Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

Phase 3

Completed

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

• Registration Number: NCT02639247
• Lead Sponsor: Gilead Sciences

Brief Summary

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-21
• Study Start: 2015-12-23
• Study First Posted: 2015-12-24
• Primary Completion: 2016-10-05
• Study Completion: 2017-01-18
• Status Verified: 2017-10
• Results First Submitted: 2017-10-04
• Results First Submitted QC: 2017-10-04
• Results First Posted: 2017-11-06
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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 not including a NS5A Inhibitor 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	SOF/VEL/VOX	SOF/VEL/VOX for 12 weeks
SOF/VEL	SOF/VEL	SOF/VEL for 12 weeks

Primary Outcome Measures

Name	Time	Method
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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With SVR at 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 after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ On Treatment	Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA	Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Virologic Failure	Up to Posttreatment Week 24	* 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.