• Andrew E Grulich, Rebecca Guy, Janaki Amin, Fengyi Jin, Christine Selvey, Jo Holden, Heather-Marie A Schmidt, Iryna Zablotska, Karen Price, Bill Whittaker, Kerry Chant, Craig Cooper, Scott McGill, Barbara Telfer, Barbara Yeung, Gesalit Levitt, Erin E Ogilvie, Nila J Dharan, Mohamed A Hammoud, Stefanie Vaccher, Lucy Watchirs-Smith, Anna McNulty, David J Smith, Debra M Allen, David Baker, Mark Bloch, Rohan I Bopage, Katherine Brown, Andrew Carr, Christopher J Carmody, Kym L Collins, Robert Finlayson, Rosalind Foster, Eva Y Jackson, David A Lewis, Josephine Lusk, Catherine C O'Connor, Nathan Ryder, Emanuel Vlahakis, Phillip Read, David A Cooper, and Expanded PrEP Implementation in Communities New South Wales (EPIC-NSW) research group.
• The Kirby Institute, University of New South Wales, Sydney, NSW, Australia. Electronic address: agrulich@kirby.unsw.edu.au.
• Lancet HIV. 2018 Nov 1; 5 (11): e629-e637.

BackgroundHIV 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.MethodsThe 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.FindingsWe 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).InterpretationPrEP 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.FundingNew South Wales Ministry of Health, Gilead Sciences.Copyright © 2018 Elsevier Ltd. All rights reserved.

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