Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant (PRO-ACT:)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 4

Conditions

Hepatitis C

Transplantation Disease Transmission

Treatments

Drug: Sofosbuvir/Velpatasvir/Voxilaprevir

Drug: Sofosbuvir/Velpatasvir

Study type

Interventional

Funder types

Other

Identifiers

NCT03619837

18-24323

Details and patient eligibility

About

In this study, subjects that do not have Hepatitis C virus (HCV) will be transplanted with livers or kidneys from donors who do have HCV. Medications that are used to treat HCV will be given to the study subjects shortly after transplant to protect them from developing the problems HCV can cause to the liver.

Enrollment

122 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
Agree to use two methods of birth control during the study;
Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.

Exclusion criteria

Donor and/or recipient HIV infection
Subject pregnant or nursing
Donor and/or recipient Hepatitis B surface antigen positive
Kidney-pancreas transplant
Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized with panel reactive antibody > 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
Individuals treated with amiodarone within 42 days of organ transplant.