Safety and Pharmacokinetics of Islatravir in Individuals with Severe Renal Insufficiency
Randolph P. Matthews, Youfang Cao, Munjal Patel, Vanessa L. Weissler, Arinjita Bhattacharyya, Inge De Lepeleire, Stefanie Last, Juan Carlos Rondón, Ryan Vargo, S. Aubrey Stoch, Marian Iwamoto
Abstract
was ~1.5-fold higher in the RI group than in the control group. The half-lives of islatravir in plasma and islatravir-TP in PBMCs were longer in participants with severe RI than in controls. These findings are consistent with renal excretion playing a major role in islatravir elimination. A single oral dose of islatravir 60 mg was generally well tolerated. These data provide guidance regarding administration of islatravir in individuals with impaired renal function. (This study has been registered at ClinicalTrials.gov under registration no. NCT04303156.).