A national multidisciplinary healthcare network for treatment of hepatitis C in PWID in Slovenia

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1 A natonal multdscplnary healthcare network for treatment of hepatts C n PWID n Slovena Prof. Mojca Matčč, MD, PhD Clnc for Infectous Dseases and Febrle Illnesses Unversty Medcal Centre Ljubljana Slovena INHSU Conference Sydney, October 8, 2015

2 Dsclosure Wthn the last 36 months: Lecturer: Abbve, Bayer, Boehrnger-Ingelhem, Janssen, Merck, Roche Manuscrpt preparaton: Abbve, Glead, Janssen, Merck, Roche Travel/accommodatonal meetng expences: Abbve, Glead, Janssen, Merck, Roche No conflct of nterest regardng ths presentaton

HCV prevalence n the general populaton of Europe WHO Evrope: 15 mllon HCV RNA postve Ant-HCV prevalence n general populaton: 0.4 5.

3 HCV prevalence n the general populaton of Europe WHO Evrope: 15 mllon HCV RNA postve Ant-HCV prevalence n general populaton: % Deaths related to HCV nfecton: / year SLOVENIA ECDC Techncal Report. Hepatts B and C n the EU neghbourhood: prevalence, burden of dsease and screenng polces. 2010;1 26 Hope VD et al. Epdemol Infect. 2014;142:

Current treansmsson route of HCV cases n EU/EEA countres, 2012 In 2015: new nfectons not common n general populaton major problem people who nject drugs (PWID) Route of transmsson: njectng

4 Current treansmsson route of HCV cases n EU/EEA countres, 2012 In 2015: new nfectons not common n general populaton major problem people who nject drugs (PWID) Route of transmsson: njectng drug use 78.1% Terrault NA, et al. Hepatology 2013;57:881 9 Thomas SL, et al. Int J Epdemol 1998;27: Prat et al, J Hepatol 45 (2006) Shepard CW, et al. Lancet Infect Ds 2005;5:558 67

5 HCV seroprevalence among PWID n the EU black squares are data wth natonal coverage, blue trangles are data wth sub-natonal (local, regonal) coverage. EMCDDA, 2013 (

6 Proporton (%) of HCV undagnosed PWID n Europe Wessng L et al. PLoS One 2014; 9(7):e103345

7 Proporton (%) of PWID co-nfected wth HCV and HIV Wessng L et al. PLoS One 2014; 9(7):e

8 Proporton (%) of HCV-nfected PWID n Europe enterng antvral treatment n observatonal studes n non-clncal settngs Wessng L et al. PLoS One 20714; 9(7):e Wessng L et al. PLoS One 2014; 9(7):e

9 Natonal level actvtes on HCV management A survey of 33 European countres N Natonal strategy, 12 (11 PWID) y y y N *Scotland was treated separately from UK Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6):

10 Natonal level actvtes on HCV management A survey of 33 European countres y Natonal strategy,12 (7 PWID) Natonal acton plan, 10 (7 PWID) y y N *Scotland was treated separately from UK Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6):

11 Natonal level actvtes on HCV management A survey of 33 European countres Natonal y strategy, 12 (10 PWID) Natonal acton plan, 10 (7 PWID) Natonal treatment gudelnes, 24 (20 PWID) y y N *Scotland was treated separately from UK Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6):

12 A survey of 33 European countres Matcc M, et al. BMC Infect Ds 2014; 14(Suppl 6):

SLOVENIA Gross natonal ncome per capta (2012): 27,240 $ Lfe expectancy at brth m/f (2011): 77 / 83 years Probablty of dyng under fve (2012): 3 / 100 000

(2011): 9.1 % GDP Inhabtants: 2 mllon Drug users: est. 10 000 PWID: est. 6 000 http://www.who.nt/countres/svn/en/ http://ecdc.europa.

13 SLOVENIA Gross natonal ncome per capta (2012): 27,240 $ Lfe expectancy at brth m/f (2011): 77 / 83 years Probablty of dyng under fve (2012): 3 / Probablty of dyng between 15 and 60 years m/f (2011): 118/51 / Total expendture on health/capta (2011): 2,519 Intl $ Total expendture on health as (2011): 9.1 % GDP Inhabtants: 2 mllon Drug users: est PWID: est Hope VD et al. Epdemol Infect. 2014;142: Seme K et al. J Med Vrol 2009; 81: Razav H et al. J Vral Hep 2015 (n press).

14 SLOVENIA Ant-HCV prevalence by selected groups Injectng Drug Users Hemophllacs Prson nmates HIV-postves Hemodalyss Health care workers General Populaton Adults 29 % (N=1050) HCV RNA: 15.6% 26,7 % (N=374) 26 % (N=378) 7.6 % (N=579) 1.1 % (N=1343) 0.7 % (N=281) 0.4 % (N=2 mllon) Pregnant women 0.09 % (N=31 849) Blood donors % (N=1.4 mljona) Average proporton of ant-hcv postve (%) Matcc M. JEADV 2008; Kastelc A et al. 2nd Slovenan Conference on HCV Infecton n IVDU, March 2007; Baklan Z, et al. Wen Kln Wochenschr 2004; 116(2): Koplovc B et al. Euro Survello 2015; 20(22): p=2144

15 HCV seroprevalence among PWID n the EU black squares are data wth natonal coverage, blue trangles are data wth sub-natonal (local, regonal) coverage. EMCDDA, 2013 (

16 HCV seroprevalence among PWID n the EU Slovena: Harm-reducton programmes snce the early nnetes OST snce 1995 Kastelc A, Kostnapfel T. ZdravVestn 2010, 79: EMCDDA,

17 HCV Prevalence SLOVENIA Ant- HCV seroprevalence accordng to gender and age N= % 1.4% 1.2% 1.0% 0.8% 0.6% 0.4% 0.2% 0.0% Males (2014) Females (2014) Seme K et al. J Med Vrol 2009; 81:

18 SLOVENIA Dynamcs of HCV-1 and HCV-3 genotypes N=1504 Seme K et al. J Med Vrol 2009; 81:

SLOVENIA 1993-2007 Dynamcs of HCV-1 and HCV-3 genotypes N=1504 genotype 1 = blood transfuson before 1992 OR, 3.

19 SLOVENIA Dynamcs of HCV-1 and HCV-3 genotypes N=1504 genotype 1 = blood transfuson before 1992 OR, 3.28 [95% CI, ]; P < genotype 3 = PWID OR3.71 [95% CI, ]; P < Seme K et al. J Med Vrol 2009; 81:

20 SLOVENIA Management of hepatts C An ntegrated approach Natonal Insttute of Publc Health of Republc Slovena (Mnstry of Health: Law on communcable dseases) Survellance of communcable dseases Strateges for reducng transmsson and harm (drug use) Natonal Vral Hepatts Expert Group (Interdscplnary team of hghly nvolved proffessonals, self-founded n 1997) Natonal strategy Acton plan Consensus clncal gudelnes Matčč M et al. Iss 1999; 8: Matčč M, Kastelc A. Zdrav Vestn 2009; 78:

21 SLOVENIA Natonal Vral Hepatts Expert Group Natonal strategy for complex management of HCV nfecton Testng: - specal populatons: case fndng, survellance - general populaton: voluntary free-of-charge testng (routne + campagns) Treatment: - avalablty, access, process, follow-up - systematcal analyss of treatment effcacy and safety (snce 1997) Natonal consensus gudelnes on management of HCV nfected Research Educaton (proffessonals, general populaton) Mass meda campagns (World Hepatts Day, etc.) Matčč M et al. Iss 1999; 8: Matčč M et al. Zdrav Vestn 2010; 79: Matčč M, Kastelc A. Zdrav Vestn 2009; 78:

22 SLOVENIA Management of HCV nfecton Slovenan Vral Hepatts Expert Group Natonal Healthcare Network for the Management of HCV nfecton n PWID Natonal campagns on free annonymous HCV testng Fnancal assessment of Th Modelng approach to HCV elmnaton Natonal Strategy and Consensus Gudelnes for the Management of HCV Infecton Natonal Consensus Gudelnes for HCV Treatment An update Natonal Consensus Gudelnes for HCV Treatment n PWID Natonal Consensus Gudelnes for the Optmzaton of HCV Treatment wth PEG/rba Natonal Consensus Gudelnes for HCV treatment wth new DAAs

23 SLOVENIA Clncal management of patents wth HCV nfecton 5 clncal centers for vral hepatts: nfectologsts, (hepatologsts) Refferental: Clnc for Infectous Dseases nad Februle Illnesses, Unversty Medcal Centre Ljubljana

24 SLOVENIA Clncal management of patents wth HCV nfecton THERAPY for HCV: IFN (1993) IFN/RBV (1999) PEG/RBV (2001) BOC/TVP (2012) SIMEPREVIR (2014) SOFOSBUVIR (2015) 3D (2015) SOFOSBUVIR+LEDIPASVIR (2015) Lver transplantaton (snce 1998) FINNANCING of HBV&HCV management : Publc Health Insurance System: Nomnated specalsts to prescrbe P/R, DAAs Natonal consensus gudelnes for the management of HCV nfecton Natonal regster: all the HCV treated patents (snce 1997)

25 SLOVENIA Centres for Preventon and Treatment of Drug Addcton Number of PWID managed per year Coordnaton of Centers for Preventon and Treatment of Illct Drug Abuse, Slovena 2011.

26 SLOVENIA Centres for Preventon and Treatment of Drug Addcton Number of PWID managed per year 16% HCV RNA postve 3% treated for HCV Coordnaton of Centers for Preventon and Treatment of Illct Drug Abuse, Slovena Kastelc A et al. 2 nd Slovenan Conference on HCV Infecton n IVDU, Ljubljana 2007

27 SLOVENIA 2007 Natonal healthcare network for managng HCV n PWID INTEGRATED already exstng facltes: 18 Drug Treatment Centers 5 Vral Hepatts Centers Matcc M, Kastelc A. Zdrav Vestn 2009; 78: Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6): 12-3.

28 SLOVENIA A multdscplnary team for HCV treatment n PWID Psychatrst / psychotherapst Vral hepatts specalsts: nfectologsts hepatologsts Addcton specalst Specally traned nurses HCV Treatment Clncal vrologst Counclors: socal workers peers Other support system: famly frends co-workers Clncal pharmacst Matcc M, Kastelc A. Zdrav Vestn 2009; 78: Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6): 12-3.

29 SLOVENIA Natonal Conferences HCV n PWID for ntegrated provders of HCV treatment 1 st Slovenan Conference on HCV Infecton n IVDU (Jan 2006): basc medcal and supportve educaton strateges, nterventons 2 nd Slovenan Conference on HCV Infecton n IVDU (Mar 2007): set up Natonal gudelnes for the management of HCV n IVDUs 3 rd Slovenan Conference on HCV Infecton n IVDU (Apr 2008): vulnerable groups 4 th Slovenan Conference on HCV Infecton n IVDU (Feb 2010): experences/mprovements of the Natonal gudelnes future perspectves 5 th Slovenan Conference on HCV Infecton n IVDU (Dec 2011): role of addcton programmes, new drugs for HCV, HIV and IVDUs n Slovena 6 th Slovenan Conference on HCV Infecton n PWID (Mar2015): new DAAs, ncrease HCV testng, Inauguraton of Slovene Lver Patent Assocaton Matcc M, Kastelc A. Zdrav Vestn 2009; 78: Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6): 12-3.

30 SLOVENIA Hepatts C n drug users on substtuton treatment: Natonal gudelnes for clncal management and treatment March 2007 Matcc M, Kastelc A. Zdrav Vestn 2009; 78:

31 SLOVENIA Natonal healthcare network for managng HCV n PWID An ntegrated approach Un-nfected: counsellng to prevent HCV nfecton testng for HCV nfecton (every 6-12 mths) HBV vaccnaton Drug Tretment Centre Acutely nfected: testng and quck dagnoss Chroncally nfected: treatment: dentfcaton evaluaton of readness medcal evaluaton clncal management counsellng Drug Treatment Centre Vral Hepatts Centre + Drug Treatment Centre motvaton Matcc M, Kastelc A. Zdrav Vestn 2009; 78:

32 SLOVENIA Natonal healthcare network for managng HCV n PWID An ntegrated approach Vral hepatts specalst Drug addcton therapst drug user drug user HCV RNA + HCV RNA + Frst vst Frst vst fll-n form Follow up vsts-report Follow up fll-n form Start HCV treatment Fll-n form on psychcal - report condton, adherence Monthly FU vsts - report If necessary ntroducton of psycho-soco-pharmactherapy

33 SLOVENIA Natonal healthcare network for managng HCV n PWID Wrtten communcaton between vral hepatts and drug addcton specalsts

34 SLOVENIA Natonal healthcare network for managng HCV n PWID 16% HCV RNA postve 3% treated for HCV 13% treated for HCV Coordnaton of Centers for Preventon and Treatment of Illct Drug Abuse, Slovena Matcc M, Kastelc A. Zdrav Vestn 2009; 78: Matcc M et al. Suchtmed 2013; 15: 245. Matcc M et al. BMC Infect Ds 2014; 14(Suppl 6): Strategy Network Gudelnes

35 SLOVENIA Four prospectve natonal studes on currently recommended treatment of all nave patents wth chronc hepatts C Standard of care treatment Perod % of treated PWID Among all the treated patents n Slovena Interferon % Interferon/ rbavrn % Pegnterferon/rbavrn % Natonal healthcare network for PWID 2007 Optmsed pegnterferon/rbavrn Brnovec V et al. Hepatogastroenterology 2002; 49: Brnovec V et al. Hepatogastroenterology 2004; 51:

36 SLOVENIA Four prospectve natonal studes on currently recommended treatment of all nave patents wth chronc hepatts C Standard of care treatment Perod % of treated PWID Among all the treated patents n Slovena Interferon % Interferon/ rbavrn % Pegnterferon/rbavrn % Natonal healthcare network for PWID 2007 Optmsed pegnterferon/rbavrn % Brnovec V et al. Hepatogastroenterology 2002; 49: Brnovec V et al. Hepatogastroenterology 2004; 51: Matcc M et al. Suchtmed 2013; 15: 245. Selc-Kurncc T, et al. Intervrology 2014; 57:23-30.

37 SLOVENIA HCV treatment success n PWID Optmsed PegIFN/RBV CURED: 82% Matčč M, et al.. Suchtmed 2013: 15: 245.

SLOVENIA 2008 2010 HCV treatment success n PWID Optmsed PegIFN/RBV

38 SLOVENIA HCV treatment success n PWID Optmsed PegIFN/RBV CURED: 82% Non-adherent: 4,3% Matčč M, et al.. Suchtmed 2013: 15: 245.

39 Dfferent models for HCV treatment n PWID (Peg/rba) Study HCV No of IDUs SVR SVR SVR Non- Treated at: ntatng Th All Gen 1 Gen 3 adherent Wlknson 2008 (London) Ltwn 2009 (USA) Curco 2010 (Italy) Sasadeusz 2011 (Australa) Matcc 2013 (Slovena) Drug Th Center % 45 % - 19 % Drug Th Center % 40 % 36 % NR Multdscplnary % 50 % 87 % 7 % Hepatts Th Center % 36 % 71 % 15 % Multdscplnary % 80 % 91 % 4,3 % (Natonal) Wlknson et al. Alment Pharmacol Ther 2009; 29: Ltwn et al. J Subst Abuse Treat 2009; 37: Curco et al. J Addct Med 2010; 4: Sasadeusz et al. Addcton 2011; 106: Matcc et al. Suchtmed 2013: 15: 245.

40 Dfferent models for HCV treatment n PWID (PEG/rba) Study HCV No of IDUs SVR SVR SVR Non- Treated at: ntatng Th All Gen 1 Gen 3 adherent Wlknson 2008 (London) Ltwn 2009 (USA) Curco 2010 (Italy) Sasadeusz 2011 (Australa) Matcc 2013 (Slovena) Drug Th Center % 45 % - 19 % Drug Th Center % 40 % 36 % NR Multdscplnary % 50 % 87 % 7 % Hepatts Th Center % 36 % 71 % 15 % Multdscplnary % 80 % 91 % 4,3 % (Natonal) Wlknson et al. Alment Pharmacol Ther 2009; 29: Ltwn et al. J Subst Abuse Treat 2009; 37: Curco et al. J Addct Med 2010; 4: Sasadeusz et al. Addcton 2011; 106: Matcc et al. Suchtmed 2013: 15: 245.

41 Dfferent models for HCV treatment n PWID (PEG Ifn / rba) Study HCV No of IDUs SVR SVR SVR Non- Treated at: ntatng Th All Gen 1 Gen 3 adherent Wlknson 2008 (London) Ltwn 2009 (USA) Curco 2010 (Italy) Sasadeusz 2011 (Australa) Matcc 2013 (Slovena) Drug Th Center % 45 % - 19 % Drug Th Center % 40 % 36 % NR Multdscplnary % 50 % 87 % 7 % Hepatts Th Center % 36 % 71 % 15 % Multdscplnary % 80 % 91 % 4,3 % (Natonal) Wlknson et al. Alment Pharmacol Ther 2009; 29: Ltwn et al. J Subst Abuse Treat 2009; 37: Curco et al. J Addct Med 2010; 4: Sasadeusz et al. Addcton 2011; 106: Matcc et al. Suchtmed 2013: 15: 245.

42 DAAs A game changer

43 Conclusons Natonal healthcare network for HCV treatment n PWID ncreases HCV screenng among PWID, mproves dentfcaton of HCV treatment elgble PWID and motvates others, ncreases proporton of PWID beeng treated for HCV and gans satsfactory HCV treatment adherence, effcacy and safety.

44 Conclusons Natonal healthcare network for HCV treatment n PWID ncreases HCV screenng among PWID, mproves dentfcaton of HCV treatment elgble PWID and motvates others, ncreases proporton of PWID beeng treated for HCV and gans satsfactory HCV treatment adherence, effcacy and safety. Already exstng facltes can be used to set up a natonal healthcare network and a multdscplnary team of provdrs for HCV treatment n PWID

45 Conclusons Natonal healthcare network for HCV treatment n PWID ncreases HCV screenng among PWID, mproves dentfcaton of HCV treatment elgble PWID and motvates others, ncreases proporton of PWID beeng treated for HCV and gans satsfactory HCV treatment adherence, effcacy and safety. Already exstng facltes can be used to set up a natonal healthcare network and a multdscplnary team of provdrs for HCV treatment n PWID Close cooperaton of a multdscplnary team s crucal

46 Conclusons Natonal healthcare network for HCV treatment n PWID ncreases HCV screenng among PWID, mproves dentfcaton of HCV treatment elgble PWID and motvates others, ncreases proporton of PWID beeng treated for HCV and gans satsfactory HCV treatment adherence, effcacy and safety. Already exstng facltes can be used to set up a natonal healthcare network and a multdscplnary team of provdrs for HCV treatment n PWID Close cooperaton of a multdscplnary team s crucal A comprehensve natonal polcy s needed to set up natonal strateges, acton plans and clncal gudelnes for the ntegrated management of HCV nfecton n PWID

47 Thank you!

A national multidisciplinary healthcare network for treatment of hepatitis C in PWID in Slovenia Prof. Mojca Matičič, MD, PhD

A national multidisciplinary healthcare network for treatment of hepatitis C in PWID in Slovenia Prof. Mojca Matičič, MD, PhD Clinic for Infectious Diseases and Febrile Illnesses University Medical Centre