Overview

This trial has been completed.

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 333 participants
Trial identifier NCT02639247, 2015-003167-10, GS-US-367-1170

Summary

This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

United States No locations recruiting
Other countries No locations recruiting

Study Design

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

Primary Outcomes

Measure
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

Measure
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

All participants at least 18 years old.

Key Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL at screening - Chronic HCV infection (≥ 6 months) - Treatment experienced with a direct acting antiviral medication not including a NS5A Inhibitor for HCV - Use of protocol specified methods of contraception Key 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 results outside of acceptable ranges 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.

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 12 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Gilead Sciences.