New Delhi: In a notable advancement in HIV prevention, the U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ lenacapavir, a long-acting injectable drug offering near-complete protection against HIV with just two doses annually. Marketed as Yeztugo, it marks the world’s first biannual pre-exposure prophylaxis (PrEP) shot.
The drug is seen as a game-changer, especially for individuals facing challenges with daily medication adherence due to stigma, access issues, or personal circumstances. However, its steep price tag—$28,218 per person per year—raises concerns about accessibility, particularly in low- and middle-income countries.
As the global health community celebrates the approval, attention is now shifting toward affordability. Experts like Dr. Ishwar Gilada, Secretary General of the People’s Health Organisation (PHO), have emphasized that “the real breakthrough would be when lenacapavir becomes accessible, affordable, and available to all those in need.”
Indian pharmaceutical manufacturers are reportedly preparing generic versions of lenacapavir, which could provide a cost-effective alternative and bolster global HIV prevention efforts. Earlier, UNAIDS also urged Gilead to lower the drug’s price to enhance global access.
“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.
Despite Gilead Sciences granting voluntary licenses to six generic drug manufacturers—four of them Indian—Dr. Ishwar Gilada has urged domestic pharmaceutical companies to develop fully 'Made in India' versions of lenacapavir to ensure global affordability and access.
“The voluntary licenses give hope that the medicine may cost less than $100—that's just 0.3% of the innovator’s cost,” said Gilada, President Emeritus of the AIDS Society of India (ASI).
India, which had 2.4 million people living with HIV and reported nearly 42,000 AIDS-related deaths in 2021, faces an urgent public health need, according to the National AIDS Control Organisation (NACO). Gilada emphasized that India must take the lead in distributing lenacapavir equitably and swiftly. “Only India can deliver lenacapavir to those in need worldwide—in quality, quantity, and speed,” he noted, pointing to India’s past success with affordable antiretroviral therapy (ART).
Meanwhile, Dr. Rajeev Jayadevan, Convener of the Research Cell at Kerala State IMA, called lenacapavir a major breakthrough, highlighting its twice-yearly injectable format. “For the first time, we have an FDA-approved HIV prevention shot effective with just two doses a year,” he said.
Current PrEP regimens require daily pills, which many people struggle to maintain. Jayadevan stressed that if lenacapavir becomes accessible and affordable, it could revolutionize HIV prevention—especially in high-risk communities where daily medication adherence is difficult.
(inputs from IANS)