Safety and Tolerability of Oral Islatravir Once Monthly as Pre-Exposure Prophylaxis in Cisgender Men and Transgender Women Who Have an Elevated Likelihood of HIV-1 Exposure: Results From the IMPOWER-2

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Islatravir once monthly (qm) was evaluated for safety and tolerability in cisgender men and transgender women at increased likelihood of HIV-1 exposure.
IMPOWER-24 was a double-blind, Phase 3 study with participants randomized to islatravir 60 mg oral qm or a comparator (FTC/tenofovir disoproxil or FTC/TAF qd).
The study was discontinued early due to lymphocyte reductions observed in the islatravir group.
Most adverse events (AEs) were mild or moderate, with one leading to discontinuation (islatravir; gastroesophageal reflux).
Serious AEs occurred in less than 2% of participants, none related to the study product.
A decrease in total lymphocytes (-7.4%) was observed in the islatravir group at Month 3, with a trend toward recovery after discontinuation.
No HIV-1 infections occurred in either group during the double-blind phase.
Original primary efficacy objectives were not assessed due to early study stoppage.

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