ARTICLE: Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study
JOURNAL: Ann Intern Med. 2021 Jan;174(1):137-138. doi: 10.7326/M20-1468. Epub 2020 Sep 8.
Background: Kidneys from deceased donors with hepatitis C virus (HCV) are increasingly available, yet hundreds are discarded annually because of a limited number of HCV-viremic candidates. An innovative strategy of transplanting kidneys from HCV-positive donors to HCV-negative recipients (HCV D+/R−) by using direct-acting antivirals (DAAs) has shown early success, but the optimal timing and duration of DAA therapy remain unclear. Our first trial of DAA prophylaxis (first dose before transplant, followed by a posttransplant course) found that a 12-week course prevented chronic HCV infection without complications in 10 recipients (1).
Objective: To investigate 4-week prophylaxis with the pangenotypic combination of glecaprevir, 300 mg, and pibrentasvir, 120 mg (G/P) (REHANNA [Renal Transplants in Hepatitis C Negative Recipients With RNA Positive Donors]; ClinicalTrials.gov: NCT03627299).
Methods and Findings: In this single-center, open-label, nonrandomized study approved by the Johns Hopkins Institutional Review Board, eligible candidates had HCV antibody and RNA negativity, were on the deceased-donor kidney transplant waitlist, and did not have HIV, active hepatitis B virus, or liver disease. Eligible donors were aged 13 to 55 years and had positive results on HCV nucleic acid testing, a creatinine level less than 309.4 μmol/L (3.5 mg/dL), and no long-term changes on kidney biopsy.
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