Zimbabwe's approval of long-acting drug could provide effective options for HIV prevention

Zimbabwe's approval of the long-acting cabotegravir (CAB-LA) for use by HIV-negative people to reduce the risk of getting HIV could pave the way for effective options for HIV prevention, experts say.

Among people of ages 15 to 49 years old in Zimbabwe, the proportion with HIV in 2021 was 11.6 per cent, according to UNAIDS estimates.

Zimbabwe is the first African country and the first low- and middle-income country globally to approve the drug, the World Health Organization said, announcing the milestone earlier this month.

CAB-LA received regulatory approval from the US Food and Drug Administration in December 2021 and Australia's Therapeutic Goods Administration in August 2022 for HIV prevention, making Zimbabwe the third country in the world to approve it.

"The extended-release injectable preparation is an additional option which has the benefits of reduced dosing frequency, [and] potentially improved adherence," said Farai Masekela, head of evaluations and registration at the Medicines Control Authority of Zimbabwe (MCAZ), which approved the drug last month (19 October).

"Data from clinical trials shows that it is more effective than the current approved oral options," he added.

Two large-scale studies showed that CAB-LA injections every two months were "safe, well-tolerated, and highly effective in reducing the risk of HIV acquisition", according to a WHO statement.

Masekela told SciDev.Net that Zimbabwe now has an alternative for HIV prevention given that only oral medicines have been available on the market for use by HIV-negative people to prevent them from getting HIV, an approach called pre-exposure prophylaxis.

Decisions on how CAB-LA will be procured and made available to people will be led by global health partners and the Zimbabwean government, experts say.

In July, the WHO welcomed the licensing agreement between ViiV Healthcare and the Medicine Patent Pool that will allow selected generic manufacturers in 90 low- and middle-income countries including Zimbabwe to develop, manufacture and supply generic versions of the drug, subject to required regulatory approvals.

Meg Doherty, WHO's director of global HIV, hepatitis and sexually transmitted infections programmes, welcomed Zimbabwe's approval of CAB-LA, saying it could boost the provision of safe and effective HIV prevention.

Based on WHO recommendations, CAB-LA may be offered to people at substantial risk of HIV infection as part of a comprehensive HIV prevention approach.

The approval of using long-acting injectable cabotegravir (CAB-LA) for HIV prevention could spur further studies on how this drug can be adopted in Zimbabwe and other countries, experts add.

Accelerating HIV prevention for girls and young women requires an expansion of available choices. I am excited and proud to know that my own country, Zimbabwe, has approved the use of CAB-LA. This will contribute to our basket of HIV prevention tools that work for us as girls and women in Zimbabwe."

Nyasha Sithole, Founder of Development Agenda for Girls and Women in Africa Network, Zimbabwe