ViiV Healthcare on Thursday announced the start of HPTN 084,a phase III study to evaluate long-acting cabotegravir for the prevention of HIV infection in sexually active women.
ViiV is the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders,
The study will evaluate injections of cabotegravir given every two months compared with daily oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate.
The study seeks to enrol 3,200 women aged 18 to 45 years from sub-Saharan African countries and 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. The study is sponsored by NIAID, and study medications are being provided by Gilead Sciences, Inc. and ViiV Healthcare.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare said: “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. 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.”
Since the 1960s, physicians have had long-acting, injectable medicines to aid in patient adherence to treatment for chronic illnesses. In addition, long-acting, injectable contraceptives have been available as an option for women seeking to manage family planning since the early 1990s. Similar to the varying needs of contraceptive options for family planning, women seeking PrEP may have privacy and convenience considerations that might make long-acting, injectable PrEP a desirable option.
Image: A red ribbon is put on the sleeves of a man by his friend to show support for people living with HIV during a program to raise awareness about AIDS on World AIDS Day in Kathmandu December 1, 2013. World AIDS Day is observed annually on December 1. According to the Government of Nepal, Ministry of Health and Population, National Center for AIDS and STD Control, the estimated number of people living with HIV is around 48,600 in Nepal. REUTERS/Navesh Chitrakar (NEPAL – Tags: HEALTH SOCIETY) – RTX15ZGI