1. Expanded PrEP implementation across Australia Expanded implementation of PrEP across Australia 1

2. Expanded PrEP implementation across Australia Newly diagnosed HIV infections in Australia, 1984-2014 2 Source: State and Territory health authorities, Australia

3. Expanded PrEP implementation across Australia The 2014 HIV diagnosis and care cascade 3 Source: State and Territory health authorities, Australia

4. Expanded PrEP implementation across Australia Use of PrEP among men who have sex with men (MSM) (behavioural surveillance data) first record of informal use of PrEP by MSM (Zablotska et al. JAIDS 2012) during 2011-2015, PrEP use fluctuated around 2.5% of gay community-attached men, but increased from 3% to 10% among high-risk men PrEP awareness and acceptability (cross-sectional behavioural surveys) PrEPARE study (2012): 27% of HIV negative men were aware about PrEP and willing to take it (Holt et al. JAIDS, 2014) TORCH study (2013): 71% of high risk men were willing to take PrEP (high risk defined as in Australian PrEP guidelines Early research on PrEP 4

5. Expanded PrEP implementation across Australia Health in Men cohort (HIM, 2001-07) Factors associated with increased HIV incidence among Australian MSM 5 High Risk behaviour in last 6 monthsIncidence per 100 PY 95% CI Overall HIV incidence0.78 0.59-1.02 Regular partner of an HIV-positive man, at least some condomless sex 5.42.8-10 Receptive condomless sex with any casual HIV- positive or HIV status unknown male partner 2.31.5-3.6 Rectal gonorrhoea7.02.3-21 Rectal chlamydia3.61.3-9.5 Methamphetamine use1.91.3-2.8

6. Expanded PrEP implementation across Australia In the last 3 months: 1.Been the regular sexual partner of an HIV-infected man (not on treatment and/or detectable viral load) and not used condoms consistently 2.Had ≥1 episode of receptive condomless anal intercourse (CLAI) with a casual male partner of HIV-positive or unknown status 3.Been diagnosed with rectal gonorrhoea, rectal chlamydia or infectious syphilis 4.Used methamphetamines  Recommend prescribing daily PrEP The high risk approach to PrEP eligibility 6 Sources: NSW PrEP guidelines (2014, updated 2016) Australian PrEP guidelines (2015) http://arv.ashm.org.au/images/Australian_National_PrEP_Guidelines.PDF

7. Expanded PrEP implementation across Australia Early PrEP demonstration projects in Australia 7 VICPrEP (Victoria): 115 participants (2014- ) PrELUDE (NSW): 300 participants (2014- ) Qprep (Queensland):50 participants (2016- ) Lessons learned –Very high levels of adherence –Very high rates of condomless anal intercourse and sexually transmissible infections –Estimated HIV incidence in PrELUDE: 4 per 100 PY –No HIV seroconversions seen in about 500 person- years S Vaccher et al. PrELUDE study. Poster WEPEC255

8. Estimated population of MSM at high risk for HIV 8 ABS ASHR-2 / Estimation GCPS Estimation Total population in Australia Number of men aged 16-69 who identify as gay/homosexual, are sexually active and at risk for HIV % 16-69 year-old men at HIGH risk for HIV (practices consistent with high risk criteria from PrEP guidelines) Number of men who are at HIGH risk for HIV and eligible for PrEP (per criteria from PrEP guidelines) 23,490,736 101,997 14.6% 14,910 Data source Description of the calculation Number of men ABS – Australian Bureau of Statistics ASHR-2 – 2 nd Australian Survey of Health and Relationships GCPS – Gay Community Periodic Surveys (national HIV behavioural surveillance)

9. Expanded PrEP implementation across Australia Estimated 3700 high risk MSM are eligible for PrEP under current PrEP guidelines Assumptions HIV incidence is as in PrELUDE study – 4 per 100 py PrEP is 86% effective (as in iPERGAY and PROUD studies) Expected impact of a PrEP access program for 3700 high-risk gay/homosexual men: about 150 HIV infections averted in the first 12 months on PrEP (~50% of the number HIV diagnoses in NSW in 2014) Potential effect of targeted PrEP on HIV in NSW 9

10. Expanded PrEP implementation across Australia World AIDS Day 2015 – Health Minister of NSW announces support for EPIC-NSW trial 10

11. 1 March 2016 - EPIC-NSW enrols the first participant I Zablotska et al, 22 July, 11-1230, Session Room 1 https://epic-nswstudy.org.au/

12. “EPIC trial enrols 1000th participant as access to PrEP for HIV prevention expands”

13. Expanded PrEP implementation across Australia 13

15. Expanded PrEP implementation across Australia 15 Facilitators of the rapid PrEP roll-out RESEARCH EVIDENCE

16. Expanded PrEP implementation across Australia –TDF/FTC was not licensed for prevention at the start of the study Truvada licensed on 6 May 2016 Generic TDF/FTC not licensed –TDF/FTC is free in the trial context –Evaluation of the study outcomes (HIV, STIs, eGFRs) Research framework 16

17. Expanded PrEP implementation across Australia Roll-out of PrEP implementation trials in Victoria and Queensland Further steps in PrEP roll-out 17

18. Expanded PrEP implementation across Australia 18 Queensland: QPreP NSW: PrELUDE and EPIC-NSW Victoria: VicPrEP and PrePX

19. Expanded PrEP implementation across Australia PrEP implementation trials in Victoria and Queensland Other jurisdictions partner with NSW, Victoria and Queensland and join large implementation trials Truvada considered for public subsidy in July 2016 Further steps in PrEP roll-out 19

20. Summary Key features of the Australian PrEP roll-out: Time limited target for HIV prevention – to eliminate HIV transmission by 2020 Evidence-based PrEP guidelines Staged PrEP implementation: first step – targeting of high- risk population groups Strong partnership and community advocacy across HIV sector Implementation research and ongoing evaluation of PrEP roll- out

21. Expanded PrEP implementation across Australia The EPIC-NSW team

22. Expanded PrEP implementation across Australia Investigator teams of VICPrEP and QPrEP studies State Ministries of Health, particularly the NSW Ministry of Health for funding the implementation trials Gilead Sciences Inc. for donation of Truvada for Australian trials Australian Society for HIV Medicine for leadership in policy development Community organisations in NSW, VIC and Queensland for active support of PrEP implementation The Kirby Institute and UNSW Australia Acknowledgements 22