South Africa has the highest number of HIV-positive people in the world. Of the 39 million people affected worldwide last year, 20.8 million lived in eastern and southern Africa, including 8.45 million in South Africa alone (almost 14% of the population), according to the latest figures from the United Nations Joint Programme Nations on HIV/AIDS (UNAIDS). That's why the South African government is eyeing an injection from British pharmaceutical company ViiV Healthcare, administered every eight weeks, that eliminates the risk of sexually contracting HIV. The drug, which is injected into the buttocks, contains an antiretroviral drug, cabotegravir, which is released over a period of two months, which is why it is called CAB-LA (short for long-acting cabotegravir). But South Africa is encountering a seemingly insurmountable obstacle: price.
ViiV Healthcare recently announced a “not-for-profit” price per injection unit of between R540 and R570 (approximately 26 to 28 euros). The beneficiaries will be 90 countries that the World Bank classifies as low- and middle-income countries. However, South Africa's Department of Health says these costs are still more than four times what it can afford.
More information
CAB-LA injections are not sold individually but in packs of 25 vials. In the United States, ViiV sells each vial for $3,700 (approximately €3,400); Some health insurance companies pay for it with a prescription. The non-profit price is about 127 times cheaper than what an American customer would pay, but is still more than four times what the Department of Health pays for a daily HIV prevention pill (R64.50, something). more than three euros). for a month's supply per patient). The risk of infection can also be significantly reduced with the pill, but only if taken daily, which is difficult for some people.
For CAB-LA to be profitable for the South African government, the price would need to be within a reasonable range compared to oral PrEP (the daily pill).
Khadija Jamaloodien, Chief Procurement Director of the South African Ministry of Health
“For CAB-LA to be profitable for the South African government, the price would have to be reasonable compared to oral PrEP (the daily pill), which is 129 rand (6.3 euros) for a two-month supply. We cannot afford to pay double or triple this price, especially in the context of the ministry’s budget cuts,” explains Khadija Jamaloodien, chief purchasing director of the National Ministry of Health. South African Finance Minister Enoch Godongwana announced a R1 billion cut to the Ministry of Health's medium-term budget for HIV treatment earlier this month.
“ViiV’s non-profit price does not include distribution costs and will therefore be even higher,” emphasizes Jamaloodien. “We asked ViiV for a budget that includes transport and logistics, as we do with the other tenders. “We are still waiting for an answer.”
The donor solution
One way to avoid the high price of this shot is to have it paid for by donors such as the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the government donor that provides most of the funding for antiretroviral treatment in Africa and has also provided funding for oral PrEP in other African countries.
ViiV has already sent PEPFAR-sponsored shipments to Malawi, Zambia and Zimbabwe, which will arrive in late November, according to Mitchell Warren of the Coalition to Accelerate Access to Long-Acting PrEP. Between 2023 and 2025, Malawi is expected to receive 10,000 injections, Zimbabwe between 10,000 and 12,000 and Zambia between 8,000 and 10,000. The shares go to government health programs and not to research. Warren and several South African HIV researchers say PEPFAR has assured them that South Africa will be on the funding list for programmatic use in early 2024. However, PEPFAR declined to comment as it is still “in the consultation phase with the National Ministry of Health and other interested parties.”
However, the Ministry of Health says it has not yet decided whether it will accept donations from CAB-LA. Jamaloodien explains: “We won’t reject that across the board, but we also have to take sustainability into account. South Africa, for example, pays for all of its antiretroviral drugs to treat HIV itself, and we still need to think about which path we will take with CAB-LA.”
Will people use the shot?
In early 2024, South Africa will receive shipments of ViiV-sponsored CAB-LA to conduct usage studies (i.e. for research purposes). According to the Department of Health, seven of these trials will begin once supplies arrive and the South African Health Products Regulatory Authority has approved their distribution.
Use studies analyze the level of “real life” adherence, the best way to administer the drug and create demand for a product, rather than whether the drug works, as use studies are only conducted when data on its effectiveness already exists available. “We will count how many people use CAB-LA, we will see which groups use it, who has difficulties and how they adhere to it, in the context of all the ups and downs of a 'real life' healthcare system,” explains Linda – Gail Bekker, who will lead the Desmond Tutu Health Foundation utilization study.
Warren says the British drugmaker has said it can produce 995,000 CAB-LA injections for low- and middle-income countries at its non-profit price between 2023 and 2025, up from a previous commitment of 360,000 to 590,000 vials. “It's still below what we think the market is, but the truth is we just still don't know how big that market is going to be,” Warren says. “That's why we all need application studies to know whether new experiences and good acceptance in effectiveness studies lead to acceptance in 'real life'.”
America's lesson
A small study presented in October during Infectious Diseases Week, an annual meeting of infectious disease experts in the United States, shows that the introduction of CAB-LA in this country, where CAB-LA became available in late 2021, was slow, which is mainly due to the high cost and complicated procedures of health insurance companies. Only slightly more than half (52.9%) of HIV-negative study participants who filled a prescription for CAB-LA received a first injection.
“An important lesson is that we need to make it easier for people to get preventative medications if we want them to use them,” says Bekker. “We may need to bring CAB-LA into communities using mobile clinics or set up separate, fast lines in clinics.” The drug needs to be injected deep into the person's muscle tissue and therefore needs to be administered by healthcare professionals. Therefore, unlike the daily pill, it is not possible to distribute the injections to users, says Bekker.
More than a million people in South Africa have used the pill, which was introduced in 2016. “We have to look at PrEP like fast food,” explains Bekker. “You need self-service, home delivery or pick-up points so people can choose how they want to receive the food. The more delivery options there are, the more likely you are to order it.”
It is very expensive for young women and men to become infected with HIV because we have to give them lifelong antiretroviral drugs and there is a risk that they will transmit the virus to other people
Linda-Gail Bekker, researcher
Since last August, a ruling in South Africa has allowed HIV prevention pills to be dispensed by trained pharmacists, meaning users no longer have to go to the doctor to get a prescription.
A distant horizon
Last March, ViiV granted licenses to three Indian drugmakers to produce cheaper generic versions of CAB-LA in collaboration with the Medicines Patent Pool (MPP), a United Nations-backed organization that helps poorer countries gain access to medicines. One of the companies, Cipla, has a factory in the South African city of Durban where it plans to produce the shot.
However, for this to happen, Cipla must first have the technology (a process that has already begun), build facilities and, once the drug is manufactured, conduct tests that show its product works the same as the drug (known as bioequivalence tests). Generics will therefore not be available until 2027 at the earliest, says Warren, meaning that by then the price of the brand-name drug must be as low as possible.
Producing CAB-LA is significantly more complex than oral PrEP, and the Department of Health can procure the pill cost-effectively because its ingredients (the antiretroviral drugs tenofovir and emtricitabine) are also commonly used for HIV treatment in South Africa. It is possible to have exceptionally large quantities Tendering orders, which leads to a drop in prices.
However, Bekker points out that CAB-LA is affordable for two reasons. “It is very expensive for young women and men to become infected with HIV because we have to provide them with antiretroviral drugs for life and there is a risk that they will transmit the virus to other people; and in the case of pregnant women, their babies too. “We have to ask ourselves what the cost is of protecting someone from infection and thereby enabling them to live a healthier life.”
Antiretroviral drugs are medications that people infected with HIV take to keep the virus at bay. However, in the case of CAB-LA, they are used as pre-exposure prophylaxis, also known as PrEP. In other words, the drug protects an uninfected person from becoming infected with the virus. The new global HIV report, released at the end of November, estimates that there will be 1.3 million new infections on the planet in 2022 and that South Africa continues to top the list of new infections.
Mia Malan She is the founder and editor-in-chief of the health magazine Bhekisisa.
This article was originally published in English on Bhekisisa.
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