New injectable variant of HIV-preventing drug in ‘poorest’ countries soon, claims health official

Gilead Sciences is seeking approval from the USFDA and the World Health Organization (WHO) for a global rollout of its injectable drug version.

A new variant of Lenacapavir, a drug used to treat multi-resistant HIV, could be available for use in the world’s poorest countries by the end of 2025 or early 2026. The new formulation comes with a year-long active potency and could play a preventive role in defence against HIV.

Lenacapavir, already approved for use in the United States, costs around $42,250 for the first year of therapy. (Representative image) (Shutterstock)

Lenacapavir, already approved for use in the United States, costs around $42,250 for the first year of therapy. Clinical trials of the drug this year showed its potency in preventing the infection, Reuters reported.

Gilead Sciences is now seeking approval for a global rollout for its injectable version from the United States Food and Drug Administration (FDA) and the World Health Organisation (WHO).

What are the challenges?

Hui Yang, head of supply operations at the Global Fund to Fight AIDS, Tuberculosis, and Malaria, told Reuters that the global rollout is contingent on receiving necessary approvals from the FDA & WHO. \

“We don't want low and low-middle income countries to wait, to be at the back of the line when these approvals come in,” said Yang, pointing to an issue of low-income countries being left behind in access to life-saving medicines.

Will it be affordable?

To address high cost, the Global Fund said on Tuesday that it would partner with join forces with the United States President’s Emergency Plan for AIDS Relief (PEPFAR), with funding from the Children’s Investment Fund Foundation and the Bill and Melinda Gates Foundation, to enable affordable access to pricey Lenacapavir in countries they work from “day one”.

The fund did not provide further details on the proposed partnership, but said it aimed to reach at least two million people over three years.

Gilead had signed deals with six generic drugmakers in October this year to manufacture and sell cheaper versions of lenacapavir in 120 low and middle-income countries. The move was criticized for leaving out countries, especially in Latin America.

Gilead's chief executive and chairman Daniel O'Day said that the initiative would help accelerate access to help more people access lenacapavir from the outset, the Reuters report added.

The health official said that no deal has been signed by the Global Fund with Gilead or any of these generic producers but promised to work with all stakeholders involved.