Two Indian generic drugmakers — Hetero and Dr Reddy’s — will be funded by the Gates Foundation and Unitaid, respectively, to produce and sell the twice-a-year anti-HIV shot, lenacapavir, for $40 (around R692) per person per year.
That price is about the same as what it costs to stop HIV-negative people from contracting the virus by taking a daily HIV prevention pill, which is stocked for free in most government clinics in South Africa.
The price of the daily pill is mostly what the health department’s essential medicines list committee, which decides if a drug is cost-effective to buy, uses as a benchmark to compare the cost of newer HIV prevention medicine to.
The country’s regulator, the South African Health Products Regulatory Authority, Sahpra, is expected to register lenacapavir by November 26 at the latest.
Hetero and Dr Reddy’s are two of six generic drugmakers — the other four are Emcure, Eva Pharma, Ferozsons Laboratories Limited and Mylan, a subsidiary of Viatris — to which Gilead Sciences, the company that developed the branded version of LEN, gave licences in October last year to make cheaper, generic versions of the medicine.
Both Hetero and Dr Reddy’s have a history of making generic antiretroviral drugs (ARVs), which are used for HIV treatment. HIV prevention medication, also called PrEP, is also made with ARVs.
The idea behind the funding, says the Gates Foundation’s head of global health, Trevor Mundel, is to “incentivise” at least two companies to bring generics to the market by 2027, so that the medicine becomes available as quickly as possible and there is competition which will hopefully push down prices.
“There’s some investment in the manufacturing process, so companies set up the right processes and move quickly on that,” Mundel explains.
“Some of the funding will also help to cover the cost of bioequivalence tests [tests generic companies have to do to prove their drugs work as well as originator drugs] and the production of the active pharmaceutical ingredient [the ingredient that makes the medicine work] for lenacapavir.”
Both the Gates Foundation and Unitaid have given the companies volume guarantees — the assurance that, should some of the doses they produce as part of their partnership agreements not get sold, the deficit will be covered.
Neither the Gates Foundation nor Unitaid disclosed the number of doses they’re providing volume guarantees for, or the amount of their grants and other investments in Hetero and Dr Reddy’s. The Gates Foundation, did however, confirm their investment is for an initial duration of five years.
How well does LEN work?
Studies have shown that LEN, which is injected under the skin of someone’s stomach every six months, works better than the daily pill. Researchers believe this is mainly because the jab is easier to stick to than the pill, as it only requires someone to visit a clinic twice a year.
Scientists reckon if enough HIV-negative people get the shot, HIV could be stopped in its tracks.
In a study carried out in South Africa and Uganda among teen girls and women between the ages of 16 and 25, not a single study participant who took the medicine became infected with HIV.
Such young women in South Africa are contracting HIV much faster than anyone else — 122 of them get infected with the virus each day — figures from the country’s Thembisa model, which the health department uses to plan its programmes, shows.
As a result, four out of every 10 new infections in the country are in this group, even though they make up only about 8% of the total population.
A second study in South Africa, Argentina, Brazil, Mexico, Peru, Thailand and the USs revealed LEN also provides near-complete protection for men who have sex with men and gender-diverse people.
Branded LEN’s price
Right now, until generic LEN becomes available in 2027, Gilead’s branded product is all that is available.
The drug, which was registered for HIV prevention in the US in June, is, however, sold at an unaffordable price — $28 218 (just over R505 000) for a year’s treatment for one person — in that country.
Gilead hasn’t announced a price for its shot in poorer countries. Instead, it is selling relatively small numbers to the Global Fund for HIV, TB and Malaria to distribute in such countries once the medicine is registered by regulators, including South Africa, at an undisclosed price.
How much LEN would SA need?
Modelling studies show countries with high HIV infection rates like South Africa would need millions of doses of LEN every year to meaningfully bring down the number of new HIV infections.
If LEN is unaffordable, governments would simply not be able to buy enough doses to make a dent in new infections.
In 2024, South Africa had 178 000 new infections and 105 000 people with HIV died (of any cause, for instance, old age) during that period.
To end Aids as a public health threat in the country within the next to 14 to 18 years, the calculations of a soon-to-be-released modelling study of the Health Economics and Epidemiology Research Office at Wits University (HE2RO) shows, between 600 000 and 4.5 million people per year would need to use LEN at least once.
Ending Aids as a public health threat means the country would have reached a stage where fewer people are getting newly infected with HIV than the number of HIV-positive people dying (of any cause).
The sooner South Africa wants to end Aids, the more LEN doses would be needed. If we aim to end Aids by 2039, the study estimates between 910 000 and 4.5 million people would need to use LEN, each year, at least once; if we’d try to end the epidemic by 2043, between 590 000 and 3 million people would need to take it annually.
Increasing the number of people on the daily HIV prevention pill “to similar high numbers on its own will not end Aids in the next 20 years”, lead study author Lise Jamieson says.
“That’s because full protection requires taking a pill every day, which studies have shown many people fail to do. In comparison, an injection given every 6 months offers near 100% protection without the need to remember taking a pill every day.”
According to health department data, by the end of April, 1.9 million people had taken the daily pill at least once since it was introduced in 2016.
Where is SA at?
The health department plans to start rolling out Gilead’s branded LEN in April 2026 at over 300 government clinics in health districts with high rates of new infections.
The department will buy LEN doses with R513 million ($29.2 million) of its larger three-year Global Fund for HIV, TB and Malaria grant, of R7.1 billion ($402 450 343), which kicks in on October 1.
It will pay $60 (just over R1 000) for a year of treatment per patient, but that isn’t the actual price at which Gilead sells the drug to the fund; that price is under wraps. The difference in the selling price and the $60 the health department will be paying will be covered by the Children’s Investment Fund.
The department calculated that the Global Fund money is enough to phase 456 396 people in on the medicine over two years, Hasina Subedar, who heads up PrEP in the health department, told Bhekisisa in August.
The Global Fund money is far too little to cover enough people on LEN to make a noticeable dent in new infections. In fact, the 456 396 people it will cover over a period of two years, is less than the minimum number of 590 000 people that would need to use LEN at least once in just 2025-26 if we want to end Aids by 2043, according to the Wits modelling study.
And, each year the study says, the number of people on LEN would need to increase by at least 200 000 people if South Africa is to end Aids by 2043. By that year SA would need 2.43 million people on LEN.
That’s why the health department would need to buy generic LEN. Subedar says the government anticipates to start buying generic LEN doses by April 2027. If tenders for generics are in place by 2027, the department will expand the availability of LEN to more of the country’s 3 484 public primary healthcare facilities, says Subedar.
But the department’s budget will determine how many doses it would be able to buy.
If it buys enough LEN to put 590 000 people on the medicine at least once in 2025-26, as Jamieson’s study suggests, and pays $20 (R345) per dose (because two doses, for a year’s treatment costs $40 under the agreements with Hetero and Dr Reddy’s), it would cost R203.5 million just for that financial year.
The department’s total expected cost of the HIV programme for 2025-26 is R30-billion, of which an estimated R110 million is currently spent on buying HIV prevention pills, according to HE2RO.
So, in order to put 590 000 people on LEN, the department’s spent LEN doses would be at least 85% more than what it currently spends on the daily pill.
In addition to the $40 per patient per year that Hetero and Dr Reddy’s would be selling LEN for, the department would also need to buy “loading doses” — four pills that people who start taking LEN need to take along with the first injection — which will be sold for between $15 and $17.
Meanwhile, two implementation studies, one in Tshwane run by Wits RHI and funded by Unitaid, and another in Cape Town, led by the Desmond Tutu Health Foundation and funded by Gates, will kick off in October, if Sahpra approvals for the medicine used in the studies are through.
The research will look at how long people stay on LEN in reality, how many people are prepared to use it and which ways work best to get LEN to people.
Linda-Gail Bekker, who will head up the Cape Town study, explains: “New innovation cannot do its magic unless it gets to all the people who need it. We therefore need to make sure we do this in the right way and document those lessons.”
The Gates Foundation is quoted in this story. Bhekisisa gets funding from the Gates Foundation, but the foundation doesn’t exercise editorial control over what we publish.
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.
Hetero and Dr Reddy’s will be funded by the Gates Foundation and Unitaid to produce and sell the twice-a-year anti-HIV shot around R692 per person a year