- Gilead Sciences, the maker of a twice-a year anti-HIV injection, has approached South Africa’s medicine regulator to discuss how to get the shot registered locally as fast as possible in the country.
- The jab, lenacapavir, protected HIV-negative women 100% against HIV infection in a trial of which the results were published in July.
- Although the South African Health Products Regulatory Authority, Sahpra, has the technical know-how to evaluate data for new medicines, the body is severely understaffed and therefore unable to review new medicines speedily.
- To save time, the health department is now considering making an unprecedented move, issuing a request for information — a formal way of asking manufacturers at which price they can provide a product — before Sahpra’s approval has been concluded.
In today’s newsletter, Mia Malan explains why Gilead Sciences and Sahpra are talking about lenacapavir. Sign up for our newsletter now.
Gilead Sciences, the maker of a twice-a-year anti-HIV injection, has approached the South African Health Products Regulatory Authority (Sahpra) — the country’s medicine regulator that has to approve the safety and efficacy data of medicines before they can be used — to discuss how to get the shot registered locally as fast as possible.
Cheaper, generic versions of the jab, which contains the antiretroviral drug, lenacapavir, will be sold to 120 countries with high HIV rates, of which South Africa is one. The generic shots are likely to become available in 2027, according to Mitchell Warren, the executive director of the New York-based advocacy organisation, Avac.
In the meantime Gilead has committed to selling their branded injection to 18 countries, of which South Africa is also one, at a no-profit price.
What can lenacapavir do for South Africa?
Lenacapavir, which is injected under the skin, usually in someone’s tummy, protected HIV-negative women between the ages of 16 and 25 years 100% against HIV infection in a trial of which the results were published in July.
More recently, at the 5th HIV Research for Prevention Conference in Peru in early October, researchers announced that another study showed that lenacapavir also dramatically reduced the chances of HIV infection for other groups of people — gay men, trans and non-binary people of 16 years and older, who have sex with partners classified as male at birth — by 96%.
Although South Africa’s new HIV infections have decreased considerably since 2010, the country has fallen behind reaching a United Nations target to reduce new infections by 90% by 2030 (compared to 2010).
In 2010, South Africa had about 350 000 new infections, so the goal should be to have only 35 000 in 2030. In 2023, though, South Africa had 150 000 new cases — almost five times more than where we want to be.
The World Health Organisation (WHO) says long-acting jabs such as lenacapavir could potentially help to slow down new infections significantly, at least partly because it only has to be taken twice a year, which makes it easier to adhere to than, for instance, a daily anti-HIV pill.
Why Sahpra will take too long to conduct a review on its own
Gilead announced on 2 October that it will start “a series of global regulatory filings by the end of 2024”, but didn’t specify with which countries it will start. Although lenacapavir is registered as treatment for HIV-infected people who have become resistant to other antiretrovirals, in the United States (US), Canada and some European countries, no country has yet approved the drug as a medicine that is used to prevent HIV-negative people from contracting the virus.
But while Sahpra has the technical know-how to evaluate data for new medicines, and the World Health Organisation (WHO) considers it a stable and well-functioning regulator — one of Africa’s top six — the body is severely understaffed and therefore unable to review new medicines as fast as it would like to, resulting in long waiting periods for both new and generic medicines to go to market, CEO, Boitumelo Semete-Makokotlela, told the health portfolio committee in parliament last week.
Semete-Makokotlela has told Bhekisisa: “That is why our conversations with Gilead focused on how Sahpra can access help to speed up the review process for lenacapavir by using mechanisms such as EU Medicines for All (EU-M4all).”
How EU-M4All works
EU-M4all runs at the same time as the European Medicine Agency’s approval process (to save time). This helps countries outside of the European Union to speed up their own checks because they can rely on already-scrutinised data.
So far, EU-M4All has been used to speed up the review process for 15 medicines, such as vaccines for malaria and dengue fever, as well as a vaginal ring that can prevent HIV infection.
Semete-Makokotlela says, as a member of EU-M4all, Sahpra would be allowed to participate in their lenacapavir evaluation, by offering some of its own expertise for parts of the review. “In essence, it will be a joint evaluation with the European Medicines Agency,” she says. “This will certainly be faster than if Sahpra was to do the review on its own.”
Sahpra, for example, took over a year (from November 2021 to December 2022) to approve another anti-HIV injection, CAB-LA, which contains the antiretroviral medicine cabotegravir and is taken every other month. With EU-M4all, reviews take a maximum of seven months (210 days) and the regulators of participating countries then have three months to finalise the process locally.
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Gilead will have to use its local branch to file for registration with Sahpra, and in lenacapavir’s case, that can only be done once the EU-M4all review has been completed, because the approved evaluation data, prepared by EU-M4all, would have to be used. The contents of that dossier will have to be slightly adjusted for the local application, so that the application complies with Sahpra’s regulations.
Gilead would need to pay Sahpra R208 400 to work through its request, because it falls under the category of “a new chemical entity, new biotherapeutic other than vaccines” in Sahpra’s fee structure, explains Semete-Makokotlela.
If the filing takes place after new fee structures have been gazetted, the price will be slightly higher.
So with which regulator is Gilead likely to file first? Warren says the company will almost certainly prioritise the US’s Food and Drug Administration (FDA), which could approve lenacapavir for HIV prevention, also called pre-exposure prophylaxis (PrEP), in as little as six months.
He says: “In addition to the FDA that is likely to register lenacapavir first, the hope is to see multiple countries having approved it by this time [October] next year.”
How will the health department decide if lenacapavir is worth SA’s while?
Meanwhile, the national health department’s head of procurement, Khadija Jamaloodien, told Bhekisisa the department is considering publishing a request for information (RFI ) — this is a government department’s formal way of asking manufacturers at which price they can provide a product, how much of it they can make and what they will charge for it — before Sahpra’s approval has been concluded.
It would be an unprecedented move, in order to save time, similar to Gilead issuing licences to six generic companies in India (3), Egypt (1), Pakistan (1) and the US (1) in early October, before the company had applied for registration of lenacapavir with any regulators.
That way, generic companies can start to prepare to make lenacapavir while registration applications are being processed and not lose that time; months, and sometimes years, during which thousands of people around the world would get infected with HIV.
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“We may do it [issue an RFI before lenacapavir has been registered] this time,” Jamaloodien explains. “But it’s still early days. Let’s give those six generic companies a little time to work out how they will approach us.”
However, in order to do this, the country’s national essential medicines list committee, NEMLC, first has to study lenacapavir’s safety and efficacy data from trials and decide at what price the jab would be cost effective for South Africa.
The health department can only buy medicines that the NEMLC recommends to be added to the country’s shopping list — and tenders can only be issued once Sahpra has registered a medicine.
Jamaloodien says that the NEMLC has started its review for lenacapavir, but she can’t yet reveal details.
What can SA afford to pay for anti-HIV jabs?
In July, the department published an RFI for the two-monthly anti-HIV jab (CAB-LA), of which generic versions are expected to go to market in 2027. Jamaloodien says she had received “several responses” by the 9 September deadline that the department is now studying; the outcome of the review will be made public between January and March 2025.
South Africa will receive 96 000 donated CAB-LA jabs from the US government by December, and another 135 000 more through the course of next year. The jabs — 231 000 in total — will be available for free at 857 government clinics, but the doses are enough to only cover 21 000 people over two years.
CAB-LA can slash the country’s new HIV infections by more than a quarter over 20 years, a modelling study shows. (Similar figures are not yet available for lenacapavir.)
But the outcome of the RFI and the fact that the health department would be starting people on CAB-LA with donations that, at least at this stage, will last for only two years, is no guarantee that South Africa will put out a tender for CAB-LA.
“We don’t know if the market can bear both lenacapavir and CAB-LA,” says Warren. “I suspect it will all come down to price.”
For injectable PrEP to be affordable for South Africa, the NEMLC compares the price to what a daily HIV prevention pill, which is available for free in most state clinics, costs the government (R629.40 for a year’s medication for one patient, according to the health department).
A cost model, which looked at the affordability of CAB-LA, shows for the jab to become widely available at state clinics, the shots should cost the same or at most double what the government pays to give someone two months’ prevention pills (two months, because CAB-LA is taken every second month).
From that reasoning, a lenacapavir jab should not cost more than R624.36 a dose (a dose consists of two shots per visit) — thus around R1 250 for a year of protection against HIV.
CAB-LA’s manufacturer, ViiV Healthcare, sells the jab at £23.50 (about R540 at the current exchange rate) per dose to donors and low- and middle-income countries such as South Africa until cheaper generics become available. This works out to just over five times more than what the government pays for a two-month supply of the daily HIV prevention pill.
Gilead hasn’t announced the no-profit price at which it will sell its branded product to South Africa and other countries until generics become available, but Warren says he’s hoping it will be no more than $100 (R1 760 at the current exchange rate) for a year’s supply per person (so R880 per shot — R255 more than what SA is likely to be able to afford).
But, even this price, Warren says, is only possible when vials for at least one million users per year — so four million jabs — are produced (each user gets two jabs per six-monthly visit).
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A modelling study released earlier this year, shows lenacapavir can be made for as little as $40 (R704 at the current exchange rate) per year per patient — but only if 10-million people take it up.
At this price, the study authors say, drug makers would still make a profit of 30%.
But Warren warns getting to such low prices will take time — and competition. And there’d need to be guaranteed buyers, or drug makers won’t consider it worthwhile to make the medicine.
“There are six generic companies who will compete to sell their lenacapavir products, which will drive down prices. But they can only compete if there’s demand, so we need to create a market,” he explains.
“It’s like a driver’s licence — if you have a licence, but no car, you can’t really drive anywhere.”
Mia Malan is the founder and editor-in-chief of Bhekisisa. She has worked in newsrooms in Johannesburg, Nairobi and Washington, DC, winning more than 30 awards for her radio, print and television work.
