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. 2019 Apr 9;321(14):1380-1390.
doi: 10.1001/jama.2019.2947.

Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection

Michael W Traeger  1 , Vincent J Cornelisse  2   3   4   5 , Jason Asselin  1 , Brian Price  2 , Norman J Roth  4 , Jeff Willcox  6 , Ban Kiem Tee  7 , Christopher K Fairley  3   5 , Christina C Chang  2   5 , Jude Armishaw  2 , Olga Vujovic  2 , Matthew Penn  8 , Pauline Cundill  8 , George Forgan-Smith  9 , John Gall  9 , Claire Pickett  10 , Luxi Lal  1   2 , Anne Mak  2 , Tim D Spelman  1   11   12 , Long Nguyen  1 , Dean A Murphy  13   14 , Kathleen E Ryan  1   2 , Carol El-Hayek  1 , Michael West  15 , Simon Ruth  16 , Colin Batrouney  16 , John T Lockwood  2 , Jennifer F Hoy  2 , Margaret E Hellard  1   2   11 , Mark A Stoové  1   11 , Edwina J Wright  1   2   12 ; PrEPX Study Team
Affiliations

Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection

Michael W Traeger et al. JAMA. .

Abstract

Importance: Emerging evidence suggests that risk of bacterial sexually transmitted infections (STIs) increases among gay and bisexual men following initiation of HIV preexposure prophylaxis (PrEP).

Objective: To describe STI incidence and behavioral risk factors among a cohort of predominantly gay and bisexual men who use PrEP, and to explore changes in STI incidence following PrEP commencement.

Design, setting, and participants: The Pre-exposure Prophylaxis Expanded (PrEPX) Study, a multisite, open-label intervention study, was nested within the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance (ACCESS) clinic network. A total of 4275 participants were enrolled (July 26, 2016-April 1, 2018) in Victoria, Australia. Of these, 2981 enrolled at 5 ACCESS clinics (3 primary care, 1 sexual health, and 1 community-based HIV rapid testing service), had at least 1 follow-up visit, and were monitored until April 30, 2018.

Exposures: Upon enrollment, participants received daily oral tenofovir disoproxil fumurate and emtricitabine for HIV PrEP, quarterly HIV and STI testing, and clinical monitoring.

Main outcomes and measures: The primary outcome was incidence of chlamydia, gonorrhea, or syphilis. Incidence rates and hazard ratios describing behavioral risk factors of STI diagnosis were calculated. Incidence rate ratios (IRRs), adjusted for change in testing frequency, described changes in STI incidence from 1-year preenrollment to study follow-up among participants with preenrollment testing data (n = 1378).

Results: Among the 2981 individuals (median age, 34 years [interquartile range, 28-42]), 98.5% identified as gay or bisexual males, 29% used PrEP prior to enrollment, 89 (3%) withdrew and were censored at date of withdrawal, leaving 2892 (97.0%) enrolled at final follow-up. During a mean follow-up of 1.1 years (3185.0 person-years), 2928 STIs were diagnosed among 1427 (48%) participants (1434 chlamydia, 1242 gonorrhea, 252 syphilis). STI incidence was 91.9 per 100 person-years, with 736 participants (25%) accounting for 2237 (76%) of all STIs. Among 2058 participants with complete data for multivariable analysis, younger age, greater partner number, and group sex were associated with greater STI risk, but condom use was not. Among 1378 participants with preenrollment testing data, STI incidence increased from 69.5 per 100 person-years prior to enrollment to 98.4 per 100 person-years during follow-up (IRR, 1.41 [95% CI, 1.29-1.56]). After adjusting for testing frequency, the increase in incidence from 1 year preenrollment to follow-up was significant for any STI (adjusted IRR, 1.12 [95% CI, 1.02-1.23]) and for chlamydia (adjusted IRR, 1.17 [95% CI, 1.04-1.33]).

Conclusions and relevance: Among gay and bisexual men using PrEP, STIs were highly concentrated among a subset, and receipt of PrEP after study enrollment was associated with an increased incidence of STIs compared with preenrollment. These findings highlight the importance of frequent STI testing among gay and bisexual men using PrEP.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Cornelisse reports receipt of speaker’s fees and conference assistance from Gilead Sciences, speaker’s fees and conference assistance from Merck Sharp & Dohme, and advisory board fees from ViiV Healthcare outside the submitted work. Dr Stoové reports receipt of grants from the Commonwealth Department of Health and the National Health and Medical Research Council during the conduct of the study. Mr Asselin reports receipt of grants from the Australian Department of Health and the Victorian Department of Health and Human Services during the conduct of the study. Mr Price reports receipt of grants from the Department of Health Victorian government, Thorne Harbour Health, and Alfred Health during the conduct of the study. Dr Fairley reports receipt of grants from the Department of Health and Human Services during the conduct of the study. Dr Chang reports receipt of grants from the Australian National Health and Medical Research Council during the conduct of the study. Dr Vujovic reports receipt of nonfinancial support from Alfred Health and Thorne Harbour Health; and grants from the Department of Health Victorian government during the conduct of the study. Dr Ryan reports receipt of grants from Alfred Health, the Victorian government, and Thorne Harbour Health during the conduct of the study. Ms El-Hayek reports receipt of grants from the Australian Department of Health during the conduct of the study. Mr West reports receipt of grants from Victorian Department of Health and Human Services during the conduct of the study. Mr Lockwood reports receipt of grants from the Victorian government and Thorne Harbour Health during the conduct of the study. Dr Hoy reports receipt of grants from the Victorian government during the conduct of the study. Dr Hellard reports receipt of grants from Gilead, AbbVie, and Bristol-Myers Squibb during the conduct of the study. Dr Wright reports receipt of grants from the Victorian government, the Tasmanian government, Thorne Harbour Health, and the South Australian government during the conduct of the study; other from Gilead Sciences (free study drug, compensation to her institution for chairing a nursing education session and for attending an advisory board meeting, and uncompensated attendance for attending 2 Gilead meetings regarding listing of Truvada on the Australian pharmaceutical benefits scheme); grants from Gilead Science and Merck Sharp & Dohme outside the submitted work; and financial support from Gilead Sciences, Abbott Laboratories, Janssen-Cilag, Boehringer Ingelheim, ViiV Healthcare, and Merck Sharp & Dohme. No other disclosures were reported.

Figures

Figure.
Figure.. Distribution of Participants and STI Diagnoses by Number of Infections per Participant During Follow-up
See eTable 3 for corresponding data.
See this image and copyright information in PMC

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