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 Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: RBV; Drug: SOF/VEL/VOX

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536313

GS-US-367-1871

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

SOF/VEL/VOX

Experimental group

Description:

SOF/VEL/VOX for 12 weeks

Treatment:

Drug: SOF/VEL/VOX

SOF/VEL/VOX + RBV

Experimental group

Description:

SOF/VEL/VOX + RBV for 12 weeks

Treatment:

Drug: RBV

Drug: SOF/VEL/VOX