SOUTH AFRICA — 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 modeling 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.

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.

Adolescent girls and young women in South Africa will be the first to access injectable PrEP using the antiretroviral drug cabotegravir every other month as part of the Unitaid-supported demonstration project.

The pilot will follow regulatory approval for the drug, which Unitaid expects in early 2023. A similar demonstration project for the dapivirine vaginal ring, which is also a form of PrEP is expected to begin this month, Unitaid confirmed.

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.

This follows an initial announcement in March that Wits RHI had been selected as a partner in the project alongside the department.

Zimbabwe recently became the first African country to approve long-acting cabotegravir as PrEP. Only two other countries – the United States and Australia – have approved it.

However, just days ago, the European Medicines Agency confirmed it had formally accepted drugmaker ViiV Healthcare’s application for eventual approval in the European Union.

Wits RHI’s pilot of the HIV prevention injection will be the first of several implementation studies envisioned by the South African National Health Department that will inform a national rollout, the department’s Hasina Subedar said at the 24th International AIDS Conference in July.

What we learned from oral PrEP is that… [studies] learn in a very controlled environment and it doesn’t necessarily reflect the real-world situation in our public health facilities,” she said.

There needs to be central coordination of all these projects so that they answer the questions that will assist us in making a decision about scale-up of the product.”

The vast majority of the country’s 5.5 million people on HIV treatment receive their antiretrovirals through the public sector. PrEP provision remains similarly concentrated.

South Africa accounted for about one in 10 people on oral PrEP globally in 2020, data collated by the HIV prevention advocacy organization AVAC shows.

The country — together with Kenya and the United States — made up about 40% of people on oral PrEP globally.

Many of the details of a national rollout will be in part decided by how the national regulator, the South African Health Products Regulatory Authority (SAHPRA), classifies the HIV prevention injection.

Restrictions imposed by the regulator (known as schedules) will determine who can administer it, for example. SAHPRA could also choose to limit the injection for certain groups, depending on available data.

Meanwhile, messages around the HIV prevention injection will have to hit the mark with communities.

For almost four decades, a person’s HIV prevention options were largely confined to the condom. Now, with injectable PrEP and the dapivirine ring in the pipeline, healthcare workers will have to change the way they think — and talk about prevention choices to patients and communities.

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