Gilead’s Twice-Yearly PrEP Drug Achieves 100% Efficacy in HIV Prevention

1. 100% Efficacy: Gilead's twice-yearly, subcutaneous lenacapavir has shown 100% efficacy in preventing HIV infections in a phase 3 trial, marking a significant milestone in HIV prevention.
2. PURPOSE Trials: Lenacapavir is being evaluated in multiple trials under the PURPOSE program, including PURPOSE 1, which demonstrated zero infections, and PURPOSE 2, which is expected to report results in late 2024 or early 2025.
3. Threat to GSK's Apretude: Lenacapavir's success poses a major threat to GSK's Apretude, which can currently be administered only up to every two months. GSK plans to launch an every-four-month version in 2026 and start a registrational study for a twice-yearly option in 2027.
4. Market Impact: The HIV PrEP market is expected to more than double in size to around 4 billion to 5 billion pounds by 2031, with long-acting injectables taking up about 80% of the market value. Lenacapavir is expected to garner a significant share of the market.
5. Access and Future Developments: Gilead plans to make a public announcement regarding its access approach for high-incidence, resource-limited countries. The company is also working on ultralong-acting regimens for HIV treatment and pairing lenacapavir with other drugs for once-weekly oral candidates.