ViiV Healthcare is committed to enabling access to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP). We are pleased to have received approval from the Medicines Control Authority of Zimbabwe (MCAZ) for Apretude, cabotegravir LA for HIV PrEP, the first and only long-acting option to reduce the risk of sexually acquired HIV-1.
This milestone marks the first approval of cabotegravir LA for PrEP in a country that took part in the HPTN 084 study, which included participants from across seven countries in sub-Saharan Africa (Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda and Zimbabwe). Regulatory submissions are currently underway in the countries that took part in the HPTN083 and 084 studies. For more information on ongoing submissions around the world, please visit our website.
The approval of cabotegravir LA for PrEP in Zimbabwe is a step forward in delivering on our commitment to enable access to this medicine in countries where the HIV burden and unmet need is highest. Roughly two thirds of all new cases of HIV occur in sub-Saharan Africa, and women and young girls in this region bear a disproportionate burden of the HIV epidemic.
The global regulatory approvals of cabotegravir LA for PrEP are supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV.
We are continuing to work closely with partners to help enable access to this new option for HIV prevention, particularly for areas where the unmet need is the greatest.