ViiV Healthcare has initiated a Phase III study exploring the efficacy of long-acting cabotegravir for the prevention of HIV infection in sexually active women.
The HPTN 084 study will assess injections of the drug - an investigational integrase strand transfer inhibitor not yet approved anywhere in the world - given every two months compared with daily oral pre-exposure prophylaxis (PrEP) with Gilead’s Truvada (emtricitabine/tenofovir disoproxil).
Around 3,200 women aged 18 to 45 years from sub-Saharan African countries will be enrolled in the trial, which is being conducted through a public private funding collaboration composed of ViiV Healthcare, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Bill & Melinda Gates Foundation.
NIAID is sponsoring the study, while study medications are being provided by Gilead and ViiV.
“In sub-Saharan Africa, women account for more than half of all new HIV infections in adults and there is clearly a public health need for prevention strategies that empower women to protect themselves from HIV,” said John Pottage, ViiV’s chief scientific and medical officer.
“ViiV Healthcare is committed to the inclusion of women in our efforts to develop innovative therapeutic options for the treatment and prevention of HIV and this study start is an important step in that direction.”
ViiV is majority owned by GSK, with Pfizer and Shionogi as shareholders.