Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
- Registration Number
- NCT02639338
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic genotype 3 HCV infection (≥ 6 months)
- Presence of cirrhosis
- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- Use of protocol specified methods of contraception
Key
- Current or prior history of clinically significant illness that may interfere with participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory parameters outside the acceptable range at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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 SOF/VEL/VOX SOF/VEL/VOX tablet for 8 weeks SOF/VEL SOF/VEL SOF/VEL tablet for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event Up to 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) Posttreatment Weeks 4 and 24 SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ On Treatment Weeks 1, 2, 4, 8 and 12 Change From Baseline in HCV RNA Weeks 1, 2, 4, 8 and 12 Percentage of Participants With Virologic Failure Up to Posttreatment Week 24 Virologic failure was 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), or
* Virologic relapse:
* Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit