Zimbabwe has made history by becoming the first African country to approve a long-acting drug for HIV prevention.
On Monday, the Medicines Control Authority of Zimbabwe (MCAZ) announced that it had approved the use of long-acting injectable cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV prevention.
According to the World Health Organisation (WHO), CAB-LA injections which are given every two months, are “highly effective in reducing the risk of HIV acquisition among men who have sex with men and transgender women and among cisgender women.”
Zimbabwe is the first country in Africa and the first low- and middle-income country to approve CAB-LA.
Until now, CAB-LA has only received regulatory approval in 2 high-income countries. The US Food and Drug Administration (FDA) was the first to approve CAB-LA for HIV prevention in December 2021.
In August 2022, Australia’s Therapeutic Goods Administration (TGA) was the second national regulatory body to approve CAB-LA.
Two large studies showed that CAB-LA injections every 2 months were safe, well-tolerated, and highly effective in reducing the risk of HIV acquisition among men who have sex with men and transgender women and among cisgender women.
WHO released comprehensive guidelines, calling for countries to consider this effective prevention option, and highlighted the need for implementation science to support its introduction.
CAB-LA is the third PrEP product recommended by WHO for HIV prevention. Tenofovir-based oral PrEP was recommended in 2015 and the dapivirine vaginal ring, another long-acting product, in 2021. The availability of these three products provides increased choices for HIV prevention.
Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, said,
“WHO welcomes the news that Zimbabwe has approved the use of CAB-LA, which will pave the way for its use, providing safer and effective options for HIV prevention.”
Ms Nyasha Sithole, of the Development Agenda for Girls and Women in Africa Network (DAWA), Zimbabwe, said,
“Accelerating HIV prevention for girls and young women requires an expansion of choices available. 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.”