1.2 Million Acquired HIV in 2025 and the Cheap Shot Has No Launch Date

An estimated 1.2 million people acquired HIV in 2025, and the generic injection that could prevent many of those infections still has no launch date. The US Food and Drug Administration gave tentative approval on Monday 2 November to a $40-a-year version of lenacapavir made by India’s Dr. Reddy’s Laboratories, according to AFP. It is meant for 120 countries that the reports do not name. Tentative approval is not full approval.

The gap between approval and a clinic

The shot works. Lenacapavir was approved in the United States in June 2025 and was more than 99.9% effective in large clinical trials, according to the reports. What is missing is delivery. The France 24 report of the manufacturer’s announcement gives no date for first shipments, and it does not say which 120 countries are included or whether the approval covers the US market. The price and the figures come from the manufacturer and the health agency Unitaid, not from an independent source.

The $40 price comes from an agreement announced in September 2025 between Dr. Reddy’s, Unitaid, Wits RHI and the Clinton Health Access Initiative. Gilead Sciences, which developed the drug, granted voluntary licences to six generic makers in late 2024. Gilead’s own version costs about $28,000 a year in the United States before insurance, and more than 125,000 people in 10 early-adopter African countries have already started on it.

Chart: GoodBad. Data from AFP and France 24 reports of 2 November 2026. The US figure is before insurance.

The arithmetic of the price is simple. At $40 a year, protecting one million people for a year costs $40 million in drug alone, before clinics, staff and delivery. At the US price it would cost about $28 billion. Neither figure includes the cost of finding and reaching the people who most need the shot.

What the epidemic looks like now

The World Health Organization estimates that 41.0 million people were living with HIV at the end of 2025, with 64% of them in its African Region. About 570,000 people died of HIV-related causes that year. HIV has killed more than 40 million people in four decades, according to the AFP report. WHO says 89% of the people who knew their status were on treatment, which leaves new infections as the number prevention has to bring down.

Earlier prevention tools exist but ask more of the patient. Daily oral pills won US approval in 2012, and the injectable cabotegravir, approved in 2021, needs a shot every two months. Lenacapavir needs two a year, and WHO lists it among the methods it recommends. Unitaid’s Carmen Perez-Casas said the price is comparable to daily prevention pills and that the world cannot afford to lose momentum, according to AFP.

Question	What the reports say
Who approved it?	US FDA, tentatively, on 2 November 2026
Who makes it?	Dr. Reddy’s Laboratories, India
Price	$40 per person per year
Where	120 countries, not listed in the reports
Launch date	Not given
Already in use	More than 125,000 people in 10 African countries (Gilead’s version)

What would change the picture

Three things would turn a tentative approval into protection. The first is a date for the first shipments. The second is the list of 120 countries, so that people can see who is inside the agreement and who is outside it. The third is full approval or whatever regulatory step each country requires before clinics can give the shot. Dr. Reddy’s says the approval was granted under PEPFAR, the US President’s Emergency Plan for AIDS Relief, but the reports do not say how much of the plan’s budget will buy the generic. Until those answers exist, the number that matters for a reader is the 1.2 million, not the $40.