WHO Endorses Injectable Lenacapavir As ‘Game-Changer’ In Global HIV Prevention Strategy

Injectable Lenacapavir (LEN) is emerging as a key breakthrough in the global fight against HIV with the World Health Organization (WHO) releasing new guidelines recommending biannual use of the jab as an additional option for pre-exposure prophylaxis (PrEP) to prevent HIV infection.

The long-acting injectable, administered just twice a year, offers a significant advancement in HIV prevention, especially for populations with limited access to daily medication. The announcement was made at the 13th International AIDS Society Conference, held in Kigali, Rwanda.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized the significance of this advancement, stating: "While an HIV vaccine remains elusive, Lenacapavir stands out as the most promising preventive innovation available today. A biannual dose could dramatically reduce new infections, particularly among high-risk groups."

Medical communities and rights organizations worldwide have welcomed WHO's endorsement, calling it a “game-changer” in the battle against HIV/AIDS.

Echoing the WHO Chief views, they said the move marks a significant breakthrough as LEN is especially life-saving for high-risk groups such as sex workers, men who have sex with men (MSM), healthcare workers treating HIV-positive individuals, people who inject drugs, and incarcerated populations.

Lenacapavir belongs to a new class of drugs known as Capsid Inhibitors that interrupt multiple stages of the HIV replication cycle. Developed by American pharmaceutical giant Gilead Sciences, it is the first injectable pre-exposure prophylaxis (PrEP) treatment that requires administration only twice a year — offering both convenience and enhanced adherence.

The drug had previously received approval from the U.S. Food and Drug Administration (FDA) in 2022 for HIV treatment and has since shown promising results in clinical trials for prevention. Its ability to remain effective in the body for extended periods offers a practical and potent alternative to daily oral PrEP regimens.

Unlike traditional daily pills, Lenacapavir’s twice-yearly injectable format addresses compliance challenges — particularly in low-resource settings or among populations facing stigma and barriers to healthcare access.

This development comes at a time when global HIV prevention efforts are under increasing financial strain. According to WHO estimates, 1.3 million people were newly infected with HIV in 2024 alone while by the end of the same year, an estimated 40.8 million people were living with HIV worldwide, with nearly 65 per cent of them residing in Africa, according to the latest global estimates. Among the newly infected were an estimated 120,000 children.

The majority were from marginalized and vulnerable populations with limited access to preventive services.

During the year, approximately 630,000 people died due to HIV-related causes.

Despite medical advances and expanded access to treatment and prevention, the figures underline the continuing challenge in ending the HIV/AIDS epidemic, particularly in low- and middle-income countries.

Public health experts warn that without sustained funding and innovative interventions, the global progress against HIV may stall. The introduction of Lenacapavir offers a strategic opportunity to reverse this trend and reinforce public health infrastructure. UN agencies working in the sector warn that if the funding isn't replaced, it could lead to more than 4 million more HIV infections by 2029.

UNITAID said in a post on social platform X: “We have the means to end AIDS as a public health threat. Lenacapavir can be a turning point, if equity leads the way. The world must now step up with the funding, urgency, and solidarity this moment demands.”

Data from the recent India HIV Estimations 2023 report show that more than 2.5 million people are living with HIV in India. But with concerted efforts, the adult HIV prevalence is at 0.2 per cent and estimated annual new HIV infections are at around 66,400.

“India has made great strides in combating HIV/AIDS through innovative programmes and robust partnerships,” said the then Union Health Minister Anupriya Singh Patel Minister last year at an event organized by UNAIDS, the Global Fund, and PEPFAR.