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

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Hepatitis C

Treatments

Drug: LDV/SOF

Study type

Interventional

Funder types

Industry

Identifiers

NCT01924949

GS-US-337-0125

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.