Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (ASTRAL-3)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201953

GS-US-342-1140

2014-001682-27 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide written informed consent
• HCV RNA ≥ 10^4 IU/mL
• HCV genotype 3
• Chronic HCV infection (≥ 6 months)
• Females of childbearing potential must have a negative serum pregnancy test
• Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion criteria

• Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
• Screening ECG with clinically significant abnormalities
• Laboratory results outside of acceptable ranges at Screening
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

SOF/VEL 12 Weeks

Experimental group

Description:

SOF/VEL FDC for 12 weeks

Treatment:

Drug: SOF/VEL

SOF+RBV 24 Weeks

Experimental group

Description:

SOF+RBV for 24 weeks

Treatment:

Drug: RBV

Drug: SOF