An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection

Gilead Sciences0 sites111 target enrollmentFebruary 23, 2015

ConditionsHepatitis C Virus Infection

InterventionsSOF/VEL

DrugsSOF/VEL

Overview

Phase: Phase 3
Intervention: SOF/VEL
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Enrollment: 111
Primary Endpoint: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

Registry

clinicaltrials.gov

Start Date

February 23, 2015

End Date

June 15, 2016

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
•Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
•Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138
•HCV RNA ≥ 10\^4 IU/mL at screening
•Classification as treatment naive or treatment experienced
•Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

•Current or prior history of clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
•Screening electrocardiogram (ECG) with clinically significant abnormalities
•Laboratory results outside of acceptable ranges at screening
•Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
•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 for 12 weeks

Intervention: SOF/VEL

Outcomes

Primary Outcomes

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

Time Frame: Up to 12 weeks

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

Time Frame: Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

Secondary Outcomes

Percentage of Participants With HCV RNA < LLOQ While on Treatment(Baseline to Week 12)
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
HCV RNA Change From Baseline(Baseline to Week 12)