Transplanting Hepatitis C Infected Organs Into Uninfected Recipients: A Pharmacy Perspective
M. L. Holt, A. James, K. Gutierrez, T. Sparkman, J. Banbury, D. Jones
University of Alabama at Birmingham Hospital, Birmingham, AL
Meeting: 2021 American Transplant Congress
Abstract number: 364
Keywords: Donors, marginal, Hepatitis C, Liver transplantation, Viral therapy
Topic: Clinical Science » Infectious Disease » Non-Organ Specific: Viral Hepatitis
Session Information
Session Time: 6:00pm-7:00pm
Presentation Time: 6:30pm-6:35pm
Location: Virtual
*Purpose: Due to direct acting antivirals (DAAs), hepatitis C virus (HCV) positive patients are now resources for organ transplantation in HCV negative recipients. Our institution initiated a HCV donor positive/recipient negative (D+/R-) protocol that utilizes glecaprevir/pibrentasvir (G/P) in recipients of nucleic acid amplification testing (NAT) positive organs for 12 weeks beginning post-operative day three. Per protocol, NAT negative transplant recipients are initiated on treatment only after developing HCV viremia. Pharmacists play an integral role in G/P insurance approval and the medication acquisition process. The aim of this study is to assess antiviral efficacy and identify common barriers to G/P acquisition.
*Methods: The current study is a single-center, cohort analysis of recipients of a kidney or liver transplant from a HCV positive donor transplanted November 2019-June 2020. The primary objective is to determine rate of sustained virologic response (SVR12). Secondary objectives are to describe G/P cost and evaluate the prior authorization (PA) process.
*Results: Forty patients were included. Most patients were male (73%) African American (40%) renal transplant recipients (63%) who received anti-thymocyte globulin (58%). Thirty-one patients received NAT positive organs and were treated with G/P. The most common genotype was 1a (25%). All patients completed 12 weeks of therapy and achieved end of treatment response. No recipient of a NAT negative organ (n=9) developed viremia within the study period. All treated patients with a full data set available (87%) achieved SVR12. All G/P prescriptions required a PA with most (80%) requiring at least one appeal. The average time to PA approval was 3.35 days (range, 1-12). Pharmacy dispensing data was available for 27 patients indicating most patients required financial assistance (63%). Average copay, per fill, was less than $3.00 with average assistance equaling $1,265, $570 and $397 on each of three fills, respectively (range, $0-$3,892). Amounts rounded to nearest US dollar. Additional data collection is ongoing.
*Conclusions: Preliminary results suggest that the HCV donor positive/recipient negative protocol appears to be safe and effective in abdominal transplant recipients. Pharmacy involvement ensured patients were able to obtain DAA treatment to facilitate discharge.
To cite this abstract in AMA style:
Holt ML, James A, Gutierrez K, Sparkman T, Banbury J, Jones D. Transplanting Hepatitis C Infected Organs Into Uninfected Recipients: A Pharmacy Perspective [abstract]. Am J Transplant. 2021; 21 (suppl 3). https://atcmeetingabstracts.com/abstract/transplanting-hepatitis-c-infected-organs-into-uninfected-recipients-a-pharmacy-perspective/. Accessed November 22, 2024.« Back to 2021 American Transplant Congress