The United States Food and Drug Administration (FDA) on Wednesday approved Lenacapavir (LEN), the most promising HIV prevention medicine to be made so far, and according to Dr I S Gilada, president emeritus, AIDS Society of India, the real breakthrough would be when LEN becomes accessible, affordable and available to everyone in India and across the world.
Lenacapavir is an antiretroviral medicine that is used for HIV prevention as a pre-exposure prophylaxis or PrEP. PrEP is a medication that can reduce the risk of HIV infection for individuals who are HIV-negative but are at risk of contracting the virus. The results of two key studies have shown that it helps prevent 99.9 per cent of all HIV transmission.
“LEN is an injectable PrEP that is to be taken twice yearly,” said Dr Glory Alexander, president of AIDS Society of India (ASI) and founder director of ASHA Foundation, Bengaluru.
PrEP was first approved by the US FDA in 2012, but the Indian government’s National AIDS Control Organisation is yet to roll it out. “If we invest in HIV prevention, we not only protect people’s health but also save expenses in providing lifelong HIV care, including lifelong antiretroviral therapy (ART). HIV prevention must remain at the centre-stage of our national AIDS response,” said Dr Gilada.
“Indian regulators should work with Indian generic manufacturing companies to ensure that ‘made in India’ generic LEN versions when available, are first rolled out in India,” Dr Gilada told The Indian Express.
“The scientific breakthrough translates into public health impact in terms of stopping the spread of HIV infection. The major impediment is the cost: LEN as PrEP to be sold as Yeztugo by Gilead is priced at US$ 28,218 per person per year. However, Gilead’s wisdom by giving voluntary licenses to four Indian generic companies, gives hope that the medicine may cost less than US$ 100 – that is 0.3 per cent of the innovator’s cost,” Dr Gilada explained.
“India needs to lead from the front for LEN’s equitable and timely distribution at the required scale to prevent HIV transmission and help end AIDS,” said Dr Gilada, adding that only India can deliver LEN to all those in need worldwide, in terms of quality, quantity and speed.
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Though India meets 92 per cent of the global requirement for ART and the global community (WHO, UNAIDS, Global Fund, World Bank, etc) widely uses Indian generic pharma for their strategies like Treatment as Prevention (TasP), Test and Treat, Post-exposure Prophylaxis (PEP), PreP, etc, it is unfortunate that they are shy to acknowledge this, he said.
Gilead had faced a lot of backlash from health advocates and communities last year over the astronomical pricing for LEN, pegged at over US$ 40,000 per person per year, which has now been slashed by 30 per cent.
Earlier, Gilead’s Hepatitis C treatment, which cost $84,000 in the US for a three-month course, was made available in India for less than $300. So the firm knew what was to be done this time, and granted voluntary licensing to six generic manufacturers, including four Indian: Dr Reddy’s Laboratories, Emcure, Hetero Healthcare, and Viatris.
“All international antiretroviral therapy and prevention guidelines are conceptualised and implemented on the strength of India. Only India can meet the global demand for LEN at such low cost, just as it did for ART, at 0.3 per cent of the innovator’s cost,” Dr Gilada said.