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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

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.