A twice-yearly injectable HIV preventive drug, Lenacapavir, is set to reach over 2 million people by 2027

Lenacapavir, a twice-yearly injection, shows great promise as a tool to prevent HIV, boasting a near-perfect success rate in blocking infections.Currently approved in the US and other countries for treating drug-resistant HIV in adults, lenacapavir has proven highly effective in two clinical trials when used as pre-exposure prophylaxis (PrEP).

Over the next three years, around two million people in countries supported by PEPFAR and the Global Fund, including Kenya, are expected to gain access to this innovative treatment.

Approval of lenacapavir for PrEP use will depend on the US Food and Drug Administration (FDA), national drug regulators, and World Health Organization (WHO) recommendations.

WHO has previously recommended various HIV prevention methods. In 2015, oral PrEP using tenofovir disoproxil fumarate was advised for those at high risk. In 2021, the dapivirine ring was suggested for women at substantial risk. By 2022, WHO endorsed long-acting injectable cabotegravir (CAB-LA) for individuals at significant risk of HIV. CAB-LA involves injections every eight weeks after an initial two-dose series four weeks apart.

Lenacapavir offers a simpler alternative, requiring just two injections per year. During the PURPOSE 1 trial, none of the 2,138 women who received lenacapavir contracted HIV. In the PURPOSE 2 trial, which included men and gender-diverse participants, only two out of 2,179 became infected, achieving a success rate exceeding 99%.

This long-acting injection is easier to adhere to compared to daily pills, making it a superior option. "We cannot achieve a sustainable response to HIV without rapidly reducing the 1.3 million new HIV infections that occur each year worldwide. Lenacapavir offers a potentially enormous opportunity to transform the impact of HIV programmes," said Dr. John Nkengasong, US Global AIDS Coordinator and head of PEPFAR.

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Gilead, the manufacturer of lenacapavir, announced in October that it had signed agreements with six pharmaceutical companies to produce generic versions of the drug for 120 low- and lower-middle-income countries. Regulatory submissions for lenacapavir as PrEP are expected to begin by the end of 2024.

The FDA has granted lenacapavir breakthrough therapy designation, aimed at speeding up the development and review of innovative drugs with significant benefits over existing treatments. This development could lead to global guidelines ensuring the drug is effective, safe, and accessible.

Peter Sands, Executive Director of the Global Fund, highlighted the potential of lenacapavir to reduce new HIV infections among high-risk groups. He emphasized that the collaboration between organizations like PEPFAR, CIFF, BMGF, and Gilead will ensure affordable and equitable access to the drug.

Chris Hohn, founder of CIFF, stressed the importance of making lenacapavir available: "It would be a travesty if the communities that need it most don't have access."