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Engaging health care providers in ARV based prevention
Edwina Wright MD PhDAlfred Hospital, Monash University The Burnet Institute
World AIDS Conference,Melbourne July 2014
Symposium on ARV-based Prevention in Practice: Social and Behavioural Aspects
Picture credits provided at end of talk
• Recipient of unrestricted funding for research from Gilead, Abbott, Janssen, Boeringher Ingelheim
• Payments received for lectures for ViiV and consultancy for ViiV, Gilead, MSD and Abbott: used for research purposes only
Conflicts of Interest
Outline
• Focus on doctors & other healthcare workers involved in prescribing and providing antiretrovirals for – Treatment as Prevention (TasP) – Pre-exposure prophylaxis (PrEP)
• Address the challenges and obstacles and offer some solutions
• Non-occupational postexposure prophylaxis (NPEP)1
1. Jain and Mayer, AIDS 2014
TasP Challenges & Obstacles
• Clinicians’ perceptions around their role in HIV prevention
• Balancing duty of care to patients vs duty of care to partners and broader community
• Confidence in the science of early ART• Patients eligibility, readiness and ability to
start ART
Clinicians’ perceptions around their role in HIV preventionStrategies available in clinical practice (theoretically at least)Which strategies involve clinicians?
CLINICAL BENEFIT to INDIVIDUAL
based upon clinical, virological, immunological and
pathophysiological studies
TRANSMISSIONREDUCTION
BENEFIT to other
individualsbased on clinical
studies
TRANSMISSION REDUCTION
BENEFIT to the community
(ecological benefit)based on
observational and prospective cohort
studies
Palella,1998; Ananworanich 2012; Hunt, 2012; Zeng, 2012; Cohen , 2011, Das, 2010; Geng, 2012; Tanser, 2013; Montaner, 2014
Balancing duty of care to patients vs duty of care to partners and broader community
Risk of coercion of doctors and patients
Balancing duty to patient care vs duty to prevent HIV transmission to others and community
CLINICAL BENEFIT to INDIVIDUAL
based upon clinical, virological, immunological and
pathophysiological studies
TRANSMISSIONREDUCTION
BENEFIT to other
individualsbased on clinical
studies
TRANSMISSION REDUCTION
BENEFIT to the community
(ecological benefit)based on
observational and prospective cohort
studies
Palella,1998; Ananworanich 2012; Hunt, 2012; Zeng, 2012; Cohen , 2011, Das, 2010; Geng, 2012; Tanser, 2013; Montaner, 2014. Rodger et al, CROI 2014
Adapted from De Cock, El-Sadr NEJM, 2013
Lower levels Evidence
CD4>500 BIII
CD4 350-500
AII
CD4 <350
AI
Higher levels Evidence
Confidence in the science of early ART
Patients’ eligibilty, readiness and ability to start ART
• Identifying people eligible for TasP may not be straightforward– Sub-Saharan Africa, 34% of HIV+ participants surveyed in TEMPRANO
study were unaware of partner’s HIV status1…fear and stigma...– WHO guidelines for HIV serodifferent couples hard to implement2
• Stigma again…– Higher rates LTFU women started on ART during pregnancy vs those
started on ART following WHO stage 3/4 illness3
• ART access– Patients unable to afford ART– ART not available, or is not indicated according to country guidelines
1.Kouame et al, AIDS 2014. 2. WHO, 2013. 3. Tenthani, et al. AIDS 2014
JASON32 year old gay male, single• HIV+ 2 weeks ago• Has booked 5 month holiday starting in
3 weeks• CD4+ cells = 640/mm3
• VL = 4,500 copies/ml• Wants to start treatment now
Patient readiness and need for time to develop therapeutic relationship
Case developed by Dr David Baker for ASHM’s Early Treatment Workshop 2014
Solutions• Clinicians already play a key role in HIV prevention• Countries need to form HIV societies working in
partnership with HIV affected communities to support and educate clinicians to better understand how to fully integrate TasP into clinical setting
• Clinicians’ first responsibility is to the patient• When considering TasP in patients with CD4+ cells
• Get to know one’s patients• Socioeconomic status• Drug use/ Depression
• Recognise that stigma will shape patients’ treatment decisions
• Clinicians work with partners to remove laws that stigmatise our patients
• Resist coercionTEMPRANO Study
PrEP Challenges and Obstacles
• Clinician awareness, willingness to prescribe and experience
• Opposition and stigma• Identifying eligible patients• Monitoring patients’ health, adherence and
behaviour during PrEP therapy• Poor global access to and cost of PrEP
Clinician awareness, willingness to prescribe and experience
• Clinician willingness to prescribe PrEP– 74% willing in survey of 573 physicians in US and Canada in 20131
• Chief concerns: adherence, cost, toxicity, lack of data on PrEP use in ‘real world’
• Main risk factor that would prompt PrEP prescription was the person having an HIV+ partner not on ART
– 43% willing in survey of 56 healthcare providers in Canada in 20122
• Clinician awareness– PrEP awareness 57.5% in survey of 186 healthcare providers in
Peru3 • Clinician experience in prescribing PrEP
– 9% in USA1
1. Karris et al, CID 2014. 2.Sharma et al, Annual Canadian Conference on HIV Research 2013. 3. Tang et al, AIDS Res Hum Retroviruses 2014
Identifying eligible patients• CDC guidance document1
– Ask questions about sexual and injecting risk taking– Clues: recent STIs or pregnancy in the past 6/12
1.CDC PrEP for prevention of HIV in the United States, 2014 Clinical Practice Guideline
May be difficult for patients to provide candid answer to these questions? • Risk of disappointing doctors/ losing their trust• Risk of criminal liability in some jurisdictions and countries
Monitoring patients’ health, adherence and behaviour during PrEP therapy
• PrEP and clinical trials– Monthly bloods, surveys, drug levels, ancillary
support around adherence and behaviour• PrEP and the real world
– Capacity to evaluate acute HIV infection, toxicity, adherence and behaviour very different
– ? More difficult in low- and middle- income settings
1.CDC PrEP for prevention of HIV in the United States, 2014 Clinical Practice Guideline. 2
PrEP availability July 20141 and cost
Open label extension study Demonstration studyNew clinical trial Studies closed- futility
PRELUDE
QPrEP
1. Avaaz, 2014
Cost Truvada: A $900 month
L= licensed
L
Solutions• Clinician awareness over time• data from demonstration projects
published => clinicians informed & confident about PrEP1,2
• Licensing of PrEP drugs needed to increase clinicians’ experience with PrEP
• HIV clinicians & societies & peak bodies partner to remove laws that stigmatise our patients
1. Liu et al, CROI 2014. 2. Grant et al, Lancet ID 2014
Solutions• Involvement nurses, peers & computer-
assisted questionnaires may permit greater patient candor re sexual/ injecting practices
• Partner against stigma• Use clinical guidelines for monitoring
• PrEP only available through demonstration projects globally except US
• WHO: PrEP in MSM prevention packages1
• Clinicians/ HIV societies work with peak bodies to lobby regulators/pharma to license drugs for PrEP urgently
1. WHO, HIV Prevention, Treatment and Care for Key populations, 2014
• Clinicians are experienced in HIV prevention– Need more guidance, support and experience in area of TasP and
PrEP• Clinicians need HIV societies and strong partnerships with HIV
communities and peak bodies to optimise their role in ARV based HIV prevention– Stigma and criminalisation are key factors that will mitigate
clinicians’ efforts in ARV based HIV prevention• Await further science from START/TEMPRANO and PrEP
Demonstration Projects to build clinicians’ confidence• Rapid licensing and subsidization of PrEP drugs urgently
needed
Conclusions
Homebased testing : www.rebeccagawthorne.com.auAIDS 2014 legacy : http://gaynewsnetwork.com.au/Crossroads: http://www.australiantraveller.com/alere determine combo: http://www.alere.co.uk/sexual-health/articles/alere-determinetm-hiv-combo-customer-training-239/text.htmPrEP ribbonhttp://www.google.com.au/search? PEPimage http://www.google.com.au/search? End HIVhttp://www.baywindows.com/FENWAY-HEALTH-COMMENDS-FDA-ON-APPROVAL-OF-FTC-TDF-AS-PRE-EXPOSURE-PROPHYLAXIS-FOR-HIV-PRETasp graphic: http://www.google.com.au/search? Pronto: http://pronto.org.au/Microbicide: www.caprisa.orgneedle exchangehttp://www.canberratimes.com.au/act-news/needle-exchanges-can-curb-hep-c-20130116-2cu46.htmlsex positionshttp://www.betterworldbooks.com/position-sex-card-deck-id-1592333192.aspxIVF: http://www.google.com.au/searchBC map: www.google.com.au/searchSTART logo: http://www.thestartstudy.org/Truvada t shirt: http://gaytherapyla.com/AHF leaflet: http://www.frontiersla.com/Map: freeworldmaps.net
Picture credits