Outcomes of Hepatitis C Nucleic Acid Testing Positive Donors in Aviremic Recipients With Delayed Direct-Acting Antiviral Initiation
M. Hudson, A. Webb, A. Logan, A. Silverman, A. Brueckner
Pharmacy, Tampa General Hospital, Tampa, FL
Meeting: 2021 American Transplant Congress
Abstract number: 363
Keywords: Heart/lung transplantation, Hepatitis C, Kidney/liver transplantation, Outcome
Topic: Clinical Science » Infectious Disease » Non-Organ Specific: Viral Hepatitis
Session Information
Session Time: 6:00pm-7:00pm
Presentation Time: 6:25pm-6:30pm
Location: Virtual
*Purpose: The purpose of this study was to assess the clinical impact of utilizing hepatitis C virus (HCV) nucleic acid testing (NAT)+ donors in HCV NAT- solid organ transplant (SOT) recipients in a real-world practice where direct-acting antiviral (DAA) initiation is largely dependent on insurance coverage.
*Methods: A single-center, retrospective chart review of HCV NAT- recipients who underwent SOT from a HCV NAT+ donor between 4/1/2019-5/27/2020 was conducted. The main objective of this study was to evaluate the sustained virologic response at 12 weeks (SVR12) after completion of DAA therapy. Secondary objectives were to assess the safety and efficacy of DAA therapy, as well as transplant related outcomes.
*Results: Sixty-two HCV NAT- patients underwent SOT with a HCV NAT+ organ, with 59 transplant recipients included for evaluation: 22 kidney (KT), 18 liver (LiT), 10 heart (HT), 9 lung (LuT). HCV transmission occurred in 100% of recipients. Average time to DAA initiation was 46.7 ± 25 days after transplant. SVR12 was achieved in 97.8% (45/46; 13 patients lacked complete SVR12 data for primary endpoint analysis). Treatment failure occurred in 1 LuT patient on glecaprevir/pibrentasvir due to a P32del mutation, requiring alternative therapy with sofosbuvir/velpatasvir/voxilaprevir and ribavirin. 58.5% of KT, HT, and LuT patients experienced post-transplant liver dysfunction. No patients developed fibrosing cholestatic hepatitis. Two patients died, 1 secondary to anastomotic complication (LuT) and 1 due to pulmonary embolism (HT). De novo donor specific antibodies were present in 1 KT, 1 HT, and 2 LuT recipients, developing 402 days, 4 days, and a median of 137.5 (56-219) days post-transplant, respectively. Clinically significant rejection was diagnosed and treated in 1 HT patient (ACR2) and 1 LiT (RAI 5/9). No episodes of KT or LuT rejection were diagnosed. Six patients (10.2%) had documented adverse effects attributed to DAA therapy, including gastrointestinal, fatigue, orthostatic hypotension, and nail discoloration. One LuT required alternative therapy with sofosbuvir/velpatasvir due to intractable vomiting on glecaprevir/pibrentasvir, but successfully obtained SVR12.
*Conclusions: This study adds to the paucity of literature describing the delayed start of DAA therapy for donor transmitted HCV in SOT and assuages the concerns of HCV sequelae by demonstrating efficacy via high SVR12 rates and no fibrosing cholestatic cirrhosis. This delay in DAA initiation shifts the financial burden to 3rd party insurances without compromising transplant related outcomes.
To cite this abstract in AMA style:
Hudson M, Webb A, Logan A, Silverman A, Brueckner A. Outcomes of Hepatitis C Nucleic Acid Testing Positive Donors in Aviremic Recipients With Delayed Direct-Acting Antiviral Initiation [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/outcomes-of-hepatitis-c-nucleic-acid-testing-positive-donors-in-aviremic-recipients-with-delayed-direct-acting-antiviral-initiation/. Accessed November 21, 2024.« Back to 2021 American Transplant Congress