CHENNAI: The European Medicines Agency (EMA)’s advisory committee has issued a positive opinion for the twice-yearly injectable, lenacapavir, the world’s first HIV prevention treatment. This is another key milestone for the US drug researcher and maker Gilead Sciences in its journey to curb the still rapidly spreading HIV/AIDS in the world.
The EMA decision on Thursday (July 24) clears the way for approval by the European Commission later this year, following similar regulatory clearance in the United States in June 2025.
Lenacapavir, a HIV pre-exposure prophylaxis (PrEP), is to be marketed in Europe under the brand name Yeytuo, is a long-acting injectable designed to prevent HIV infection with just two subcutaneous doses annually, following an initial oral lead-in. This innovative therapy is part of a new class of HIV-1 capsid inhibitors that disrupt multiple stages of the viral replication cycle. It represents the first and only twice-yearly PrEP option for individuals at risk of HIV, offering a significant alternative to the currently available daily oral pills like Truvada (TDF/FTC).
Clinical trials have demonstrated strong efficacy. In the PURPOSE 1 trial, conducted among over 5,000 cisgender women and adolescent girls in South Africa and Uganda, lenacapavir achieved 100% efficacy—zero new HIV infections were reported in the treatment group.
A second trial, PURPOSE 2, involving a broader group of cisgender men, transgender, and non-binary adults, showed a 96% reduction in HIV risk compared to those on daily PrEP. These results prompted early unblinding of both trials due to overwhelming benefit. Participants also reported high satisfaction with the twice-yearly regimen, citing ease of adherence, reduced stigma, and fewer missed doses compared to daily pills.
Gilead’s chief medical officer, Dr. Dietmar Berger, was on Friday quoted in reports saying that lenacapavir “has the potential to become a critical tool for public health,” especially for individuals who face barriers to consistent healthcare access. The product is expected to play a vital role in addressing rising HIV infections in Europe, where more than 24,700 new diagnoses were reported in 2023—an 11.8% increase from the previous year across the EU, Iceland, Liechtenstein, and Norway.
Beyond Europe, Gilead is pursuing a global access strategy for lenacapavir. The company has licensed the drug for generic production in 120 low-and lower-middle-income countries and is working toward WHO prequalification and inclusion in international HIV prevention guidelines. It is also eligible for EU-M4all procedures, which would streamline regulatory pathways for resource-limited settings.
India HIV status
As of 2023, India is estimated to have around 2.54 million people living with HIV, with adult prevalence at approximately 0.20%. The epidemic is largely concentrated in certain high-burden states, especially in the Northeast—Mizoram, for instance, has a prevalence as high as 2.73%. Transmission is predominantly through heterosexual contact, followed by injecting drug use and same-sex transmission among men. The epidemic remains geographically uneven, and while India has made progress in expanding access to testing and antiretroviral therapy, detailed data on annual new infections for 2024–2025 is limited. However, UNAIDS estimates suggest India continues to see tens of thousands of new cases annually.
India’s HIV response is driven by the National AIDS Control Organisation (NACO), which is working to align with the global 95-95-95 targets (diagnosis, treatment, and viral suppression). While national efforts have improved access to care and treatment, particularly through free ART programs, achieving the last-mile goal remains a challenge in rural and high-stigma areas. Continued focus on localised interventions, prevention for key populations, and improved surveillance will be critical to containing the epidemic and reducing new infections in the coming years.
While the affordability of preventive treatment remains a challenge, countries like India should develop appropriate strategies to address it, said a NACO official who spoke to The New Indian Express.
Access to the new preventive treatment
However, affordability and equitable access remain pressing challenges. In the US, the annual price of lenacapavir is approximately $28,000, raising concerns over access in middle-income countries where insurance and donor support are limited. Activists and public health officials have called for differential pricing and broader funding to ensure lenacapavir does not remain out of reach for those most at risk.
Despite these hurdles, lenacapavir’s twice-yearly dosing represents a potential game-changer in HIV prevention. It reduces dependence on daily adherence, expands options for vulnerable populations, and aligns well with global health goals to end new HIV infections. Its approval in Europe would mark a critical step forward, reinforcing the importance of long-acting technologies in the next phase of the HIV response.
If implemented effectively with supporting infrastructure, education, and equitable pricing, lenacapavir could significantly strengthen global efforts to prevent HIV transmission and ultimately reduce the incidence of the disease worldwide.