A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 268
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Study Overview
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Willing and able to provide written informed consent
- •HCV RNA > 10^4 IU/mL at screening
- •Chronic HCV infection (≥ 6 months)
- •Confirmed CPT class B (7-9) at screening
Exclusion Criteria
- •Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
- •Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Screening ECG with clinically significant abnormalities
- •Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
- •Laboratory results outside of acceptable ranges at screening
Arms & Interventions
SOF/VEL 12 weeks
Participants will receive SOF/VEL FDC for 12 weeks.
Intervention: SOF/VEL (Drug)
SOF/VEL+RBV 12 weeks
Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
Intervention: SOF/VEL (Drug)
SOF/VEL+RBV 12 weeks
Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
Intervention: RBV (Drug)
SOF/VEL 24 weeks
Participants will receive SOF/VEL FDC for 24 weeks.
Intervention: SOF/VEL (Drug)
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) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks plus 30 days
Secondary Outcomes
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24(Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24(Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score(Baseline to Posttreatment Week 24)
- Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score(Baseline to Posttreatment Week 24)