HOPE in action: A prospective multicenter pilot study of liver transplantation from donors with HIV to recipients with HIV

• Type of Material: Article
• Authors: Aneesh Mehta, Emory University; G. Lyon, Emory University; William Kitchens Jr, Emory University; Christine M Durand, Johns Hopkins School of Medicine; Sander Florman, The Mount Sinai Hospital; Jennifer D Motter, Johns Hopkins School of Medicine; Diane Brown, Johns Hopkins School of Medicine; Darin Ostrander, Johns Hopkins School of Medicine; Sile Yu, Johns Hopkins School of Medicine; Tao Liang, Johns Hopkins School of Medicine; William A Werbel, Johns Hopkins School of Medicine; Andrew Cameron, Johns Hopkins School of Medicine; Shane Ottmann, Johns Hopkins School of Medicine; James P Hamilton, Johns Hopkins School of Medicine; Andrew D Redd, Johns Hopkins School of Medicine; Mary G Bowring, Johns Hopkins School of Medicine; Yolanda Eby, Johns Hopkins School of Medicine; Reinaldo E Fernandez, Johns Hopkins School of Medicine; Brianna Doby, Phoenix, AZ; Nazzarena Labo, Leidos Inc.; Denise Whitby, Leidos Inc.; Wendell Miley, Leidos Inc.; Rachel Friedman-Moraco, Emory University; Nicole Turgeon, Emory University; Jennifer C Price, UCSF School of Medicine; Peter Chin-Hong, UCSF School of Medicine; Peter Stock, UCSF School of Medicine; Valentina Stosor, Northwestern University Feinberg School of Medicine; Varia Kirchner, University of Minnesota Twin Cities; Timothy Pruett, University of Minnesota Twin Cities; David Wojciechowski, Massachusetts General Hospital; Nahel Elias, Massachusetts General Hospital; Cameron Wolfe, Duke University Medical Center; Thomas C Quinn, Johns Hopkins School of Medicine; Jonah Odim, National Institute of Allergy and Infectious Diseases (NIAID); Megan Morsheimer, National Institute of Allergy and Infectious Diseases (NIAID); Sapna A Mehta, New York University; Meenakshi M Rana, Icahn School of Medicine at Mount Sinai, New York; Shirish Huprikar, Icahn School of Medicine at Mount Sinai; Allan Massie, Johns Hopkins School of Medicine; Aaron AR Tobian, Johns Hopkins School of Medicine; Dorry L Segev, Johns Hopkins University School of Medicine
• Language: English
• Date: 2022-03-01
• Publisher: Elsevier Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2022 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1111/ajt.16886
• Title of Journal or Parent Work: American Journal of Transplantation
• Volume: 22
• Issue: 3
• Start Page: 853
• End Page: 864
• Grant/Funding Information: This work was supported by the by National Institute of Allergy and Infectious Diseases grant numbers 1P30AI094189 (Johns Hopkins Center for AIDS Research), 1R01AI120938 (Tobian), U01AI138897 (Durand/Segev) and U01AI134591 (Durand/Segev) and in part by the Division of Intramural Research, NIAID, NIH (Quinn and Redd) and the Regional Oncology Research Center, 3P30CA006973 NCI/NIH (Nelson) and with federal funds from the National Cancer Institute, National Institutes of Health under Contract No. HHSN261200800001E and Contract No. 75N91019D00024 (Whitby). The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organizations imply endorsement by the U.S. Government.
• Keywords: liver disease; infection and infectious agents - viral: hepatitis C; Liver Transplantation; Tissue Donors; Hepatitis C; Humans; Pilot Projects; liver transplantation/hepatology; infection and infectious agents - viral: human herpesvirus 8 (HHV-8); Graft Survival; Prospective Studies; clinical research/practice; HIV Infections; liver disease: infectious; ethics and public policy; infection and infectious agents - viral: human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS); Follow-Up Studies; infectious disease

Abstract

Liver transplantation (LT) from donors-with-HIV to recipients-with-HIV (HIV D+/R+) is permitted under the HOPE Act. There are only three international single-case reports of HIV D+/R+ LT, each with limited follow-up. We performed a prospective multicenter pilot study comparing HIV D+/R+ to donors-without-HIV to recipients-with-HIV (HIV D−/R+) LT. We quantified patient survival, graft survival, rejection, serious adverse events (SAEs), human immunodeficiency virus (HIV) breakthrough, infections, and malignancies, using Cox and negative binomial regression with inverse probability of treatment weighting. Between March 2016–July 2019, there were 45 LTs (8 simultaneous liver-kidney) at 9 centers: 24 HIV D+/R+, 21 HIV D−/R+ (10 D− were false-positive). The median follow-up time was 23 months. Median recipient CD4 was 287 cells/µL with 100% on antiretroviral therapy; 56% were hepatitis C virus (HCV)-seropositive, 13% HCV-viremic. Weighted 1-year survival was 83.3% versus 100.0% in D+ versus D− groups (p =.04). There were no differences in one-year graft survival (96.0% vs. 100.0%), rejection (10.8% vs. 18.2%), HIV breakthrough (8% vs. 10%), or SAEs (all p >.05). HIV D+/R+ had more opportunistic infections, infectious hospitalizations, and cancer. In this multicenter pilot study of HIV D+/R+ LT, patient and graft survival were better than historical cohorts, however, a potential increase in infections and cancer merits further investigation.