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.

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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.

For more information visit janssen.com.

This article originally appeared on MPR