Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02301936

GS-US-337-1405

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic genotype 1 or 4 infected patients with sickle cell disease
• HCV RNA ≥ 1,000 IU/mL at screening
• Cirrhosis determination by transient elastography
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

• Pregnant or nursing female
• Co-infection with HIV or hepatitis B virus (HBV)
• Current or prior history of clinical hepatic decompensation
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol

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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10 participants in 2 patient groups

LDV/SOF 12 weeks

Experimental group

Description:

Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks.

Treatment:

Drug: LDV/SOF

LDV/SOF 24 weeks

Experimental group

Description:

Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.

Treatment:

Drug: LDV/SOF