Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis (POLARIS-3)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02639338

2015-002996-12 (EudraCT Number)

GS-US-367-1173

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

Enrollment: 220 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 genotype 3 HCV infection (≥ 6 months)
• Presence of cirrhosis
• HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
• 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 parameters outside the acceptable range 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: None (Open label)

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220 participants in 2 patient groups

SOF/VEL/VOX

Experimental group

Description:

SOF/VEL/VOX tablet for 8 weeks

Treatment:

Drug: SOF/VEL/VOX

SOF/VEL

Experimental group

Description:

SOF/VEL tablet for 12 weeks

Treatment:

Drug: SOF/VEL