ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the start of a phase III study to evaluate long-acting injectable cabotegravir for the prevention of HIV infection. The study will evaluate injections of cabotegravir given every two months compared to daily oral Pre-Exposure Prophylaxis (PrEP) with Truvada® and is being conducted through a public-private collaboration of ViiV Healthcare, the HIV Prevention Trials Network (HPTN), the US National Institute of Allergy and Infectious Disease (NIAID) and Gilead Sciences.
The global phase III study called HPTN 083 will seek to enrol 4,500 men who have sex with men, and transgender women who have sex with men, at more than 40 sites in North and South America, Asia and Africa.
Participants will be aged 18 years or older and at high risk for HIV infection.
A second phase III study, to evaluate long-acting cabotegravir for the prevention of HIV infection in young women, is anticipated to start in 2017.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “Twenty years ago we couldn’t have imagined a future with so many effective medicines to treat HIV. However, there remains a need to provide more options for preventing HIV infection, such as long-acting regimens that don’t require daily dosing. ViiV Healthcare is committed to studying new prevention options and through our public-private collaboration on this large phase III study, we will evaluate whether long-acting injectable cabotegravir could be an option in the pre-exposure prophylaxis setting.”
In 2014, UNAIDS set forth ambitious goals with the aim towards ending the AIDS epidemic by 2030. An important element of the strategy to end the epidemic is to reduce HIV transmission rates. Antiretroviral therapy has been shown to be effective in preventing HIV transmission, however, adherence to daily oral therapy varies among different populations. Because adherence to prevention regimens has been correlated with efficacy in preventing HIV infection, it is important to continue to evaluate options that may facilitate adherence, including regimens that do not require daily dosing.
ViiV Healthcare is collaborating on the clinical trial of injectable cabotegravir with NIAID, the NIH-funded HIV Prevention Trials Network (HPTN) and Gilead Sciences. NIAID is sponsoring the trial and HPTN is conducting the study. ViiV Healthcare and NIAID are providing financial support and ViiV Healthcare and Gilead Sciences are providing the study medications.
Truvada is a registered trademark of Gilead Sciences, Inc.