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.

Findings highlight the importance of efforts to minimize STIs among PrEP users and their sexual partners. Monitoring of risk compensation among MSM in the context of PrEP scale-up is needed to assess the impact of PrEP on the sexual health of MSM and to inform preventive strategies.

Background Gay and bisexual men (GBM) are a key population affected by HIV and hepatitis C (HCV) co-infection. Providing HCV treatment scale-up across specialist and non-hepatitis specialist settings may eliminate HCV in this population. We aimed to (1) deliver and measure HCV treatment effectiveness, and (2) determine the population impact of treatment on HCV prevalence and incidence longitudinally. Methods The co-EC Study (Enhancing care and treatment among HCV/HIV co-infected individuals to Eliminate Hepatitis C transmission) was an implementation trial providing HCV direct-acting antiviral treatment in Melbourne, Australia, from 2016-2018. Individuals with HCV/HIV co-infection were prospectively enrolled from primary and tertiary-care services providing care for 85% of GBM with HIV in our jurisdiction. HCV-viraemic prevalence and HCV-antibody/viraemic incidence were measured using a state-wide, individually-linked, electronic surveillance system. Results Among 200 participants recruited, 186 initiated treatment during the study period. Sustained virological response among primary care participants (98%, 95%CI:93-100%) was not different to tertiary care (98%, 95%CI:86-100%). From 2012-2019, 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, 10-14% were anti-HCV positive. Among those anti-HCV positive, viraemic prevalence declined 83% during the study (54% to 9%; 2016 to 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; CI:0.68-0.83;p<0.001). Conclusion High treatment effectiveness by non-specialists demonstrates the feasibility of treatment scale-up in this population. Substantial declines in HCV incidence and prevalence among GBM with HIV-infection provides proof-of-concept for HCV micro-elimination. Registration ClinicalTrials.gov (Identifier: NCT02786758).

Background Hepatitis C virus (HCV) infection has been reported among gay, bisexual, and other men who have sex with men (GBM) globally including GBM with human immunodeficiency virus (HIV) and HIV-negative GBM, particularly those using HIV preexposure prophylaxis (PrEP). In Australia, HCV direct-acting antiviral treatment (DAA) was government-funded from 2016. Large implementation studies of PrEP also began in 2016. We examined HCV incidence among GBM to assess whether HCV incidence has changed since 2015. Methods Data were drawn from the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance. We included GBM who tested HCV antibody negative at their first test and had ≥1 subsequent test. Generalized linear modeling (Poisson distribution) was used to examine HCV incidence from 2009 to 2019 stratified by HIV status, and among HIV-negative GBM prescribed PrEP from 2016 to 2019. Results Among 6744 GBM with HIV, HCV incidence was 1.03 per 100 person-years (PY). Incidence declined by 78% in 2019 compared to 2015 (incidence rate ratio [IRR], 0.22 [95% confidence interval {CI}: .09–.55]). Among 20 590 HIV-negative GBM, HCV incidence was 0.20/100 PY, with no significant change over time. Among 11 661 HIV-negative GBM prescribed PrEP, HCV incidence was 0.29/100 PY. Compared to 2016, incidence among GBM prescribed PrEP declined by 80% in 2019 (IRR, 0.20 [95% CI: .06–.64]). Conclusions HCV incidence among GBM living with HIV declined following DAA availability. There was no observed change in HCV incidence among HIV-negative GBM overall. Among GBM prescribed PrEP, incidence declined since the early years of PrEP implementation in Australia. Australia is on track to eliminate HCV among GBM before global 2030 targets.

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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 1 st March 2016. Among ever RNA-positive individuals, we constructed two care cascades at the end of the pre-DAA and post-DAA periods.

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