PROGRESS IN OUR HIV PREVENTION COMMITMENTS AS CABOTEGRAVIR LONG-ACTING FOR PREP REGISTRATIONS CONTINUE IN SUB-SAHARAN AFRICA
We are pleased with our progress as registrations for Apretude, the first and only complete long-acting option to reduce the risk of sexually acquired HIV-1, continue in Sub-Saharan Africa. Registrations in South Africa, Zimbabwe, and Malawi mark continued progress in our commitment towards registering cabotegravir LA for PrEP in the seven countries that took part the in the HPTN 084 study. Regulatory submissions are currently under review in the countries that took part in the HPTN083 and 084 studies.
The approval of cabotegravir LA for PrEP in these countries is an important step in delivering on our commitment, with the support of our partners, 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 believe cabotegravir LA for PrEP has the potential to change the shape of the HIV epidemic and we are ambitious for the impact we can have with our partners to bring this medicine to those who need it around the world. For more information on ongoing submissions around the world, please click here.
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If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.
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