Expanded PrEP implementation in NSW (EPIC-NSW) 1 AIDS 2016 | 22 July 2016

Expanded PrEP implementation in NSW (EPIC-NSW) Disclosures 2 The NSW Ministry of Health provided funding and procured TDF/FTC for this study. Gilead Sciences donated Truvada® (equivalent to 2000 person-years of follow-up).

Expanded PrEP implementation in NSW (EPIC-NSW) New HIV diagnoses in New South Wales (NSW), Australia:

Expanded PrEP implementation in NSW (EPIC-NSW) NSW HIV prevention strategy

Expanded PrEP implementation in NSW (EPIC-NSW) Target PrEP to MSM at high risk for HIV infection, that is men who in the last 3 months reported: Condomless anal intercourse (CLAI) with a regular male sexual partner who is HIV-positive, not on treatment/detectable VL Receptive CLAI with any HIV positive or status unknown casual male partner Diagnosis of rectal gonorrhoea, rectal chlamydia or infectious syphilis Using any methamphetamine NSW PrEP guidelines 5

Estimated number of MSM in NSW (aged 16-69) at risk for HIV 6 ABS ASHR-2 / Estimation GCPS Estimation Total population in NSW Number of men aged who identify as gay/homosexual, are sexually active and at risk for HIV % 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) 7,518,472 29,621 12% 3,700 Data source Description of the calculation Number of men ASHR-2 – Second Australian Survey of Health and Relationships GCPS – Gay Community Periodic Surveys ABS – Australian Bureau of Statistics

Expanded PrEP implementation in NSW (EPIC-NSW) Assumptions: HIV incidence 4 /100 person years PrEP is 86% effective (as in iPERGAY and PROUD studies) Expected impact of a PrEP access program for 3700 high-risk MSM: about 150 HIV infections averted in the first 12 months on PrEP (~50% of the number HIV diagnosed in 2014) Potential effect of PrEP on HIV in NSW 7

Expanded PrEP implementation in NSW (EPIC-NSW) World AIDS Day 2015 – Health Minister of NSW announces support for EPIC-NSW trial 8

Expanded PrEP implementation in NSW (EPIC-NSW) –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 –Provided for up to 2 years Research framework 9

Expanded PrEP implementation in NSW (EPIC-NSW) The Concept 10 Single-arm, open label, implementation trial Large scale intervention (~25 sites, 3,700 participants) Rapid roll-out (1 March - 31 December 2016) Target high-risk people (as per NSW PrEP guidelines) “Real-life” implementation

Expanded PrEP implementation in NSW (EPIC-NSW) Objectives 11 Primary 1.Assess the incidence of HIV among the study participants and the number of new HIV diagnoses in the cohort of people prescribed PrEP 2.Measure the population-level impact of the rapid roll-out and provision of PrEP on HIV diagnoses among MSM in NSW over a two-year period Secondary 1. Evaluate the rate of PrEP uptake 2. Assess the incidence of STI (GN, CT, Syphilis) in people prescribed PrEP 3. Measure the effect of the rapid roll-out of PrEP on the overall number of notifications of GC, CT, Syphilis in NSW 4. Describe patterns of PrEP use and medication adherence 5. Monitor behavioural risk practices among PrEP users in the cohort

Expanded PrEP implementation in NSW (EPIC-NSW) Study assessments (per updated NSW PrEP guidelines) 12 Follow-up schedule Screening/ Enrolment 1 Follow-up 1 Subsequent Follow-ups Timeline Week 0Month 1 Month 3 and every 3 months thereafter Medical history X Renal function (creatinine clearance) X X STI testing X X HIV testing XXX Hep B (immunize if not immune) X Hep C XX 2 Survey of adherence and behaviour (optional) X X [1] [1] Screening and enrolment may be combined if HIV test result available [2] [2] at least once a year

Expanded PrEP implementation in NSW (EPIC-NSW) Easy access to PrEP through any participating clinical site Standard of care services as recommended by NSW PrEP guidelines ( Free stop/restart Real life implementation 13

Expanded PrEP implementation in NSW (EPIC-NSW) ACON: PrEP resources/information online Community mobilisation forums Using social networking Peer-support Clinical services: PrEP info line Advertisement on social networking websites Consent forms and resource materials in English and 6 other languages Fostering demand for PrEP 14

Expanded PrEP implementation in NSW (EPIC-NSW) Minimal data collection at enrolment Extraction and ongoing linkage of data from clinical data collection systems Quarterly analyses to evaluate impact of the intervention – HIV and STI diagnoses in the cohort – Notifications of HIV and STI diagnoses in NSW – PrEP prescriptions – Behaviour and adherence to medication Cumulative follow-up of 7400 person-years End of the trial – December 2018 Data collection and analyses 15

“EPIC trial enrols 1000th participant as access to PrEP for HIV prevention expands” (20 May 2016)

Expanded PrEP implementation in NSW (EPIC-NSW) The Kirby Institute: Research Design and implementation Public and private health services across the state Ministry of Health HIV Strategy funding team support AIDS Council of NSW (ACON): Resources Social marketing Community forums/education Peer-support Community leadership Government support ResearchersClinicians Partnership 18

Expanded PrEP implementation in NSW (EPIC-NSW) EPIC-NSW: “Real life” intervention an implementation trial aimed to evaluate the estimated impact of PrEP on HIV diagnoses in NSW, Australia Ongoing analysis of the study outcomes to monitor progress towards the goal of eliminating HIV by 2020 Informing and refining PrEP policy In conclusion 19

Expanded PrEP implementation in NSW (EPIC-NSW) The EPIC-NSW team

Expanded PrEP implementation in NSW (EPIC-NSW) The NSW Ministry of Health Gilead Sciences Inc. for donation of Truvada for Australian trials Clinical services participating in the study AIDS Council of NSW (ACON) The Kirby Institute and UNSW Australia Acknowledgements 21