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 were in eastern and southern Africa, with 8.45 million in South Africa alone (almost 14% of the population), according to the latest figures from the Joint United Nations Program on HIV/AIDS (UNAIDS). For this reason, the South African Government has its eyes on an injection manufactured by the British pharmaceutical company ViiV Healthcare that eliminates the chances of contracting HIV sexually if administered every eight weeks. The medication, 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 has hit a seemingly insurmountable obstacle: price.
ViiV Healthcare recently announced a “not-for-profit” price per unit of the injection of between R540 and R570 (approximately €26 to €28). The beneficiaries will be 90 countries that the World Bank classifies as low and middle income. But the South African Department of Health says that this cost is still more than four times what it can afford.
The CAB-LA injections They are not sold individually, but in packs of 25 vials. In the United States, ViiV sells each vial for $3,700 (about 3,400 euros); some health insurance companies pay for it with a prescription. The non-profit price is therefore about 127 times cheaper than what an American customer would pay, but it is still more than four times what the Department of Health pays for a daily HIV prevention pill (64 .50 rand, just over three euros, for a month's supply per patient). The pill also significantly reduces the chances of infection, but only if it is taken every day, something some people find difficult.
For CAB-LA to be profitable for the South African Government, the price would have to be within a reasonable range compared to oral PrEP (the daily pill)
Khadija Jamaloodien, Chief Procurement Director of the South African National Department of Health
“For CAB-LA to be profitable for the South African government, the price would have to be within a reasonable range compared to oral PrEP (the daily pill), which is 129 rand (6.3 euros) for a supply of two months. We cannot afford to pay double or triple that price, especially in the context of the Department's budget cuts,” explains Khadija Jamaloodien, chief procurement director at the National Department of Health. South African Finance Minister Enoch Godongwana announced a R1 billion cut to the Ministry of Health's mid-term budget for HIV treatment earlier this month.
“ViiV's non-profit price does not include distribution costs, so it will be even higher,” Jamaloodien points out. “We have asked ViiV for a budget that includes transportation and logistics, as we do with the rest of our tenders. “We are still waiting for a response.”
The donor solution
One way to avoid the high price of this injection is to allow it to be paid for by donors such as the US President's Emergency Plan for AIDS Relief (PEPFAR), the government donor that has paid the most for antiretroviral treatment in Africa and also funds oral PrEP in other African countries.
ViiV has already sent PEPFAR-sponsored supplies 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 scheduled to receive 10,000 injections, Zimbabwe between 10,000 and 12,000, and Zambia between 8,000 and 10,000. The stock will go to government health programs and not research. Warren, and also several South African HIV researchers, say PEPFAR has assured them that South Africa is on the grant list for programmatic use in early 2024. But PEPFAR declined to comment because it is still “in deliberation phase with the National Department of Health and other interested parties.”
However, the Department of Health says it has not yet decided whether it will accept donations from CAB-LA. Jamaloodien explains: “It is not something we are going to reject out of hand, but we also have to take sustainability into account. South Africa, for example, pays for all its antiretroviral drugs for the treatment of HIV itself, and we have yet to consider 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 in order to carry out utilization studies (in other words, for research purposes). According to data from the Department of Health, seven of these trials will begin as soon as stocks arrive and the South African Health Products Regulatory Authority has approved their distribution.
Utilization studies analyze the degree of adherence to treatment in “real life,” the best way to deliver the medication and create demand for a product, and not whether the drug works, because utilization trials are only conducted carried out when data on its effectiveness is already 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 healthcare system in 'real life,' explains Linda-Gail Bekker, who will direct the utilization study of the Desmond Tutu Health Foundation.
Warren says the British drugmaker has said it will be able to manufacture 995,000 CAB-LA injections for low- and middle-income countries between 2023 and 2025 at its non-profit price, up from a previous commitment of between 360,000 and 590,000 vials. “It's still short of what we think the market might be, but the truth is that we simply still don't know what the size of that market will be,” Warren says. “That's why we need all utilization studies, to know if novel experience and good acceptance during efficacy trials translate into 'real life' acceptance.”
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 in this country, where CAB-LA became available in late 2021, its Adoption has been slow, mainly due to the high cost and complicated procedures of health insurance companies. Only just over 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 have to make it easier for people to get preventive medication if we want them to use it,” says Bekker. “We may have to bring CAB-LA to communities with mobile clinics or create separate, fast lines at clinics.” The drug has to be injected deep into the person's muscle tissue, so it must be administered by a healthcare worker. Therefore, it is not feasible to distribute the injections to users, unlike with the daily pill, Bekker says.
More than a million people in South Africa have used the pill, which was introduced in 2016. “We have to think of PrEP like fast food,” explains Bekker. “You have to have 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 contract HIV because we have to give them antiretrovirals for life, and there is a risk that they w
ill transmit the virus to other peopleLinda-Gail Bekker, researcher
Since last August, following a ruling in South Africa, HIV prevention pills can be dispensed by trained pharmacists, so users no longer have to go to the doctor to have them prescribed.
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 access medicines. One of the companies, Cipla, has a factory in the South African town of Durban, where it plans to produce the injection.
But for this to happen, Cipla first needs to have the technology (a process that has already begun), build facilities and, once the drug has been manufactured, conduct trials to show that its product works in the same way as the drug. brand (known as bioequivalence assays). Therefore, generic products will be available in 2027 at the earliest, Warren says, meaning that until then they will need the price of the brand-name drug to be as low as possible.
CAB-LA is considerably more complex to manufacture than oral PrEP, and the Department of Health is able to source the pill cheaply because its ingredients (the antiretrovirals tenofovir and emtricitabine) are also widely used for HIV treatment in South Africa. , so it is possible to tender exceptionally large orders, which causes the price to drop.
However, Bekker points out that CAB-LA's affordability is two-fold. “It is very expensive for young women and men to contract HIV because we have to provide them with antiretrovirals for life, and there is a risk that they will transmit the virus to other people; and in the case of pregnant women, also their babies. “We have to ask ourselves what the price is of saving someone from an infection and therefore giving them a healthier life.”
Antiretrovirals are the medications that people infected with HIV take to keep the virus at bay, but in the case of CAB-LA, it is used as pre-exposure prophylaxis, also known as PrEP. In other words, the medication protects an uninfected person from contracting the virus. The new report The global HIV report, published at the end of November, estimates that in 2022 there will be 1.3 million new infections on the planet, and that South Africa continues to lead the list of new infections.
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