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We know DAAs work for PWID, now what? Simplifying HCV testing, linkage to care and treatment
Associate Professor Jason Grebely
National Drug & Alcohol Research Centre, Sydney, Australia, 17th May 2018
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Disclosures • Funding and speaker fees from AbbVie, Bristol-Myers Squibb, Cepheid,
Gilead Sciences and Merck
• This presentation will include the discussion of the investigative use of medical devices (Xpert HCV Viral Load Finger Stick, Cepheid)
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Enhancing HCV testing, care and treatment in PWID
• What have we learned about DAA therapy among PWID?
• Will HCV reinfection be an issue? • Testing, diagnosis and linkage to care will be a major barrier to HCV elimination
• We must simplify our existing models of care and interventions • “One size will not fit all” – need multiple models and interventions adapted to specific
settings
• Is HCV elimination among PWID really feasible??
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What have we learned about DAA therapy among PWID?
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DAA therapy is safe and effective among PWID, even in the “real-world”
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Defining populations of PWID
Former PWID
Current PWID
PWID in OST
Current PWUD
Larney S, et al. Int Journal Drug Policy 2015. Grebely J, Hajarizadeh B, and Dore GJ Nat Rev in Gastroenterology & Hepatology 2017
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94% 94% 96% 96% 96% 92% 96% 97% 98% 96% 98% 95%
0
20
40
60
80
100
OST no OST
SVR
12 (%
)
OBV/PTV/r + DSV + RBV1
SOF/VEL/VOX4
140 149
4405 4598
SOF/LDV + RBV2
66 70
SOF/VEL3 GZR/ELB6,7
1822 1882
49 51
966 984
47 49
967 1007
269 296
299 316
People receiving OST – phase II/III trials
GLE/PIB5
151 157
2055 2099
1) Grebely J, et al ILC 2017 (FRI-236). 2) Grebely CID 2016. 3) Grebely CID 2016. 4) Grebely J, ILC 2017 (FRI-235). 5) Grebely J, INHSU 2017. 6) Zeuzem, S. Ann Intern Med 2015. 7) Dore, GJ Ann Intern Med 2016. 8) Grebely J, Hajarizadeh B, and Dore GJ Nat Rev in Gastroenterology & Hepatology 2017.
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1) Norton B, et al. Int J Drug Pol 2017. 2) Hull M, et al. INHSU 2016. 3) Alimohammadi 7th Canadian HCV Symposium 2018. 4) Bouscaillou EASL 2017. 5) Powis J. Int J Drug Policy 2017. 6) Read P. Int J Drug Policy 2017; 7) Litwin AL, et al. ILC 2017; 8) Sulkowski M, et al. ILC 2017. 9) Mazhnaya Int J Drug Policy 2017. 10) Grebely J, Hajarizadeh B, and Dore GJ Nat Rev in Gastroenterology & Hepatology 2017.
96% 89% 85% 88% 87% 82%
95% 90% 86%
0
20
40
60
80
100
SVR
12 (%
)
Norton 20171
Powis 20175
44 46
Hull 20162
89 100
Alimohammadi 20183
Read 20176
60 69
59 72
Bouscaillou 20174
153 180
215 244
SVR12 among former/recent PWID
Litwin 20177
Sulkowski 20178
142 150
88 98
971 1126
Mazhnaya 20179
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Recent PWID – The SIMPLIFY Study (SOF/VEL) • Investigator-initiated, Kirby/UNSW sponsored, international open-label trial • 19 sites, 7 countries • Study recruitment conducted through a network of drug and alcohol clinics
(n=1), hospital clinics (n=12), and community clinics (n=2) • Participants enrolled between April 2016 and October 2016
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SIMPLIFY – Study Design
• DAA treatment-naïve patients with GT1-6 chronic HCV infection (F0-4) • People with recent injecting drug use (past six months) • Participants with HIV and decompensated liver disease excluded • Electronic blister packs to monitor adherence
Sofosbuvir/velpatasvir 400/100 mg od, n=103
Week 0 Week 12 Week 24
SVR12
3 yrs
Six-monthly follow-up for reinfection
Grebely J, et al. The Lancet Gastroenterology & Hepatology 2018
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Grebely J, et al. The Lancet Gastroenterology & Hepatology 2018
0 10 20 30 40 50 60 70 80 90
100
Res
pons
e (%
)
96%
ETR 99/103
94%
SVR12
97/103
Recent PWID – The SIMPLIFY Study (SOF/VEL) • 100% injecting in past 6 months, 35% G1a, 58% G3, 9% cirrhosis, DAA-treatment naïve • No virological failures, no viral relapse, 1 case of reinfection, 4 deaths due to overdose
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Adherence among PWID needs to be optimized, but does not impact SVR
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Adherence: Median, 94%, Mean, 89% Missed doses • No missed doses (100% adherent) – 12% • 1-4 missed doses (95-<100% adherent) – 35% • 5-8 missed doses (90-<95% adherent) – 19% • 9-17 missed doses (80-<90% adherent) – 17% • ≥18 missed doses (<80% adherent) – 17%
Longest episode of non-adherence • 1 day – 43% • 2 days – 18% • 3 days – 3% • 4 days – 9% • 5 days – 2% • 6 days – 3% • ≥7 days – 11%
Grebely J, et al. Lancet Gastro Hep 2018, Cunningham EB, et al. In Preparation 2018
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Adherent Non-adherent
All participants achieved SVR
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There is no impact of drug use on SVR during DAA therapy
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SIMPLIFY – Drug use during treatment
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SIMPLIFY - Impact of OST and drug use on SVR
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We need to acknowledge and accept that HCV reinfection will occur
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What is the risk of HCV reinfection following therapy?
Not calculated among people
with recent injecting post-
therapy
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Specific issues on HCV reinfection for PWID
Razavi H, et al. INHSU Sydney, Australia 2015. Grebely J, Hajarizadeh B, and Dore GJ Nature Reviews in Gastroenterology & Hepatology 2017
• Acknowledgement: there will be cases of HCV reinfection; if there are no cases, it is not a current PWID population
• Harm reduction optimisation (NSP, OST access): HCV reinfection incidence will reflect HCV incidence in the setting
• Rapid scale-up: a slow scale-up will create HCV “susceptible” PWID without reduction in viraemic pool
• Individual-level strategies: treatment of injecting partners crucial
• Access to re-treatment: without stigma and discrimination
• Community engagement and partnership: use of peer workers
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Testing, diagnosis and linkage to care will be a major barrier to HCV elimination
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HCV testing, linkage to care, treatment
Grebely J, Hajarizadeh B, and Dore GJ Nat Rev in Gastroenterology & Hepatology 2017. Iversen J, et al. Int J Drug Pol 2017.
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Global cascade of care for chronic HCV infection - 2015
Lazarus J, Nat Rev Gastro Hep 2017
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Innovative strategies to enhance HCV testing and diagnosis are needed
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The long journey to an HCV diagnosis….
Grebely J, Applegate TA, Cunningham P, and Feld JJ Exp Rev Mol Diag 2017
Anti-HCV antibody (Physician)
Phlebotomy (Phlebotomist)
Receive diagnosis (Physician)
Central Lab
Antibody test 1-2 weeks
Phlebotomy (Phlebotomist)
Central Lab
RNA test 1-2 weeks
Receive diagnosis (Physician)
Visit #1 Visit #2 Visit #3 Visit #4 Visit #5
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Further barriers to HCV testing and diagnosis
1) Grebely J, Applegate TA, Cunningham P, and Feld JJ Exp Rev Mol Diag 2017; 2) Cox J, et al. J Viral Hepat. 2011;18:e332–340; 3) Gupta L, et al. J Gastroenterol Hepatol. 2006;21:694–699; 4) Shehab TM, et al. J Viral Hepat. 2001;8:377–383; 5) Marshall AD, et al. Int J Drug Policy. 2015;26:984–991; 6) Treloar C, et al. Drug Alcohol Rev. 2012;31:918–924.
• Poor knowledge and competence of HCV testing among many general practitioners1-4
• Poor knowledge among patients about HCV testing5-6
• Further work is needed to educate patients and providers on HCV testing (e.g. drug and alcohol settings)
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HCV antibody testing with reflex RNA testing
100% 100%
74% (100% of Ab+)
100%
56% 51%
(92% of referred)
0
20
40
60
80
100
(%)
HCV Ab+
Phlebotomy (Phlebotomist)
Receive diagnosis (Physician)
Central Lab
RNA test 1-2 weeks
Order anti-HCV antibody with reflex HCV RNA
(Physician)
RNA Tested HCV RNA+ HCV RNA+ Referred 1st appoint Sena Public Health Rep 2016
326 326 326
241 326
134 241 241 123
241
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HCV antibody testing with reflex RNA testing
100% 100%
74% (100% of Ab+)
100%
56% 51%
(92% of referred)
0
20
40
60
80
100
(%)
HCV Ab+
Phlebotomy (Phlebotomist)
Receive diagnosis (Physician)
Central Lab
RNA test 1-2 weeks
Order anti-HCV antibody with reflex HCV RNA
(Physician)
RNA Tested HCV RNA+ HCV RNA+ Referred 1st appoint Sena Public Health Rep 2016
326 326 326
241 326
134 241 241 123
241
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Advances in diagnostics and point-of-care testing
Fourati S, et al. INHSU 2017, New York, United States, September 6-8, 2017
Rapid diagnostic tests Dried blood spot testing Point of care and random access
HCV RNA testing
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Rapid HCV antibody testing
Bottero J Open Forum Inf Dis 2017
Rapid anti-HCV antibody test
(Health care worker)
Phlebotomy (Phlebotomist)
Receive diagnosis (Physician)
Central Lab
RNA test 1-2 weeks
Standard serology-based testing (n=162)
Point-of-care rapid testing (n=162)
• Single-center free testing clinic • People randomized to interventions for testing of HIV, HBV, and HCV
Aware of status 64% (n=104)
98% (n=159)
P<0.001
Linked to care 60%
90%
P=0.04
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Dried blood spot testing
Dried blood spot sample
(Health care worker)
Receive diagnosis (Physician)
Central Lab
Antibody test 1-2 weeks
Advantages Disadvantages 1) Enhances HCV testing and linkage to care 1) Still requires centralized testing 2) Avoids need for phlebotomy 2) Requires 2nd visit to get result 3) Enables reflex virological testing 3) Sometimes requires multiple pricks 4) Stable, easy to transport and store 4) May yield a lower HCV RNA titer 5) Can be used for other purposes (e.g. HIV) 6) Collection by peers or community workers
Grebely J, Applegate TA, Cunningham P, and Feld JJ Exp Rev Mol Diag 2017
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Dried blood spot testing
Dried blood spot sample
(Health care worker)
Receive diagnosis (Physician)
Central Lab
Antibody test 1-2 weeks
Advantages Disadvantages 1) Enhances HCV testing and linkage to care 1) Still requires centralized testing 2) Avoids need for phlebotomy 2) Requires 2nd visit to get result 3) Enables reflex virological testing 3) Sometimes requires multiple pricks 4) Stable, easy to transport and store 4) May yield a lower HCV RNA titer 5) Can be used for other purposes (e.g. HIV) 6) Collection by peers or community workers
Grebely J, Applegate TA, Cunningham P, and Feld JJ Exp Rev Mol Diag 2017
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Finger-stick testing for HCV RNA detection
McHugh J Clin Micro 2017, Grebely Lancet Gastro Hep 2017, Lamoury Journal of Infectious Diseases 2018
• Relatively easy-to-use point-of-care HCV RNA test – GeneXpert in many LMIC • Real-world performance for HCV RNA quantification very good
• Venepuncture HCV Viral Load – Sensitivity – 99%, Sensitivity 96%1 • Modified finger-stick assay – Sensitivity – 98%, Sensitivity 99%2 • Xpert® HCV Viral Load Fingerstick - Sensitivity – 100%, Sensitivity 100%3
• One step closer to a single-visit diagnosis (needs to be more “rapid”)
60 mins
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Moving to a single-visit hepatitis C diagnosis
Grebely J, et al Exp Rev Mol Diag 2017
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Simplification of existing models of care and interventions is critical
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What is a model of care?
WHERE WHO WHAT HOW
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Settings, services, and providers
Drug and alcohol clinics
Primary health care / GPs
Prisons
Community health centres
NSP services
Sexual health
Settings Services Providers
Task-shifting • Specialists • Drug and alcohol specialist • Primary care providers • Nurses • Pharmacists • Peer support workers • Others
Pharmacies
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Need to move towards simplified models of HCV care • Many programs for HCV treatment are built upon interferon-era
• Need to move towards simplification of existing models and management
• Not at the expense of strengthening foundation for other health priorities (e.g. drug and alcohol use)
Modified from John Dillon
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“One size will not fit all” – We need multiple models and interventions adapted to specific settings
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Why is there a drop from diagnosis to DAA therapy?
Patel RC Public Health Rep 2016
100%
73% 52%
(71% of Ab+)
0
20
40
60
80
100
(%)
1,201 1,497
1,497 938 1,497
HCV RNA+ Referred 1st appoint
Why the drop?
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Why do patients who are referred not make it to clinic?
• Barriers experienced when trying to access services (e.g., limited hours of service, long wait times, and shortage of health care practitioners)
• Lack of coverage of services
• Stigma and discrimination from past encounters with the health system • Distance from tertiary care service
• Fear of letting down their providers (e.g., missing appointments, forgetting to get blood tests, etc.).
• HCV is not always the most important priority in people’s lives
Grebely J, et al Journal of the International AIDS Society 2017
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Traditional referral model of HCV testing and treatment
Drug and alcohol clinics
Primary health care / GPs
Prisons
Community health centres
Needle and syringe
programmes
Sexual health
Pharmacies
Tertiary care hospital
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Redefining models of HCV testing and linkage to care
Drug and alcohol clinics
Primary health care / GPs
Prisons
Community health centres
Needle and syringe
programmes
Sexual health
Pharmacies
Tertiary care hospital
• Need to bring HCV care to the community where patients access services
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Enhancing testing, linkage to care, and treatment in PWID • Systematic review of interventions to enhance HCV testing, linkage to care or
treatment among PWID
• 10,116 records – 14 studies with comparative interventions included
• Interventions to enhance HCV testing • On-site testing with pre-test counselling and education • Dried-blood spot testing
• Interventions to enhance linkage to care • Facilitated referral for HCV
• Interventions to enhance HCV treatment • Integrated care for HCV and drug use delivered by a multidisciplinary team (with or without non-
invasive liver disease assessment) Bajis S, et al. International Journal of Drug Policy 2017
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We have a lot of different models - one size will not fit all… HCV testing • Peer-delivered outreach HCV testing and counselling1 • Prison-based outreach testing and counselling2 • Patient referral contact tracing programme with monetary incentive for testing3 • Rapid HCV antibody testing at community pop-up/mobile clinics or low threshold settings4-6 • DBS testing7,8 • Integrated on-site testing, counselling and education9,10 HCV linkage to care • Patient navigation and facilitated referral for HCV evaluation11-13 • Nurse-led pre-treatment assessment in prison with specialist support via telemedicine14 • Non-invasive liver disease assessment using transient elastography with facilitated referral to care7,15-17 • Integrated HCV care in drug & alcohol setting/primary care, including on-site HCV assessment with/without peer support18-23 • Community-based nurse-led HCV evaluation and liver disease assessment using transient elastography; and subsequent referral to specialist for treatment24 • HCV bridge counsellor employed to provide education, scheduling of specialist appointments, home visits to locate individuals, incentives and transportation10 • Multidisciplinary mobile clinic offering point of care testing, counselling and liver disease assessment using transient elastography6 HCV treatment uptake • Integrated HCV care in drug & alcohol setting/primary care, including on-site HCV assessment with/without peer support19,20,25 • Integrated HCV care and drug use care in primary care, with/without onsite treatment22,23,26,27 • Community-based nurse-led HCV evaluation, including ordering of blood tests and disease assessment using transient elastography; and subsequent referral to
specialist for treatment24 • Patient navigation including motivational interviewing and treatment readiness counselling13
1) Aitken CK, Drug and Alcohol Review 2002; 2) Skipper C, Gut 2003; 3) Brewer DD, Eurosurveillance 2009; 4) Conway B, J Hepatitis 2015; 5) Cosmaro ML, Infection 2011; 6) Remy AJ, U Euro Gastro J 2015; 7) O'Sullivan M, J Hepatology 2015; 8) Tait JM, J Hepatology 2013; 9) Pace CA, J Gen Int Med 2014; 10) Sena AC, Pub Health Rep 2016; 11) Trooskin SB, J Gen Int Med 2015; 12) Islam MM, J Sub Abuse Treat 2012; 13) Ford MM, Clin Inf Dis 2016; 14) Lloyd AR, Clin Inf Dis 2013; 15) Foucher J, J Viral Hep 2009; 16) Marshall A, Int J Drug Pol 2015; 17) Lambert JS, J Hepatology 2016; 18) Alavi M, Clin Infect Dis 2013; 19) Grebely J, Eur J Gastro Hep 2010; 20) Keats J, Int J Drug Pol 2015; 21) Martinez AD, J Viral Hep 2012; 22) Harris KA, J Addict Med 2010; 23) Malnick S, Israel J Psychiatry Rel Sci 2014; 24) Wade AJ, PLOS ONE 2015; 25) Newman AI, Can J Gastro 2013; 26) Seidenberg A, BMC Infect Dis 2013; 27) Woodrell C, J Addict Med2015; 28) Bajis S, et al. Int J of Drug Pol 2017.
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How to broaden access to HCV services?
• Implement HCV care services in settings where people are already accessing other services (e.g. drug treatment clinics, community clinics, prisons, NSPs)
• Outreach by specialists and/or nurses from tertiary-care hospitals
• Patient- or peer-navigators to facilitate linkage to care (or between community and hospitals)
• Education and training of providers in the community to enable broadened prescribing (e.g. drug and alcohol specialists or trained general practitioners)
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Task shifting to community-based non-specialist providers • Three hour education and training • Overall SVR12 following sofosbuvir/ledipasvir was 87% • No difference by provider type: NPs, 90%; PCPs, 88%; and specialists, 85%
Kattakuzhy S, et al. Ann Intern Med. 2017
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HCV education and training in primary care and D&A settings
http://inhsueducation.org/canada/
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Is HCV elimination among PWID really feasible?
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DAA reimbursement restrictions must be removed
Marshall A, et al. Lancet Gastroenterology and Hepatology 2017
46% >F2 (advanced disease) 17% drug/alcohol use 94% specialist prescribing
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The removal of DAA restrictions is starting to occur
Marshall A, et al. Journal of Hepatology 2018 29% >F2 (advanced disease)
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May 2015: “Access for all to highly effective HCV treatment a priority” December 2015: $AUD1 billion for HCV treatment over 5 years (2016-2020) “a watershed moment”
Health Minister: Sussan Ley
March 2015: PBAC recommends funding of IFN-free DAA regimens ($AUD15,000/ICER)
Australia one of the first countries to make “access for all” public health policy
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Features • Unrestricted DAA access; no cap on treatment numbers; cap on expenditure • Risk-sharing arrangement with pharma (2016-2020): cost/patient AU$10,000 (2016) • Involvement of non-specialists in DAA prescribing • Minimal administration for clinicians; minimal co-payment for patients (Euro 4-25/month) Development • National Hepatitis C Strategies since 2000 (4th currently, 5th soon) • Bipartisan support and political leadership • Partnership approach: government, community, clinical, academic reps • Funding of hepatitis C and drug user community organisations • General practitioner and addiction medicine clinician education since early 2000s
53
Key features and development of DAA program
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Tolerability
Effic
acy
PEG-IFN + RBV + SOF (GT 4-6) SOF/VEL (GT1-6) EBR/GZR (GT1, 4) PrOD + RBV (GT1, 4) SOF/LDV (GT1) SOF + DCV (GT1, 3) SOF + RBV (GT2, 3)
12 weeks
Australian Government-funded DAAs
Gilead Sciences, SOVALDI Australian PI, March 2015; Gilead Sciences, HARVONI Australian PI, June 2016; Bristol-Myers Squibb, DAKLINZA Australian PI, August 2016; AbbVie; VIEKIRA PAK-RBV PI, August 2016,
Merck Sharp & Dohme, ZEPATIER ARTG August 2016; Gilead Sciences, EPCLUSA Australian PI August 2017 54
8 weeks
24 weeks
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227,000
Pre-cirrhosis, naive Pre-cirrhosis, experienced Cirrhosis
Australians live with chronic HCV infection
Epidemiology of HCV in Australia: 2015
Slide from Gregory Dore
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0
5000
10000
15000
20000
25000
30000
35000
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
IFN-based IFN-free
IFN-free DAA = 61,085 (26% chronic HCV)
Initial DAA uptake encouraging
Hajarizadeh B, et al. J Gastro Hepatol 2016 [updated]
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57 Kirby Institute 2018
DAA treatment numbers have declined DAA initiations/month
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Kirby Institute 2017
Gastro ID Other specialist GP Other
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
HCV treatment in Australia: Prescriber type
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Australia – Treatment among PWID
Iversen J, et al. INHSU 2017, New York, United States, September 6-8, 2017
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81%
47%
-
25,000
50,000
75,000
100,000
125,000
150,000
175,000
200,000
225,000
250,000
Living with chronic hepatitis C
Diagnosed with chronic hepatitis C
Hepatitis C RNA tested
Received treatment in 2016
Cured in 2016
14% of those with chronic HCV at start of 2016 received treatment. Of those treated 93% were cured.
Kirby Institute, Annual Surveillance Report 2017
Hepatitis C care cascade: end 2016
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Key PWID populations for HCV elimination efforts
Former PWID N=180,000 !
with chronic HCV!
Current PWID
PWID in OST N=24,000
with chronic HCV
N=38,000 With chronic HCV
Prisoners N=40,000
Chronic HCV 25% N=10,000
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Bring HCV testing and treatment to the people…
• Community health centres
• Drug treatment services • Prisons
• Needle and syringe programmes
• Supervised consumption facilities
• Homelessness services • Hospital in-patient
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The burden of HCV among PWID is considerable
Degenhardt L, et al. Lancet Global Health 2017, Grebely, et al. Addiction 2018 Under Review
• 6.1M (3.4-9.2) PWID are living with HCV infection (39%)
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Recent injecting drug use among all people living with HCV infection
Grebely J, et al. Addiction 2018 Under Review
• Globally, people with recent injecting drug use comprise 8.5% (UI 4.6-13.1) of all HCV infections • North America (30.5%, UI 11.7-56.7) • Latin America (22.0%, UI 15.3-30.4) • Eastern Europe (17.9%, UI 8.2-30.9)
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Harm reduction services remain inadequate globally
Larney S, et al. Lancet Global Health 2017
Only 1% of PWID live in countries with high coverage of both NSP and OST
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Is global HCV elimination among PWID really feasible?
Grebely J, et al. Addiction 2018 Under Review
4 countries account for 51% of burden (Russia, United States, China, and Brazil)
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Harm reduction services remain inadequate globally
Larney S, et al. Lancet Global Health 2017
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Remaining challenges to enhance HCV care in PWID
• Implementation of strategies to enhance testing and diagnosis • Further simplification of testing and treatment
• Continue to address stigma, discrimination, and HCV awareness • Continue to engage people in care other than HCV (e.g. drug user
health)
• One size will not fit all – different settings will require different interventions
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Remaining challenges to enhance HCV care in PWID
• Need to remove disease-stage reimbursement restrictions (double restriction)
• Task shifting to community-based providers (e.g. drug and alcohol
specialists)
• Education and training of patients, front-line workers, and providers • Act regionally, but think globally (micro-elimination)
• Changes in drug policy to enable expansion of OST and NSP globally
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Kirby, UNSW Sydney Prof. Gregory Dore Dr. Evan Cunningham Dr. Tanya Applegate Mr. Francois Lamoury A/Prof. Gail Matthews Dr. Behzad Hajarizadeh Ms. Pip Marks Ms. Sophie Quiene NDARC, UNSW Sydney Prof. Louisa Degenhardt Dr. Sarah Larney Dr. Amy Peacock Dr. Janni Leung Ms. Samantha Colledge Prof. Michael Farrell
Acknowledgements
Collaborators Prof. Matt Hickman Prof. Peter Vickerman Dr. Homie Razavi Ms. Emma Day
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