Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (ESRD)

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT03036839

GS-US-337-4063

2016-003489-25 (EudraCT Number)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/ nonlactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV coinfection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 3 patient groups

LDV/SOF for 8 weeks

Experimental group

Description:

Treatment-naive participants with genotype 1 without cirrhosis will receive LDV/SOF for 8 weeks

Treatment:

Drug: LDV/SOF

LDV/SOF for 12 weeks

Experimental group

Description:

Treatment-experienced participants with genotype 1 and treatment-naive or treatment-experienced participants with genotype 2 (Taiwan only), 4, 5 and 6 without cirrhosis will receive LDV/SOF for 12 weeks

Treatment:

Drug: LDV/SOF

LDV/SOF for 24 weeks

Experimental group

Description:

Participants with compensated cirrhosis will receive LDV/SOF for 24 weeks

Treatment:

Drug: LDV/SOF