The Use of Hepatitis C Positive Livers in Hepatitis C Negative Liver Transplant Recipients
- Conditions
- Liver TransplantHepatitis C
- Interventions
- Registration Number
- NCT03819322
- Lead Sponsor
- Naudia Jonassaint. MD
- 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).
- Detailed Description
This is a prospective, single center, pilot, open-label study of transplantation of livers of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a liver from HCVAb+/NAT- donors will be in arm 1 (the transmission-triggered arm) of the study. In this arm, the study will monitor transmission of HCV by measuring HCV RNA in liver transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.
Recipients of a liver from HCVAb+/NAT+ donors will be in arm 2 (the prophylaxis arm) of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) immediately post-operatively and will undergo close monitoring of HCV RNA for evidence of transmission.
To be eligible for the study, subjects need to be listed for liver transplantation, be not infected with HCV, HBV or HIV, and sign informed consent.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 73
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HCV seropositive non-viremic (HCV Ab+/NAT-) donor sofosbuvir/velpatasvir 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). HCV seropositive viremic (HCV Ab+/NAT+) donor sofosbuvir/velpatasvir 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).
- Primary Outcome Measures
Name Time Method Adverse events 5 years Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in study participants in each experimental group
HCV free at 1 year 1 year Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation
- Secondary Outcome Measures
Name Time Method All-cause mortality 5 years All-cause mortality at 5 years
Waitlist time after enrollment 5 years Waitlist time after enrollment
Incidence of graft loss 5 years Incidence of graft loss at 5 years
Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients 5 years Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients
Incidence of allograft rejection 5 years Incidence of allograft rejection at 5 years
Trial Locations
- Locations (1)
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States