South Africa is expected to begin piloting the every-other-month HIV prevention shot early next year, according to the international medicine financing initiative Unitaid. New modelling released this week shows that the injection could prevent as many as 52 000 new HIV infections in the next two decades if rolled out nationally. But to be cost-effective in South Africa, the research suggests the price of the injection must fall to levels drugmaker ViiV Healthcare says are unrealistic.
Wits Reproductive Health and HIV Institute (Wits RHI) and the national health department are expected to begin providing injections of the antiretroviral cabotegravir to young women to prevent HIV infection as part of a small Unitaid-funded project, spokesperson Hervé Verhoosel told Spotlight. This follows an initial announcement in March that Wits RHI had been selected as a partner in the project alongside the national health department.
Given every other month, the injection is the latest form of pre-exposure prophylaxis (PrEP) to use antiretroviral medication to prevent HIV infection in HIV-negative people.
Oral PrEP in the form of a once-a-day tablet has been available in South Africa since 2016. Today, the pill is available at more than 2 000 sites nationwide. Better known by its brand name Truvada, the tablet combines two antiretroviral drugs, emtricitabine, and tenofovir disoproxil fumarate. When taken correctly, the pill can reduce a person's risk of contracting HIV by almost 99%.
Still, results from two large clinical trials led in part by South African researchers have found that people who were given an injection of the antiretroviral cabotegravir every other month were about 80% less likely to contract HIV than those on the HIV prevention pill. The bi-monthly shot likely outperformed Truvada, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.
The HIV prevention shot could be coming to a pharmacy near you
The Wits RHI pilot will follow the shot's likely approval by the South African Health Products Regulatory Authority (SAHPRA). Unitaid told Spotlight it expects SAHPRA to approve the injection early next year. ViiV Healthcare applied for regulatory approval with SAHPRA in August 2021. The injection was approved by the United States Food and Drug Administration in December 2021.
The Wits RHI pilot, which will see the shot provided in some public health facilities and also via the organisation's mobile clinics, is expected to be the first of several planned demonstration projects to see how best to roll out the shot.
The #FDA has approved the first long-acting injectable medication for use as pre-exposure prevention, or #PrEP, against #HIV. Rather than as a daily pill, the newly approved drug, #Apretude, is given to patients every two months. 🌈 pic.twitter.com/dva3zf8OsL
-- Project MORE (@DoMoreLGBTQ) December 22, 2021
Similar programmes are slated for Clicks pharmacies, for instance, according to the HIV prevention organisation AVAC. Divisional director of the health research organisation Ezintsha Dr Francois Venter confirmed to Spotlight that they will be partnering with Clicks and the health department to offer the injection alongside Truvada and a monthly vaginal ring that uses the antiretroviral dapivirine to prevent HIV infection. Clicks also confirmed that they are in discussions with Ezintsha to take part in a future pilot.
In large clinical trials, the soft silicon ring reduced women's risk of contracting HIV by between 27 to 35%, but this increased to 50% or more in more real-world settings, the WHO explains. Wits RHI is expected to begin piloting the ring with the national health department this month, according to Unitaid.
The catch may be the cost: Shot retails for hundreds of thousands of rands in US
In the short term, the HIV prevention shot is likely to be confined to small pilot projects as the national health department - like many around the world - continues to study how best to bring complicated injections out of health facilities and closer to communities.
Price is also a potential stumbling block. The injection can cost as much as R391 000 per patient per year in the United States. But for the shot to be cost-effective in South Africa, this price would have to fall to at least R1 800 - less than one percent of the official US price tag, according to new modelling published this week in The Lancet HIV by the University of the Witwatersrand's Health Economics and Epidemiology Research Office (HE2RO).
ViiV Healthcare, however, says that the price is unrealistic.
"Based on ViiV's experience making [long-acting cabotegravir] for PrEP, this significantly underestimates the cost of manufacture," ViiV Healthcare spokesperson Catherine Hartley told Spotlight in late September in response to a pre-print of the HE2RO study.
"Long-acting cabotegravir is a highly innovative, complex, sterile injectable medicine," Hartley explained. "Manufacturing is more expensive and much harder than for generic oral PrEP, which is a simple white tablet."
HE2RO's study sought to compare the cost-effectiveness and impact of the HIV prevention shot with Truvada to determine the price tag at which the injection would become cost-effective. To do this, researchers built a mathematical model, plugging in projected costs for the drugs, staff needed to administer them, and even the bills for laboratory tests required for patient monitoring, for example. The model also makes several assumptions, for instance, how fast a rollout of the shot would grow and that more people would opt for the HIV prevention shot over the pill - an assumption borne out by available data.
Partly because more people are likely to choose the injection over a pill - and because it's easier to take, HE2RO found that a national rollout of the shot would avert three times as many infections and save triple the number of lives as increasing access to oral PrEP alone.
But for the injection to be cost-effective, the study found, it could only cost the same or double what South Africa currently pays for oral PrEP.
"Although long-acting injectable cabotegravir has the potential to change HIV prevention, for large-scale implementation across low-income and middle-income countries, it first needs to be affordable," researchers write. "Lessons learned from oral PrEP programmes show that scale-up and demand creation should be coordinated between all partners and should be fast enough to build momentum and yield results as high as [we have] projected."
In July, ViiV Healthcare announced it had entered into an agreement with the Medicines Patent Pool (MPP) to grant an initial three licenses to generic manufacturers with hopes of producing affordable versions of the shot for low- and lower-middle income countries - as well as all sub-Saharan African countries regardless of income level. The deal includes South Africa.
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But, the MPP predicts it will take between three and five years before generics are ready to be marketed.
Until that happens, ViiV Healthcare publicly committed at this year's International AIDS Conference to providing affordable prices for countries covered by the MPP deal. In The Lancet HIV, researchers write that ViiV is considering what it says is a non-profit price of between R4 262 to R4 794 per patient per year.
ViiV Healthcare declined to confirm any pricing figures when asked by Spotlight in late September. Instead, the company said it was working with AVAC, Unitaid, the Bill & Melinda Gates Foundation, and others to examine affordable pricing and innovative financing.
"Given that work is getting started and we don't want to pre-empt it, we're not in a position to talk about pricing details or comment on specific numbers," Hartley told Spotlight. "We're committed to engaging, collaborating positively, and working openly with global health partners and the HIV community to reduce the cost of long-acting cabotegravir for PrEP to help enable broad access for people who could benefit from it."
NOTE: Professor Francois Venter is quoted in this article. Venter is a member of Spotlight's Editorial Advisory Panel. The panel provides the Spotlight editors with advice and feedback on the quality and relevance of Spotlight's public interest health journalism. The Spotlight editors, however, remain editorially independent and solely responsible for all editorial decisions. Read more on the role and purpose of the panel here.
