MALATTIA EPATICA AVANZATA DA HCV:
ENTITA’ DEL PROBLEMA
Carlo Cammà
Cattedra di Gastroenterologia
Università di Palermo
[email protected]
WEF-E
Roma 11-12 Febbraio 2014
Epidemiology provides data
for policy and action
HCV1,2
Prevalence
185M
Incidence
4M
Mortality
0.35M
4-5M coinfected patients,
depending on location and routes of transmission
1HANAFIAH
et al, Hepatology 2013
2PERZ et al, J Hepatol 2006
Global Burden: Basics
Global data:
z Little more has been done at country level since
first WHO estimates in 1997
z 38 different HCV surveillance systems in 27 EU
countries (Rantala 2008)
z Anti-HCV > RNA positive confirmed in 40-90%
- EMCCDA. Annual report 2006
HCV infects 185 million people worldwide
HAJARIZADEH et al. Nat Rev Gastroenterol Hepatol 2013;10:553-562
NEGRO and ALBERTI. Liver Int 2011;31 Suppl 2:1-3
HANAFIAH et al. Hepatology 2013;57:1333-1342
Age-specific prevalence of HCV infection
% 5
5
Alter et al. N. Engl. J. Med. 1999
4
Dubois et al. Hepatology 1997
%
4
3
USA
3
2
2
1
1
0
FRANCE
0
6-19
20-29
30-39
40-49
50-59
> 60
20-29
Abdel-Aziz et al. Hepatology 2000
%70
30-39
40-49
50-59
45
40
60
35
50
30
40
25
30
20
15
20
EGYPT
10
ITALY
10
5
0
0
5
10
20
30
40
50
60
65
> 65
< 30
30 - 39
40 - 49
50 - 59
> 60
Estimates of HCV infected persons
in Europe
0.2
0.1
0.2
0.2
2.7
1.3
1.5
2.5
0.2
<0.5%
0.5-1.0%
1
2
0.2
1
1
0.6
1.1-1.5%
4
1
1
0.5
1.6-2.5%
1
1.3
2.6-3.5%
3
0.8
6
2
3.5
2
2
3
≥3.6%
1.5
1
2.5
Esteban JI et al. J Hepatol. 2008;48:148-62.
3
2
Epidemiology of HCV in Europe
• Prevalence varies from 0.4% in Sweden, Germany
and The Netherlands to 2-3% in some Mediterranean
Countries.
• 9 million people chronically infected with HCV (1.5
million infected with HIV).
• 86.000 deaths in 2002 because of HCV.
Muhlberger BMC Public Health 2009
Emiroglou, WHO Summit Conference October 2010
Hatzakis JVH 2011
Burden of liver disease in Europe
Review of 260 European epidemiological studies published in the
last 5 years
– Liver cirrhosis is responsible for 170,000 deaths per year, with large
inter-country variation
– Liver cancer is responsible for 47,000 deaths
– More than 5500 liver transplants per year are performed
Blachier M, J Hepatol 2013;58(3):593-608
Deaths from liver cirrhosis in Europe
Zatonski WA, Eur Addict Res 2010;16(4):193-201
Hepatocellular carcinoma in Europe
Blachier M, J Hepatol 2013;58(3):593-608
Hepatocellular carcinoma in Italy
Santi V, J Hepatol 2012; 56(2):397-405
Deaths associated with different diseases in ITALY
Disease
Deaths (n.)
Colon and rectum cancers
20,269
Breast cancers
13,222
Chronic obstructive pulmonary disease
21,527
Nephritis and nephrosis
8744
Liver cancer
9753
Cirrhosis of the liver
8165
Comparison of the number of deaths associated with selected
diseases compared to liver diseases based on death certificates (agestandardized) in Italy (population 59,6 millions)
Blachier M, J Hepatol 2013;58(3):593-608
Costi trattamento per stadi di evoluzione
della malattia epatica
Epatite cronica
€ 246,03
Cirrosi compensata
€ 347,19
Cirrosi scompensata
€ 5.465,88
Carcinoma epatocellulare
€ 6.075,46
Trapianto di Fegato
€ 150.000,00 *
Trapianto di Fegato (dopo 1° anno)
€ 4.729,29
Costo trattamento farmacologico
(P/R 48 settimane)
€ 14.750,40
* comprese le spese pre-chirurgiche ed i farmaci immunosoppressivi seguenti l’operazione
Libro Bianco AISF 2011. Proposta per un piano nazionale per il controllo delle malattie epatiche. Definizione ambiti e possibili interventi.
Full text available for download from the web site: http://www.alleanzacontroepatite.it/public/LIBRO_BIANCO_AISF_2011.pdf
Health care costs associated with
hepatitis C for 2001-2040
Life Expectancy with no Treatment
HCV-Compensated Cirrhosis vs General Population
Years of life
40
General population
38
Compensated cirrhosis
29
30
21
19
20
16
13
10
0
40
50
60
Age (years)
Wong JB. Prev Med Managed Care, 2000.
HCV: l’impegno sanitario per l’Italia
• La malattia da HCV assorbe in un anno da circa 700 milioni fino
a circa 1.200 milioni di euro
• Di questa cifra, poco meno della metà è costituita da costi
diretti:
• 26% per farmaci e 21% per spese ospedaliere e di gestione
• La spesa ospedaliera risulta molto elevata: pochi pazienti
ospedalizzati con spesa media pro capite molto elevata
• I costi diretti sostenuti dal SSN aumentano
proporzionalmente alla severità del quadro clinico
Infezione da HCV in Italia: distribuzione per stadio di malattia
Malattia lieve
(epatite cronica F0-F1)
Conoscenza dello
stato di infezione
cronica da HCV
Malattia significativa
(epatite cronica F2-F3;
Cirrosi F4, Child A)
Malattia avanzata
(Cirrosi, Child B-C,
HCC, trapianto)
Infezione da HCV in Italia: chi curiamo oggi
Malattia lieve
(epatite cronica F0-F1)
Malattia significativa
(epatite cronica F2-F3;
Cirrosi F4, Child A)
Terapie basate sull’IFN
(PEG IFN + ribavirina)
+/- boceprevir o
telaprevir
Conoscenza dello
stato di infezione
cronica da HCV
Malattia avanzata
(Cirrosi, Child B-C,
HCC, trapianto)
Markov model
SVR
Time horizon = 20 years
Life-year-gained=LYG (QALY)
 PI 1° generazione (BOC TVR)
SO-FOSBUVIR
Hepatology 2014 in press
SO-RAFENIB
Current scenario of HCV burden in Italy: 2014
Evidence of
Liver damage
Chronic
hepatitis
± cirrhosis
Asympt.
carrier
Knowledge
of
infection
Chronic
hepatitis
± cirrhosis
Asympt.
carrier
Infezione da HCV in Italia: chi cureremo domani
Malattia lieve
(epatite cronica F0-F1)
Malattia significativa
(epatite cronica F2-F3;
Cirrosi F4, Child A)
Costo – beneficio?
Conoscenza dello
stato di infezione
cronica da HCV
Malattia avanzata
(Cirrosi, Child B-C,
HCC, trapianto)
Terapie senza IFN con
DAAs +/- ribavirina
Screening
IL NUOVO
F0
F1/2
COMPENSATED
CHIRROSIS (F4)
F3
DECOMPENSATED CHIRROSIS (DC)
VARICES
BLEEDING
ASCITES
BLEEDING
HCC
LIVER TRANSPLANT
(LT)
POST LIVER
TRANSPLANT (PLT)
DEATH