Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy

Phase 3

Completed

• Conditions: Hepatitis C
• Interventions: Drug: SOF/VEL/VOX; Drug: Placebo

• Registration Number: NCT02607735
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-11
• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2016-10-10
• Study Completion: 2017-06-21
• Results First Submitted: 2017-10-04
• Results First Submitted QC: 2017-11-14
• Results First Posted: 2017-12-13
• Status Verified: 2018-07
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOF/VEL/VOX (Primary Study)	SOF/VEL/VOX	SOF/VEL/VOX for 12 weeks
Placebo (Primary Study)	Placebo	Placebo to match SOF/VEL/VOX for 12 weeks
SOF/VEL/VOX (Deferred Treatment Substudy)	SOF/VEL/VOX	SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)	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 (Primary Study)	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)	Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA (Primary Study)	Baseline; Weeks 1, 2, 4, 8 and 12
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)	Posttreatment Week 24	SVR24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With Virologic Failure (Primary Study)	Up to Posttreatment Week 24	Virologic failure is 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.
Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)	Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)	SVR4, SVR12 and SVR24 was defined as HCV RNA \< LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)	Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Change From Baseline in HCV RNA (Deferred Treatment Substudy)	Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)	Up to Posttreatment Week 24 (Deferred Treatment Substudy)	Virologic failure is 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.