The HPTN 084 study will evaluate injections given every two months.
London, UK 30 November 2017 – Today, ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the start of HPTN 084,1 a phase III study to evaluate long-acting cabotegravir for the prevention of HIV infection in sexually active women. 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 enroll 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.2 In addition, long-acting, injectable contraceptives have been available as an option for women seeking to manage family planning since the early 1990s.3 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.
In December 2016, ViiV Healthcare announced the start of a complementary study (HPTN 083) in HIV-uninfected men and transgender women who have sex with men — also sponsored by NIAID and funded through a public‑private collaboration with NIAID and ViiV Healthcare.
1. Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at: https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed: November 2017
2. Miyamoto S et al. The Use of Long-Acting Injectable Antipsychotics in Schizophrenia. Current Treat Options Psychiatry. 2017; 4(2): 117–126.
3. Green W et al. The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis. Food Drug Law Journal. 2013; 68(2):115-35.