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Biological products industry

Gilead Presents New Data on Efficacy and Safety of Lenacapavir for HIV Prevention at IAS 2025

Strategic Insights

— 1 min read

Gilead Sciences Inc has showcased the efficacy and tolerability of twice-yearly injectable lenacapavir (Yeztugo) for HIV pre-exposure prophylaxis (PrEP) across diverse populations, including pregnant and lactating women, adolescents, and young adults. The new data from the Phase 3 PURPOSE trials highlighted zero HIV infections among pregnant and breastfeeding participants on Yeztugo, with no safety concerns and minimal drug exposure in infants. The findings support Yeztugo as a compelling alternative to daily regimens, with over 75% of surveyed trial participants preferring twice-yearly injections.

Key Takeaways:

  • The data from the PURPOSE 1 and PURPOSE 2 trials showed zero HIV infections among pregnant and breastfeeding participants on Yeztugo, with no safety concerns and minimal drug exposure in infants.
  • The efficacy and pharmacokinetic profiles were consistent in adolescents aged 16-25, and modeling supported co-administration with tuberculosis treatments through adjusted dosing.
  • Over 75% of surveyed trial participants preferred twice-yearly injections to daily oral PrEP, citing increased confidence in adherence and protection against HIV.
  • No new safety issues were reported, and the findings support Yeztugo as a compelling alternative to daily regimens.
  • Gilead secured US FDA approval for Yeztugo on June 18, 2025, and has filed for regulatory authorizations in Europe, Australia, Brazil, Canada, South Africa, and Switzerland.
  • A recent partnership with the Global Fund will provide lenacapavir at no profit to up to two million individuals over three years in eligible countries.
  • The PURPOSE program, comprising five global trials, is the most comprehensive HIV prevention trial initiative to date.
  • Lenacapavir is being developed as a foundation for long-acting treatment and prevention strategies.

Statistics:

  • Over 75% of surveyed trial participants preferred twice-yearly injections to daily oral PrEP.
  • Zero HIV infections were reported among pregnant and breastfeeding participants on Yeztugo in the PURPOSE 1 and PURPOSE 2 trials.
  • No safety concerns or drug exposure in infants were reported in the PURPOSE 1 and PURPOSE 2 trials.
  • The efficacy and pharmacokinetic profiles were consistent in adolescents aged 16-25.
  • The modeling supported co-administration with tuberculosis treatments through adjusted dosing.

Sources:

  • M2 PHARMA, "Gilead showcases efficacy of twice-yearly lenacapavir for HIV prevention at IAS 2025"
  • Gilead Sciences Inc,
  • IAS 2025 conference

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