Janssen Pharmaceutical Companies of Johnson & Johnson has reported topline results from the Antiretroviral Therapy as Long-Acting Suppression (ATLAS) trial.
ATLAS is a Phase lll trial of a two-drug regimen (2DR) of long-acting, injectable rilpivirine and cabotegravir for the treatment of HIV-1.
The trial is designed to evaluate the 2DR once in a month in comparison with a daily oral regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent (standard of care).
The open-label, active-controlled, multicentre, parallel-group, non-inferiority trial enrolled 618 men and women living with HIV-1 at various research centres in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden, and the US.
The primary endpoint of the trial is the proportion of participants with plasma HIV-1 RNA at more than 50 copies per millilitre using the FDA Snapshot algorithm at week 48.
The newly revealed topline results showed similar efficacy between 2DR of long-acting rilpivirine and cabotegravir injected once a month, and the standard of care, oral three-drug regimen against which the 2DR was compared, at week 48 of the trial.
In addition, the injectable treatment regimen met the trial’s primary endpoint.
Overall safety, virologic response and drug resistance results of the injectable regimen were also reported to be consistent with results from the Phase II LATTE and LATTE-2 trials.
Janssen Pharmaceutica Global Public Health research and development head Wim Parys said: “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.
“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.”
Rilpivirine, which is currently under development by Janssen Sciences Ireland UC, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV in combination with other antiretrovirals.
Cabotegravir, which is yet to be approved by any regulatory authorities in the world, is an investigational integrase inhibitor (INI) being currently developed by ViiV Healthcare for the treatment and prevention of HIV.