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