A new twice-yearly HIV injection providing near-total protection should be made widely available, heralding a transformative milestone in the global fight against HIV/AIDS. The drug, called lenacapavir and produced by Gilead Sciences, has recently received strong endorsements from major health authorities, including the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO), based on clinical trial data showing near 100% effectiveness when administered twice a year.
Lenacapavir works as a long-acting pre-exposure prophylaxis (PrEP) by inhibiting the HIV capsid, preventing the virus from replicating and spreading in the body. Unlike previous HIV prevention methods, which primarily involved daily oral pills such as Truvada or monthly injections, lenacapavir requires only two injections annually, significantly reducing the burden of adherence and improving accessibility for at-risk populations.
“This is a historic moment in HIV prevention,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, at the International AIDS Society Conference 2025 in Kigali, Rwanda. “While an HIV vaccine remains elusive, lenacapavir is the next best thing, offering long-lasting protection with just two doses per year. This could be a game-changer, especially for people facing barriers to daily pill adherence because of stigma, access, or lifestyle challenges.”
Clinical trials known as PURPOSE 1 and PURPOSE 2 encompassed diverse participant groups, including both men and women at high risk for HIV infection. The results were groundbreaking: more than 99.9% of participants receiving lenacapavir remained HIV negative during the study periods. Side effects were minimal, primarily limited to mild pain or swelling at the injection site.
Dr. Carlos del Rio, co-director of the Emory Center for AIDS Research, emphasized lenacapavir’s potential impact. “The twice-yearly injection could overcome major adherence obstacles seen with daily oral PrEP, dramatically boosting uptake and persistence. This is especially critical for populations historically underserved or stigmatized,” he said.
The new injection is already gaining regulatory approval beyond the U.S. The European Medicines Agency has issued a positive opinion, with formal approval expected soon. The Global Fund and the Elton John AIDS Foundation have pledged support to ensure broad access, particularly in regions with high HIV incidence like sub-Saharan Africa. The Global Fund aims to have initial shipments reach African countries by the end of 2025.
Real-world implications of lenacapavir could be profound. In the U.S. alone, more than 100 new HIV diagnoses occur daily, with millions identified as candidates for PrEP but many unable or unwilling to adhere to daily pill regimens due to stigma, side effects, or access barriers. The twice-yearly shot offers a discrete, low-maintenance option that has the potential to dramatically curb new infections.
However, challenges remain. Stakeholders caution about ensuring affordability, equitable distribution, and education to maximize uptake. Funding constraints and healthcare infrastructure gaps, especially in low- and middle-income countries, could impede rapid scale-up.
“The success of lenacapavir depends not only on the drug but on political will, financing, and community engagement to reach those who need it most,” noted Dr. Monica Gandhi of UCSF. “It’s an extraordinary tool in our HIV prevention arsenal—but only if deployed widely.”
Summary and Next Steps
Lenacapavir, as the first and only FDA-approved twice-yearly injection for HIV prevention, represents a breakthrough that could reshape the HIV epidemic worldwide. Its near-complete protection against infection and user-friendly dosing schedule provide an unprecedented opportunity to enhance prevention efforts, especially among populations facing adherence challenges.
Global health leaders now urge governments, funders, and healthcare providers to prioritize rapid introduction and scale-up of lenacapavir. Ensuring affordable access in high-incidence regions, coupled with robust education and supportive policies, will be vital to leveraging this innovation in the ongoing battle against HIV. Further monitoring and real-world implementation studies will guide optimization of delivery strategies to maximize impact.
With these actions, lenacapavir could meaningfully reduce new HIV infections, bring the world closer to epidemic control, and mark a pivotal step in ending AIDS.
