A Phase 3 Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection and Compensated Cirrhosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 37
- Locations
- 22
- Primary Endpoint
- Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
Study Overview
Brief Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic HCV-infected males and non-pregnant/non-lactating females
- •Treatment-naïve or treatment-experienced individuals
- •Compensated cirrhosis at Screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
- Not provided
Arms & Interventions
SOF/VEL
Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.
Intervention: SOF/VEL (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Study Drug
Time Frame: First dose date up to Week 12.1
TEAEs were defined as any AEs with an onset date on or after the study drug start and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of the study drug.
Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Treatment (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) \< LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.
Secondary Outcomes
- Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Treatment (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Treatment (SVR24)(Posttreatment Week 24)
- Percentage of Participants With Virologic Failure(First dose date up to posttreatment Week 24)