Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus (HCV) has changed the landscape of HCV therapy dramatically in the last several years with reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV positive patients including those who have received liver or kidney transplants. Since these new regimens do not include interferon and have already been studied in the post-liver and kidney transplant setting, they now offer a unique opportunity to expand the donor pool and improve the lives of those awaiting renal transplant. The address this gap in knowledge, the investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV medication to cure HCV soon after transplant would allow for safe transplantation of HCV positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable risks and improved survivals compared with historical cohorts.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Antiviral Agents; Elbasvir-grazoprevir drug combination; Sofosbuvir; Sofosbuvir-velpatasvir drug combination

Criteria

Inclusion Criteria:

• No evidence of HCV infection by HCV PCR (done at the time of the initial consent)

• Age>60 yrs with an expected waiting time>2 years; or

• Age<60 yrs with any one of the following risk factors: Diabetes, coronary artery disease, peripheral artery disease and/or cerebrovascular disease

• Willingness to provide informed consent

• Absence of a living donor.

Exclusion Criteria:

• Estimated life expectancy of less than one year based on clinical judgment of the investigator

• Prior liver or renal transplantation

• Pregnant women

• Incarcerated patients

• Medical or social condition which in the opinion of the investigator will interfere with or prevent follow-up per protocol

• Unable or unwilling to return for follow-up visits

Donor Exclusion Criteria:

• HBV sAg positive

• HIV PCR or antibody positive

• HCV RNA negative