ATLAS-2M trial: similar efficacy of Cabotegravir and Rilpivirine administered every eight weeks compared to four-week administration
Positive results from global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen ( 2DR ) of Cabotegravir and Rilpivirine for the treatment of HIV were announced.
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 or equal to 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.
The ATLAS-2M study has demonstrated that it is possible to maintain suppression of the HIV virus with an injectable regimen containing two drugs administered every two months.
Results mean that people living with HIV could maintain viral suppression with six total treatments per year, instead of a daily oral treatment 365 times per year.
The ATLAS-2M study is a randomised, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the non-inferior antiviral activity and safety of long-acting Cabotegravir and Rilpivirine administered every eight weeks compared to long-acting Cabotegravir and Rilpivirine administered every four weeks over a 48-week treatment period in 1,045 adults living with HIV-1.
Subjects were required to be virally-suppressed for six months or greater, on first or second regimen, with no prior failure.
The primary outcome measure for the study is the proportion of participants with HIV-RNA greater than or equal to 50 c/mL at week 48 using the FDA Snapshot algorithm. ( Xagena )
Source: ViiV Healthcare, 2019