Janssen announced positive top-line results from the phase 3 ATLAS-2M study evaluating the two-drug long-acting injectable regimen of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) administered every 2 months in patients with HIV-1 infection.
ATLAS-2M was a phase 3, randomized, open-label, multicenter, parallel-group, noninferiority study that evaluated the efficacy and safety of rilpivirine + cabotegravir administered intramuscularly every 2 months compared to a monthly regimen in adults with HIV-1 infection for 48 weeks (N=1045). The primary end point was the proportion of patients with plasma HIV-RNA ≥50 copies per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population).
Results demonstrated rilpivirine + cabotegravir every 2 months was as effective in maintaining viral suppression compared with the monthly dosing regimen; overall safety, virologic response, and drug resistance were also consistent with results from the phase 3 ATLAS study. Full detailed data from the ATLAS-2M study will be presented at an upcoming scientific meeting.
The New Drug Application (NDA) for the long-acting injectable formulation was submitted to the Food and Drug Administration in April 2019. Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently approved in an oral formulation to treat HIV-1 in combination with other antiretrovirals, while cabotegravir is an investigational integrase inhibitor. In addition to the NDA for the injectable formulation, a second NDA for an oral form of cabotegravir has also been submitted for review for treatment in combination with oral rilpivirine.
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