Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Genotype 5 HCV; Chronic Genotype 4 HCV

Treatments: Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081079

GS-US-337-1119

2013-003978-27 (EudraCT Number)

Details and patient eligibility

About

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HCV RNA ≥ 10^4 IU/mL at screening
• Chronic genotype 4 or 5 HCV Infection
• Individuals may be treatment naive or treatment experienced
• Presence or absence of cirrhosis, a liver biopsy may be required
• Healthy according to medical history and physical examination with the exception of HCV diagnosis
• Agree to use two forms of highly effective contraception for the duration of the study

Exclusion criteria

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
• Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
• History of any other clinically significant chronic liver disease
• Evidence of or history of decompensated liver disease
• HIV or chronic hepatitis B (HBV) infection
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of immunosuppressive agents or immunomodulatory agents

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Genotype 4

Experimental group

Description:

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection

Treatment:

Drug: LDV/SOF

Genotype 5

Experimental group

Description:

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

Treatment:

Drug: LDV/SOF