Display options
Cite
Tan DHS, Schnubb A, Lawless J, et al. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018;6(4):E611-E617doi: 10.9778/cmajo.20180068.
Tan, D. H. S., Schnubb, A., Lawless, J., Szadkowski, L., Grennan, T., Wilton, J., Fowler, S., Hart, T. A., Maxwell, J., & Raboud, J. M. (2018). Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ open, 6(4), E611-E617. https://doi.org/10.9778/cmajo.20180068
Tan, Darrell H S, et al. "Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study." CMAJ open vol. 6,4 (2018): E611-E617. doi: https://doi.org/10.9778/cmajo.20180068
Tan DHS, Schnubb A, Lawless J, Szadkowski L, Grennan T, Wilton J, Fowler S, Hart TA, Maxwell J, Raboud JM. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018. PMID: 30530721; PMCID: PMC6287974.
Copy Download .nbib Format: NLM
Share it on

CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018.

Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study.

CMAJ open

Darrell H S Tan, Alexandre Schnubb, James Lawless, Leah Szadkowski, Troy Grennan, James Wilton, Shawn Fowler, Trevor A Hart, John Maxwell, Janet M Raboud

Affiliations

  1. Division of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont. [email protected].
  2. Division of Infectious Diseases (Tan, Schnubb, Lawless), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto; Toronto General Hospital Research Institute (Tan, Raboud) and Biostatistics Research Unit (Szadkowski), University Health Network, Toronto, Ont.; British Columbia Centre for Disease Control (Grennan); Division of Infectious Diseases (Grennan), University of British Columbia, Vancouver, BC; Ontario HIV Treatment Network (Wilton); Hassle Free Clinic (Fowler); Department of Psychology (Hart), Ryerson University; Dalla Lana School of Public Health (Hart, Raboud), University of Toronto; AIDS Committee of Toronto (Maxwell), Toronto, Ont.

PMID: 30530721 PMCID: PMC6287974 DOI: 10.9778/cmajo.20180068

Abstract

BACKGROUND: Preexposure prophylaxis is efficacious at preventing HIV infection, but concerns persist about adherence and sexually transmitted infections (STIs). We assessed preexposure prophylaxis acceptability, adherence and clinical outcomes in a pilot demonstration project.

METHODS: HIV-uninfected adult gay and bisexual men who scored 10 or higher on a validated HIV risk score (HIV Incidence Risk Index for MSM) and reported condomless receptive anal sex were sequentially enrolled into a 1-year open-label single-arm pilot study of daily oral therapy with tenofovir disoproxil fumarate/emtricitabine in Toronto. The primary outcome was acceptability of preexposure prophylaxis. Secondary outcomes were preexposure prophylaxis adherence (4-d recall, pill count and dried blood spot analysis), HIV seroconversion, STIs and adverse events.

RESULTS: Of the 86 men screened, 52 were enrolled. Participants were mostly young (median age 33 yr [interquartile range (IQR) 28-37 yr) white (38 [73%]) gay (49 [94%]) men. Preexposure prophylaxis acceptability was high: all participants reported their experience as "good" or "very good." The median adherence rate was high, at 100% (IQR 95%-100%) by self-report and 96.9% (IQR 93.4%-98.4%) by pill count. Dried blood spot analysis suggested that doses were taken 4-7 days/week at 88.7% (173/195) of month 3-12 visits. No cases of HIV seroconversion occurred, but 25 participants (48%) experienced at least 1 bacterial STI, with incidence rates per 100 person-years of 32.8, 32.8, 8.2 and 8.2 for chlamydia, gonorrhea, syphilis and lymphogranuloma venereum, respectively. No adverse events led to discontinuation of prophylaxis, but the estimated glomerular filtration rate declined by 0.22 mL/min per month.

INTERPRETATION: Preexposure prophylaxis was associated with high adherence and acceptability and no HIV infections in this study. Frequent STIs and clinically unapparent toxic renal effects reinforce the need for ongoing vigilance.

TRIAL REGISTRATION: ClinicalTrials. gov, no. NCT02149888.

Copyright 2018, Joule Inc. or its licensors.

Conflict of interest statement

Competing interests: In the past 2 years, Darrell Tan’s institution has received research support for investigator-initiated research studies from Gilead Sciences and ViiV Healthcare, and Darrell Tan

References

  1. AIDS Care. 2000 Jun;12(3):255-66 - PubMed
  2. BMC Med Res Methodol. 2010 Jan 06;10:1 - PubMed
  3. N Engl J Med. 2010 Dec 30;363(27):2587-99 - PubMed
  4. J Pharm Biomed Anal. 2011 Sep 10;56(2):390-401 - PubMed
  5. Int J STD AIDS. 2011 Dec;22(12):738-41 - PubMed
  6. AIDS Behav. 2012 Jul;16(5):1243-59 - PubMed
  7. J Acquir Immune Defic Syndr. 2012 Aug 1;60(4):421-7 - PubMed
  8. N Engl J Med. 2012 Aug 2;367(5):399-410 - PubMed
  9. N Engl J Med. 2012 Aug 2;367(5):423-34 - PubMed
  10. AIDS Res Hum Retroviruses. 2013 Feb;29(2):384-90 - PubMed
  11. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1183-9 - PubMed
  12. Lancet. 2013 Jun 15;381(9883):2083-90 - PubMed
  13. AIDS. 2014 Mar 27;28(6):851-9 - PubMed
  14. J Nephrol. 2014 Dec;27(6):635-41 - PubMed
  15. Clin Infect Dis. 2014 Sep 1;59(5):716-24 - PubMed
  16. Lancet Infect Dis. 2014 Sep;14(9):820-9 - PubMed
  17. PLoS One. 2014 Aug 18;9(8):e105283 - PubMed
  18. JAMA Intern Med. 2015 Feb;175(2):246-54 - PubMed
  19. Int J STD AIDS. 2016 Jul;27(8):608-16 - PubMed
  20. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):19980 - PubMed
  21. J Int AIDS Soc. 2015 Jul 20;18(4 Suppl 3):20222 - PubMed
  22. Top Antivir Med. 2015 May-Jun;23(2):85-90 - PubMed
  23. Lancet. 2016 Jan 2;387(10013):53-60 - PubMed
  24. JAMA Intern Med. 2016 Jan;176(1):75-84 - PubMed
  25. J Acquir Immune Defic Syndr. 2016 Apr 1;71(4):e115-8 - PubMed
  26. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):287-94 - PubMed
  27. J Acquir Immune Defic Syndr. 2016 Apr 1;71(4):374-80 - PubMed
  28. AIDS. 2016 Jul 31;30(12):1973-83 - PubMed
  29. J Int AIDS Soc. 2016 Jun 03;19(1):20777 - PubMed
  30. AIDS. 2016 Sep 10;30(14):2251-2 - PubMed
  31. AIDS Behav. 2018 Apr;22(4):1063-1074 - PubMed
  32. CMAJ. 2017 Nov 27;189(47):E1448-E1458 - PubMed
  33. BMC Public Health. 2018 Feb 27;18(1):292 - PubMed
  34. JAMA. 2018 Mar 27;319(12):1261-1268 - PubMed
  35. J Am Geriatr Soc. 1985 Apr;33(4):278-85 - PubMed

Publication Types