Session Time: 6:00pm-7:00pm
Presentation Time: 6:05pm-6:10pm
*Purpose: This prospective study aims to assess the efficacy of preemptive therapy with eight days of a combination of direct-acting antivirals (DAAs) (Mavyret) (Pibrentasvir /Glecaprevir) and Zetia (ezetimibe) in recipients of HCV viremic solid organ transplant (kidney or heart).Background: Zetia (ezetimibe), which is generally used as a lipid-lowering agent, was found to help blocking the cholesterol receptor used by the HCV virus for cell entry. The combination of this drug with DAA’s can potentially be more effective in preventing the transmission of hepatitis C infection in recipients of solid organ transplants from donors with active viremia at time of procurement
*Methods: This is a prospective open label. internally funded, single center study. Solid organ recipients (kidney, heart) who agreed to accept HCV viremic organs are consented for the study. Once patients are admitted for an HCV viremic organ, HCV pre-emptive therapy with Mavyret and Zetia was initiated upon call to the operative room. Mavyret was the choice in view of highly effective pan genotypic coverage, ability to use in the setting of advanced kidney disease, and low side effect profile. Combination therapy was continued for 7 days after transplant (total of eight doses). HCV RNA was monitored at day 0.1, 3, 7 and then weekly until 13 weeks post-transplant. SVR 12 was defined as undetectable HCV RNA 12 weeks after last dose of therapy (week 13 post-transplant)
*Results: Eight patients have enrolled in the study so far (7 kidney transplants, one kidney pancreas transplant). All patients completed 8 days of combination therapy without interruption. Patients tolerated treatment without and treatment related adverse events. All patients developed transient viremia by day 3 post-transplant with median peak viral load of 129 IU/ml (<15-1030). At day 7 post-transplant: 6/8 patients showed undetectable HCV RNA while 2/8 patients had detectable virus (<15). All patients achieved undetectable viremia at day 14 post-transplant. Two patients had follow up more than 13 weeks and both achieved SVR 12.
*Conclusions: Early data confirm that preemptive therapy with shortened course with Pibrentasvir /Glecaprevir and ezetimibe was effective in recipients of non-liver solid organ transplants. Study continues to enroll and we anticipate the final data will be presented at the meeting. This approach may prove to be cost effective and will allow wider use of HCV viremic organs.
To cite this abstract in AMA style:Aqel B, Khamash H, Moss A, Steidley DE, Dickson RC. Pilot Study for the Use of Shortened Preemptive Therapy with Glecaprevir/pibrentasvir (g/p) and Ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney and Heart) of Hepatitis C Viremic Donors [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/pilot-study-for-the-use-of-shortened-preemptive-therapy-with-glecaprevir-pibrentasvir-g-p-and-ezetimibe-in-hepatitis-c-seronegative-solid-organ-transplant-recipients-kidney-and-heart-of-hepatitis/. Accessed June 18, 2021.
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