New Long-Acting HIV Tool (Lenacapavir) Approved Amidst Funding Crisis

On World AIDS Day, the World Health Organization (WHO) issued an urgent call to action, pushing governments and partners to prioritize the rapid deployment of new WHO-approved prevention tools, including the highly effective, twice-yearly injectable lenacapavir (LEN), to combat rising infections. This call comes as sharp cuts to foreign aid are severely disrupting essential HIV services worldwide.

A Breakthrough Intervention

The global HIV response has gained significant momentum in 2025 with the introduction and WHO approval of lenacapavir for HIV pre-exposure prophylaxis (PrEP). LEN is a transformative, long-acting alternative to daily oral pills, requiring only two injections per year. This makes it a crucial tool for people who struggle with regular adherence or face stigma when accessing health care.

  • WHO released new guidelines in July 2025 recommending LEN as an additional PrEP option.

  • The drug was WHO prequalified on 6 October 2025 and has since received national regulatory approvals in South Africa, Zimbabwe, and Zambia.

Funding Cuts Jeopardize Progress

Despite the innovation, the HIV response is at a crossroads due to sudden and sharp reductions in international funding. These cuts have led to the scaling back or complete shutdown of vital community-led programs, including PrEP and harm reduction initiatives for people who inject drugs.

  • The AIDS Vaccine Advocacy Coalition estimates that 2.5 million people who were using PrEP in 2024 lost access to their medication in 2025 due to donor funding cuts alone.

  • This disruption threatens to derail global efforts to end AIDS 2030.

Infections Stagnate, Key Populations Disproportionately Affected

In 2024, HIV prevention efforts stagnated globally, resulting in 1.3 million new infections. These new cases disproportionately affected key and vulnerable populations, who accounted for almost half (49%) of all new HIV infections.

  • Key populations—including sex workers, men who have sex with men, transgender women, and people who inject drugs—face significantly higher risks of acquiring HIV.

    • People who inject drugs face an 18-fold higher risk.

    • Men who have sex with men face an 17-fold higher risk.

    • Sex workers and transgender women face a 34-fold higher risk.

  • Globally, an estimated 40.8 million people were living with HIV, and 630,000 died from HIV-related causes.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated: “Expanding access to those tools for people at risk of HIV everywhere must be priority number one for all governments and partners.”

A Dual-Track Approach

Marking World AIDS Day under the theme “Overcoming disruption, transforming the AIDS response,” WHO is urging a dual-track approach: increased solidarity and investment in innovations, combined with the integration of HIV services into primary health care. By strengthening health systems and protecting human rights, countries can safeguard gains and ensure vulnerable populations are not left behind.

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