TY - JOUR
T1 - Preemptive Treatment With Elbasvir and Grazoprevir for Hepatitis C–Viremic Donor to Uninfected Recipient Kidney Transplantation
AU - Sise, Meghan E.
AU - Strohbehn, Ian A.
AU - Chute, Donald F.
AU - Gustafson, Jenna
AU - Van Deerlin, Vivianna M.
AU - Smith, Jennifer R.
AU - Gentile, Caren
AU - Wojciechowski, David
AU - Williams, Winfred W.
AU - Elias, Nahel
AU - Chung, Raymond T.
N1 - Funding Information:
This study was supported by an investigator-initiated grant to Massachusetts General Hospital by Merck Sharp & Dohme Corp. to RTC. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. In addition, MES was supported by NIH K23 DK117014 . RTC was supported by NIH K24 DK078772 and the Massachusetts General Hospital Research Scholars Program. We acknowledge the contribution of the pretransplantation coordinators Linda Walsh, Laura Cornacchini, and Wendy Valerius; the post-transplantation coordinators Kim Sullivan, Colleen Dunbar, and Ana Chan; Peter Reese and David Goldberg from the University of Pennsylvania; and the New England Donor Services, particularly Jillian Wojtowicz and Christopher Curran. The authors would like to thank Xavier Vela Parada for creating the visual abstract.
Funding Information:
This study was supported by an investigator-initiated grant to Massachusetts General Hospital by Merck Sharp & Dohme Corp. to RTC. The opinions expressed in this paper are those of the authors and do not necessarily represent those of Merck Sharp & Dohme Corp. In addition, MES was supported by NIH K23 DK117014. RTC was supported by NIH K24 DK078772 and the Massachusetts General Hospital Research Scholars Program. We acknowledge the contribution of the pretransplantation coordinators Linda Walsh, Laura Cornacchini, and Wendy Valerius; the post-transplantation coordinators Kim Sullivan, Colleen Dunbar, and Ana Chan; Peter Reese and David Goldberg from the University of Pennsylvania; and the New England Donor Services, particularly Jillian Wojtowicz and Christopher Curran. The authors would like to thank Xavier Vela Parada for creating the visual abstract.
Publisher Copyright:
© 2020 International Society of Nephrology
PY - 2020/4
Y1 - 2020/4
N2 - Introduction: Long wait times for kidney transplants have prompted investigation into strategies to decrease the discarding of potentially viable organs. Recent reports suggest that kidneys from hepatitis C virus (HCV)−infected donors may be transplanted into HCV-naive donors followed by direct-acting antiviral therapy. Methods: This was a pilot clinical trial to transplant kidneys from HCV-infected donors into HCV-naive recipients with preemptive use of elbasvir and grazoprevir for 12 weeks. The primary outcome was sustained virologic response 12 weeks after completion of therapy. Secondary outcomes were safety, quality of life, and early viral kinetics. Results: A total of 33 patients were screened, and 8 underwent kidney transplantation from a HCV-viremic donors from August 2017 to March 2019. The median donor kidney donor profile index was 31% (range, 29%−65%), and patients who underwent transplantation waited a median of 6.5 months (range, 1−19 months). None had detectable HCV viremia beyond 2 weeks post-transplantation, and all achieved sustained virologic response 12 weeks after therapy (SVR12). There were no study-related severe adverse events. One patient experienced early graft loss due to venous thrombosis, whereas the remaining 7 patients had excellent allograft function at 6 months. Conclusion: Preemptive elbasvir and grazoprevir eliminated HCV infection in HCV-naive patients who received a kidney transplant from an HCV-infected donor.
AB - Introduction: Long wait times for kidney transplants have prompted investigation into strategies to decrease the discarding of potentially viable organs. Recent reports suggest that kidneys from hepatitis C virus (HCV)−infected donors may be transplanted into HCV-naive donors followed by direct-acting antiviral therapy. Methods: This was a pilot clinical trial to transplant kidneys from HCV-infected donors into HCV-naive recipients with preemptive use of elbasvir and grazoprevir for 12 weeks. The primary outcome was sustained virologic response 12 weeks after completion of therapy. Secondary outcomes were safety, quality of life, and early viral kinetics. Results: A total of 33 patients were screened, and 8 underwent kidney transplantation from a HCV-viremic donors from August 2017 to March 2019. The median donor kidney donor profile index was 31% (range, 29%−65%), and patients who underwent transplantation waited a median of 6.5 months (range, 1−19 months). None had detectable HCV viremia beyond 2 weeks post-transplantation, and all achieved sustained virologic response 12 weeks after therapy (SVR12). There were no study-related severe adverse events. One patient experienced early graft loss due to venous thrombosis, whereas the remaining 7 patients had excellent allograft function at 6 months. Conclusion: Preemptive elbasvir and grazoprevir eliminated HCV infection in HCV-naive patients who received a kidney transplant from an HCV-infected donor.
KW - direct-acting antivirals
KW - hepatitis C virus
KW - kidney transplantation
KW - organ allocation
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U2 - 10.1016/j.ekir.2020.01.001
DO - 10.1016/j.ekir.2020.01.001
M3 - Article
C2 - 32280841
AN - SCOPUS:85080077881
SN - 2468-0249
VL - 5
SP - 459
EP - 467
JO - Kidney International Reports
JF - Kidney International Reports
IS - 4
ER -