by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
November 22, 2022
Sigman EF, Ondrush NM. Utilization of bictegravir/emtricitabine/tenofovir alafenamide in patients with end-stage renal disease on hemodialysis. Am J Health Syst Pharm. 2022 Nov 14; zxac339. doi:10.1093/ajhp/zxac339. PMID 36373751.
This case series from a single U.S. medical center describes the use of co-formulated bictegravir/emtricitabine/tenofovir alafenamide (BIK) among 6 adult PWH with end stage renal disease on hemodialysis. Patients were identified through an electronic medical record query if they transitioned to BIK and were receiving hemodialysis between January 2018 and October 2022. Ages ranged from 51-70 years, and the average time since HIV diagnosis was 24 years. All had co-occurring cardiovascular disease. All case patients were on INSTI-containing regimens prior to starting BIK: 4 were taking dolutegravir once daily, 1 was taking dolutegravir twice daily, and 1 was receiving elvitegravir/cobicistat. Four patients were on a 3-class ART regimen. At 1 year prior to starting BIK, 3 patients had HIV-1 RNA levels > 50 copies/mL (3 had an undetectable viral load). At 1 month prior to starting BIK, 3 patients had HIV-1 RNA levels > 50 copies/mL. Four patients were transitioned to BIK alone and 2 patients started BIK plus doravirine. By 1 year after starting BIK, 5 patients had an undetectable viral load, and the 6th patient had an undetectable viral load after ~2.5 years. No patient-reported adverse effects were documented in the electronic medical record after transition to BIK-based regimens, and overall patients reported adherence to their new regimens.
Observations from this small real world case series are consistent with findings from an extension study initially presented at IDWeek 2020, namely regarding tolerability and general safety of BIK among PWH with end stage renal disease on chronic hemodialysis. For the extension study, potential participants were excluded if they had any documented history of HIV drug resistance to elvitegravir, emtricitabine, lamivudine, or tenofovir. By contrast, in this series, there was concern for or documented history of potentially relevant ARV resistance in 4 of 6 patients. Nevertheless, all but one patient achieved virologic suppression one year after ART modification to a BIK-based regimen, and the other patient suppressed after ~2.5 years. Although data from this retrospective study were gathered solely from electronic health records, findings suggest BIK may be a reasonable simplification option for ART-experienced PWH on chronic hemodialysis who desire a streamlined regimen with relatively few drug-drug interactions.
The author has no conflicts of interest to disclose.
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