New Delhi: Two Indian drugmakers backed by global philanthropists have now declared their intent to make available generic lenacapavir, a revolutionary medicine that has achieved nearly 100 percent success in preventing HIV and AIDS, in low- and- middle income countries at a fraction of the price set by the drug’s innovator in developed countries.
Over the last few days, Hyderabad-based Hetero Pharma and Dr Reddy’s Laboratories have announced their partnerships with US-based Gates Foundation and Unitaid, an agency hosted by the World Health Organisation and Clinton Health Access Initiative, respectively, to make available lenacapavir in nearly 120 countries from 2027 at a cost of about $40 (Rs 3,549) per year.
The listed price of lenacapavir was first kept at $42,250 (Rs 35.38 lakh) per year in the US, which was later reduced by half following much criticism.
The drug, lenacapavir, has shown 100 percent efficacy in preventing HIV infection. Developed by California-based pharmaceutical firm Gilead Sciences, lenacapavir was approved in the European Union (EU) and the US in 2022 for drug-resistant AIDS, and is available under the brand name Sunlenca. It is administered as a twice-yearly injection.
This is a long-acting antiretroviral medication for Pre-Exposure Prophylaxis (PrEP)—administered as a twice-yearly subcutaneous injection—offering a powerful alternative to daily oral PrEP. It is designed to address common barriers such as adherence, stigma, and limited access to daily pills.
However, in October 2024, Gilead had signed non-exclusive, royalty-free voluntary licensing (VL) agreements with six generic manufacturers to make and sell generic lenacapavir for HIV treatment and prevention in 120 resource-limited countries.
Voluntary licensing allows production of generic versions of a patented drug typically in the event of a public health emergency.
Despite global efforts to combat HIV and AIDS, the epidemic persists with 1.3 million new infections annually. In India too, the viral disease has been showing an uptick with 68,451 new HIV infections registered in 2023. The disease has particularly shown an upward trend in select states in the country.
The latest development, meanwhile, has experts excited.
India, already recognised as a global hub for affordable generic medicines, is set to provide this game-changing pre-exposure prophylaxis (PrEP) through strategic partnerships with upfront funding and volume guarantees, say experts.
“This is a major step forward for public health—making a generic version of lenacapavir highly affordable for all those in need,” said Dr Ishwar Gilada, Secretary General of People’s Health Organisation (PHO) and President Emeritus of the AIDS Society of India (ASI).
“It exemplifies how a groundbreaking scientific innovation by Gilead, offering a promising alternative to daily oral PrEP, can become truly impactful when paired with an equally crucial contribution from Indian pharmaceuticals focused on access and affordability,” he added.
The Clinton Health Access Initiative said in a statement that the long-acting injectable could transform HIV prevention for millions of people who struggle with daily oral pre-exposure prophylaxis (PrEP) pills.
“Moreover, the agreement now brings the price of the injectable on par with oral PrEP, a key condition for uptake in low- and middle-income countries,” it also said.
(Edited by Viny Mishra)