A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) Infection

Gilead Sciences15 sites in 2 countries119 target enrollmentApril 4, 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: 119
Locations: 15
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 objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Registry

clinicaltrials.gov

Start Date

April 4, 2016

End Date

September 13, 2017

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

•HCV RNA ≥ 10\^4 IU/mL at screening
•Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Exclusion Criteria

•Any other chronic liver disease
•Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
•Clinical hepatic decompensation
•Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
•Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Arms & Interventions

SOF/VEL

SOF/VEL 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) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event

Time Frame: Up to 12 weeks

Secondary Outcomes

Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2(Week 2)
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4(Week 4)
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8(Week 8)
Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)(Posttreatment Week 24)
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1(Week 1)
Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12(Week 12)
Change From Baseline in HCV RNA at Week 1(Baseline (Day 1); Week 1)
Change From Baseline in HCV RNA at Week 2(Baseline (Day 1); Week 2)
Change From Baseline in HCV RNA at Week 4(Baseline (Day 1); Week 4)
Change From Baseline in HCV RNA at Week 8(Baseline (Day 1); Week 8)
Change From Baseline in HCV RNA at Week 12(Baseline (Day 1); Week 12)
Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)