Cabotegravir for HIV prevention in cisgender men and transgender women

Background: Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. Methods: We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. Results: The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. Conclusions: CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure.



Work Title Cabotegravir for HIV prevention in cisgender men and transgender women
Open Access
  1. R. J. Landovitz
  2. D. Donnell
  3. M. E. Clement
  4. B. Hanscom
  5. L. Cottle
  6. L. Coelho
  7. R. Cabello
  8. S. Chariyalertsak
  9. E. F. Dunne
  10. I. Frank
  11. J. A. Gallardo-Cartagena
  12. A. H. Gaur
  13. P. Gonzales
  14. H. V. Tran
  15. J. C. Hinojosa
  16. E. G. Kallas
  17. C. F. Kelley
  18. M. H. Losso
  19. J. V. Madruga
  20. K. Middelkoop
  21. N. Phanuphak
  22. B. Santos
  23. O. Sued
  24. J. Valencia Huamani
  25. E. T. Overton
  26. S. Swaminathan
  27. C. Del Rio
  28. R. M. Gulick
  29. P. Richardson
  30. P. Sullivan
  31. E. Piwowar-Manning
  32. M. Marzinke
  33. C. Hendrix
  34. M. Li
  35. Z. Wang
  36. J. Marrazzo
  37. E. Daar
  38. A. Asmelash
  39. T. T. Brown
  40. P. Anderson
  41. S. H. Eshleman
  42. M. Bryan
  43. C. Blanchette
  44. J. Lucas
  45. C. Psaros
  46. S. Safren
  47. J. Sugarman
  48. H. Scott
  49. J. J. Eron
  50. S. D. Fields
License In Copyright (Rights Reserved)
Work Type Article
  1. New England Journal of Medicine
Publication Date August 12, 2021
Publisher Identifier (DOI)
Deposited November 17, 2021




This resource is currently not in any collection.

Work History

Version 1

  • Created
  • Added HPTN_083_Main_Article_nejmoa2101016.pdf
  • Added Creator R. J. Landovitz
  • Added Creator D. Donnell
  • Added Creator M. E. Clement
  • Added Creator B. Hanscom
  • Added Creator L. Cottle
  • Added Creator L. Coelho
  • Added Creator R. Cabello
  • Added Creator S. Chariyalertsak
  • Added Creator E. F. Dunne
  • Added Creator I. Frank
  • Added Creator J. A. Gallardo-Cartagena
  • Added Creator A. H. Gaur
  • Added Creator P. Gonzales
  • Added Creator H. V. Tran
  • Added Creator J. C. Hinojosa
  • Added Creator E. G. Kallas
  • Added Creator C. F. Kelley
  • Added Creator M. H. Losso
  • Added Creator J. V. Madruga
  • Added Creator K. Middelkoop
  • Added Creator N. Phanuphak
  • Added Creator B. Santos
  • Added Creator O. Sued
  • Added Creator J. Valencia Huamani
  • Added Creator E. T. Overton
  • Added Creator S. Swaminathan
  • Added Creator C. Del Rio
  • Added Creator R. M. Gulick
  • Added Creator P. Richardson
  • Added Creator P. Sullivan
  • Added Creator E. Piwowar-Manning
  • Added Creator M. Marzinke
  • Added Creator C. Hendrix
  • Added Creator M. Li
  • Added Creator Z. Wang
  • Added Creator J. Marrazzo
  • Added Creator E. Daar
  • Added Creator A. Asmelash
  • Added Creator T. T. Brown
  • Added Creator P. Anderson
  • Added Creator S. H. Eshleman
  • Added Creator M. Bryan
  • Added Creator C. Blanchette
  • Added Creator J. Lucas
  • Added Creator C. Psaros
  • Added Creator S. Safren
  • Added Creator J. Sugarman
  • Added Creator H. Scott
  • Added Creator J. J. Eron
  • Added Creator S. D. Fields
  • Published
  • Updated
  • Updated