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

Study Overview
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: LDV/SOF


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDV/SOF<br>Participants will receive LDV/SOF FDC for 12 weeks. | Drug: LDV/SOF<br>* Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily<br>* Other names: GS-5885/GS-7977;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 | 
| Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 | 
| Percentage of Participants With HCV RNA < LLOQ on Treatment |  | Up to 12 weeks | 
| HCV RNA Change From Baseline |  | Baseline; Weeks 1, 4, and 8 | 
| Percentage of Participants Experiencing Virologic Failure | Virologic failure was defined as On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Baseline to posttreatment Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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7977, 5885, GS-7977, GS-5885, SOF, LDV, Sofosbuvir, Ledipasvir, FDC