Andrew E Grulich1, Rebecca Guy2, Janaki Amin3, Fengyi Jin2, Christine Selvey4, Jo Holden4, Heather-Marie A Schmidt4, Iryna Zablotska5, Karen Price6, Bill Whittaker4, Kerry Chant4, Craig Cooper7, Scott McGill8, Barbara Telfer4, Barbara Yeung2, Gesalit Levitt2, Erin E Ogilvie2, Nila J Dharan2, Mohamed A Hammoud2, Stefanie Vaccher2, Lucy Watchirs-Smith2, Anna McNulty9, David J Smith10, Debra M Allen11, David Baker12, Mark Bloch13, Rohan I Bopage14, Katherine Brown15, Andrew Carr16, Christopher J Carmody17, Kym L Collins18, Robert Finlayson19, Rosalind Foster20, Eva Y Jackson21, David A Lewis22, Josephine Lusk23, Catherine C O'Connor24, Nathan Ryder25, Emanuel Vlahakis26, Phillip Read27, David A Cooper2. 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. New South Wales Ministry of Health, Sydney, NSW, Australia. 5. Western Sydney Sexual Health Centre and Sydney Medical School-Westmead, University of Sydney, Sydney, NSW, Australia. 6. ACON, Sydney, NSW, Australia. 7. Positive Life NSW, Sydney, NSW, Australia. 8. Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine, Sydney, NSW, Australia. 9. Sydney Sexual Health Centre, Sydney, NSW, Australia. 10. North Coast HIV/Sexual Health Services, Lismore, NSW, Australia. 11. Holden Street Clinic, Gosford, NSW, Australia. 12. East Sydney Doctors, Darlinghurst, NSW, Australia. 13. The Kirby Institute, University of New South Wales, Sydney, NSW, Australia; Holdsworth House Medical Practice, Darlinghurst, NSW, Australia. 14. The Albion Centre, Surry Hills, NSW, Australia. 15. Illawarra Sexual Health Service, Wollongong, NSW, Australia. 16. St Vincent's Hospital, Darlinghurst, NSW, Australia. 17. Liverpool Sexual Health Clinic, Liverpool, NSW, Australia. 18. Albury Sexual Health Service, Albury, NSW, Australia; Brookong Sexual Health Centre, Wagga Wagga, NSW, Australia. 19. Taylor Square Private Clinic, Surry Hills, NSW, Australia. 20. Clinic 16, Northern Sydney Sexual Health, St Leonards, NSW, Australia. 21. Nepean Blue Mountains Local Health District, Department of Sexual Health, Penrith, NSW, Australia. 22. 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. 23. Short Street Clinic, Kogorah, St George Hospital, NSW, Australia. 24. RPA Sexual Health, Camperdown, NSW, Australia. 25. 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. 26. Coffs Harbour Sexual Health, Coffs Harbour, NSW, Australia. 27. Kirketon Road Centre, Kings Cross, NSW, Australia.
Abstract
BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective in men who have sex with men (MSM) at the individual level, but data on population-level impact are lacking. We examined whether rapid, targeted, and high-coverage roll-out of PrEP in an MSM epidemic would reduce HIV incidence in the cohort prescribed PrEP and state-wide in Australia's most populous state, New South Wales. METHODS: The Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) study is an implementation cohort study of daily co-formulated tenofovir disoproxil fumarate and emtricitabine as HIV PrEP. We recruited high-risk gay men in a New South Wales-wide network of 21 clinics. We report protocol-specified co-primary outcomes at 12 months after recruitment of the first 3700 participants: within-cohort HIV incidence; and change in population HIV diagnoses in New South Wales between the 12-month periods before and after PrEP roll-out. The study is registered with ClinicalTrials.gov, number NCT02870790. FINDINGS: We recruited 3700 participants in the 8 months between March 1, 2016, and Oct 31, 2016. 3676 (99%) were men, 3534 (96%) identified as gay, and 149 (4%) as bisexual. Median age was 36 years (IQR 30-45 years). Overall, 3069 (83%) participants attended a visit at 12 months or later. Over 4100 person-years, two men became infected with HIV (incidence 0·048 per 100 person-years, 95% CI 0·012-0·195). Both had been non-adherent to PrEP. HIV diagnoses in MSM in New South Wales declined from 295 in the 12 months before PrEP roll-out to 221 in the 12 months after (relative risk reduction [RRR] 25·1%, 95% CI 10·5-37·4). There was a decline both in recent HIV infections (from 149 to 102, RRR 31·5%, 95% CI 11·3 to 47·3) and in other HIV diagnoses (from 146 to 119, RRR 18·5%, 95% CI -4·5 to 36·6). INTERPRETATION: PrEP implementation was associated with a rapid decline in HIV diagnoses in the state of New South Wales, which was greatest for recent infections. As part of a combination prevention approach, rapid, targeted, high-coverage PrEP implementation is effective to reduce new HIV infections at the population level. FUNDING: New South Wales Ministry of Health, Gilead Sciences.
BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is highly effective in men who have sex with men (MSM) at the individual level, but data on population-level impact are lacking. We examined whether rapid, targeted, and high-coverage roll-out of PrEP in an MSM epidemic would reduce HIV incidence in the cohort prescribed PrEP and state-wide in Australia's most populous state, New South Wales. METHODS: The Expanded PrEP Implementation in Communities-New South Wales (EPIC-NSW) study is an implementation cohort study of daily co-formulated tenofovir disoproxil fumarate and emtricitabine as HIV PrEP. We recruited high-risk gay men in a New South Wales-wide network of 21 clinics. We report protocol-specified co-primary outcomes at 12 months after recruitment of the first 3700 participants: within-cohort HIV incidence; and change in population HIV diagnoses in New South Wales between the 12-month periods before and after PrEP roll-out. The study is registered with ClinicalTrials.gov, number NCT02870790. FINDINGS: We recruited 3700 participants in the 8 months between March 1, 2016, and Oct 31, 2016. 3676 (99%) were men, 3534 (96%) identified as gay, and 149 (4%) as bisexual. Median age was 36 years (IQR 30-45 years). Overall, 3069 (83%) participants attended a visit at 12 months or later. Over 4100 person-years, two men became infected with HIV (incidence 0·048 per 100 person-years, 95% CI 0·012-0·195). Both had been non-adherent to PrEP. HIV diagnoses in MSM in New South Wales declined from 295 in the 12 months before PrEP roll-out to 221 in the 12 months after (relative risk reduction [RRR] 25·1%, 95% CI 10·5-37·4). There was a decline both in recent HIV infections (from 149 to 102, RRR 31·5%, 95% CI 11·3 to 47·3) and in other HIV diagnoses (from 146 to 119, RRR 18·5%, 95% CI -4·5 to 36·6). INTERPRETATION: PrEP implementation was associated with a rapid decline in HIV diagnoses in the state of New South Wales, which was greatest for recent infections. As part of a combination prevention approach, rapid, targeted, high-coverage PrEP implementation is effective to reduce new HIV infections at the population level. FUNDING: New South Wales Ministry of Health, Gilead Sciences.
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