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