This trial is active, not recruiting.

Condition hepatitis c virus infection
Treatments sof/vel/vox, sof/vel
Phase phase 3
Sponsor Gilead Sciences
Start date December 2015
End date October 2016
Trial size 220 participants
Trial identifier NCT02639338, 2015-002996-12, GS-US-367-1173


This study will 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 adults with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis who have not previously received treatment with direct-acting antiviral (DAA) therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
SOF/VEL/VOX for 8 weeks
sof/vel/vox GS-7977/GS-5816/GS-9857
SOF/VEL/VOX (400/100/100 mg) FDC tablet administered orally once daily with food
SOF/VEL for 12 weeks
sof/vel GS-7977/GS-5816
SOF/VEL (400/100 mg) FDC tablet administered orally once daily without regard to food

Primary Outcomes

Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
time frame: Up to 12 weeks

Secondary Outcomes

Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
Proportion of Participants With HCV RNA < LLOQ On Treatment
time frame: Up to 12 weeks
Change From Baseline in HCV RNA
time frame: Baseline and up to 12 weeks
Proportion of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Additional Information

Official title A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.