Daijiworld Media Network - New Delhi

New Delhi, Jun 20: The United States Food and Drug Administration (FDA) has approved Lenacapavir (LEN), a long-acting injectable antiretroviral hailed as a breakthrough in HIV prevention. Experts in India have welcomed the move, urging for swift and affordable access to the drug in the country.

Describing LEN as the “most promising HIV prevention medicine so far,” Dr I S Gilada, president emeritus of the AIDS Society of India, said the real success will lie in ensuring the drug becomes accessible and affordable, especially in countries like India. "India must lead in making generic LEN widely available at a fraction of the innovator’s cost," he asserted.

Lenacapavir is administered twice a year as a pre-exposure prophylaxis (PrEP) for individuals at high risk of HIV infection. Two landmark studies have shown it can prevent 99.9% of HIV transmissions.

Dr Glory Alexander, president of the AIDS Society of India and founder-director of ASHA Foundation, Bengaluru, highlighted LEN’s ease of use. “An injectable PrEP taken just twice a year makes it easier for users to stay protected,” she said.

Despite PrEP being FDA-approved in the US since 2012, India’s National AIDS Control Organisation is yet to roll it out nationally. Dr Gilada emphasized that HIV prevention must be prioritized. “Investing in prevention saves long-term healthcare costs and curbs new infections,” he noted.

LEN, to be sold as Yeztugo by Gilead, currently costs US$ 28,218 annually, raising affordability concerns. However, Gilead has granted voluntary licenses to four Indian generic drug manufacturers — Dr Reddy’s, Emcure, Hetero, and Viatris — offering hope that the cost may fall below US$ 100, or just 0.3% of the innovator price.

Dr Gilada urged Indian regulators to expedite the approval and rollout of generic LEN in India. “India already supplies 92% of global antiretroviral therapy. We must now lead the charge for global LEN access too,” he said.

This move mirrors Gilead’s past approach with Hepatitis C treatment, which dropped from US$ 84,000 in the US to under US$ 300 in India following local licensing.

With India playing a pivotal role in global HIV treatment supply chains, public health advocates say making LEN available at scale could be a game-changer in the global fight to end AIDS.