Durban — The South African Health Products Regulatory Authority (Sahpra) has registered a new HIV pre-exposure drug.
On Friday, Sahpra said it had registered cabotegravir (Apretude 600 mg/3ml injection), a long-acting HIV pre-exposure prophylactic that plays an important role in preventing HIV infection.
Sahpra chief executive Dr Boitumelo Semete-Makokotlela said: “Sahpra joins the global fight against this disease. The priority review pathway followed to assess and finally register long-acting cabotegravir (CAB-LA) marks a bold step in this direction.”
Sahpra said cabotegravir was an antiretroviral drug (ARV) that people living with HIV may use, together with other ARVs, to keep the virus in their bodies from making copies of itself. When such medicine is used to prevent HIV infection — that is, if it is taken before exposure to HIV — it is called pre-exposure prophylaxis, or PrEP, and thus plays an important role in preventing HIV infection.
It said that Apretude 600 mg/3ml injection is the first and only long-acting, injectable PrEP for reducing the risk of getting HIV. This drug is a safe and highly effective prevention option for people at substantial risk of HIV infection. HIV prevention efforts have stalled, with 1.5 million new HIV infections in 2021, as indicated by the World Health Organization. Having such options will go a long way in reducing the rate of new infections.
Last month, the Daily News reported that the HIV prevention shot is expected to be rolled out in health facilities once Sahpra has approved it. This is according to Professor Saiqa Mullick, director of implementation science at the Wits Reproductive Health & HIV Institute.
Mullick said cabotegravir is a new HIV prevention method that provides eight weeks of continuous protection against HIV infection through a single intramuscular injection. This provides an alternative to oral pre-exposure prophylaxis, which can reduce the risk of HIV infection by 99%.
Unitaid, a global health initiative, said long-acting cabotegravir addressed challenges users face with regular pills that reduce the impact of oral PrEP in real-world settings. It also mitigates fears pills will be misinterpreted for HIV treatment and cause the user to suffer stigma, discrimination or intimate-partner violence as a result.
Mullick emphasised that one needed to be HIV negative to be eligible to take the prevention shot. She said this would give people an additional choice.
“We have an oral pill, but we know this can be difficult. People can forget to take the pill, or other things can get in the way,” said Mullick.
The trial, known as HIV prevention trials network 084, was headed by Dr Sinead Delany-Moretlwe, a research professor at Wits and director of research at Wits RHI. She said researchers from the network announced last week that data from the clinical trial of the PrEP regimen of long-acting cabotegravir (CAB LA) injections once every eight weeks indicated it was safe and superior to the daily oral tenofovir/emtricitabine currently used for HIV prevention among women in sub-Saharan Africa.
Overall, the trial enrolled 3 223 women at research sites in Botswana, eSwatini, Kenya, Malawi, South Africa, Uganda, and Zimbabwe. Some 57% of the participants were under the age of 25, the average age of participants was 26, 82% were not living with a partner, 55% reported two or more partners in the past month, and 34% reported having a primary partner who is living with HIV or has unknown HIV status.
A total of 38 HIV infections occurred during follow-up, with four infections in the CAB LA arm.
Daily News