Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Adults With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Hepatitis C Infection With HIV Co-Infection

Treatments

Drug: LDV/SOF

Study type

Interventional

Funder types

Industry

Identifiers

NCT02457611

GS-US-337-1612

2014-004812-12 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
Confirmed HIV-1 infection
CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Key Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non HCV etiology
Coinfection with hepatitis B virus (HBV)
Treatment with any investigational drug or device within 60 days of the screening visit.
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply