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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDV/SOF

Participants will receive LDV/SOF FDC for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

Interventions

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LDV/SOF

Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No