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Single-tablet regimen well-tolerated in HIV-infected adults on hemodialysis

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January 2, 2019

Switching to a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide is well tolerated by HIV-1-infected adults with end-stage renal failure who are on chronic hemodialysis, phase 3 study findings showed.

Researchers said the regimen, which is approved in the United States, Europe and other regions, “might provide a tolerable and convenient option for ongoing treatment of HIV-1 infection” in this population.

“Current treatment for HIV-infected individuals with renal failure on hemodialysis frequently requires complex regimens with multiple pills,” Joseph J. Eron Jr., MD, professor of medicine in the division of infectious diseases at the University of North Carolina School of Medicine, and colleagues wrote in The Lancet HIV.

Eron and colleagues assessed the regimen in HIV-infected adults with end-stage renal disease on long-term hemodialysis in an open-label, single-arm, multicenter, phase 3b trial at 26 outpatient clinics in Austria, France, Germany and the U.S. According to the study, they enrolled 55 participants between Feb. 1 and Nov. 3, 2016, giving them at least one dose of the study drug.

Overall, the treatment was well tolerated, with adverse events leading to study discontinuation in just three of 55 participants. Through week 48, 18 of the 55 participants had an adverse event of grade 3 or higher, Eron and colleagues reported. According to the study findings, adverse events that occurred in more than one participant included anemia, osteomyelitis, prolonged electrocardiogram QT, fluid overload, hyperkalemia, hypertension and hypotension. No adverse event of grade 3 or higher was considered by site investigators to be treatment related, they said. Treatment-related adverse events were reported in six patients, the most common being nausea.

“At 48 weeks, switching to the single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic hemodialysis was well tolerated, as evidenced by an overall low incidence of adverse events that were considered to be treatment related or that led to early discontinuation of study drug, with maintenance of virological suppression,” the authors wrote.

“In conclusion, these results support the use of the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide once daily for the treatment of HIV-1 infection in adults with end-stage renal disease on chronic hemodialysis with minimal residual renal function. This regimen might provide a tolerable and convenient option for ongoing treatment of HIV-1 infection in this population and could reduce pill burden and the potential for dosing errors.” – by Caitlyn Stulpin

Disclosures: Eron reports being an ad hoc consultant to Gilead Sciences, Merck, Janssen and ViiV Healthcare. The University of North Carolina received support for Eron from Gilead for the study, and the university also receives research contracts from Janssen and ViiV that support Eron outside the study. Please see the study for all other authors’ relevant financial disclosures.

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