A single-pill regimen containing tenofovir alafenamide (TAF), a prodrug of tenofovir, may be tolerable for people living with HIV who are on chronic hemodialysis, a small multi-center study published in The Lancet found.
Researchers switched 55 HIV-positive, virally suppressed people who had end-stage renal disease from their current antiretroviral regimen to a once-daily regimen of elvitegravir, cobicistat, emtricitabine, and TAF (E/C/F/TAF, Genvoya). All participants had been on chronic hemodialysis for no less than six months prior to joining the study.
Given the generally ill health of study participants, the significantly higher rate of severe adverse events (33% of the 55 participants experienced a grade 3 or higher event by week 48) compared to otherwise healthy people was not unexpected, study authors noted. However, none of those events at or above grade 3 were deemed to be treatment-related. Most such events were instead related to participants’ comorbid conditions, and most treatment-related AEs were less severe (grades 1 and 2).
Study authors concluded that E/C/F/TAF can be used in people with end-stage renal disease. Barcelona, Spain, researchers Juan Ambrosioni, M.D., Ph.D., and José M. Miró, M.D., Ph.D., cautioned in a commentary article that the study did not assess bone health or mitochondrial toxicity, nor were potential drug-drug interactions explored. However, a single tablet regimen for people on dialysis who are waiting for a kidney transplant is a welcome alternative, they concluded.