Two-drug injection treatment for HIV-1 non-inferior to three-drug regimen, notes study results

The Janssen Pharmaceutical Companies of Johnson & Johnson has reported the positive topline results from the ATLAS Phase III study investigating a novel, long acting injectable two-drug regimen for the treatment of HIV-1.

Meeting its primary endpoint, the study has shown that long-acting rilpivirine (Janssen Sciences Ireland UC) and cabotegravir (ViiV Healthcare) administered as an injection once a month, were similar in efficacy to the standard of care daily, oral three-drug regimen at week 48. Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.

“These results offer new evidence that suggest this investigational, two-drug, once a month dosing regimen may reduce the impact of treatment on people’s lives,” said Dr Wim Parys, head of R&D, Global Public Health, Janssen Pharmaceutica NV. “This novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 days a year to just 12 times per year.”

The ATLAS study, which is being co-funded by Janssen and ViiV Healthcare, was designed to establish whether or not patients with HIV-1 would remain suppressed if switched over to the two-drug long acting regimen from the three-drug oral treatment regimen.

Full results of the study will be presented at an upcoming scientific meeting and topline results from another trial (FLAIR) are expected to be released later on tis year (2018).