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

Edgar T. Overton, Gary Richmond, Giuliano Rizzardini, Anders Thalme, Pierre Marie Girard, Alexander Wong, Norma Porteiro, Susan Swindells, Jacques Reynes, Sebastian Noe, Conn Harrington, Carlos Martín Español, Carolina Acuipil, Asma Aksar, Yuanyuan Wang, Susan L. Ford, Herta Crauwels, Veerle van Eygen, Rodica Van Solingen-Ristea, Christine L. LathamShanker Thiagarajah, Ronald D’Amico, Kimberly Y. Smith, Kati Vandermeulen, William R. Spreen

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

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 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.

Original languageEnglish (US)
Pages (from-to)1646-1654
Number of pages9
JournalClinical Infectious Diseases
Volume76
Issue number9
DOIs
StatePublished - May 1 2023

Keywords

  • HIV-1
  • antiretroviral therapy
  • cabotegravir
  • long-acting
  • rilpivirine

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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