WHO Advocates for Twice-Yearly HIV Prevention Injection Amid Funding Concerns

The World Health Organization (WHO) has put forth a global recommendation urging nations to adopt lenacapavir, a newly approved drug, as an HIV prevention tool. This announcement was made on Monday during the International AIDS Conference held in Kigali, Rwanda. The endorsement follows a recent approval from the US Food and Drug Administration (FDA), which granted lenacapavir the status of a twice-yearly injection for preventing the human immunodeficiency virus (HIV).

Lenacapavir was first approved in 2022 for treating specific HIV infections. Evidence from clinical trials suggests it can significantly diminish the risk of infection, providing nearly complete protection against the virus.

Dr. Meg Doherty, the director of WHO's Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, stated in a news briefing: "These new recommendations are designed for real-world use. WHO is working closely with countries and partners to support the implementation."

She emphasised that the first recommendation prioritises lenacapavir as an additional prevention option for individuals at risk of HIV. This guideline is underscored by moderate to high confidence in the evidence supporting its efficacy. Furthermore, the WHO advises the adoption of rapid diagnostic tests, such as at-home tests, to facilitate screenings for HIV among those initiating, continuing, or ceasing long-acting pre-exposure prophylaxis (PrEP).

HIV is mainly transmitted through unprotected sexual contact or sharing of needles. If untreated, it depletes the immune system, potentially leading to acquired immunodeficiency syndrome (AIDS). As of the end of 2023, approximately 40 million people worldwide were living with HIV, according to WHO statistics.

PrEP as a preventive measure has been available for several years, often in the form of daily oral medications like Truvada or bi-monthly injections such as Apretude. The introduction of lenacapavir provides an alternate six-monthly injection option, appealing particularly to those who prefer fewer clinical visits or encounter difficulties adhering to daily medication schedules. Dr. Doherty pointed out, "It could improve adherence and reach more people who need HIV prevention and can be used in pregnant and breastfeeding women."

WHO plans to facilitate technical support to nations keen on implementing lenacapavir alongside simplified HIV testing strategies. This initiative will occur in partnership with entities like the Global Fund and UNAIDS. Dr. Doherty called on governments and stakeholders to “work together for implementing and integrating lenacapavir into HIV programmes. The time to act is now.”

However, concerns over the funding landscape for global HIV prevention efforts have arisen. According to the United Nations, international aid constitutes 80% of preventive initiatives in low- and middle-income countries. In recent months, the US has notably scaled back its foreign assistance funding. The Trump administration's measures have dismantled the United States Agency for International Development (USAID) and curtailed support for the President’s Emergency Plan for AIDS Relief (PEPFAR), widely regarded as the most significant commitment from any nation to combat a single disease.

In a recent development, Gilead Sciences, the manufacturer of lenacapavir, confirmed an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for HIV prevention at no profit to the company. This arrangement allows lenacapavir to be provided at production and delivery cost, ensuring availability for up to two million individuals in low- and lower-middle-income countries before generic alternatives emerge. Daniel O’Day, Gilead’s Chairman and CEO, stated, “We are providing the medicine at no profit to Gilead, and in enough supply.”

While the annual list price of lenacapavir for HIV prevention in the United States stands at approximately £23,000, Gilead noted this price remains similar to other preventive medications.

Experts warn of dire consequences if necessary funding for HIV initiatives is withdrawn. Peter Sands, Executive Director of the Global Fund, remarked, “LEN has the potential to change the course of the HIV epidemic, but it must reach those who need it most.” Despite ambitious plans to distribute long-acting PrEP to two million people, Sands underlined the requirement for sustained global financial support.

The United Nations has issued a stark warning, indicating that millions more could succumb to HIV-related complications by 2029 if funding for essential HIV programs diminishes permanently. A report detailing responses from 60 low- and middle-income countries noted that 25 of these governments planned to increase their domestic budgets for HIV efforts in the coming year. Nevertheless, experts caution that such increases may not suffice in compensating for the loss of international funds.

Mary Mahy, Director of UNAIDS’s Data for Impact department, highlighted, "If none of the PEPFAR funding is replaced, we’d expect an additional 4 million deaths between 2025 and 2029 alongside 6 million new infections." The alarming trend of diminishing services has already been observed in countries like Nigeria, where PrEP recipients plummeted from approximately 40,000 to fewer than 7,000 in recent months.

UNAIDS’ Executive Director, Winnie Byanyima, emphasised the urgent nature of the crisis, calling it “a ticking time bomb.” She stated that the withdrawal of financial support has led to the abrupt discontinuation of critical health services, pushing vulnerable groups further away from necessary care.

Byanyima concluded, “There is still time to transform this crisis into an opportunity. Countries are stepping up with domestic funding. Communities are demonstrating effective solutions. We now require global solidarity to reinforce their courage and resilience.”