Could Lenacapavir Be the Key to Affordable HIV Prevention?

New Delhi, June 21 (NationPress) Following the approval of lenacapavir by the US Food and Drug Administration (FDA), the availability of generic versions produced in India may provide a more cost-effective solution to enhance global efforts in preventing HIV.

In a significant advancement, the US FDA has sanctioned lenacapavir this week -- a long-acting injectable treatment that offers nearly complete protection against HIV with merely two doses per year.

Branded as Yeztugo, this pioneering twice-yearly HIV prevention injection could revolutionize pre-exposure prophylaxis (PrEP) alternatives. This drug could be particularly vital for individuals facing challenges in adhering to daily medication regimens due to stigma, accessibility issues, or lifestyle constraints.

However, the steep price tag of $28,218 per person annually may hinder global HIV prevention objectives.

While the USFDA's approval is a significant milestone, the true breakthrough will occur when lenacapavir is accessible, affordable, and available to everyone in need,” stated Dr. Ishwar Gilada, Secretary General of the People’s Health Organisation (PHO).

Previously, UNAIDS has also urged Gilead to reduce the cost of the lenacapavir HIV prevention injection.

“If this revolutionary medication remains unaffordable, it will achieve nothing. I call upon Gilead to take the correct steps. Lower the price, increase production, and ensure that the world has a chance to eradicate AIDS,” remarked Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General.

Even though Gilead has issued voluntary licenses to six generic manufacturers, including four Indian companies: Dr. Reddy’s Laboratories, Emcure, Hetero Healthcare, and Viatris, Gilada has urged Indian generic manufacturers to create ‘made in India’ versions.

“The voluntary licenses provide hope that the medication may be priced below $100 -- a mere 0.3 percent of the innovator’s cost,” said Gilada, who also serves as the President Emeritus of the AIDS Society of India (ASI).

In accordance with the National AIDS Control Organisation (NACO), approximately 2.4 million individuals were living with HIV in India in 2021, with 41,970 AIDS-related deaths reported that year, highlighting a persistent public health challenge.

“India must take the lead in ensuring lenacapavir's equitable and timely distribution at the necessary scale to prevent HIV transmission and contribute to ending AIDS,” asserted Dr. Gilada.

“Only India can provide lenacapavir to all those in need worldwide, with respect to quality, quantity, and speed,” he added, emphasizing that only India can fulfill global demand for lenacapavir at such low costs, akin to its achievements with Antiretroviral therapy (ART) -- the standard treatment for HIV -- priced at just 0.3 percent of the innovator’s cost.

Dr. Rajeev Jayadevan indicated to IANS that the effectiveness of lenacapavir, requiring only two injections annually, presents a significant advantage.

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

In contrast, currently available PrEP typically necessitates taking one pill daily. It is effective when consumed consistently. However, many individuals find it difficult to adhere to a daily medication schedule.

“If made affordable and accessible, lenacapavir could transform the global approach to HIV prevention -- particularly in communities with high HIV risk where daily medication is impractical,” Jayadevan told IANS.