People with HIV and end-stage kidney failure who are on dialysis and switch their antiretroviral (ARV) treatment to Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) generally tolerate the single-tablet regimen well, Healio reports.
Publishing their findings in The Lancet HIV, researchers conducted a Phase IIIb trial at 26 outpatient clinics in Austria, France, Germany and the United States. They enrolled 55 people with HIV who had end-stage kidney disease—with a creatinine clearance less than 15 milliliters per minute—and who had been on dialysis for at least six months.
All the participants had fully suppressed HIV for six months prior to the study, thanks to an ARV regimen that was not Genvoya. Additionally, they all had a CD4 count of at least 200.
Everyone was switched to Genvoya and then seen for study visits at weeks 2, 4, 8, 12, 24, 36 and 48 and then every 12 weeks up to 96 weeks.
The study authors were primarily concerned with the rate of adverse events of Grade 3 or higher that the participants developed after switching to Genvoya. Through week 48 of the study, 18 (33 percent) of the participants experienced such an adverse event, none of which were considered related to Genvoya. Six people experienced milder adverse events that were considered related to Genvoya, most commonly nausea.
“This regimen might provide a tolerable and convenient option for ongoing treatment of HIV-1 infection in adults with end-stage renal [kidney] disease on chronic [dialysis],” the study authors concluded.
To read the Healio article, click here.
To read the study abstract, click here.