Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection

An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection

This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.

Inclusion Criteria:

• Body mass index (BMI) greater than or equal to 18 kg/m^2.
• HCV RNA greater than or equal to 1000 IU/mL at screening.
• Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
• Screening laboratory values within predefined thresholds.
• Use of two effective contraception methods if female of childbearing potential or sexually active male.
• Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Exclusion Criteria:

• Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
• Prior exposure to an HCV NS5a inhibitor.
• Pregnant or nursing female.
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
• History of solid organ transplantation.
• Current or prior history of clinical hepatic decompensation.
• History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
• Known hypersensitivity to LDV, SOF, or formulation excipients.