Indian pharmaceutical giants Dr. Reddy’s Laboratories and Hetero Labs are set to disrupt HIV prevention worldwide, announcing plans to offer generic versions of a breakthrough drug for just $40 a year starting in 2027.
A Breakthrough in HIV Prevention
Lenacapavir, developed by Gilead Sciences and approved earlier this year under the brand name Yeztugo, is a twice-yearly injection that demonstrated nearly 100% effectiveness in preventing HIV in large clinical trials.
AIDS continues to infect 1.3 million people a year and this injection, as per some AIDS experts, would help control the 44-year-long epidemic. Notably, as per the World Health Organization estimates, it has killed 44.1 million.
The low price, aimed at expanding access in low- and middle-income countries, stands in stark contrast to the estimated $28,000 annual cost of branded Yeztugo in the U.S.
Supporting this effort, Unitaid—a WHO-hosted global health agency focused on making new medicines more affordable—is providing technical and financial assistance to Dr. Reddy’s. The initiative also involves the Clinton Health Access Initiative and South Africa’s Wits Reproductive Health and HIV Institute (Wits RHI) at the University of the Witwatersrand.
Professor Saiqa Mullick, director of implementation science at Wits RHI said “Generic manufacture of lenacapavir is essential to ensure this breakthrough HIV prevention option is not limited to a privileged few”. She added that a generic version with low price point could be a preferred choice by millions affected in low-income countries.
Expanding Access and Addressing Barriers
The two companies are among six granted royalty-free licenses by Gilead last year to produce and sell the drug in 120 low- and lower-middle-income countries with the highest HIV burden by 2027, pending approvals.
Carmen Perez Casas, Unitaid’s strategic lead for HIV, using the short phrase for pre-exposure prophylaxis, or preventive, drugs said that “The ($40) price that we have negotiated… brings the product in parity with the cost of the oral PrEP”.
She added that taking injections at a 6-month interval could benefit those for whom stigma, logistical challenges, or other barriers make daily pills difficult.
U.S. biotech Gilead has faced criticism from patient advocacy groups and activists for not including upper-middle- income countries such as those in Latin America in the generics agreement.
Casas said that they were helping organizations and countries explore ways to overcome access barriers in excluded nations, noting that some countries, including Brazil, had participated in trials of the drug but remained unable to access generics under the current Gilead agreement.
Gilead is already working with the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. government to get doses of its branded drug at a reduced price to 2 million people starting this year while generics ramp up production.
But experts estimate that long-term demand is likely to be closer to 10 million people or more, highlighting the need for cheaper generics at scale.
“The availability of generics at an affordable price… will magnify the impact of this game-changing innovation,” Peter Sands, chief executive of the Global Fund, told Reuters.
Summary
Indian drug makers Dr. Reddy’s and Hetero Labs will produce low-cost generic lenacapavir, a twice-yearly HIV-prevention injection nearly 100% effective in trials, for $40 a year in low- and middle-income countries by 2027. Backed by Unitaid, Clinton Health Access Initiative, and Wits RHI, this move could transform HIV prevention, addressing access barriers that make daily pills difficult and expanding coverage for millions.
