Ending HIV and Australia s success story in PrEP implementation Dr Heather-Marie Schmidt

Transcription

1 Ending HIV and Australia s success story in PrEP implementation Dr Heather-Marie Schmidt BBV and STI Unit Centre for Population Health NSW Ministry of Health

2 Session overview 1. Background: HIV & Healthcare in Australia 2. Design of a pragmatic clinical trial: EPIC-NSW 3. Examine the impact of EPIC-NSW 4. Discuss the next steps and lessons learned 5. Ask me a question!

3 BACKGROUND: HIV AND HEALTHCARE IN AUSTRALIA

4 Introduction to healthcare in Australia Universal access to sexual health services: Publicly funded clinic (free to consumer) General practice / primary care (free or co-payment) Pharmaceuticals (co-payment) Pharmaceutical Benefits Schedule (PBS) listing based on safety, effectiveness and cost effectiveness

5 No. notifications New HIV diagnoses: Australia, Stable notifications 70-80% in gay and bisexual men Despite close to 90/90/90 goals Year Men Women Total Source: state and territory health authorities; presented in the HIV, viral hepatitis and sexually transmissible infections in Australia Annual Surveillance Report 2017 (Kirby Institute)

6 The NSW HIV Response 10,000 people with HIV in NSW committed to ending HIV transmission in NSW by 2020 Partnership: clinicians, researchers, community & policy makers Focus: treatment as prevention Increasing treatment coverage Increasing testing coverage Maintaining prevention Enhanced data collection systems

7 HIV diagnoses in NSW:

8 A perfect [PrEP] storm Evidence PrEP is highly effective Public health benefits of high PrEP coverage Government commitment New HIV Strategy prioritises PrEP access Partners aligned

9 DESIGN OF A PRAGMATIC CLINICAL TRIAL: EPIC-NSW

10 EPIC-NSW: Expanded PrEP Implementation in Communities in NSW Design Clinical trial 2 year public health intervention State-wide - public clinics and general practice Rapid rollout and enrolment High coverage of those eligible (no cap) Estimate 9600 people eligible Equity

11 EPIC-NSW: clinical trial lite As close to real world as possible Cost efficient No payments from sponsor or patient Embed into routine service delivery (sustainability) Clinical care based on NSW PrEP Guidelines Flexible models permitted

12 Models of care Flexibility to implement the best model of care at each clinic Drop-in vs specific PrEP clinics Doctor-led clinics Nurse-led clinics Remote models utilising telehealth Peers in PrEP clinics Enrolment at community testing sites (atest) In-clinic and public hospital pharmacy dispensing

13 Behavioural eligibility criteria

14 Clinical guidelines & follow-up schedule Follow-up schedule Enrolment/ baseline Follow-up 1 Subsequent Followups Timeline Week 2 or 0 Month 1 Month 3 & every 3 months thereafter Informed consent X Review eligibility X X X Medical history Renal function (creatinine clearance) X X X e Serious adverse events, pregnancy X X Hepatitis C testing X X STI testing X X HIV testing X X X Dispense study drug X X X Survey of adherence and behaviour X X h

15 Data collection Data lite to support clinics to focus on patients Use existing systems to collect data Notifications for HIV & STIs Grhanite software for remote extraction from electronic medical record e.g. HIV, STI & kidney function, select demographics Short, optional quarterly participant survey including adherence, select demographics Real-time monitoring of enrolments, HIV

16 Community mobilisation & communication

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18 1 Targeted promotion to Gay and bisexual men of diverse ethnicities

19 EPIC-NSW: A true partnership EPIC-NSW Management Committee NSW Ministry of Health The Kirby Institute Public & private clinicians, administrators, health promotion etc. ACON

20 IMPACT OF EPIC-NSW

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23 EPIC-NSW cumulative enrolments: 1 Mar Feb February 2018

24 Enrolment data demographics 98.9% Male; 98.9% Gay or bisexual 1.7% Aboriginal and/or Torres Strait Islander 94.2% reside in a major city Age at enrolment similar to new diagnoses 61% born in Australia 14% born in Asia Age at enrolment (years) % <

25 STI diagnoses at baseline, by quarter of enrolment, 1 Mar Jun

26 Evaluation: HIV notifications in NSW by exposure type, Jan 2011-Sep 2017 EPIC- NSW

27 PREPARING FOR THE FUTURE: STOCKTAKE & NEXT STEPS

28 Enablers for PrEP access Political commitment is key Partnership, not just consultation Timing Clinical trial framework allowed generic PrEP Community mobilisation Existing universal healthcare system MSM-concentrated epidemic Flexible models for implementation Data systems for monitoring and evaluation

29 PrEPIT-WA PrEPX-SA QPrEPd EPIC-NSW (& ACT) PrEPX PrEPX-Tasmania

30 Embedding PrEP into the Australian Healthcare system Now standard of care within NSW and other Australian states/territories >14,000 participants enrolled in PrEP trials True national roll-out requires federal government subsidy for TDF/FTC Recommended for funding through Australia s healthcare system on 9 February 2017 Individuals at medium to high risk Cost effective at $2,500 AUD per person per year Forms part of a comprehensive approach to sexual health & complements condom use

31 The EPIC-NSW Research Team

32 EPIC-NSW Site Coordinators

33 The EPIC-NSW team thanks the participants. EPIC-NSW is funded by the NSW Ministry of Health. We thank Gilead Sciences for providing a donation of 2000 person years Truvada for use in EPIC-NSW. Study drug is also purchased from Mylan Pty Ltd. The views expressed in this presentation do not necessarily represent the position of the Australian or NSW Governments.

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