hiv/sexual health clinical education session...number of people living with hcv • pre daas- est...
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HIV/Sexual HealthClinical Education Session
http://courses.ashm.org.au/HIV/hiv-sexual-health-clinical-education-session/
ASHM SSHC 2018 HIV/Sexual Health Clinical Education Centre
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Hepatitis C and“hard to reach” populations
Dr Phill Read
Director, Kirketon Road Centre
ASHM/SSHC registrar talks 2018
Disclosures
• Speaking and advisory board fees• MSD, Abbvie, Gilead, Jansen
• Research funding• Gilead
Number of people living with HCV
• Pre DAAs- est 227,000
• 2% with HCV attending NSPs
treated annually
• 10,000 new notifications/yr
• 82% diagnosed
• 30-40k undiagnosed
• Aboriginal notification 5x higher
• 90% new infections in PWUD
Source: Kirby Surveillance report 2017
Projected disease burden
• Cirrhosis, death and HCC doubled over last 10 years
• Projected to continue to rise without intervention
• Impact of DAAs already being seenSource: Kirby Surveillance report 2017
High risk populations for HCV
• 75,000 people living with HCV in “high-risk” populations, and potentially at risk of reinfection if scale up not rapid
• Also means >100,000 untreated people not currently in those populations
• Proportion undiagnosed 18%
Data based on Larney IJDP 2017, and Kirby Institute modelling
The DAA era in Australia• >43,000 initiated DAAs from March-2016-June 17
Source: https://kirby.unsw.edu.au/sites/default/files/kirby/report/Monitoring-hep-C-treatment-uptake-in-Australia_Iss8-DEC17.pdf
6000170,000
= >95% of residual disease
Treatment uptake
• Approx 2000/month initiating
• Some variation state-state
• ACT 30%, NSW 19% total treated
Sexual Health Doctors
Source: https://kirby.unsw.edu.au/sites/default/files/kirby/report/Monitoring-hep-C-treatment-uptake-in-Australia_Iss8-DEC17.pdf
Progress towards WHO targets
• Incidence of chronic HCV infections: 90% reduction
• Treatment of HCV (coverage %): 80% of eligible treated
• Deaths from chronic HCV infections: 65% reduction
Kwon et al AVHEC 2017
People who inject drugs
• Not excluded
• Crucial to elimination
• Succeed with good support
• Est. 45,000 PWID with HCV
• 8% treated per year• Reduce prevalence to 5%
• Reinfection re-treatable
• Harm reduction crucial
Reference: Martin et al Hepatology 2013 http://onlinelibrary.wiley.com/doi/10.1002/hep.26431/full
Rapid scale up works over time
Razavi H et al. INHSU 2015
Martin NK, et al. Clinical Infectious Diseases 2013
NSP and OST help to optimize HCV TasP
To achieve 60% reduction in prevalence 45/1000 treated per year reduces to 20/1000/yr with high coverage NSP and OST
• NDARC est. 93,000 (67-118,000) PWID annually1
• >50% of PWID in ANSP survey are HCV Ab positive2
• AIHW- AOD dataset- does not capture primary care• 134,000 individuals provided care
in 2015-16
• 23% of episodes ATS, 6% heroin
• >1/3 consults are counselling, ¼ support and information
Engagement with AOD SETTINGS
NOPSAD- (National opioid pharmacotherapy data)34,000 individuals received OST at some point in 2016
Est. 40-50% of opioid dependant users engaged in care
Opioids ≈50% of IV drug use
1472 prescribers- 70% private
1. NDARC www.brise.com.au, 2.ANSP report Kirby Institute 2017
Impact of DAA treatment in NSP
Source: Iversen et al INSHU, New Jersey, Sept 2017
OST and Hepatitis C treatment
1) Feld, J.J. N Engl J Med 2014. 2) Puoti, M. AASLD 2014. 3) Lalezari, J. J Hepatol 2015. 4) Grebely CID 2016. 5) Grebely CID 2016. 6) Zeuzem, S. Ann Intern Med 2015. 7) Dore, G.J. Ann Intern Med 2016.
Slide courtesy Jason Grebely
C-EDGE CO-STAR:Elbasvir/grazoprevirGT1/4/6, treatment naïve, F0-4
On OST with additional illicit drug use
0
10
20
30
40
50
60
70
80
90
100
189/201
Intention to treat1 Per protocol2
184/201
92% 94%
SVR
12
(%
)
1. Dore GJ et al. Ann Intern Med [Epub ahead of print 9 August 2016]. 2. Dore GJ et al. EASL, 13–17 April 2016, Barcelona Spain, Poster SAT-163.
Treating people who continue to use drugs
Impact of illicit drug use on SVR in CO-STAR
Dore, et al. Ann Int Med 2016
Urine drug screen: Baseline & on-treatment
Adapted from Dore GJ et al. Ann Intern Med [Epub ahead of print 9 August 2016].
Treatment adherence
66/70 54/56 49/51
Number (%) of patients with missed doses
Number of missed dosesImmediate treatment arm
(n=199)
Deferred treatment arm
(n=97)
0 153 (76.9) 80 (82.5)
1 23 (11.6) 8 (8.2)
2 8 (4.0) 6 (6.2)
3 8 (4.0) 0
4 1 (0.5) 3 (3.1)
5 0 0
6 2 (1.0) 0
7 1 (0.5) 0
8 1 (0.5) 0
9 0 0
10 0 0
11 2 (1.0) 0
≥12 0 0
96.5% 96.9%
Adapted from Dore GJ et al. AASLD, 13–17 November 2015, San Francisco CA. Abstract 40.
Active PWID; no OST requirement• SIMPLIFY Study: 12 weeks sof/velpatasvir- recent (6
month) injecting drug use 57% on OST
Grebely et al EASL 2017
SVR12 among former/recent PWID treated with DAAs –Real World Experience
96%
89% 88%
82%
95%90% 87%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Norton2017
Hull2016
Bouscaillou2017
Read2017
Litwin2017
Mazhnaya2017
Mason2017
4446
215244
142150
9711126
6069
89100
5972
1) Norton B, et al Intl J Drug Pol 2017; 2) Hull M et al. INSHU 2016; 3) Bouscaillou et al EASL 2017; 4) Read et al Intl J Drug Pol 2017; 5) Litwin et al. EASL 2017 6) Mazhnaya et al Intl J Drug Pol 2017; 7) Mason et al Intl J Drug Pol 2017
Injecting profile of Kirketon Road Centre clients initiating DAAs
Slide design courtesy Greg Dore
Treatment Outcomes
176
133
96 96
37
0
20
40
60
80
100
120
140
160
180
200
Commenced Rx SVR12 due SVR12 taken SVR12 Notdetected
No SVR12
Virological outcomes
Per protocol SVR12 100%ITT 72%
• 133 due: 37 not tested• 4 died during treatment- 3 drug
overdose, 1 unknown cause
• 6 lost to follow-up on treatment
• 1 deferred treatment and SVR12 date postponed
• 1 pending (Successful ETR)
• 25 completed treatment but late for SVR12• 6 less than 12 weeks late
• Associations with no SVR12 test• Homelessness (OR 3.7, 95%CI 1.0-
12.9 p=0.042)
• Poly-drug use (OR 3.3, 95%CI 0.8-13.9 p=0.109)
• Neither significant in MV analysis
• Homelessness associated with late SVR12 • aOR 25.4 95%CI 2.8-234.7,
p=0.004
Reasons for no SVR12 test
• 61% managed monthly treatment• Telephone support
• 39% utilised intensive support• Daily dosing at KRC• Pick up medication weekly dosette box• Arrange dispensing through another facility• Delivery of medications to prison,
psychiatric units, police cells, homeless hostels
• Monitoring in outreach settings• Picking up medications at pharmacy
• Importance of primary health care model
• 25% first engaged on outreach
• 36% had some care delivered in an outreach setting• NSP
• Injecting centre
• User organisations
• Aboriginal programs
• Homeless hostels
Adherence and outreach support
Adherence to daily dosing
Chronister et al AVHEC 2017
REAL WORLD EFFICACY: AUSTRALIA • Network of treatment services across NSW, Victoria, QLD and SA
n=1618
Source: https://kirby.unsw.edu.au/sites/default/files/kirby/report/VHCRP_REACH-C_Newsletter_Iss1-JUL17.pdf
Sulkowski M, et al. ILC 2017, Amsterdam, The Netherlands, April 19-23rd, 2017 (SAT-228)
• RCT, genotype 1, HIV-infected and history of injecting drug use
• Incentives: Escalating incentives up to $220 contingent on adherence every 2 weeks
• Peer mentor group: structured interactions with trained HIV-infected peers
CHAMPS study – incentives and peer support
28
Sofosbuvir/ledipasvir400/90 mg od, n=36
Week 0Week 24
SVR12
Week 8Week 12BL
Usual care (nurse)
Sofosbuvir/ledipasvir400/90 mg od, n=54
SVR12
Usual care + incentives
Sofosbuvir/ledipasvir400/90 mg od, n=54
SVR12
Usual care + peer mentors
Sulkowski M, et al. ILC 2017, Amsterdam, The Netherlands, April 19-23rd, 2017 (SAT-228)
CHAMPS study – DAA treatment uptake
29
0
10
20
30
40
50
60
70
80
90
100
Init
iati
ng
tre
atm
en
t (%
) 67%
Usual care (nurse)
24/36
76%
UC + incentives
• Adjusting for drug use, ART use, and number of missed visits, peer support was associated with 60% higher likelihood of initiating treatment
41/54 45/54
83%
P=0.11
UC + peer support
• HCV genotype 1, 12% cirrhosis, 25% recent cocaine/heroin use
Marshall A, et al. Int J Drug Policy 2015
Engagement in HCV pre-treatment work-up: Fibroscans
• Health promotion focus on liver health in drug & alcohol clinics
• Implementation phase: four clinics; one day per week for four weeks, with subsequent clinical follow-up
• Components: Promotion of Fibroscan, resource materials (posters, video, booklets); knowledge survey
www.liverlife.org.au
Marshall A, et al. Int J Drug Policy 2015
Enhanced liver disease assessment – FibroScan®
Male
68%
Average age
43Aboriginal ethnicity
21%Born in Australia
90%
Completed high school or higher education
27%Full or part time
employment
7%
Rented housing
51%Ever been in prison
33% in the last 12 months
66%
• Pilot phase in 4 clinics (n=253) 70% HCV RNA+
• 60% returned for specialist assessment
Incentives/pyramid selling
Aboriginal program “Itha mari”
• 2004- Itha mari• Barkindji “this way in the right direction”
• Holistic model- wellbeing, not disease focussed
• Client centred- set agenda• Decide which issues are important
• Which barriers exist
• What local solutions might work
• Activities/health promotion:• Groups- including on liver health
• Lunches- NAIDOC week
• Workshops
• Art
• Storytelling
• Movies
Hepatitis C
Features of program• Employment of Aboriginal staff to drive program• Issues and content determined by Aboriginal clients• Aboriginal reference group- key partner organisations• Aboriginal representation on consumer committee• Outreach to clients
• Wayside Chapel Aboriginal program• Medically supervised injecting centre• Street based nightly outreach
• Informed by evidence• Testing experience• Appropriate explanation• Aboriginal support• Access to research
Connecting services: Homelessness
Masson CL, et al. Am J Pub Health 2013
Hepatitis care coordination
• RCT of participants attending OST clinics (n=489)
• Intervention arm received on-site screening, enhanced education and counselling, and case management services
Those receiving intervention more likely to be linked to care 6-months post-follow-up (OR = 4.10; 95% CI = 2.35, 7.17)
Summary• Impressive achievements so far:
• Access• Uptake• Community acceptability and engagement• Research demonstrating many differing populations can do well- PWID, OST
• If personal health, public health and elimination targets are to be achieved• Continued high rates of treatment• Non gastro/ID settings crucial• AOD, primary care, sexual health, prison• Sexual health clinicians are particularly well placed to diagnose, support and treat people
living with HCV• Need to diagnose the undiagnosed• “Harder to reach” requires acceptable, accessible, affordable, culturally informed and
equitable care models that don’t have a silo approach.