De la eradicarea (individuala) la eliminarea (globala) VHC ... · De la eradicarea (individuala) la...

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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

Transcript of De la eradicarea (individuala) la eliminarea (globala) VHC ... · De la eradicarea (individuala) la...

Page 1: De la eradicarea (individuala) la eliminarea (globala) VHC ... · De la eradicarea (individuala) la eliminarea (globala) VHC: Modelare pentru un Plan National de Eliminare in Romania

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

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De ce avem nevoie de o strategie globala pentru eliminarea

hepatitelor virale ? –Contextul Global

WHO 2016-2021 draft Global Health Sector Strategy on Viral Hepatitis, Gottfried Hirnschall, Director of the WHO Department of HIV and Global Hepatitis Program

• 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

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WHO: Glo al all for HCV eli i atio

May 2016: The 69th WHO General Assembly endorsed/launched first Global Health Sector Strategy for Viral Hepatitis Elimination

VISION

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

DEFINITE

GOAL HCV elimination as a major public health threat by 2030

2030 GLOBAL

TARGETS for care

and management

- Reduction in new infections & liver-related mortality

- Increase in diagnosis and enhancing therapy in patients

with HCV by 2030

FRAMEWORKS

FOR ACTION

Universal health coverage, continuum of services (from

screening to diagnosis, therapy & chronic care) and a public

health approach

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Care sunt tintele de impact ale strategiei de eliminare a

HCV & HBV pana in 2030?

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OMS a definit 5 interventii strategice pentru eliminarea VHB

& VHC ca amenintari globale pana in 2030

http://www.who.int/hepatitis/publications/hep-elimination-by-2030-brief/en/

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Magnitudinea infectiei VHC in EU & Romania

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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 2017. Published on

line March 14, 2017 http://dx.doi.org/10.1016/S2468-1253(17)30045-6

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Cascada managementului infectiei C in EU (2015)

Numarul annual al pacientilor tratati inEU 2004-2015

36.4%

4.6% 4.1% 89%

Nou diagnosticati

7.5% anual

0.64%

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 2017. Published on

line March 14, 2017 http://dx.doi.org/10.1016/S2468-1253(17)30045-6

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Prevalenta viremica, rata de diagnostic si tratament in Eu

in 2015

41.2%

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 2017. Published on

line March 14, 2017 http://dx.doi.org/10.1016/S2468-1253(17)30045-6

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Evidence-based data & date asumate pentru Romania

(inputs & assumptions)

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• 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

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Distributia prevalentei si genotipurilor

• Prevalence – CDA estimate based on data from 2010* • Source: Nationwide study, n = 13,460;

– Anti-HCV prevalence

– Viremic Rate – 85% (expert input during Meeting 2)

– Genotype distribution

* 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 2006-2008. J Gastrointestin Liver Dis 2010; 19: 373-9;

G1a G1b G1 Total G2 G3 G4 G5 G6

5.4% 92.6% 98.0% 0% 0.8% 1.2%

** Sultana C, Oprisan G, Szmal C, et al. Molecular epidemiology of hepatitis C virus strains from Romania. J Gastrointestin Liver Dis 2011; 20: 261-6.

Year of estimate anti-HCV Prevalence Total Cases

2008 – adults (18-69) 3.2% 529,000

2008 – all ages 3.3% (2.9% - 3.6%) 693,000 (637,000 – 800,000)

Year of estimate Viremic Prevalence Total Cases

2008 – all ages 2.7% (2.5% - 3.1%) 589,000 (541,000 – 680,000)

2016 (projected) – all ages 2.4% (1.9% - 2.7%) 523,000 (418,000 – 571,000)

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Distributia prevalentei in raport cu varsta si sexul

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

8.0%

9.0%

Report

ed P

revale

nce

HCV Prevalence by Age and Sex — Romania, 2008

Male Female

-

10,000

20,000

30,000

40,000

50,000

60,000

Vir

em

ic C

ases

HCV Infected Population by Age Group — Romania, 2016

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

* 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 2006-2008. J Gastrointestin Liver Dis 2010; 19: 373-9;

Born 1945-1970

Populational

screening?

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Incidence a fost calculata pe baza prevalentei si prin

estimare raportata la tarile din jur

In 2008, there were ~19,000 cases (calculation from European CDC data)

We estimate 10,400 new cases in 2017

-

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000 N

ew In

fect

ions

New HCV Infections — Romania, 1950-2016

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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

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Pacienti tratati

• Pacienti tratati 2002 to 2009* - publicatii

• Numarul initierilor terapeutice 2012-2014 (Raportul Comisiei de Experti a

CNAS)

• 2010-2011 estimare pe baza datelor expertilor

• 2015/2016 : inregistrarea centralizata a CNAS

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

1813 2189 3701 3149 2816 2446 4503 4701 5257 5812 6368 6086 4071 3378

8131

5750

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 2002-2009. J Gastrointestin Liver Dis 2012; 19: 161-7167; Gheorghe L, Oral Presentation, EASL 2011, Barcelona

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2016

DAA: 5750

(1.05%)

IFNb: 2381

DAA: 5721

(1.046%)

IFNb: 1071

99.5%

1,48% 1,24%

Date epidemiologice specifice/tara in EU 2015:

Ratele de diagnosis si tratament in era DAA

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 2017. Published on line March 14, 2017

http://dx.doi.org/10.1016/S2468-1253(17)30045-6

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Proceduri de transplant hepatic

• Liver Transplants –

– Romania National Transplant Agency (2005-2015)

http://www.transplant.ro/Statistica.htm

– International Registry on Organ Donation and Transplantation (2000-

2004)

– 27% attributable to HCV based on analysis of data*

Romania National Transplant Agency. 2014. Statistics and data (2005-2013). Available at: http://www.transplant.ro/Statistica.htm

-IRODaT. International Registry on Organ Donation and Transplantation (2000-2004) Available from: URL: http://www.irodat.org

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: 59-67.

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

7 16 14 12 16 11 20 31 43 32 51 65 75 122 122 96 179

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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?

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Razavi et al., J of Viral Hepatitis 2014 Razavi H, et al. J Viral Hepat 2014;21(Suppl. 1):34–59.

Germany France

Spain England

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

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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

-

100,000

200,000

300,000

400,000

500,000

600,000

Total Infected Cases (Viremic) - Romania

Base

-

500

1,000

1,500

2,000

2,500

3,000

3,500

Liver related Deaths - Romania

Base

-

500

1,000

1,500

2,000

2,500

3,000

3,500

HCC - Romania

Base

-

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Decompensated Cirrhosis - Romania

Base

1900

2400

Crestere cu 25% Crestere cu 30%

2700

3400

Crestere cu 30%

6500 62,900

7500

66,700

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):21-41. doi: 10.1111/jvh.12476

Scadere cu 20%

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Scenariul de baza 2017 • 2017

– 10,000 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 2017

2015 2016 2017 2018 2019 2020

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 15-74 15-74 15-74 15-74 15-74 15-74

SVR 69% 90% 95% 95% 95% 95%

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Pana in 2030, numarul total de infectii VHC va scadea cu 30%

Decesele de cauza hepatica, HCC & ciroza vor scadea cu 35-40%

-

100,000

200,000

300,000

400,000

500,000

600,000

Total Infected Cases (Viremic) — Romania

Base 2016 Base 2017

-

1,000

2,000

3,000

4,000

5,000

6,000

Decompensated Cirrhosis — Romania

Base 2016 Base 2017

-

500

1,000

1,500

2,000

2,500

3,000

HCC — Romania

Base 2016 Base 2017

-

500

1,000

1,500

2,000

2,500

3,000

Liver Related Deaths — Romania

Base 2016 Base 2017

Scadere cu 40% Scadere cu 30%

Scadere cu 35% Scadere cu 40%

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Focus pe F4, F3 & F2 (limitat la F2 plus co-morbiditati corelate VHC)

12,000 – 2017 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

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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 2021

• 2 scenarii au fost evaluate

– Mentinerea scenariului 2017: Toate asumptiile raman constante intre 2017-2030

– Indeplinirea tintelor OMS prin intensificarea diagnosticului si tratamentul tuturor

celor infectati (≥F0) incepand cu 2018

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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

2015 2016 2017 2018 2020 2025-2030

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 15-74 15-74 15-74 15-74 15-74 15-74

SVR 69% 89% 95% 95% 95% 95%

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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

-

100,000

200,000

300,000

400,000

500,000

600,000

Total Infected Cases (Viremic)

Base 2017 WHO Targets

-

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

5,000

Decompensated Cirrhosis

Base 2017 WHO Targets

-

500

1,000

1,500

2,000

2,500

HCC

Base 2017 WHO Targets

-

500

1,000

1,500

2,000

2,500

Liver Related Deaths

Base 2017 WHO Targets

Scadere cu 85%

Scadere cu 65%

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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

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It’s ti e for a tio Let’s start ow !