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
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!
BACKGROUND: HIV AND HEALTHCARE IN AUSTRALIA
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
No. notifications New HIV diagnoses: Australia, 1984-2015 2500 2000 1500 1000 2412 Stable notifications 70-80% in gay and bisexual men Despite close to 90/90/90 goals 1013 500 0 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)
The NSW HIV Response 10,000 people with HIV in NSW 2012 - 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
HIV diagnoses in NSW: 2008-2015
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
DESIGN OF A PRAGMATIC CLINICAL TRIAL: EPIC-NSW
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
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
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
Behavioural eligibility criteria
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
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
Community mobilisation & communication
1 Targeted promotion to Gay and bisexual men of diverse ethnicities
EPIC-NSW: A true partnership EPIC-NSW Management Committee NSW Ministry of Health The Kirby Institute Public & private clinicians, administrators, health promotion etc. ACON
IMPACT OF EPIC-NSW
EPIC-NSW cumulative enrolments: 1 Mar 2016 11 Feb 2018 8882 18 February 2018
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) % <20 1.2 20-29 28.3 30-39 34.8 40-49 22.0 50 13.7 http://www.health.nsw.gov.au/endinghiv/documents/q3-2017-nsw-hiv-data-report.pdf
STI diagnoses at baseline, by quarter of enrolment, 1 Mar 2016-30 Jun 2017 http://www.health.nsw.gov.au/endinghiv/documents/q3-2017-nsw-hiv-data-report.pdf
Evaluation: HIV notifications in NSW by exposure type, Jan 2011-Sep 2017 EPIC- NSW
PREPARING FOR THE FUTURE: STOCKTAKE & NEXT STEPS
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
PrEPIT-WA PrEPX-SA QPrEPd EPIC-NSW (& ACT) PrEPX PrEPX-Tasmania
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
The EPIC-NSW Research Team
EPIC-NSW Site Coordinators
The EPIC-NSW team thanks the 8700+ 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.