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.
Bibliographical noteFunding Information:
We acknowledge EPIC-NSW site coordinators Natalie Arvela, Andrew Buggie, Damien Brown, Sally-Anne Brennan, Annabelle Caspersz, Margaret Crowley, Karen Chronister, Sophie Dinning, Kim Grant, Nerida Grant, Joanne Gough, Elizabeth Griggs, Brett Hadlow, Sarah Holliday, Nives Houlihan, Alison Kincaid, Phuoc Loc Le, Jodie-Lee Little, Rasanga Liyanage, Almario Mangaran, John McAllister, Ruthy McIver, Dianne Morris, Alison Nikitas, David Ninham, Katherine Ognenovska, Michael O'Reilly, Jessie Payne, Melissa Power, Anik Ray, Elizabeth Scally, Brett Sinclair, Roisin Steward, Kylie Strong, Ching Tan, Adriana Trujillo, Jennifer Walsh, Lucy Williamson, and Michael Williamson. The site coordinators recruited, enrolled and followed up study participants. We also acknowledge the EPIC-NSW site pharmacists Bruce Hamish Bowden, Romana Cecchele, Jennifer Culverson, Jeannine Delemare, Mark Farrah, Kirstel Gelfius, Greg Gillespie, Julie Hilditch, Matthew Holder, Linda Hotung, Leo Mason, Ian Mawbey, Merrion Tom, Jasminka Sarunac, Thao Tran, and Peter Yu. The site pharmacists managed the study medication supply logistics at the site level and dispensed study medications to site personnel and study participants. We also acknowledge Shawn Clackett of the Kirby Institute who provided administrative assistance. We also acknowledge Dale Halliday of the New South Wales Ministry of Health who assisted with drug procurement, management of medication supply logistics at the study level, and other aspects of study conduct. We also acknowledge Matthew Vaughan of ACON who assisted with study recruitment and communications with potential and actual participants. We acknowledge Jason Asselin at the Burnet Institute, who managed the ACCESS data extraction for the private sites. We thank Tobias Vickers and Denton Callander for assistance with ACCESS data extraction and analyses. Gilead Sciences provided 2000 person-years of Truvada for the study, and The New South Wales Ministry of Health funded the conduct of the study. The Kirby Institute is affiliated with the Faculty of Medicine, University of New South Wales and funded by the Australian Government of Health and Ageing.
The study was funded by the New South Wales Ministry of Health, and Gilead provided 2000 person-years of Truvada (the remainder of study drug was purchased from Mylan). As an implementation study, the Ministry had an active role in the design, conduct and analysis of the study, and a number of Ministry staff were included as manuscript coauthors (CS, JH, H-MAS, KC, BT). Gilead played no role in the collection, analysis, and interpretation of data or the writing of the report or the decision to submit the paper for publication.
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