Breakthrough: Game-changer $42,000 HIV drug may sell for $40 in Africa, Asia

Gilead Sciences has announced that it will grant royalty-free licenses to six generic drug manufacturers to produce and sell cheaper versions of its new “revolutionary” HIV treatment, lenacapavir, in 120 low- and middle-income countries.

The decision comes after mounting pressure from activists and advocacy groups who have called for affordable HIV treatments in regions most affected by the virus.

Earlier this year, the company shared promising results from Phase 3 trials showing that lenacapavir was highly effective in preventing HIV infections when administered as a twice-yearly shot.

The key advantage of the drug is its ease of use as it is could be administered as shots just twice a year. But the major challenge for accessing the treatment was cost.

Lenacapavir, which is already approved in the U.S. and other countries for treating multi-drug-resistant HIV, is seen as a groundbreaking treatment. In the U.S., it is sold under the brand name “Sunlenca” at a staggering price of $42,250 per year.

The new deal would permit six companies to sell it for much less — perhaps as little as $40 — in 120 poorer nations, though the deal will not apply in many middle-income countries that account for around 20% of new infections.

Gilead signed licensing agreements with India’s Dr. Reddy’s Laboratories, Emcure Pharmaceuticals and Hetero Labs, as well as US-based Viatris’ unit Mylan, Egypt’s Eva Pharma and Pakistan-based Ferozsons Laboratories.

The U.S.-based pharmaceutical giant also revealed plans to supply the branded version of lenacapavir in 18 countries, including Botswana, Ethiopia, and Kenya, until local manufacturers can meet demand.

These nations account for about 70% of HIV cases globally.

The deal, however, has drawn criticism for excluding several countries, especially in Latin America, where HIV remains a significant public health challenge.

Patient advocacy groups have long criticized Gilead for this high price, especially given the global burden of HIV, with nearly 40 million people living with the disease according to the World Health Organization.