Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-22

Study Completion Date

2016-04-22

Brief Summary

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The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection

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 with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally

Interventions

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LDV/SOF

90/400 mg FDC tablet administered orally

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
* HCV RNA infection with quantifiable virus at screening
* Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
* Currently on the liver transplantation wait list
* Screening electrocardiogram (ECG) without clinically significant abnormalities.
* A negative serum pregnancy test result is required for females

Exclusion Criteria

* Any previous solid organ transplant
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
* HIV infection or a positive hepatitis B virus surface antigen result
* History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
* Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
* Prior exposure to an HCV non-structural protein (NS)5A inhibitor
* Patients on hemodialysis prior to or at the time of transplantation will be excluded
* Creatinine clearance (CLcr) \< 40 mL/min at screening or \< 40 mL/min on day of transplant
* Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
* Receipt or planned receipt of an organ from an HCV positive donor

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No