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

Hepatitis C Virus Infection Clinical Trial

Official title:

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic HCV for Use in the Peri-Operative Liver Transplantation Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350569
• Other study ID #: GS-US-337-1428
• Status: Completed
• Phase: Phase 2
• Start date: May 22, 2015
• Est. completion date: April 22, 2016

Study information

• Verified date: March 2017
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 22, 2016
• Est. primary completion date: March 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus Infection
• Infection
• Virus Diseases

Intervention

Drug:
• LDV/SOF
90/400 mg FDC tablet administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-210 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)	SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.	Posttreatment Week 12
Primary	Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event		Up to 4 weeks
Secondary	Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)	SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.	Posttreatment Week 4
Secondary	Percentage of Participants With Virologic Failure	Virologic failure was defined as: End of treatment virologic failure: Completed 28 days LDV/SOF treatment and had HCV RNA = LLOQ at last measurement on treatment; Virologic relapse: Confirmed HCV RNA = LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement.	Up to Posttreatment Week 12
Secondary	Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28		Days 1, 3, 5, 7, 14, 21, and 28