Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
- Registration Number
- NCT02536313
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Individuals with chronic HCV genotype 1 infection
- Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
- Absence of cirrhosis or presence of compensated cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
Key
- Co-infection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOF/VEL/VOX + RBV SOF/VEL/VOX SOF/VEL/VOX + RBV for 12 weeks SOF/VEL/VOX SOF/VEL/VOX SOF/VEL/VOX for 12 weeks SOF/VEL/VOX + RBV RBV SOF/VEL/VOX + RBV for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event Up to 12 weeks Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12) Posttreatment Week 12 SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With HCV RNA < LLOQ on Treatment Weeks 1, 2, 4, 8 and 12 Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 Virologic failure is 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.Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR 24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
HCV RNA Change From Baseline/Day 1 Through Week 12 Weeks 1, 2, 4, 8, and 12
Trial Locations
- Locations (1)
The Texas Liver Institute
🇺🇸San Antonio, Texas, United States