Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis (ASTRAL-4)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: SOF/VEL; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201901

GS-US-342-1137

Details and patient eligibility

About

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B cirrhosis.

Enrollment: 268 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 at screening
• Chronic HCV infection (≥ 6 months)
• Confirmed CPT class B (7-9) at screening

Exclusion criteria

• Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
• Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Screening ECG with clinically significant abnormalities
• Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
• Laboratory results outside of acceptable ranges at screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 3 patient groups

SOF/VEL 12 weeks

Experimental group

Description:

Participants will receive SOF/VEL FDC for 12 weeks.

Treatment:

Drug: SOF/VEL

SOF/VEL+RBV 12 weeks

Experimental group

Description:

Participants will receive SOF/VEL FDC plus RBV for 12 weeks.

Treatment:

Drug: RBV

Drug: SOF/VEL

SOF/VEL 24 weeks

Experimental group

Description:

Participants will receive SOF/VEL FDC for 24 weeks.

Treatment:

Drug: SOF/VEL