Andrew E Grulich1, Fengyi Jin2, Benjamin R Bavinton2, Barbara Yeung2, Mohamed A Hammoud2, Janaki Amin3, Gesalit Cabrera2, Shawn Clackett4, Erin Ogilvie2, Stefanie Vaccher2, Tobias Vickers2, Anna McNulty5, David J Smith6, Nila J Dharan2, Christine Selvey7, Cherie Power7, Karen Price8, Iryna Zablotska9, David A Baker10, Mark Bloch11, Katherine Brown12, Christopher J Carmody13, Andrew Carr14, Daniel Chanisheff15, Nicholas Doong16, Robert Finlayson17, David A Lewis18, Josephine Lusk19, Sarah Martin20, Catriona Ooi21, Phillip Read22, Nathan Ryder23, Don Smith24, Clara Tuck Meng Soo25, David J Templeton26, Emmanuel Vlahakis27, Rebecca Guy2. 1. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia. Electronic address: agrulich@kirby.unsw.edu.au. 2. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia. 3. Department of Health Systems and Populations, Faculty of Medicine and Health Sciences, Macquarie University, Sydney, NSW, Australia. 4. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; New South Wales Ministry of Health, Sydney, NSW, Australia. 5. Sydney Sexual Health Centre, Sydney, NSW, Australia. 6. North Coast HIV/Sexual Health Services, Lismore, NSW, Australia. 7. New South Wales Ministry of Health, Sydney, NSW, Australia. 8. ACON, Sydney, NSW, Australia. 9. Western Sydney Sexual Health Centre and Sydney Medical School Westmead, University of Sydney, Sydney, NSW, Australia. 10. East Sydney Doctors, Darlinghurst, NSW, Australia. 11. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; Holdsworth House Medical Practice, Darlinghurst, NSW, Australia. 12. Illawarra Sexual Health Service, Wollongong, NSW, Australia. 13. Liverpool Sexual Health Clinic, Liverpool, NSW, Australia. 14. St Vincent's Hospital, Darlinghurst, NSW, Australia. 15. Green Square Health, Sydney, NSW, Australia. 16. Dr Doong's Surgery, Sydney, NSW, Australia. 17. Taylor Square Private Clinic, Surry Hills, NSW, Australia. 18. Western Sydney Sexual Health Centre and Sydney Medical School Westmead, University of Sydney, Sydney, NSW, Australia; Marie Bashir Institute for Biosecurity and Infectious Diseases, University of Sydney, Sydney, NSW, Australia. 19. Short Street Clinic, Kogorah, St George Hospital, NSW, Australia. 20. Canberra Sexual Health Centre, Canberra Health Services, Canberra Hospital, Canberra, ACT, Australia. 21. Clinic 16, St Leonards, NSW, Australia. 22. Kirketon Road Centre, Kings Cross, NSW, Australia. 23. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; Hunter-New England Sexual Health, Newcastle, NSW, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. 24. The Albion Centre, Surry Hills, NSW, Australia. 25. Hobart Place General Practice and East Canberra General Practice, ACT, Australia. 26. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; Discipline of Medicine, Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Department of Sexual Health Medicine and Sexual Assault Medical Service, Sydney Local Health District Camperdown, NSW, Australia. 27. Coffs Harbour Sexual Health, Coffs Harbour, NSW, Australia.
Abstract
BACKGROUND: Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP. METHODS: Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790. FINDINGS: Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13-2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46-3·44). INTERPRETATION: HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk. FUNDING: New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences.
BACKGROUND: Daily pre-exposure prophylaxis (PrEP) is effective in preventing HIV, but few long-term data are available on effectiveness and adherence in real-world settings. Here, we report trends in HIV incidence over 3 years in individuals at high risk who were prescribed PrEP in New South Wales (NSW), as well as adherence before the transition to subsidised PrEP. METHODS: Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) was a pragmatic, prospective, single-arm, implementation study of daily, oral PrEP in 31 sites (sexual health clinics, general practices, and a hospital) in NSW, Australia. Eligible participants were HIV-negative adults (aged ≥18 years) who were at high risk of HIV infection as defined in local PrEP guidelines. Participants were prescribed coformulated (once-daily, oral tablet) tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) as HIV PrEP and were followed up with HIV testing, sexually transmitted infection testing, and PrEP dispensing. Originally planned for 3700 participants followed for 1 year, the study was expanded so that all eligible participants in the state could obtain PrEP and extended until publicly subsidised PrEP became available in Australia. The primary outcome was new HIV infection among all participants who were dispensed PrEP at least once and had at least one follow-up HIV test result. Adherence was estimated by medication possession ratio (MPR), defined as the proportion of PrEP pills dispensed in 90 days, assuming daily dosing. This study is registered with ClinicalTrials.gov, NCT02870790. FINDINGS: Between March 1, 2016, and April 30, 2018, we enrolled 9709 participants. 9596 participants were dispensed PrEP, of whom 9448 (98·3%) were gay or bisexual men. Participants were followed up until March 31, 2019, with at least one follow-up HIV test available in 9520 (99·2%) participants. Mean MPR declined from 0·93 to 0·64 from the first to the ninth quarter. There were 30 HIV seroconversions over 18 628 person-years, an incidence of 1·61 per 1000 person-years (95% CI 1·13-2·30). Being younger, living in a postcode with fewer gay men, reporting more risk behaviours at baseline, and having an MPR of less than 0·6 were each univariately associated with increased HIV incidence. In the final year of follow-up, when PrEP was mostly purchased rather than provided free by the study, HIV incidence remained low at 2·24 per 1000 person-years (1·46-3·44). INTERPRETATION: HIV incidence remained low over up to 3 years of follow-up, including during a transition from study-provided to publicly subsidised PrEP. In a setting of affordable PrEP and associated health-care services, very low HIV incidence of 1 to 2 per 1000 person-years can be maintained in gay and bisexual men who were previously at high risk. FUNDING: New South Wales Ministry of Health, Australian Capital Territory Health Directorate, Gilead Sciences.
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