ViiV Healthcare and Janssen have unveiled positive headline data from a late-stage trial of their injectable two-drug regimen for the treatment of HIV.

The Phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) study was designed to determine whether HIV-1-infected adults who had maintained viral suppression for at least six months, on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression when switched to a long-acting, injectable regimen of ViiV’s cabotegravir and Janssen’s rilpivirine.

Top-line results show that the two-drug regimen, injected once a month, had similar efficacy to a standard of care, daily, oral three-drug regimen at Week 48, meeting the primary endpoint for non-inferiority, ViiV said.

Also of note, overall safety, virologic response and drug resistance results for the injectable regimen were consistent with earlier trial results, the company revealed.

“This novel approach is another step towards potentially reducing the treatment burden for people living with HIV,” said John Pottage, chief scientific and medical officer of ViiV Healthcare, which is majority owned by GSK.

“If approved, this regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12.”

Detailed results from the study are to be presented at an upcoming scientific meeting, while headline data from FLAIR, a second pivotal trial evaluating a long-acting, injectable regimen of cabotegravir and rilpivirine in treatment-naïve individuals, are expected later this year.