A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

Gilead Sciences38 sites in 5 countries375 target enrollmentApril 19, 2016

ConditionsHepatitis C Virus Infection

InterventionsSOF/VEL

DrugsSOF/VEL

Overview

Phase: Phase 3
Intervention: SOF/VEL
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Enrollment: 375
Locations: 38
Primary Endpoint: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Registry

clinicaltrials.gov

Start Date

April 19, 2016

End Date

March 27, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide written informed consent
•HCV RNA ≥ 10\^4 IU/mL at screening
•Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
•Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
•HCV treatment-naive or treatment-experienced
•Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)

Exclusion Criteria

•Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
•Pregnant or nursing female or male with pregnant female partner
•Chronic liver disease of a non HCV etiology
•Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Arms & Interventions

SOF/VEL

SOF/VEL FDC for 12 weeks

Intervention: SOF/VEL

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Time Frame: Posttreatment Week 12

SVR12 was 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 Any Study Drug Due to an Adverse Event

Time Frame: Up to 12 weeks

Secondary Outcomes

Change From Baseline in HCV RNA(Baseline and up to Week 12)
Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)
Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 1, 2, 4, 6, 8, 10, and 12)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)