The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients

NCT03819322 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY19100082
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of livers from Hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the liver transplant waitlist. Treatment and prophylaxis will be administered, using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Conditions

Liver Transplant; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Adverse Events Due to Sofosbuvir/Velpatasvir (Epclusa)

  Adverse events due to sofosbuvir/velpatasvir (Epclusa)

  5 years

• HCV Free at 1 Year Following Transplantation

  1 year

Secondary Outcomes (5)

• Transmission Rate of HCV From HCVAb+/NAT- Donors to HCVAb- Recipients

  5 years

• Incidence of Allograft Rejection at 5 Years

  5 years

• Incidence of Graft Loss at 5 Years

  5 years

• All-cause Mortality at 5 Years

  5 years

• Waitlist Time After Enrollment

  5 years

Study Arms (2)

HCV seropositive non-viremic (HCV Ab+/NAT-) donor

EXPERIMENTAL

Liver recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Drug: sofosbuvir/velpatasvir

HCV seropositive viremic (HCV Ab+/NAT+) donor

EXPERIMENTAL

Post-operative day 1, liver recipients will be treated with 12-week oral course of sofosbuvir/ velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).

Drug: sofosbuvir/velpatasvir

Interventions

sofosbuvir/velpatasvir DRUG

12 week, oral, fixed dose

Also known as: Epclusa

HCV seropositive non-viremic (HCV Ab+/NAT-) donor; HCV seropositive viremic (HCV Ab+/NAT+) donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage liver disease listed for liver transplantation at UPMC.
• Age ≥ 18
• No available living liver donor
• Listed for an isolated liver transplant at UPMC
• Have panel reactive antibody level of \<98%
• Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
• Able to provide informed consent
• Be willing to use a contraceptive method for a year after transplant

You may not qualify if:

• HIV positive
• HCVAb or HCV RNA positive
• Presence of behavioral risk factors for contracting HCV. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.
• Hepatitis B surface antigen positive
• History of atrial fibrillation requiring the use of amiodarone over the past 12m
• Receipt of prior organ transplant
• Waitlisted for a multi-organ transplant
• Pregnant women
• Known allergy to sofosbuvir/velpatasvir
• Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
• HCV antibody positive
• HCV NAT negative or positive
• Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
• Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)
• Known ongoing therapy for HCV

Sponsors & Collaborators

• University of Pittsburgh Medical Center: collaborator
• Fernanda P Silveira, MD, MS: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

The limited sample sizes (n=1 and n=4) preclude valid statistical inference; accordingly, analyses are restricted to descriptive reporting.

Results Point of Contact

• Title: Professor of Medicine
• Organization: University of Pittsburgh

silvfd@upmc.edu

4126486512

Study Officials

• Fernanda Silviera, MD

  University of Pittsburgh

  STUDY DIRECTOR

• Naudia Jonassaint, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: August 15, 2019
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)