ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the start of a phase III study with a two-drug regimen of long-acting, injectable cabotegravir (ViiV Healthcare) and long-acting injectable rilpivirine (Janssen Sciences Ireland UC) in virally suppressed adults with HIV-1 infection.

The ATLAS-2M study is designed to demonstrate the non-inferior antiviral activity, at 48 weeks of treatment, of long-acting cabotegravir and long-acting rilpivirine administered every eight weeks compared with long-acting cabotegravir and long-acting rilpivirine administered every four weeks. ATLAS-2M will also assess patient satisfaction and provide comparative data on antiviral activity, pharmacokinetics, safety and tolerability out to 96 weeks. Initial results from this study are anticipated in 2019.

John C Pottage, Jr, MD, chief scientific and medical officer, ViiV Healthcare said: “We have a patient-centred approach to innovation that seeks to transform how HIV is treated. Our focus on 2-drug regimens is key to this strategy. HIV treatment regimens that do not require daily dosing could be an important part of making HIV feel like a smaller part of patients’ lives and with the ATLAS-2M study, we are evaluating the possibility of maintaining viral suppression with six treatments per year of long-acting cabotegravir and long-acting rilpivirine.”

This study follows the phase III ATLAS (virally suppressed patients) and FLAIR (treatment-naïve patients) studies of monthly dosing with long-acting cabotegravir and long-acting rilpivirine for the treatment of HIV-1 infection. Results from those trials are anticipated in 2018.