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 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.
Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event Up to 12 weeks
- 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
The Texas Liver Institute🇺🇸San Antonio, Texas, United States