ATLAS-2M study met its primary endpoint for cabotegravir and rilpivirine administered every eight weeks compared to four-week administration

ViiV Healthcare, announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR) of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV. The study was designed to demonstrate the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (two months) compared to every four weeks (monthly) over a 48-week treatment period in adults living with HIV-1 infection whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.

The study met its primary endpoint, showing that the long-acting regimen of cabotegravir and rilpivirine, injected every two months, was non-inferior to cabotegravir and rilpivirine administered every month at Week 48. Non-inferiority was assessed by comparison of the proportions of participants with plasma HIV-RNA greater than 50 copies per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population). Overall safety, virologic response and drug resistance results for the every-two-months injectable regimen were consistent with results from the phase III ATLAS study.

This investigational, long-acting, injectable regimen is being co-developed as a collaboration with Janssen Sciences Ireland UC and has been submitted to regulatory authorities in the United States, Canada and Europe. A Priority Review Designation for the once-monthly injectable regimen was granted by the FDA with an expected action date of December 29, 2019.