Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment

Susan Swindells, Thomas Lutz, Lelanie Van Zyl, Norma Porteiro, Matthias Stoll, Essack Mitha, Alyssa Shon, Paul Benn, Jenny O. Huang, Conn M. Harrington, Kai Hove, Susan L. Ford, Christine L. Talarico, Vasiliki Chounta, Herta Crauwels, Rodica Van Solingen-Ristea, Simon Vanveggel, David A. Margolis, Kimberly Y. Smith, Kati VandermeulenWilliam R. Spreen

Research output: Contribution to journalArticlepeer-review

33 Scopus citations


Background: ATLAS (NCT02951052), a phase 3, multicenter, open-label study, demonstrated that switching to injectable cabotegravir (CAB) with rilpivirine (RPV) longacting dosed every 4weeks was noninferior at week (W) 48 to continuing three-drug daily oral current antiretroviral therapy (CAR). Results from the W 96 analysis are presented. Methods and design: Participants completing W 52 of ATLAS were given the option to withdraw, transition toATLAS-2M(NCT03299049), or enter an Extension Phase to continue long-acting therapy (Long-acting arm) or switch from CAR to long-acting therapy (Switch arm). Endpoints assessed atW96 included proportion of participants with plasma HIV- 1 RNA less than 50 copies/ml, incidence of confirmed virologic failure (CVF; two consecutive HIV-1 RNA ≥200 copies/ml), safety and tolerability, pharmacokinetics, and patient-reported outcomes. Results: Most participants completing the Maintenance Phase transitioned to ATLAS-2M (88%, n=502/572). Overall, 52 participants were included in the W 96 analysis of ATLAS; of these, 100% (n=23/23) and 97% (n=28/29) in the Long-acting and Switch armshad plasmaHIV-1RNAless than50 copies/mlatW96, respectively.One participant had plasma HIV-1 RNA 50 copies/ml or higher in the Switch arm (173 copies/ml). No participantsmet the CVF criterion during the Extension Phase.No newsafety signals were identified. All Switch arm participants surveyed preferred long-acting therapy to their previous daily oral regimen (100%, n=27/27). Conclusion: In this subgroup of ATLAS, 98% (n=51/52) of participants at the Extension PhaseW96 analysis maintained virologic suppression with long-acting therapy. Safety, efficacy, and participant preference results support the therapeutic potential of longacting CAB RPV treatment for virologically suppressed people living with HIV-1.

Original languageEnglish (US)
Pages (from-to)185-194
Number of pages10
Issue number2
StatePublished - Feb 1 2022


  • Antiretroviral therapy
  • Cabotegravir
  • HIV-1
  • Long-acting
  • Rilpivirine

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases


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