De la eradicarea (individuala) la eliminarea (globala) VHC: Modelare pentru un Plan National de Eliminare in Romania pana in 2030

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1 De la eradicarea (individuala) la eliminarea (globala) VHC: Modelare pentru un Plan National de Eliminare in Romania pana in 2030 Liana Gheorghe Profesor de Gastroenterologie sihepatologie Universitatea de Medicina si Farmacie Carol Davila Centrul de Gastroenterologie si hepatologie Institutul Clinic Fundeni Bucuresti

2 De ce avem nevoie de o strategie globala pentru eliminarea hepatitelor virale? Contextul Global Major global public health threat Progress is inadequate, uneven and inequitable New opportunities: medicines, technologies and approaches New era of advocacy for viral hepatitis World Health Assembly requested (May 2014) Feasi ility of a d strategies eeded for the eli i atio of hepatitis B a d hepatitis C ith a ie to pote tially setti g glo al targets Added HCV in Sustainable Development Goals E d the epide i s of AIDS, TB, alaria a d.. a d o at hepatitis, water- or e diseases a d other o u i a le diseases Hepatitis alongside HIV, TB & Malaria Growing movement around hepatitis Treat e t re olutio ; ou try o e tu ; patie t de a d May 2016: The 69th WHO General Assembly launched/endorsed first Global Health Sector Strategy for Viral Hepatitis Elimination WHO draft Global Health Sector Strategy on Viral Hepatitis, Gottfried Hirnschall, Director of the WHO Department of HIV and Global Hepatitis Program

3 WHO: Glo al all for HCV eli i atio VISION DEFINITE GOAL 2030 GLOBAL TARGETS for care and management FRAMEWORKS FOR ACTION A world where viral hepatitis transmission is stopped and everyone living with HCV has access to safe, affordable, and effective prevention, care and treatment services HCV elimination as a major public health threat by Reduction in new infections & liver-related mortality - Increase in diagnosis and enhancing therapy in patients with HCV by 2030 Universal health coverage, continuum of services (from screening to diagnosis, therapy & chronic care) and a public health approach May 2016: The 69th WHO General Assembly endorsed/launched first Global Health Sector Strategy for Viral Hepatitis Elimination

4 Care sunt tintele de impact ale strategiei de eliminare a HCV & HBV pana in 2030?

5 OMS a definit 5 interventii strategice pentru eliminarea VHB & VHC ca amenintari globale pana in

6 Magnitudinea infectiei VHC in EU & Romania

7 Distributia infectiei HCV in EU: Prevalenta viremica estimata si numarul total al persoanelor infectate/tara/2015 The Europea U io HCV Colla orators* Ho ie Razavi.Lia a Gheorghe, Adria Goldis, et al. Hepatitis C virus prevale e a d level of intervention required to achieve the WHO targets for elimination in the Europena Union by 2030: A modelling study. Lancet Gastroenterol Hepatol Published on line March 14,

8 Cascada managementului infectiei C in EU (2015) Numarul annual al pacientilor tratati ineu Nou diagnosticati 7.5% anual 89% 4.6% 0.64% 4.1% 36.4% The Europea U io HCV Colla orators* Ho ie Razavi.Lia a Gheorghe, Adria Goldis, et al. Hepatitis C virus prevale e a d level of intervention required to achieve the WHO targets for elimination in the Europena Union by 2030: A modelling study. Lancet Gastroenterol Hepatol Published on line March 14,

9 Prevalenta viremica, rata de diagnostic si tratament in Eu in % 2.4% The Europea U io HCV Colla orators* Ho ie Razavi.Lia a Gheorghe, Adria Goldis, et al. Hepatitis C virus prevale e a d level of intervention required to achieve the WHO targets for elimination in the Europena Union by 2030: A modelling study. Lancet Gastroenterol Hepatol Published on line March 14,

10 Evidence-based data & date asumate pentru Romania (inputs & assumptions)

11 In 2014 am inceput colaborarea cu CDA (Homie Razavi, Amanda Sibley, Jessie Gunter, Adrian Goldis) cu scopul de a proiecta pe termen lung consecintele infectiei VHC (si VHB) in Romania in cateva scenarii : de la taking no action pana la cresterea diagnosticului, variate scenarii de acces la Tx antivirala si variate regimuri/eficacitate terapeutica CDA (Center for Disease Analysis) este o companie publica de cercetare in sanatate cu expertiza in epidemiologie si modelare a bolilor Este reputata pentru cercetarea si publicatiile in domeniul infectiei VHC Metodologie: o abordare multi-disciplinara, cercetare epidemiologica, studii avansate de modelare, analiza decizionala _ in colaborare cu experti care furnizeaza datele locale necesare de cea mai buna calitate

12 Distributia prevalentei si genotipurilor Prevalence CDA estimate based on data from 2010* Source: Nationwide study, n = 13,460; Anti-HCV prevalence Year of estimate 2008 adults (18-69) anti-hcv Prevalence 3.2% Total Cases 529, all agesrate 85% (expert input 3.3% (2.9% - 3.6%) Viremic during Meeting 2) 693,000 (637, ,000) Year of estimate Viremic Prevalence Total Cases 2008 all ages 2.7% (2.5% - 3.1%) 589,000 (541, ,000) 2.4% (1.9% - 2.7%) 523,000 (418, ,000) Genotype distribution 2016 (projected) all ages G1a G1b G1 Total G2 G3 5.4% 92.6% 98.0% 0% 0.8% G4 G5 G6 1.2% * Gheorghe L, Iacob S, Csiki E, et al. Prevalence of hepatitis C in Romania: different from European rates? J Hepatol 2008; 49:658 * Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of hepatitis C virus infection in adult population in Romania: a nationwide survey J Gastrointestin Liver Dis 2010; 19: 373-9; ** Sultana C, Oprisan G, Szmal C, et al. Molecular epidemiology of hepatitis C virus strains from Romania. J Gastrointestin Liver Dis 2011; 20:

13 Distributia prevalentei in raport cu varsta si sexul As prevalence resulted from studies was not available for all ages, a methodology was used to extrapolate HCV prevalence for older and younger age cohorts: - for older people (>74) the same prevalence as in the oldest available population was assumed - for younger age groups (<18 years old), an exponential decline in prevalence (by 25% in each age group) was used 9.0% 8.0% 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% HCV Infected Population by Age Group Romania, ,000 Viremic Cases Reported Prevalence HCV Prevalence by Age and Sex Romania, ,000 40,000 Born Populational screening? 30,000 20,000 10,000 - Male Female * Gheorghe L, Iacob S, Csiki E, et al. Prevalence of hepatitis C in Romania: different from European rates? J Hepatol 2008; 49:658 * Gheorghe L, Csiki IE, Iacob S, Gheorghe C, Smira G, Regep L. The prevalence and risk factors of hepatitis C virus infection in adult population in Romania: a nationwide survey J Gastrointestin Liver Dis 2010; 19: 373-9;

14 Incidence a fost calculata pe baza prevalentei si prin estimare raportata la tarile din jur New HCV Infections Romania, ,000 New Infections 35,000 30,000 25,000 20,000 15,000 10,000 5,000 - In 2008, there were ~19,000 cases (calculation from European CDC data) We estimate 10,400 new cases in 2017

15 Subiecti diagnosticati Anterior aprox. 90,000 pacienti viremici dg pana in 2014 Estimarea expertilor pe baza datelor CNAS & date din diverse publicatii locale Nou diagnosticati 7,500 cazuri viremice anual Estimarea expertilor & date de morbi-mortalitate din rapoartele Institutului National de Statistica si Instiutului National de Sanatate Publica

16 Pacienti tratati Pacienti tratati 2002 to 2009* - publicatii Numarul initierilor terapeutice (Raportul Comisiei de Experti a CNAS) estimare pe baza datelor expertilor 2015/2016 : inregistrarea centralizata a CNAS DAAs 2381 IFN based * Gheorghe L, Pascu O, Ceausu E, Csiki IE, Iacob S, Caruntu F, Simionov I, Vadan R. Access to Peginterferon plus Ribavirin Therapy for Hepatitis C in Romania between J Gastrointestin Liver Dis 2012; 19: ; Gheorghe L, Oral Presentation, EASL 2011, Barcelona

17 Date epidemiologice specifice/tara in EU 2015: Ratele de diagnosis si tratament in era DAA % DAA: 5750 (1.05%) IFNb: ,48% DAA: 5721 (1.046%) IFNb: ,24% The European Union HCV Collaborators* (Liana Gheorghe, Adrian Goldis). Hepatitis C virus prevalence and level of intervention required to achieve the WHO targets for elimination in the Europena Union by 2030: A modelling study. Lancet Gastroenterol Hepatol Published on line March 14,

18 Proceduri de transplant hepatic Liver Transplants Romania National Transplant Agency ( ) International Registry on Organ Donation and Transplantation ( ) % attributable to HCV based on analysis of data* Romania National Transplant Agency Statistics and data ( ). Available at: -IRODaT. International Registry on Organ Donation and Transplantation ( ) Available from: URL: Popes u I, Io es u M, Braso ea u V, Gheorghe L, et al. - Liver transplantation in Romania - Retrospective analysis of 300 cases. Annals of Fundeni Hospital 2011; 16:

19 Putem articula o strategie prin care sa trecem de la eradicarea individuala la eliminarea globala a VHC in Romania Avem instrumentele (regimuri terapeutice inovatoare) Ce se intampla daca nu facem nimic? Trebuie sa ne focalizam asupra pacientilor cu boala hepatica avansata/ciroza? Trebuie sa tratam toti pacientii infectati pentru a atinge tinta globala OMS de a elimina infectia VHC pana in 2030?

20 Ce se intampla daca nu facem nimic? Consecintele tardive ale infectiei VHC vor creste substantial de-a lungul timpului cu variate vertex-uri in functie de varsta epidemiei locale Germany France Spain England Razavi H, et al. J Viral Hepat 2014;21(Suppl.Razavi 1): et al., J of Viral Hepatitis 2014

21 In Romania, pana in 2030, numarul cazurilor viremice VHC va scadea cu 20%, in timp ce cazurile de HCC, ciroza (de)compensata si mortalitatea hepatica vor creste cu 25%, 30% si 30%, respectiv Total Infected Cases (Viremic) - Romania Liver related Deaths - Romania 3, , ,000 2, ,000 2, , , , , ,000 1,000 Scadere cu 20% 500 Crestere cu 30% - - Base Base HCC - Romania 3,000 2,500 2,000 Decompensated Cirrhosis - Romania ,500 6,000 66,700 5, ,000 1,500 3,000 1,000 2, ,000 Crestere cu 25% 1, ,900 Crestere cu 30% - Base Base Si ley A, Ha KH, A oura hed A, Gheorghe L, et al. The prese t a d future disease urde of hepatitis C irus i fe tio s ith today s treat e t paradig. J Viral Hepat 2015; 22 (Dec) (Suppl 4): doi: /jvh.12476

22 Scenariul de baza ,000 pacienti cu F2 cu co-morbiditati asociate infectiei VHC, F3 si F4 si 2,000 pacienti cu ciroza decompensata si transplant hepatic vor fi tratati cu DAAs in Treated 3,400 8,100 12,000 12,000 12,000 12,000 Newly Diagnosed 7,500 7,500 7,500 7,500 7,500 7,500 Fibrosis Stage >= F3 >= F3 >= F2 >= F2 >= F2 >= F2 Treated Age SVR 69% 90% 95% 95% 95% 95%

23 Pana in 2030, numarul total de infectii VHC va scadea cu 30% Decesele de cauza hepatica, HCC & ciroza vor scadea cu 35-40% Total Infected Cases (Viremic) Romania Decompensated Cirrhosis Romania 600,000 6, ,000 5, ,000 4, ,000 3, ,000 2,000 Scadere cu 30% 100,000 1, Base 2016 Base 2017 Base 2016 HCC Romania 3,000 2,500 2,500 2,000 2,000 1,500 1, ,000 Scadere cu 40% Base 2017 Liver Related Deaths Romania 3,000 1,000 Scadere cu 40% Scadere cu 35% Base 2016 Base 2017 Base 2016 Base 2017

24 Focus pe F4, F3 & F2 (limitat la F2 plus co-morbiditati corelate VHC) 12, based scenario Reducerea rapida a mortalitatii DAR Insuficient pentru a atinge tintele OMS Inutilitatea testarii & depistarii in absenta accesului la terapie Cum putem motiva non-interventia? Nu sunt suficient de bolnav? Trebuie sa astept sa devin cirotic sau sa apara alte complicatii/co-morbiditati care sa complice situatia mea? Pacientii cu ciroza raman la risc pentru HCC si complicatiile HTPo ei raman in supraveghere cronica cei mai s u pi di pu t de vedere al sistemului de sanatate

25 Care este nivelul de interventie necesar pentru a atinge tintele globale ale OMS pana in 2030? Fara a diagnostica mai multi pacienti si fara a extinde accesul la tratament la pacientii F2, pool-ul pacientilor eligibili va fi epuizat in scenarii au fost evaluate Mentinerea scenariului 2017: Toate asumptiile raman constante intre Indeplinirea tintelor OMS prin intensificarea diagnosticului si tratamentul tuturor celor infectati ( F0) incepand cu 2018

26 WHO Targets scenario Indeplinirea tintelor OMS in Romania necesita: Scaling up treatment to 32,000 patients annually by 2025 Scaling up diagnosis of new patients to 33,000 annually by 2025 Treating all fibrosis stages starting in 2018 High level of treatment efficiency Efforts to reduce the number of new infections through harm reduction and treatment as prevention Treated 3,400 8,100 12,000 15,000 25,000 32,000 Newly Diagnosed 7,500 7,500 10,000 22,000 25,000 33,000 Fibrosis Stage >= F3 >= F3 >= F2 >= F0 >= F0 >= F0 Treated Age SVR 69% 89% 95% 95% 95% 95%

27 Indeplinirea tintelor OMS va determina cu 85% mai putine infectii viremice pana in 2030, vor fi mai putin cu 65% HCC si ciroza decompensate comparativ cu scenariul 2017 Total Infected Cases (Viremic) Decompensated Cirrhosis 5,000 4,500 4,000 3,500 3,000 2,500 2,000 1,500 1, , , ,000 Scadere cu 85% 300, , ,000 - Base 2017 WHO Targets Base 2017 HCC Liver Related Deaths 2,500 2,500 2,000 2,000 1,500 1,500 1,000 1, Base 2017 WHO Targets WHO Targets Scadere cu 65% Base 2017 WHO Targets

28 National Action Plan: 5 strategic directions 1. Un plan national evidence-based National Action Plan & structura de guvernare Campanii de constientizare & strategie de comunicare 2. Optimizare a interventiilor Preventie Testare & diagnostic (grupuri cu risc crescut & birth cohort screening ) Link to care & intensificarea terapiei (acces universal, nivelul terapiei) 3. Abordare : o problema de sanatate publica Optimizarea serviciilor & asigurarea unui continuum Acces universal & echitabil Asigurarea fortei medicale necesare 4. Alocarea suficienta de fonduri si resurse 5. Aplicarea inovatiei de-a lungul intregului continuum - preventie, diagnostic, tratament

29 It s ti e for a tio Let s start ow!