NEW YORK (Reuters Health) – Cabotegravir plus rilpivirine given by injection every eight weeks appeared to be a promising new therapeutic option for people living with HIV at the 48-week mark in the ATLAS-2M trial.
The drug, Vocabria, was approved on Tuesday for use in Europe.
The study results are “great news for the field of HIV,” Dr. Edgar Overton of the University of Alabama at Birmingham told Reuters Health by email. “Once approved, we will have an alternative to oral therapy for people living with HIV. I look forward to collaborating on additional studies to expand the use of these long-acting injectable therapies to more patients.”
ATLAS-2M is an ongoing, randomized, multicenter (13 countries), open-label, phase-3b non-inferiority study of cabotegravir plus rilpivirine long-acting maintenance therapy given intramuscularly every eight weeks (cabotegravir 600 mg plus rilpivirine 900 mg) or every four weeks (cabotegravir 400 mg plus rilpivirine 600 mg) to treatment-experienced adults.
The primary endpoint was the proportion of participants with plasma HIV-1 RNA of 50 copies/mL or more.
A total of 1,045 participants (median age, 42; 27% female at birth; 73% white) were randomized to receive therapy every eight or four weeks, including 391 (37%) who transitioned from every four weeks in the phase-3 ATLAS study.
With respect to the primary endpoint, giving the injectable treatment every eight weeks (2%) was non-inferior to dosing every four weeks (1%), with an adjusted treatment difference of 0.8.
Virologic failures, defined as two sequential measures of at least 200 copies/mL, occurred in eight individuals (2%) in the every-eight-weeks group and two (<1%) in the every-four-weeks group, the researchers report in The Lancet.