ViiV Healthcare announces start of phase III study of long-acting cabotegravir for HIV prevention in women

Issued: London, UK

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 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 [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.
Notes to editors

About PrEP
HIV pre-exposure prophylaxis or PrEP refers to use of anti-retroviral medication in uninfected people to prevent HIV infection.

About cabotegravir
Cabotegravir is an investigational integrase strand transfer inhibitor (INSTI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting formulation for intramuscular injection (with a once-daily oral tablet used to establish safety and tolerability in individuals prior to long-acting injection).

About HPTN 084 (NCT03164564)
HPTN 084 [1] is a study to evaluate the safety and efficacy of the injectable antiretroviral, cabotegravir compared with daily oral emtricitabine/ tenofovir disoproxil fumarate, for PrEP in HIV-uninfected, sexually active, sub-Saharan African women.

The primary objectives are incidence of HIV infection in participants randomised to injectable cabotegravir compared with participants randomised to daily oral emtricitabine/ tenofovir disoproxil fumarate and safety of both regimens. Additional endpoints include characterisation of any HIV drug-resistance development, acceptability of and preference for each regimen and resource utilisation. Final data collection date for primary outcome measure is estimated for May 2022.

About HPTN 083 (NCT 02720094) [4]
This is an ongoing safety and efficacy study of injectable cabotegravir compared with daily oral emtricitabine/ tenofovir disoproxil fumarate for PrEP in HIV-uninfected cisgender men and transgender women who have sex with men. The primary objectives are incidence of HIV infection in participants randomised to injectable cabotegravir compared with participants randomised to daily oral emtricitabine/ tenofovir disoproxil fumarate and safety of both regimens. Additional endpoints include characterisation of any HIV drug-resistance development, acceptability of and preference for each regimen and resource utilisation. Final data collection date for primary outcome measure is estimated for September 2021.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

About GSK
GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

[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

[4] Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. Available at: https://clinicaltrials.gov/ct2/show/NCT02720094?term=NCT02720094&rank=1 Last accessed November 2017