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-24 Randomized Phase 3 Study.
Clin Infect DisSep 2, 2026
Raphael J Landovitz, Yvett Pinedo, Federico Hinestrosa et al.
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In 30 seconds
The IMPOWER-24 randomized Phase 3 trial evaluated the safety and tolerability of monthly oral islatravir in cisgender men and transgender women at high risk for HIV-1 exposure. The study found that 64.3% of participants on islatravir experienced at least one adverse event, with a notable decrease in total lymphocytes of -7.4% at Month 3.
Key findings
- 64.3% of participants on islatravir experienced at least one adverse event compared to 77.1% in the comparator group.
- Total lymphocytes decreased by 7.4% in the islatravir group at Month 3.
- Serious adverse events occurred in less than 2% of participants, none related to the study product.
- No HIV infections were reported in either group during the double-blind phase.
Why it matters
Understanding the safety profile of new HIV pre-exposure prophylaxis options is crucial for clinicians to make informed decisions about patient care, especially in populations at high risk for HIV exposure.