A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Overview
- Phase
- Phase 3
- Intervention
- SOF/VEL
- Conditions
- Hepatitis C Virus Infection
- Sponsor
- Gilead Sciences
- Enrollment
- 269
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent
- •HCV RNA ≥ 10\^4 IU/mL
- •HCV genotype 2
- •Chronic HCV infection (≥ 6 months)
- •Females of childbearing potential must have a negative serum pregnancy test
- •Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.
Exclusion Criteria
- •Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
- •Screening electrocardiogram (ECG) with clinically significant abnormalities
- •Laboratory results outside of acceptable ranges at Screening
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Arms & Interventions
SOF/VEL
SOF/VEL FDC for 12 weeks
Intervention: SOF/VEL
SOF+RBV
SOF+RBV for 12 weeks
Intervention: SOF
SOF+RBV
SOF+RBV for 12 weeks
Intervention: RBV
Outcomes
Primary Outcomes
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 12 weeks
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.
Secondary Outcomes
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12(Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12(Weeks 1, 2, 4, 6, 8, 10, and 12)
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)