL
SOF+VEL 25 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 25 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: RBV
SOF+VEL 100 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT3) with cirrhosis
Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: RBV
SOF+VEL 25 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Intervention: SOF
SOF+VEL 25 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Intervention: VEL
SOF+VEL 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: VEL
SOF+VEL 25 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.
Intervention: RBV
SOF+VEL 100 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: SOF
SOF+VEL 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: VEL
SOF+VEL 100 mg+RBV (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
Secondary Outcomes
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)