Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection (ASTRAL-2)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220998

GS-US-342-1139

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Enrollment: 269 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 2
• 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
• Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.

Exclusion criteria

• Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
• Screening electrocardiogram (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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269 participants in 2 patient groups

SOF/VEL

Experimental group

Description:

SOF/VEL FDC for 12 weeks

Treatment:

Drug: SOF/VEL

SOF+RBV

Experimental group

Description:

SOF+RBV for 12 weeks

Treatment:

Drug: SOF

Drug: RBV