USFDA okays Lenacapavir: Affordable, generic India-made drug key to boost global HIV prevention

New Delhi:  While Gilead Sciences’ HIV prevention drug lenacapavir got approved by the US Food and Drug Administration (FDA), its made-in-India generic versions may be a more affordable alternative that can boost the prevention of the deadly condition globally.

In a major breakthrough, the US FDA this week approved lenacapavir — a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year.

Marketed under the brand name Yeztugo, the world’s first twice-yearly HIV prevention shot can potentially, transform pre-exposure prophylaxis (PrEP) options. The drug may be particularly crucial for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors.

However, the high cost — at $28,218 per person per year — is likely to act as a deterrent to global HIV prevention goals.

Although USFDA approval is a big thing, the “real breakthrough would be when lenacapavir becomes accessible, affordable and available to all those in need,” said Dr Ishwar Gilada, Secretary General of People’s Health Organisation (PHO).

Earlier the UNAIDS also urged Gilead to drop the price of lenacapavir HIV prevention shot.

“If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production, and ensure the world has a shot at ending AIDS,” said Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General.

Even as Gilead granted voluntary licenses to six generic manufacturers earlier, including four Indian: Dr Reddy’s Laboratories, Emcure, Hetero Healthcare, and Viatris, Gilada urged Indian generic manufacturing companies to develop ‘made in India’ generic versions.

“The voluntary licenses give hope that the medicine may cost less than $100 — that is 0.3 per cent of the innovator’s cost,” said Gilada, who is also the President Emeritus of the AIDS Society of India (ASI).

According to the National AIDS Control Organisation (NACO), an estimated 2.4 million people were living with HIV in India in 2021. That year, 41,970 AIDS-related deaths were recorded, underscoring the ongoing public health challenge.

“India needs to lead from the front for lenacapavir’s equitable and timely distribution at the required scale to prevent HIV transmission and help end AIDS,” said Dr Gilada.

“Only India could deliver lenacapavir to all those in need worldwide, in terms of quality, quantity, and speed,” he added, stating that only the country can meet global demand for lenacapavir at such low cost, just as it did for Antiretroviral therapy (ART) — the standard treatment for HIV — at 0.3 per cent of innovator’s cost.

Dr Rajeev Jayadevan told IANS that the efficacy of lenacapavir, with just two injections a year, offers a huge advantage.

“This is a breakthrough in the fight against HIV. For the first time, we have an FDA-approved injection, lenacapavir, that can prevent HIV infection with just two doses a year,” said Jayadevan, Convener, Research Cell, Kerala State IMA.

On the other hand, the currently available PrEP usually means taking one pill every day. It works well if taken regularly. However, many people struggle with taking daily medication.

“If made affordable and available, Lenacapavir could change the way we prevent HIV around the world — especially in communities where HIV risk is high and daily medication isn’t practical,” Jayadevan, told IANS.

–IANS