maria cristina morelli - sifoweb.it · focus sui nuovi farmaci per epatite c bologna, 18 settembre...
Post on 19-Feb-2019
215 Views
Preview:
TRANSCRIPT
Il governo della spesa farmaceutica per la sostenibilità del SSN:
focus sui nuovi farmaci per Epatite C Bologna, 18 settembre 2015
Il Clinico: inquadramento ed epidemiologia della malattia
Maria Cristina Morelli
Gower E J Hepatol 2014; 61: s45-s57
HCV is among the most frequent active chronic infection worldwide
14 M
17 M
28 M
83 M
Epidemiology of hepatitis C virus infection in Italy:
Libro Bianco AISF 2011. Proposta per un piano nazionale per il controllo delle malattie epatiche
Time of introduction of the different HCV genotypes in Italy
Silini, J Hepatol, 1995
Genotype years
1b-2a/c ‘40- ’60
1a-3a ’70-’90 (iv drugs)
4 ‘90 (immigration, iv drugs)
Natural History of HCV disease
Complications are just beginning
Italy has the highest death rate from hepatocellular carcinoma (HCC) and cirrhosis for HCV in Europe .
Is SVR a cure ?
Morgan TR Hepatology 2010 Veldt GUT 2002
Chronich Hepatitis Cirrhosis (HALT C study)
Is SVR a cure? Meta-analysis of 29 studies in 34.653 patients with HCV infection
Hill A AASLD 2014 Boston
Is SVR a cure? Meta-analysis f 29 studies in 34.653 patients with HCV infection
Hill A AASLD 2014 Boston
HCV syndrome
HCV and insulin resistance, type II diabetes and hypertension
Younossi ZM Aliment Pharmacol Ther 2013
Webster D P Lancet 2015
HCV Therapeutics timeline
DAAs in decompensated cirrhosis
SVR1
2
Foster GR EASL 2015
15
n=5 n=5 n=2 n=3
(-8)
(+10)
CPT B CPT C
12 wk (n=30)* 24 wk (n=29)* 12 wk (n=23)* 24 wk (n=26)*
LDV/SOF in decompensated cirrhosis Change From Baseline to Follow-Up Week 4 MELD score
Flamm, AASLD, 2014, Oral #239
Market uptake of new antiviral drugs for the treatment of hepatitis C
Journal of Hepatology, Volume 49, Issue 4, 2008, 528–536
Beate Lettmeier, Nikolai Mühlberger, Ruth Schwarzer, Gaby Sroczynski, Davene Wright, Stefan Zeuzem, Uwe Siebert
Inci
denc
e of
HCV
-rel
ated
cirr
hosi
s
Deuffic–Burban S Gastroenterology, 2012
Mor
tatli
ty
Treatment impact in different countries
Benefit from therapeutic access to DAAs waiting list patients
Expected numbers of future liver graft needs for liver transplantation
Deuffic–Burban S Dig Liv Dis 2014
Sim+Sof ± RBV in Genotype 1 After Liver Transplant Real Word experience
Pungpapong S Hepatology 2015
CORAL 1: 3D+RBV in F0-F2 OLT recipients
Kwo P N Engl J Med 2014
Solar 1 & 2 LDV/SOF in Gen 1-4 OLT recipients
Manns M EASL 2015
Daclatasvir+ Sofosbuvir in severe recurrence of HCV in liver transplantation The CUPILT study
Coilly A EASL 2015
Immunosuppressive dosing changes related to hepatic function improvement
Spesa annuale complessiva media per le patologie HCV correlate in Italia.
Mennini FS 2012
DAAs effective and extended antiviral therapy • Stop progression • Can reverse decompensation • Reduce (but not eliminate) risk of HCC • Can Reduce mortality in transplant waiting list • Improve survival • Cure extra-hepatic manifestations • Ethically indisputable
Summary
top related