Display options
Cite
Swindells S, Lutz T, Van Zyl L, et al. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022;36(2):185-194doi: 10.1097/QAD.0000000000003025.
Swindells, S., Lutz, T., Van Zyl, L., Porteiro, N., Stoll, M., Mitha, E., Shon, A., Benn, P., Huang, J. O., Harrington, C. M., Hove, K., Ford, S. L., Talarico, C. L., Chounta, V., Crauwels, H., Van Solingen-Ristea, R., Vanveggel, S., Margolis, D. A., Smith, K. Y., Vandermeulen, K., & Spreen, W. R. (2022). Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS (London, England), 36(2), 185-194. https://doi.org/10.1097/QAD.0000000000003025
Swindells, Susan, et al. "Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment." AIDS (London, England) vol. 36,2 (2022): 185-194. doi: https://doi.org/10.1097/QAD.0000000000003025
Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 01;36(2):185-194. doi: 10.1097/QAD.0000000000003025. PMID: 34261093; PMCID: PMC8711605.
Copy Download .nbib Format: NLM
Share it on

AIDS. 2022 Feb 01;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

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

AIDS (London, England)

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 Vandermeulen, William R Spreen

Affiliations

  1. University of Nebraska Medical Center, Omaha, Nebraska, USA.
  2. Infektiologikum, Frankfurt, Germany.
  3. The Aurum Institute, Pretoria, South Africa.
  4. Fundación IDEAA, Buenos Aires, Argentina.
  5. Hannover Medical School (MHH), Hannover, Germany.
  6. Newtown Clinical Research Centre, Johannesburg, South Africa.
  7. University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
  8. ViiV Healthcare, Brentford, UK.
  9. GlaxoSmithKline, Mississauga, Ontario, Canada.
  10. ViiV Healthcare, Research Triangle Park, North Carolina, USA.
  11. GlaxoSmithKline, London, UK.
  12. GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
  13. Janssen Research & Development, Beerse, Belgium.
  14. Brii Biosciences, Durham, North Carolina, USA.

PMID: 34261093 PMCID: PMC8711605 DOI: 10.1097/QAD.0000000000003025

Abstract

BACKGROUND: ATLAS (NCT02951052), a phase 3, multicenter, open-label study, demonstrated that switching to injectable cabotegravir (CAB) with rilpivirine (RPV) long-acting dosed every 4 weeks 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 to ATLAS-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 at W 96 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 arms had plasma HIV-1 RNA less than 50 copies/ml at W 96, respectively. One participant had plasma HIV-1 RNA 50 copies/ml or higher in the Switch arm (173 copies/ml). No participants met the CVF criterion during the Extension Phase. No new safety 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 Phase W 96 analysis maintained virologic suppression with long-acting therapy. Safety, efficacy, and participant preference results support the therapeutic potential of long-acting CAB+RPV treatment for virologically suppressed people living with HIV-1.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

References

  1. N Engl J Med. 2020 Mar 19;382(12):1112-1123 - PubMed
  2. J Infect Dis. 2011 Sep 1;204(5):669-74 - PubMed
  3. Lancet. 2019 Jan 12;393(10167):143-155 - PubMed
  4. Curr Opin HIV AIDS. 2020 Jan;15(1):13-18 - PubMed
  5. PLoS One. 2020 Jun 12;15(6):e0234666 - PubMed
  6. Lancet. 2021 Dec 19;396(10267):1994-2005 - PubMed
  7. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):263-270 - PubMed
  8. J Acquir Immune Defic Syndr. 2019 Feb 1;80(2):190-197 - PubMed
  9. Nanomedicine (Lond). 2013 Nov;8(11):1807-13 - PubMed
  10. PLoS One. 2018 Jan 5;13(1):e0190487 - PubMed
  11. AIDS Care. 2021 Jun;33(6):801-809 - PubMed
  12. J Acquir Immune Defic Syndr. 2020 Dec 1;85(4):498-506 - PubMed
  13. N Engl J Med. 2020 Mar 19;382(12):1124-1135 - PubMed
  14. PLoS Med. 2016 Nov 29;13(11):e1002183 - PubMed
  15. Br J Clin Pharmacol. 2015 Feb;79(2):182-94 - PubMed
  16. Lancet. 2017 Sep 23;390(10101):1499-1510 - PubMed
  17. AIDS. 2021 Jul 15;35(9):1333-1342 - PubMed
  18. JAMA. 2013 Nov 27;310(20):2191-4 - PubMed
  19. Lancet HIV. 2021 Apr;8(4):e185-e196 - PubMed
  20. Lancet. 2018 Mar 3;391(10123):839-849 - PubMed

Publication Types