Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

Gilead Sciences49 enrolled

Overview

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus Infection

Interventions

SOF/VEL/VOXDRUG

400/100/100 mg FDC tablet administered orally once daily with food

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Individuals with chronic HCV genotype 1 infection * Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response * Absence of cirrhosis or presence of compensated cirrhosis * Screening laboratory values within defined thresholds * Must use specific contraceptive methods if female of childbearing potential or sexually active male Key Exclusion Criteria: * Co-infection with HIV or hepatitis B virus (HBV) * Current or prior history of clinical hepatic decompensation * Chronic use of systemic immunosuppressive agents * History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Pregnant or a nursing female Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Time frame: Posttreatment Week 12

Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event

Time frame: Up to 12 weeks

Secondary Outcomes

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 are defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Percentage of Participants With HCV RNA < LLOQ on Treatment

Time frame: Weeks 1, 2, 4, 8 and 12

HCV RNA Change From Baseline/Day 1 Through Week 12

Time frame: Weeks 1, 2, 4, 8, and 12

Percentage of Participants With Virologic Failure

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.

Time frame: Up to Posttreatment Week 24