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

Opposition & STIGMA

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

THANK YOU*

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