Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs
Background. Hepatitis C virus (HCV) nucleic acid amplification test (NAAT)–positive donors have increased the organ pool. Direct-acting antivirals (DAAs) have led to high rates of treatment success and sustained virologic response (SVR) in recipients with donor-derived HCV infection without signific...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wolters Kluwer
2023-11-01
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| Series: | Transplantation Direct |
| Online Access: | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001539 |
| _version_ | 1827631756928352256 |
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| author | Julie M. Steinbrink, MD, MHS Jennifer Byrns, PharmD Carl Berg, MD Matthew Kappus, MD Lindsay King, MD, MPH Matthew J. Ellis, MD Scott Sanoff, MD, MPH Richa Agarwal, MD Adam D. DeVore, MD, MHS John M. Reynolds, MD Matthew G. Hartwig, MD, MHS Carmelo Milano, MD Debra Sudan, MD Eileen K. Maziarz, MD Jennifer Saullo, MD, PharmD Barbara D. Alexander, MD, MHS Cameron R. Wolfe, MBBS, MPH |
| author_facet | Julie M. Steinbrink, MD, MHS Jennifer Byrns, PharmD Carl Berg, MD Matthew Kappus, MD Lindsay King, MD, MPH Matthew J. Ellis, MD Scott Sanoff, MD, MPH Richa Agarwal, MD Adam D. DeVore, MD, MHS John M. Reynolds, MD Matthew G. Hartwig, MD, MHS Carmelo Milano, MD Debra Sudan, MD Eileen K. Maziarz, MD Jennifer Saullo, MD, PharmD Barbara D. Alexander, MD, MHS Cameron R. Wolfe, MBBS, MPH |
| author_sort | Julie M. Steinbrink, MD, MHS |
| collection | DOAJ |
| description | Background. Hepatitis C virus (HCV) nucleic acid amplification test (NAAT)–positive donors have increased the organ pool. Direct-acting antivirals (DAAs) have led to high rates of treatment success and sustained virologic response (SVR) in recipients with donor-derived HCV infection without significant adverse effects, although variability remains in the timing and duration of antivirals.
Methods. This retrospective study analyzed all adult HCV-NAAT–negative transplant recipients who received an organ from HCV-NAAT–positive donors from November 24, 2018, to March 31, 2022, at Duke University Medical Center with protocolized delay of DAA initiation until after hospital discharge, with at least 180-d follow-up on all patients. Transplant and HCV-related outcomes were analyzed.
Results. Two hundred eleven transplants (111 kidneys, 41 livers, 34 hearts, and 25 lungs) were performed from HCV-NAAT–positive donors to HCV-NAAT–negative recipients. Ninety percent of recipients became viremic within 7 d posttransplant. Ninety-nine percent of recipients were initiated on pangenotypic DAAs in the outpatient setting a median of 52 d posttransplant, most commonly with 12-wk courses of sofosbuvir–velpatasvir (lungs) and glecaprevir–pibrentasvir (heart, kidney, and liver). Ninety-seven percent of recipients had SVR after a first-line DAA; all ultimately achieved SVR at 12 wk after subsequent treatment courses. The median peak HCV RNA for all organ systems was 2 436 512 IU/mL; the median time from antiviral to undetectable RNA was 48 d, although differences were noted between organ groups. No patient deaths or graft losses were directly attributable to HCV infection.
Conclusions. One hundred percent of transplant recipients of HCV-NAAT–positive organs ultimately developed SVR without significant adverse effects when HCV antivirals were initiated in the outpatient setting after transplant hospitalization, suggesting that this real-world treatment pathway is a viable option. |
| first_indexed | 2024-03-09T14:25:31Z |
| format | Article |
| id | doaj.art-1c63abab8b074dfe82c4c9a71e4e91e3 |
| institution | Directory Open Access Journal |
| issn | 2373-8731 |
| language | English |
| last_indexed | 2024-03-09T14:25:31Z |
| publishDate | 2023-11-01 |
| publisher | Wolters Kluwer |
| record_format | Article |
| series | Transplantation Direct |
| spelling | doaj.art-1c63abab8b074dfe82c4c9a71e4e91e32023-11-28T07:14:05ZengWolters KluwerTransplantation Direct2373-87312023-11-01911e153910.1097/TXD.0000000000001539202311000-00003Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive OrgansJulie M. Steinbrink, MD, MHS0Jennifer Byrns, PharmD1Carl Berg, MD2Matthew Kappus, MD3Lindsay King, MD, MPH4Matthew J. Ellis, MD5Scott Sanoff, MD, MPH6Richa Agarwal, MD7Adam D. DeVore, MD, MHS8John M. Reynolds, MD9Matthew G. Hartwig, MD, MHS10Carmelo Milano, MD11Debra Sudan, MD12Eileen K. Maziarz, MD13Jennifer Saullo, MD, PharmD14Barbara D. Alexander, MD, MHS15Cameron R. Wolfe, MBBS, MPH161 Division of Infectious Diseases, Duke University School of Medicine, Durham, NC.2 Department of Pharmacy, Duke University Hospital, Durham, NC.3 Division of Gastroenterology, Duke University School of Medicine, Durham, NC.3 Division of Gastroenterology, Duke University School of Medicine, Durham, NC.3 Division of Gastroenterology, Duke University School of Medicine, Durham, NC.4 Division of Nephrology, Duke University School of Medicine, Durham, NC.4 Division of Nephrology, Duke University School of Medicine, Durham, NC.5 Division of Cardiology, Duke University School of Medicine, Durham, NC.5 Division of Cardiology, Duke University School of Medicine, Durham, NC.6 Division of Pulmonary, Allergy and Critical Care, Duke University School of Medicine, Durham, NC.7 Division of Cardiovascular and Thoracic Surgery, Duke University School of Medicine, Durham, NC.7 Division of Cardiovascular and Thoracic Surgery, Duke University School of Medicine, Durham, NC.8 Division of Abdominal Transplant Surgery, Duke University School of Medicine, Durham, NC.1 Division of Infectious Diseases, Duke University School of Medicine, Durham, NC.1 Division of Infectious Diseases, Duke University School of Medicine, Durham, NC.1 Division of Infectious Diseases, Duke University School of Medicine, Durham, NC.1 Division of Infectious Diseases, Duke University School of Medicine, Durham, NC.Background. Hepatitis C virus (HCV) nucleic acid amplification test (NAAT)–positive donors have increased the organ pool. Direct-acting antivirals (DAAs) have led to high rates of treatment success and sustained virologic response (SVR) in recipients with donor-derived HCV infection without significant adverse effects, although variability remains in the timing and duration of antivirals. Methods. This retrospective study analyzed all adult HCV-NAAT–negative transplant recipients who received an organ from HCV-NAAT–positive donors from November 24, 2018, to March 31, 2022, at Duke University Medical Center with protocolized delay of DAA initiation until after hospital discharge, with at least 180-d follow-up on all patients. Transplant and HCV-related outcomes were analyzed. Results. Two hundred eleven transplants (111 kidneys, 41 livers, 34 hearts, and 25 lungs) were performed from HCV-NAAT–positive donors to HCV-NAAT–negative recipients. Ninety percent of recipients became viremic within 7 d posttransplant. Ninety-nine percent of recipients were initiated on pangenotypic DAAs in the outpatient setting a median of 52 d posttransplant, most commonly with 12-wk courses of sofosbuvir–velpatasvir (lungs) and glecaprevir–pibrentasvir (heart, kidney, and liver). Ninety-seven percent of recipients had SVR after a first-line DAA; all ultimately achieved SVR at 12 wk after subsequent treatment courses. The median peak HCV RNA for all organ systems was 2 436 512 IU/mL; the median time from antiviral to undetectable RNA was 48 d, although differences were noted between organ groups. No patient deaths or graft losses were directly attributable to HCV infection. Conclusions. One hundred percent of transplant recipients of HCV-NAAT–positive organs ultimately developed SVR without significant adverse effects when HCV antivirals were initiated in the outpatient setting after transplant hospitalization, suggesting that this real-world treatment pathway is a viable option.http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001539 |
| spellingShingle | Julie M. Steinbrink, MD, MHS Jennifer Byrns, PharmD Carl Berg, MD Matthew Kappus, MD Lindsay King, MD, MPH Matthew J. Ellis, MD Scott Sanoff, MD, MPH Richa Agarwal, MD Adam D. DeVore, MD, MHS John M. Reynolds, MD Matthew G. Hartwig, MD, MHS Carmelo Milano, MD Debra Sudan, MD Eileen K. Maziarz, MD Jennifer Saullo, MD, PharmD Barbara D. Alexander, MD, MHS Cameron R. Wolfe, MBBS, MPH Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs Transplantation Direct |
| title | Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs |
| title_full | Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs |
| title_fullStr | Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs |
| title_full_unstemmed | Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs |
| title_short | Real-world Experiences in the Transplantation of Hepatitis C-NAAT–positive Organs |
| title_sort | real world experiences in the transplantation of hepatitis c naat positive organs |
| url | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001539 |
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