HIV/Sexual Health Clinical Education Session.

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1 HIV/Sexual Health Clinical Education Session

2 About These Slide These slides may not be published, posted online, or used in commercial presentations without permission. Please contact for details. ASHM SSHC 2018 HIV/Sexual Health Clinical Education Centre

3 Hepatitis C and hard to reach populations Dr Phill Read Director, Kirketon Road Centre ASHM/SSHC registrar talks 2018 Phillip.read1@health.nsw.gov.au

4 Disclosures Speaking and advisory board fees MSD, Abbvie, Gilead, Jansen Research funding Gilead

5

6 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

7 Projected disease burden Source: Kirby Surveillance report 2017 Cirrhosis, death and HCC doubled over last 10 years Projected to continue to rise without intervention Impact of DAAs already being seen

8 Data based on Larney IJDP 2017, and Kirby Institute modelling 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%

9 The DAA era in Australia >43,000 initiated DAAs from March-2016-June , = >95% of residual disease Source:

10 Treatment uptake Approx 2000/month initiating Some variation state-state ACT 30%, NSW 19% total treated Sexual Health Doctors Source:

11 Kwon et al AVHEC 2017 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

12 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

13 Rapid scale up works over time Razavi H et al. INHSU 2015

14 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 Martin NK, et al. Clinical Infectious Diseases 2013

15 Engagement with AOD SETTINGS NDARC est. 93,000 (67-118,000) PWID annually 1 >50% of PWID in ANSP survey are HCV Ab positive 2 NOPSAD- (National opioid pharmacotherapy data) 34,000 individuals received OST at some point in 2016 Est % of opioid dependant users engaged in care Opioids 50% of IV drug use 1472 prescribers- 70% private AIHW- AOD dataset- does not capture primary care 134,000 individuals provided care in % of episodes ATS, 6% heroin >1/3 consults are counselling, ¼ support and information 1. NDARC 2.ANSP report Kirby Institute 2017

16 Impact of DAA treatment in NSP Source: Iversen et al INSHU, New Jersey, Sept 2017

17 OST and Hepatitis C treatment 1) Feld, J.J. N Engl J Med ) Puoti, M. AASLD ) Lalezari, J. J Hepatol ) Grebely CID ) Grebely CID ) Zeuzem, S. Ann Intern Med ) Dore, G.J. Ann Intern Med Slide courtesy Jason Grebely

18 SVR12 (%) Treating people who continue to use drugs C-EDGE CO-STAR:Elbasvir/grazoprevir GT1/4/6, treatment naïve, F0-4 On OST with additional illicit drug use % 94% / /201 0 Intention to treat 1 Per protocol 2 1. Dore GJ et al. Ann Intern Med [Epub ahead of print 9 August 2016]. 2. Dore GJ et al. EASL, April 2016, Barcelona Spain, Poster SAT-163.

19 Impact of illicit drug use on SVR in CO-STAR Dore, et al. Ann Int Med 2016

20 Urine drug screen: Baseline & on-treatment Adapted from Dore GJ et al. Ann Intern Med [Epub ahead of print 9 August 2016].

21 Treatment adherence Number of missed doses Number (%) of patients with missed doses Immediate treatment arm (n=199) 66/70 54/56 49/51 Deferred treatment arm (n=97) (76.9) 80 (82.5) 1 23 (11.6) 8 (8.2) 96.5% 96.9% 2 8 (4.0) 6 (6.2) 3 8 (4.0) (0.5) 3 (3.1) (1.0) (0.5) (0.5) (1.0) Adapted from Dore GJ et al. AASLD, November 2015, San Francisco CA. Abstract 40.

22 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

23 SVR12 among former/recent PWID treated with DAAs Real World Experience 100% 90% 80% 70% 96% 89% 88% 82% 95% 90% 87% 60% 50% 40% 30% 20% 10% % Norton 2017 Hull 2016 Bouscaillou 2017 Read 2017 Litwin 2017 Mazhnaya 2017 Mason ) 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 ) Mazhnaya et al Intl J Drug Pol 2017; 7) Mason et al Intl J Drug Pol 2017

24 Injecting profile of Kirketon Road Centre clients initiating DAAs Slide design courtesy Greg Dore

25 Treatment Outcomes Virological outcomes ITT 72% Per protocol SVR12 100% Commenced Rx SVR12 due SVR12 taken SVR12 Not detected 37 No SVR12

26 Reasons for no SVR12 test 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 p=0.042) Poly-drug use (OR 3.3, 95%CI p=0.109) Neither significant in MV analysis Homelessness associated with late SVR12 aor %CI , p=0.004

27 Adherence and outreach support 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

28 Adherence to daily dosing Chronister et al AVHEC 2017

29 REAL WORLD EFFICACY: AUSTRALIA Network of treatment services across NSW, Victoria, QLD and SA n=1618 Source:

30 CHAMPS study incentives and peer support 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 Week 0 Week 8 BL Week 12 Week 24 Usual care (nurse) Sofosbuvir/ledipasvir 400/90 mg od, n=36 SVR 12 Usual care + incentives Sofosbuvir/ledipasvir 400/90 mg od, n=54 SVR 12 Usual care + peer mentors Sofosbuvir/ledipasvir 400/90 mg od, n=54 SVR Sulkowski M, et al. ILC 2017, Amsterdam, The Netherlands, April rd, 2017 (SAT-228)

31 Initiating treatment (%) CHAMPS study DAA treatment uptake HCV genotype 1, 12% cirrhosis, 25% recent cocaine/heroin use 100 P= % 76% 83% /36 Usual care (nurse) 41/54 45/54 UC + incentives UC + peer support Adjusting for drug use, ART use, and number of missed visits, peer support was associated with 60% higher likelihood of initiating treatment 29 Sulkowski M, et al. ILC 2017, Amsterdam, The Netherlands, April rd, 2017 (SAT-228)

32 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 Marshall A, et al. Int J Drug Policy 2015

33 Enhanced liver disease assessment FibroScan Pilot phase in 4 clinics (n=253) 70% HCV RNA % 21% 90% Average age Male Aboriginal ethnicity Born in Australia 7% 27% 51% 66% Full or part time employment Completed high school or higher education Rented housing Ever been in prison 33% in the last 12 months 60% returned for specialist assessment Marshall A, et al. Int J Drug Policy 2015

34 Incentives/pyramid selling

35 Aboriginal program Itha mari 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

36

37 Hepatitis C

38 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

39 Connecting services: Homelessness

40 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) Masson CL, et al. Am J Pub Health 2013

41 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.

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