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This was a phase 1 open label, parallel design, single dose, three-cohort study with 56 volunteers who received single oral doses of islatravir 20mg and lenacapavir 600mg for the test group, islatravir 20mg alone for reference, and lenacapavir 600mg alone for reference. Plasma pharmacokinetic samples were then collected up to day 12 of islatravir and 43 for lenacapavir and analyzed. Drug interaction assessment was performed using geometric least square means (GLSM) ratios and 90 confidence intervals of the test treatments versus the reference treatments.
Preliminary results show GLSM ratios (90 CI) of AUCinf and Cmax for islatravir as 105 (90.2-123) and 87.9 (68.7-113) respectively and for lenacapavir the AUCinf and Cmax were 88.6(60.5-130) and 80.1 (50.9-126) respectively. Point estimates of GLSM ratios and 90 CIs show that the pharmacokinetics of islatravir and lenacapavir were similar when administered alone and in combination.
There is no dose adjustment needed when adminstering islatravir and lenacapavir.
Zhang H, et al.. Evaluation of potential drug-drug interactions between islatravir and lenacapavir. Conference On Retroviruses And Opportunistic Infections. . G01; 2022.