Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen

Phase 3

Completed

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

• Registration Number: NCT02822794
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic genotype 1 or 2 hepatitis C virus (HCV) infection who have previously failed a direct-acting antiviral (DAA)-containing regimen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-04
• Study Start: 2016-07-25
• Primary Completion: 2017-06-02
• Study Completion: 2017-08-25
• Results First Submitted: 2018-05-24
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-02
• Results First Posted: 2018-07-03
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• Genotype 1 or 2 HCV infection
• Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
• Previously treated with a DAA-containing regimen of at least 4 week duration

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOF/VEL FDC + RBV 12 weeks	SOF/VEL	SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL FDC + RBV 24 weeks	SOF/VEL	SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL FDC + RBV 12 weeks	RBV	SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL FDC + RBV 24 weeks	RBV	SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event	Up to 24 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)	Posttreatment Week 24	SVR 24 was defined as HCV RNA \< LLOQ at 24 weeks after stopping study treatment.
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)	Posttreatment Week 4	SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at Week 3	Week 3
Percentage of Participants With HCV RNA < LLOQ at Week 4	Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 5	Week 5
Percentage of Participants With HCV RNA < LLOQ at Week 6	Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8	Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 10	Week 10
Percentage of Participants With HCV RNA < LLOQ at Week 12	Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16	Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 1	Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2	Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 20	Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24	Week 24
Change From Baseline in HCV RNA at Week 1	Baseline; Week 1
Change From Baseline in HCV RNA at Week 2	Baseline; Week 2
Change From Baseline in HCV RNA at Week 3	Baseline; Week 3
Change From Baseline in HCV RNA at Week 4	Baseline; Week 4
Change From Baseline in HCV RNA at Week 5	Baseline; Week 5
Change From Baseline in HCV RNA at Week 6	Baseline; Week 6
Change From Baseline in HCV RNA at Week 8	Baseline; Week 8
Change From Baseline in HCV RNA at Week 10	Baseline; Week 10
Change From Baseline in HCV RNA at Week 12	Baseline; Week 12
Change From Baseline in HCV RNA at Week 16	Baseline; Week 16
Change From Baseline in HCV RNA at Week 20	Baseline; Week 20
Change From Baseline in HCV RNA at Week 24	Baseline; Week 24
Percentage of Participants With Overall 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.