Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection (ASTRAL-5)

Gilead Sciences

Status and phase

Completed

Phase 3

Conditions

Hepatitis C Virus Infection

Treatments

Drug: SOF/VEL

Study type

Interventional

Funder types

Industry

Identifiers

NCT02480712

GS-US-342-1202

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) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

HCV RNA ≥ 10^4 IU/mL at screening
HCV genotype 1, 2, 3, 4, 5, 6
Cirrhosis determination, a fibroscan or liver biopsy may be required
HIV-1 infection
Use of protocol specified method(s) of contraception
Screening laboratory values within defined thresholds

Key Exclusion Criteria:

Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
Screening ECG with clinically significant abnormalities
Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV)
Use of any prohibited concomitant medications as described in the protocol
Chronic use of systemically administered immunosuppressive agents

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.