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Long-Acting Cabotegravir and Rilpivirine: Every 2 Months,
152 Weeks ATLAS-2M.
Innovation, New Challenges, and Opportunities
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Download the PDF here - Long-Acting Cabotegravir and Rilpivirine: Innovation, New Challenges, and Opportunities
Download the PDF here - Long-Acting Cabotegravir and Rilpivirine Dosed Every 2
Months in Adults With Human Immunodeficiency Virus 1
Type 1 Infection: 152-Week Results From ATLAS-2M, a
Randomized, Open-Label, Phase 3b, Noninferiority Study
Download the PDF - Supplementary data
Clinical Infectious Diseases May 2023
Josep M. Llibre1 and Daniel A. R. Kuritzkes2
1Division of Infectious Diseases, University Hospital Germans Trias, and Fight Infections Foundation, Badalona, Barcelona, Spain; and 2Division of Infectious Diseases, Brigham and Women's
Hospital, Harvard Medical School, Boston, Massachus
Attached are published papers.
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Long-Acting Cabotegravir and Rilpivirine Dosed Every 2 Months in Adults With Human Immunodeficiency Virus 1 Type 1 Infection: 152-Week Results From ATLAS-2M, a Randomized, Open-Label, Phase 3b, Noninferiority Study
Abstract;
Background
Cabotegravir (CAB) + rilpivirine (RPV) dosed intramuscularly monthly or every 2 months is a complete, long-acting (LA) regimen for the maintenance of HIV-1 virologic suppression. Here, we report the antiretroviral therapy as long acting suppression (ATLAS)-2M study week 152 results.
Methods
ATLAS-2M is a phase 3b, randomized, multicenter study assessing the efficacy and safety of CAB+RPV LA every 8 weeks (Q8W) versus every 4 weeks (Q4W). Virologically suppressed (HIV-1 RNA <50 copies/mL) individuals were randomized to receive CAB+RPV LA Q8W or Q4W. Endpoints included the proportion of participants with plasma HIV-1 RNA ≥50 copies/mL and <50 copies/mL, incidence of confirmed virologic failure (CVF; 2 consecutive measurements ≥200 copies/mL), safety, and tolerability.
Results
A total of 1045 participants received CAB+RPV LA (Q8W, n = 522; Q4W, n = 523). CAB+RPV LA Q8W demonstrated noninferior efficacy versus Q4W dosing, with 2.7% (n = 14) and 1.0% (n = 5) of participants having HIV-1 RNA ≥50 copies/mL, respectively, with adjusted treatment difference being 1.7% (95% CI: 0.1-3.3%), meeting the 4% noninferiority threshold. At week 152, 87% of participants maintained HIV-1 RNA <50 copies/mL (Q8W, 87% [n = 456]; Q4W, 86% [n = 449]). Overall, 12 (2.3%) participants in the Q8W arm and 2 (0.4%) in the Q4W arm had CVF. Eight and 10 participants with CVF had treatment-emergent, resistance-associated mutations to RPV and integrase inhibitors, respectively. Safety profiles were comparable, with no new safety signals observed since week 48.
Conclusions
These data demonstrate virologic suppression durability with CAB+RPV LA Q8W or Q4W for ∼3 years and confirm long-term efficacy, safety, and tolerability of CAB+RPV LA as a complete regimen to maintain HIV-1 virologic suppression.
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