Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection

Phase 3

Completed

• Conditions: Hepatitis C Virus Infection
• Interventions: Drug: SOF/VEL

• Registration Number: NCT02346721
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-27
• Study Start: 2015-02-23
• Primary Completion: 2016-03-23
• Study Completion: 2016-06-15
• Status Verified: 2017-03
• Results First Submitted: 2017-03-23
• Results First Submitted QC: 2017-03-23
• Results First Posted: 2017-05-03
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Key

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SOF/VEL	SOF/VEL	SOF/VEL for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 12 weeks
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Percentage of Participants With HCV RNA < LLOQ While on Treatment	Baseline to Week 12
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	Virologic failure was defined as: * On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or; * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or; * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); * Virologic relapse: * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
HCV RNA Change From Baseline	Baseline to Week 12