Background: Hepatitis B virus (HBV)-related cirrhosis and malignancy are common indications for orthotopic liver transplantation (OLT) worldwide. Hepatitis B immunoglobulin (HBIG) infusions are widely used after OLT to prevent recurrent HBV viremia. This study aims to evaluate whether Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/E) can be administered without concurrent HBIG therapy to prevent HBV recurrence post-OLT. Secondarily, we aim to demonstrate the cost-effectiveness of such therapy based on current costs of TDF/E and HBIG.
Methods: We performed a retrospective chart review of 62 patients (75.8% male, average 59 years-old) post-OLT for HBV-related disease (61.3% with hepatocellular carcinoma) at a large urban transplant center. Patients were treated with 6 months of HBIG+TDF/E at which point HBIG was stopped and oral TDF/E monotherapy was continued. We analyzed this cohort to identify patients who had become serum HBV DNA positive (threshold of 1.6log IU). We calculated the time interval from the last HBIG infusion to the last negative serum HBV DNA level and obtained the median time of treatment. We also calculated the cumulative cost of HBIG infusions (assuming injections of 10,000IU bimonthly) during the interval that patients were on TDF/E monotherapy to arrive at the average cost savings. Annual cost savings were calculated by dividing the cost savings by the mean time on TDF/E monotherapy.
Results: We identified only one patient who developed HBV viremia while receiving TDF/E oral monotherapy, a 98.4% treatment success rate. This patient was receiving concurrent chemotherapy for metastatic hepatocellular carcinoma. The median HBV DNA seronegative interval on TDF/E monotherapy was 86 weeks (range: 2-228 weeks). On TDF/E oral monotherapy, cost savings averaged $49,804 per patient over the study or $28,150 per patient life year when compared with conventional HBIG-based therapy. This figure was based on medication-only costs, calculating laboratory and infusion center charges would increase savings. As 10-year survival approaches 75%, there are substantial cost savings to be made over a patient's life span.
Conclusions: After a 6 months of TDF/E+HBIG post-OLT, TDF/E monotherapy can be continued with minimal risk of HBV recurrence. Considering the high cost of HBIG infusions, this can save upwards of $28,000 per patient per year of therapy.
Teperman, L.: Grant/Research Support, Truvada.
To cite this abstract in AMA style:Grodstein E, Gelb B, Layman R, Mittal R, Teperman L. Nucleoside Reverse Transcriptase Inhibitors without HBIG Can Be Safely and Cost-Effectively Administered To Prevent Recurrent Hepatitis B Viremia Post-Liver Transplant [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/nucleoside-reverse-transcriptase-inhibitors-without-hbig-can-be-safely-and-cost-effectively-administered-to-prevent-recurrent-hepatitis-b-viremia-post-liver-transplant/. Accessed May 28, 2020.
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