Evaluation of Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet of Islatravir and Lenacapavir.

%GLSM ratio [90% CI]: 103 [80.6-132]). Food had no appreciable effect on islatravir pharmacokinetics, whereas lenacapavir exposure increased, consistent with the known food effect for lenacapavir. Islatravir and lenacapavir were generally well tolerated when coadministered or as an FDC in the fed or fasted state, with a safety profile consistent with known single-agent administration. These results supported and informed phase 3 investigations of an islatravir/lenacapavir FDC tablet as a once-weekly oral treatment option for HIV-1 without regard to food.