Viiv HealthCare initiates Phase III HPTN 083 study of cabotegravir versus Truvadafor Pre-Exposure Prophylaxis (PrEP)to prevent HIV infection.

ViiV Healthcare 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.

This is a non-inferiority, double blind, double dummy, safety and efficacy study of injectable cabotegravir compared to daily oral tenofovir disoproxil fumarate/emtricitabine (Truvada ), for pre-exposure prophylaxis 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 to participants randomised to daily oral tenofovir disoproxil fumarate/emtricitabine and safety of both regimens. Additional endpoints include HIV drug resistance, acceptability of and preference for each regimen and resource utilisation. Primary outcome data are anticipated for 2020.