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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: LDV/SOF

• Registration Number: NCT01924949
• Lead Sponsor: Gilead Sciences

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2015-05
• Results First Submitted: 2015-05-13
• Results First Submitted QC: 2015-05-13
• Results First Posted: 2015-05-29
• Last Update Submitted: 2018-10-19
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LDV/SOF	LDV/SOF	Participants will receive LDV/SOF FDC for 12 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
HCV RNA Change From Baseline	Baseline; Weeks 1, 4, and 8
Percentage of Participants Experiencing Virologic Failure	Baseline to posttreatment Week 24	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.
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)	Posttreatment Weeks 4 and 24	SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With HCV RNA < LLOQ on Treatment	Up to 12 weeks