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Background: Changes in condom use and serosorting associated with HIV PrEP and treatment as prevention may be driving syphilis transmission in gay and bisexual men (GBM). We describe trends in syphilis testing and incidence among a large, national, retrospective cohort of GBM in Australia over a decade spanning PrEP implementation. Methods: Data were extracted from 55 sentinel clinics participating in the ACCESS project. GBM with ≥2 visits and ≥2 syphilis tests from Jan2012-Dec2021 were included in testing and incidence analyses, respectively. Annual rates of syphilis testing and diagnosis (primary, secondary, early-latent) per 100 person-years (py) were calculated disaggregated by HIV status and PrEP use (evidence of PrEP prescription; dichotomised as ever-PrEP vs never- PrEP). Poisson regression tested for trends from 2012-2021. Among those diagnosed with syphilis, rate of syphilis reinfection was calculated. Multivariable Cox regression explored risk factors for syphilis between 2016 (post-PrEP availability) to 2019 (pre-COVID). Results: 135,443 GBM (mean age=35.9 years; 7.8% with HIV; 31.0% ever-PrEP-users) had ≥2 visits and 93,918 GBM had ≥2 syphilis tests. There were 653,438 syphilis tests (median days between tests=119) over 610,996 person-years (testing rate=107.0/100py); testing was highest among GBM with HIV (152.2/100py). Between 2012-2021, testing increased from 68.3/100py to 132.7/100py (p< 0.001), mostly driven by increases among ever-PrEPusers [Figure]. There were 13,662 syphilis infections diagnosed in 9,546 (10.2%) GBM over 399,399 person-years (incidence rate=3.4/100py). Syphilis incidence was highest among GBM with HIV (6.7/100py), followed by ever-PrEP-users (3.7/100py) and never-PrEP-users (1.6/100py). Between 2012-2021, syphilis incidence increased among ever-PrEP-users from 1.4/100py to 5.0/100py (p< 0.001) and fluctuated between 5.8/100py and 7.4/100py among GBM with HIV. Rate of syphilis reinfection was 12.5/100py, and similar across groups. Ever previously diagnosed with syphilis (adjusted Hazard Ratio [HR]=2.63, 95%CI=2.45-2.82) was the strongest predictor of syphilis incidence, followed by recent (< 12m) syphilis diagnosis (aHR=2.04, 95%CI=1.89-2.20), living with HIV (aHR=2.07, 95%CI=1.94-2.23) and recently (< 12m) prescribed PrEP (aHR=1.91, 95%CI=1.77-2.06). Conclusions: Syphilis trends between GBM with HIV and GBM with evidence of PrEP use have been converging over the past decade. Previous syphilis infection was the strongest predictor of subsequent infection, highlighting the importance of including prior diagnosis as an indication for new targeted strategies (e.g., doxy-PEP). [ABSTRACT FROM AUTHOR]

Background Gay and bisexual men (GBM) are a key population affected by human immunodeficiency virus (HIV) and hepatitis C virus (HCV) coinfection. We aimed to measure HCV treatment effectiveness and to determine the population impact of treatment scale-up on HCV prevalence and incidence longitudinally among GBM. Methods The co-EC Study (Enhancing Care and Treatment Among HCV/HIV Coinfected Individuals to Eliminate Hepatitis C Transmission) was an implementation trial providing HCV direct-acting antiviral treatment in Melbourne, Australia, during 2016–2018. Individuals with HCV/HIV coinfection were prospectively enrolled from primary and tertiary care services. HCV viremic prevalence and HCV antibody/viremic incidence were measured using a statewide, linked, surveillance system. Results Among 200 participants recruited, 186 initiated treatment during the study period. Sustained virological response in primary care (98% [95% confidence interval {CI}, 93%–100%]) was not different to tertiary care (98% [95% CI, 86%–100%]). From 2012 to 2019, between 2434 and 3476 GBM with HIV infection attended our primary care sites annually, providing 13 801 person-years of follow-up; 50%–60% received an HCV test annually, and 10%–14% were anti-HCV positive. Among those anti-HCV positive, viremic prevalence declined 83% during the study (54% in 2016 to 9% in 2019). HCV incidence decreased 25% annually from 1.7/100 person-years in 2012 to 0.5/100 person-years in 2019 (incidence rate ratio, 0.75 [95% CI,.68–.83]; P  < .001). Conclusions High treatment effectiveness by nonspecialists demonstrates the feasibility of treatment scale-up in this population. Substantial declines in HCV incidence and prevalence among GBM provides proof-of-concept for HCV microelimination. Clinical Trials Registration NCT02786758. [ABSTRACT FROM AUTHOR]

Background: PrEPX was an Australian HIV pre-exposure prophylaxis (PrEP) study conducted between 2016 and 2018. This analysis aimed to estimate hepatitis C (HCV) incidence and explore likely modes of transmission. Setting: Cohort study of PrEP users in Victoria, Australia. Methods: HCV tests were conducted at enrollment and every 12 months thereafter. HCV incident cases were identified from laboratory data. Likely modes of transmission were inferred from computer-assisted self-interviews, medical records, and interviews. Results: Among 3202 PrEPX participants tested for HCV at baseline, HCV RNA-positive prevalence was 0.22% (95% confidence interval: 0.09 to 0.45). Among participants testing HCV antibody-negative or RNA-negative at baseline, 2058 had at least one follow-up HCV test. Eight incident HCV cases were identified during 2111 person-years of follow-up (incidence 0.38/100 person-years); all were primary infections in men who had sex with men. Clinical, laboratory, and computer-assisted self-interviews data were available for all, and 6 cases were interviewed. Three cases were attributable to injecting drug use (IDU). A fourth case reported IDU, but his HCV was attributable to sexual transmission. Four other cases reported no IDU and probably acquired HCV sexually. Most cases reported anal trauma in the context of condomless receptive anal intercourse during group sex at sex-on-premises venues. Conclusions: In PrEPX, HCV incidence was low compared to international PrEP studies, and most cases were transmitted sexually. Our findings highlight the need for HCV prevention messaging by clinicians, in sex-on-premises venues, and on digital platforms used to arrange group sex; and the need for HCV screening among some PrEP-using men who have sex with men. [ABSTRACT FROM AUTHOR]

Background: Hepatitis C elimination will require widespread access to treatment and responses at the health-service level to increase testing among populations at risk. We explored changes in hepatitis C testing and the cascade of care before and after the introduction of direct-acting antiviral treatments in Victoria, Australia. Methods: De-identified clinical data were retrospectively extracted from eighteen primary care clinics providing services targeted towards people who inject drugs. We explored hepatitis C testing within three-year periods immediately prior to (pre-DAA period) and following (post-DAA period) universal access to DAA treatments on 1st March 2016. Among ever RNA-positive individuals, we constructed two care cascades at the end of the pre-DAA and post-DAA periods. Results: The number of individuals HCV-tested was 13,784 (12.2% of those with a consultation) in the pre-DAA period and 14,507 (10.4% of those with a consultation) in the post-DAA period. The pre-DAA care cascade included 2,515 RNA-positive individuals; 1,977 (78.6%) were HCV viral load/genotype tested; 19 (0.8%) were prescribed treatment; and 12 had evidence of cure (0.5% of those RNA-positive and 63.6% of those eligible for cure). The post-DAA care cascade included 3,713 RNA-positive individuals; 3,276 (88.2%) were HCV viral load/genotype tested; 1,674 (45.1%) were prescribed treatment; and 863 had evidence of cure (23.2% of those RNA-positive and 94.9% of those eligible for cure). Conclusion: Marked improvements in the cascade of hepatitis C care among patients attending primary care clinics were observed following the universal access of DAA treatments in Australia, although improvements in testing were less pronounced. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Doxycycline used as post-exposure prophylaxis (doxyPEP) within 72 hours of sex reduces the risk of bacterial sexually transmitted infections (STIs) in people assigned male sex at birth. Little is known about current use of antibiotics as STI prophylaxis in U.S. populations likely to benefit from doxyPEP., Methods: We conducted an online survey in September 2023 of U.S. adults recruited via sexual networking apps used mainly by gay and bisexual men (GBM). Respondents were asked about the use of antibiotics around the time of sex to prevent bacterial STIs., Results: Of 903 respondents, most (96.2%) identified as GBM; 19.0% were living with HIV and 42.5% using HIV pre-exposure prophylaxis. Half (49.1%) had heard of using antibiotics to prevent STIs and 95.6% were interested in use. Overall, 21.0% had used antibiotic STI prophylaxis and 15.9% had done so in the past year. Among those reporting any use, most (78.1%) had used doxycycline; some used amoxicillin (16.7%), azithromycin (14.5%), or other antibiotics (14.1%). Among those reporting use in the past year, 46.9% used it for some, 28.1% for most, and 25.0% for all sex acts with casual partners during that period. Most (78.3%) of STI prophylaxis users reported their condom use did not change during periods of STI prophylaxis use, 17.2% indicated their condom use declined, and 4.5% indicated their condom use increased. For doxyPEP specifically, 35.7% had heard of it and 13.0% had used it in the past year, of whom 21.0% had used a dosage other than the 200 mg dose shown to be effective., Conclusions: In this sample of primarily GBM, interest in bacterial STI prophylaxis was nearly universal. However, some of the use was not informed by current clinical guidance or evidence from research studies. Efforts are needed to increase awareness of effective dosing and monitor real-world use., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.)

To achieve the elimination of the hepatitis C virus (HCV), sustained and sufficient levels of HCV testing is critical. The purpose of this study was to assess trends in testing and evaluate the effectiveness of strategies to diagnose people living with HCV. Data were from 12 primary care clinics in Victoria, Australia, that provide targeted services to people who inject drugs (PWID), alongside general health care. This ecological study spanned 2009-2019 and included analyses of trends in annual numbers of HCV antibody tests among individuals with no previous positive HCV antibody test recorded and annual test yield (positive HCV antibody tests/all HCV antibody tests). Generalised linear models estimated the association between count outcomes (HCV antibody tests and positive HCV antibody tests) and time, and χ2 test assessed the trend in test yield. A total of 44 889 HCV antibody tests were conducted 2009-2019; test numbers increased 6% annually on average [95% confidence interval (CI) 4-9]. Test yield declined from 2009 (21%) to 2019 (9%) (χ2P = <0.01). In more recent years (2013-2019) annual test yield remained relatively stable. Modest increases in HCV antibody testing and stable but high test yield within clinics delivering services to PWID highlights testing strategies are resulting in people are being diagnosed however further increases in the testing of people at risk of HCV or living with HCV may be needed to reach Australia's HCV elimination goals.

Background: PrEPX was an Australian HIV pre-exposure prophylaxis (PrEP) study conducted between 2016 and 2018. This analysis aimed to estimate hepatitis C (HCV) incidence and explore likely modes of transmission., Setting: Cohort study of PrEP users in Victoria, Australia., Methods: HCV tests were conducted at enrollment and every 12 months thereafter. HCV incident cases were identified from laboratory data. Likely modes of transmission were inferred from computer-assisted self-interviews, medical records, and interviews., Results: Among 3202 PrEPX participants tested for HCV at baseline, HCV RNA-positive prevalence was 0.22% (95% confidence interval: 0.09 to 0.45). Among participants testing HCV antibody-negative or RNA-negative at baseline, 2058 had at least one follow-up HCV test. Eight incident HCV cases were identified during 2111 person-years of follow-up (incidence 0.38/100 person-years); all were primary infections in men who had sex with men. Clinical, laboratory, and computer-assisted self-interviews data were available for all, and 6 cases were interviewed. Three cases were attributable to injecting drug use (IDU). A fourth case reported IDU, but his HCV was attributable to sexual transmission. Four other cases reported no IDU and probably acquired HCV sexually. Most cases reported anal trauma in the context of condomless receptive anal intercourse during group sex at sex-on-premises venues., Conclusions: In PrEPX, HCV incidence was low compared to international PrEP studies, and most cases were transmitted sexually. Our findings highlight the need for HCV prevention messaging by clinicians, in sex-on-premises venues, and on digital platforms used to arrange group sex; and the need for HCV screening among some PrEP-using men who have sex with men., Competing Interests: Gilead Sciences funded this analysis of hepatitis C within the PrEPX study; however, Gilead did not have input into the study design or the analysis. V.J.C. has received speaker's fees and conference assistance from Gilead Sciences and advisory board fees from ViiV Healthcare. M.W.T. received speaker's fees from Gilead Sciences. E.J.W. reports receipt of grants from the Victorian, Tasmanian, and the South Australian governments for PrEPX; other from Gilead Sciences (free study drug for VicPrEP, 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 and Dohme outside the submitted work; and financial support from Gilead Sciences, Abbott Laboratories, Janssen-Cilag, Boehringer Ingelheim, ViiV Healthcare, and Merck Sharp and Dohme. D.M. received grants from Alfred Health. M.S. received a research fellowship from the National Health and Medical Research Council, and investigator-initiated grants from Gilead Sciences and Bristol–Myers–Squibb. M.H. received grants from the Australian Department of Health, Gilead Sciences, AbbVie, and Bristol–Myers–Squibb. J.A. received grants from the Australian Government's Department of Health. J.S. has grant research funding from Gilead, AbbVie, and Merck. He has also received speaker fees from Gilead Sciences. Gilead Sciences donated study drug to the VicPrEP study (precursor to the PrEPX study). The remaining authors have no conflicts of interest to disclose., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)