The South African Health Products Regulatory Authority (Sahpra) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare. 

“We are very pleased that this week, Sahpra granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. 

“It brings a much-needed innovative HIV-prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP [pre-exposure prophylaxis] options.” 

At the time of publication, Sahpra had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021. 

ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licences to at least three generic producers that could potentially supply the injection to South Africa. It is, however, expected to take three to five years before any of the generics will be ready. 

The executive director of the HIV-prevention organisation Avac confirmed the authorisation late on Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from it.  

Thursday’s announcement makes South Africa at least the third African country to approve the shot for use, following similar approvals in Zimbabwe, Uganda, and Botswana. A duo of large clinical trials, led in part by South African researchers, 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. 

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The bimonthly shot probably outperformed the pill, 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.  

Previously, Spotlight reported that pilot projects were expected to begin providing access to the HIV-prevention shot early next year. Demonstration projects run in partnership with the national health department, and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV-prevention shot, pill, or monthly vaginal ring. 

The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national roll-out, including how to create national awareness campaigns about the HIV-prevention injection and how to provide it outside of hospitals and clinics and closer to communities.  

Sahpra authorisation marks the first step toward an eventual national roll-out, according to national health department HIV-prevention technical adviser Hasina Subedar. Subedar spoke to Spotlight in July at the International Aids Conference. In particular, the finer details of the registration — which are still not public — will guide who can and can’t receive the shot.  

Many will be watching to see whether the injection will be made available to pregnant and breastfeeding people, who remain at high risk of contracting HIV in South Africa. Early data presented at the International Aids Conference in July suggest that the injection is safe to use during pregnancy, although research is ongoing. DM/MC

This article was published by Spotlight – health journalism in the public interest.