BHEKISISA | SA wants to buy the two-monthly anti-HIV jab, 18 days after a US donation deal

The national health department has published a request for information about the two-monthly anti-HIV jab, CAB-LA, 18 days after it accepted a donation of 231,000 doses over two years from the US government President’s Emergency Plan for Aids Relief, Pepfar.

A request for information 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 how much they will charge for it.  

“When we accept donations, we also need to make sure we can provide the medicine after the donation has ended, which is why the department is looking into how we can buy CAB-LA at affordable prices,” said Khadija Jamooldien, the national health department’s head of procurement. 

“It’s a signal to the market that this is a medicine being considered for inclusion in the HIV care package being offered.” 

Manufacturers have until September 9 to show their interest. 

CAB-LA, which is a long-acting injection of the antiretroviral drug cabotegravir, could slash the country’s new HIV infections by more than a quarter over 20 years, a modelling study showed. Cabotegravir stops infection because it prevents the virus from getting into a person’s white blood cells.

South Africa reported about 150,000 new HIV infections in 2023, according to the Thembisa model which the health department uses to plan its programmes.

CAB-LA was registered as an HIV prevention medicine in South Africa in December 2022. 

However, the health department has had no plans to buy the medicine because it’s so expensive. 

CAB-LA’s manufacturer, ViiV Healthcare, sells the jab for £23.50 (R553) per dose to donors and low- and middle-income countries such as South Africa, which works out to roughly four times more than government pays for a two-month supply of the daily HIV prevention pill. 

The health department can only buy medicines that the National Essential Medicines List Committee recommends to be added to the country’s shopping list because they think it will work for the country and be cost effective. Jamooldien said once companies have submitted their prices, the committee will sit to make a decision. 

Studies have shown CAB-LA works better than the daily pill, mostly because it is easier to adhere to because it is taken only every other month, as opposed to daily. 

The first batch of Pepfar donations — more than 96,000 doses — will arrive between October and December this year, and will be stocked in 867 government health facilities. 

However, the donation alone won’t be nearly enough for South Africa’s needs as 231,000 shots will cover only around 21,000 people over two years.

The shots will be received in two consignments, with about 13,800 people able to get it for a full two years, and around another 7,500 to start their injections when the next batch arrives at the beginning of the second year of the roll-out.

Between 10 and 50 people will be able to get a shot from each of the 867 clinics on the department’s roll-out list, in line with goals for starting people on prevention medication and also ease of distribution, said Hasina Subedar, a senior technical advisor for the health department.

Subedar is leading the CAB-LA roll-out.  

The size of Pepfar’s CAB-LA donation is linked to how much ViiV healthcare can produce. Part of the reason for small amounts being available at the moment is that it’s a difficult and time-consuming process to make the final injectable solution.

Research shows, however, that a marked drop in HIV infections in a community is seen only if anti-HIV medication reaches a lot of people. For example, in places where the incidence rate — the rate at which people are getting infected — is 3% or more, 33 people need to take prevention medication to stop one new infection, the study showed. Some areas in Southern Africa have high incidence rates like this. In places where the chances for new infections is lower, 200 people have to take HIV prevention drugs to stop one new infection. 

To slow new HIV infections substantially, South Africa would therefore need millions of CAB-LA doses.

In March 2023, ViiV issued licences to three Indian generic drugmakers — Airobindo, Cipla and Viatris — through the Medicines Patent Pool (MPP) to make cheaper versions of CAB-LA, as the companies would receive the drug’s recipe and ViiV would share the know-how of how to apply the recipe, without the generic companies having to cover the cost of developing the drug. 

Cipla has a plant in Durban, where the company plans to eventually make at least some CAB-LA.

Generics will be on the market only by early 2027, experts at the International Aids Conference in Munich last week said, because of how complex it is to make the jab.

Putting together ingredients to build cabotegravir — the chemical that stops HIV from replicating and called the active ingredient in the CAB-LA shot — is “fairly straightforward”, said Andrew Hill, a pharmacology expert who’s been working at universities and with pharmaceutical companies on the development of antiretrovirals for the past 30 years. 

However, to make cabotegravir long acting, “it has to be ground down so finely that you essentially get single drug particles rather than powder granules [which can then be mixed with a liquid to make a solution]”.

This is a difficult and expensive process for which special equipment is needed, he said. 

Once a generic product has been made, it needs to be tested to make sure it works as well as the original product. For this, something called a bioequivalence study is done, which tests if the generic and branded medicine releases the same amount of drug, and at the same rate, into a person’s body. 

Jamooldien said “we need competition to get the best price” and ViiV’s current not-for-profit price is certainly not the only price to go by”. 

The request for information, published on July 16, asks manufacturers to indicate how much CAB-LA they’ll be able to supply over three years, what they will charge per dose, how long they will take to deliver the first batch, and, once a contract has been awarded, how long they will take to get orders to clinics from the date the order was placed.  

Drugmakers have to fill in prices for different amounts of doses: what they will charge for 100,000, 500,000 and 1-million “for the department to see how they adjust their price based on volume”, said Jamooldien. 

What price is right? 

“I can’t answer this question at present. We are constantly reviewing our decisions on information we receive. It can be dynamic.”

She said the dates for the three years that the request for information document refers to have not yet been established, and the department “will have more information about when suppliers are able to supply”. 

No supplier has yet responded to the document.

How much CAB-LA the health department would need would depend on how open people are to getting the jab and if they’d be prepared to use it consistently. 

To determine this, researchers do implementation trials. Five such studies are under way in South Africa across 16 different sites, and early results of the research were released at the International Conference on Aids.

Some results show when people have a choice between taking the daily HIV prevention pill, which the health department provides free at most government clinics, and a monthly vaginal ring, up to three-quarters go for the jab.

For example, researchers from the Desmond Tutu Health Foundation in Cape Town found among 1 084 people between 19 and 28 years old, 74% chose the injection.

In another small study, run by the health organisation Ezintsha at the University of the Witwatersrand, 77% of 172 people started on HIV prevention medication chose CAB-LA when they could pick the jab or the daily pill. 

Moreover, people come back for next shots. For example, more than eight in 10 people who chose the CAB-LA shot in the Cape Town study came to get their follow-up shot, while results from a trial in KwaZulu-Natal, run by the Africa Health Research Institute, show only three in 10 people who were due for a refill of pills came to fetch them. This matches trends expected from the three-year CAB-LA clinical trial in sub-Saharan African countries, which showed people find it easier to stick to a long-acting injection than having to take a daily pill. 

“Injectable HIV prevention medicine provides a terrific option that is less dependent on a user taking a pill every day, and the less often you need to go to a provider for the injection, the less burden on the health system,” said Mitchell Warren from the New York-based advocacy organisation Avac.   

The results of another shot, which only has to be taken once every six months, as opposed to CAB-LA’s two-monthly dose, which were also released at the conference, have made world headlines. 

Not one of the 2,134 women in the study who took lenacapavir, made by the drug company Gilead, contracted HIV. 

While Warren said the manufacturing process of lenacapavir is simpler than that of CAB-LA, and it would therefore be easier to produce in large quantities, no price for the medicine has been announced and generic licences have not yet been awarded. 

As a treatment for drug-resistant HIV, lenacapavir is sold for between $41,000 (R753,000) and $44,000 (R808,000) in Norway, France and the US for a year’s supply. 

The medicine has also not yet been registered anywhere as an HIV prevention drug. Gilead will not apply with medicine regulators until the results of a second study become available at the end of the year or early 2025, a company representative said at a press briefing at the conference last week. 

But Warren said affordable, generic versions of lenacapavir could, potentially, become available in 2027 or 2028. 

“We’re looking at companies competing for the market, and that’s going to drive down the price,” he said. “Can the market bear two injectables? I don’t know. That’s an askable and answerable question. That’s something we all need to be looking at over the months and years ahead.”

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.