Premium
Transplanting hepatitis C virus–infected hearts into uninfected recipients: A single‐arm trial
Author(s) -
McLean Rhondalyn C.,
Reese Peter P.,
Acker Michael,
Atluri Pavan,
Bermudez Christian,
Goldberg Lee R.,
Abt Peter L.,
Blumberg Emily A.,
Van Deerlin Vivianna M.,
Reddy K. Rajender,
Bloom Roy D.,
Hasz Richard,
Suplee Lawrence,
Sicilia Anna,
Woodards Ashley,
Zahid Muhammad Nauman,
Bar Katharine J.,
Porrett Paige,
Levine Matthew H.,
Hornsby Nicole,
Gentile Caren,
Smith Jennifer,
Goldberg David S.
Publication year - 2019
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.15311
Subject(s) - medicine , interquartile range , hepatitis c virus , hepatitis c , adverse effect , transplantation , gastroenterology , surgery , immunology , virus
The advent of direct‐acting antiviral therapy for hepatitis C virus ( HCV ) has generated tremendous interest in transplanting organs from HCV ‐infected donors. We conducted a single‐arm trial of orthotopic heart transplantation ( OHT ) from HCV ‐infected donors into uninfected recipients, followed by elbasvir/grazoprevir treatment after recipient HCV was first detected ( NCT 03146741; sponsor: Merck). We enrolled OHT candidates aged 40‐65 years; left ventricular assist device (LVAD) support and liver disease were exclusions. We accepted hearts from HCV ‐genotype 1 donors. From May 16, 2017 to May 10, 2018, 20 patients consented for screening and enrolled, and 10 (median age 52.5 years; 80% male) underwent OHT . The median wait from UNOS opt‐in for HCV nucleic‐acid‐test ( NAT )+ donor offers to OHT was 39 days (interquartile range [ IQR] 17‐57). The median donor age was 34 years ( IQR 31‐37). Initial recipient HCV RNA levels ranged from 25 IU / mL to 40 million IU / mL , but all 10 patients had rapid decline in HCV NAT after elbasvir/grazoprevir treatment. Nine recipients achieved sustained virologic response at 12 weeks (SVR ‐12). The 10th recipient had a positive cross‐match, experienced antibody‐mediated rejection and multi‐organ failure, and died on day 79. No serious adverse events occurred from HCV transmission or treatment. These short‐term results suggest that HCV ‐negative candidates transplanted with HCV ‐infected hearts have acceptable outcomes.