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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C Virus Infection

Treatments: Drug: LDV/SOF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02350569

GS-US-337-1428

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

LDV/SOF

Experimental group

Description:

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.

Treatment:

Drug: LDV/SOF