ViiV Healthcare has kicked off a late-stage study testing a long-acting, two-drug regimen of its cabotegravir and Janssen’s rilpivirine in virally suppressed adults with HIV-1 infection.
The Phase III ATLAS-2M study is designed to show non-inferior antiviral activity, at 48 weeks of treatment, of long-acting forms of cabotegravir and rilpivirine, administered every eight weeks, compared four-week administration.
It will also evaluate patient satisfaction and provide comparative data on antiviral activity, pharmacokinetics, safety and tolerability out to 96 weeks, the firm noted.
“We have a patient-centred approach to innovation that seeks to transform how HIV is treated. Our focus on two-drug regimens is key to this strategy,” said John C Pottage, chief scientific and medical Officer at ViiV.
“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.”
A first-look at data from the trial is expected sometime in 2019.
The study follows the Phase III ATLAS (involving virally suppressed patients) and FLAIR (involving treatment-naïve patients) studies, assessing monthly dosing with long-acting cabotegravir and long-acting rilpivirine for the treatment of HIV-1 infection. Results from these trials are expected next year.
A two-drug regimen containing ViiV’s dolutegravir, an integrase strand transfer inhibitor, and Janssen’s rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor, was approved for patients with HIV in the US last week.