Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607735

GS-US-367-1171

2015-003455-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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416 participants in 3 patient groups

SOF/VEL/VOX (Primary Study)

Experimental group

Description:

SOF/VEL/VOX for 12 weeks

Treatment:

Drug: SOF/VEL/VOX

Placebo (Primary Study)

Experimental group

Description:

Placebo to match SOF/VEL/VOX for 12 weeks

Treatment:

Drug: Placebo

SOF/VEL/VOX (Deferred Treatment Substudy)

Experimental group

Description:

SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo

Treatment:

Drug: SOF/VEL/VOX