Access to treatment and disease burden

Transcription

1 Access to treatment and disease burden Robert Flisiak Department of Infectious Diseases and Hepatology Medical University in Białystok, Poland Moulin de Vernègues, August 2015

2 Disclosures Advisor and/or speaker for AbbVie, Bristol-MyersSquibb, Gilead, Janssen, Merck, Novartis, Roche

3 Quality of HCV epidemiological data 3 Gower, E. i et al. Global epidemiology and genotype distribution of the hepatitis C virus. J Hepatology 2014; 61 (suppl. 1): s45-s67

4 millions of infected Number of active HCV infections (HCV RNA positive) in countries responsible for 80% of worldwide infections 37 mln Gower, E. i wsp. Global epidemiology and genotype distribution of the hepatitis C virus, J Hepatology (2014) 4

5 HCV genotypes Smith DB, et al. Hepatology 2014; 59:

6 Global prevalence of HCV genotypes Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 Gower, E. i wsp. Global epidemiology and genotype distribution of the hepatitis C virus, J Hepatology (2014) 48% 14% 22% 13% 1% 2% 6

7 Distribution of HCV genotypes depending on income Razavi H, Gower E, Estes C, Hindman S. Global HCV Genotypes. Poster presented at: The Liver Meeting 2013; 2013 Nov 1-5; Washington, DC, United States. 7

8 Global chronic (viremic) HCV prevalence, total number of infections and HCV genotype distribution North America Europe, Western Europe, Central Europe, Eastern Asia, Central Asia Pacific, High Income Caribbean Asia, Southeast Asia, East Latin America, Central Latin America, Tropical Latin America, Southern Asia, South Australasia Latin America, Andean North Africa/Middle East Sub-S Africa, Central Sub-S Africa, Southern Sub-Saharan Africa, West Razavi H, Gower E, Estes C, Hindman S. Global HCV Genotypes. AASLD 2013; 2013 Nov 1-5; Washington, DC, 8

9 Chronic (viremic) HCV prevalence, total number of infections and HCV genotype distribution in Europe Ireland United Kingdom France Switzerland Belgium Norway Denmark Sweden Germany Austria Netherland s Finland Hungary Czech Republic Slovakia Poland Lithuania Latvia Belarus Russia Serbia Romania Georgia Estonia Turkey Armenia Albania Macedonia Luxembourg Prevalence (Viremic) 0.0%-0.6% 0.6%-0.8% 0.8%-1.3% 1.3%-2.9% 2.9%-7.8% Total Infected (Viremic) 0-200K 200K-650K 650K-1.9M 1.9M-3.5M Portugal Spain Italy Greece Slovenia Croatia Bosnia & Herzegovina Montenegro Gower, E. et al. Global epidemiology and genotype distribution of the hepatitis C virus. J Hepatology 2014; 61 (suppl. 1): s45-s679

10 The age distribution of viremic HCV cases varies by country, with younger populations seen in England, Poland and Sweden Razavi H, Waked I, Sarrazin C, et al. J Viral Hepat 2014; 21 Suppl 1:

11 Distribution of viremic cases by age and gender can be very different Poland Slovakia Bruggmann P et al. J Viral Hepatitis, 2014, 21, (Suppl. S1), 533 Russia Czech Rep 11

12 Worldwide distribution of hepatic fibrosis related to HCV infection Dore GJ, Ward JW., Thursz. J Viral Hepatitis, 2014, 21, (Suppl. S1), 1 4 Wedemeyer H, Dore GJ, Ward JW. J Viral Hepatitis, 2015, 22, (Suppl. S1),

13 Countries with a younger HCV infected population tend to have a larger proportion of F0 and F1 patients Dore GJ, Ward JW., Thursz. J Viral Hepatitis, 2014, 21, (Suppl. S1), 1 4 Wedemeyer H, Dore GJ, Ward JW. J Viral Hepatitis, 2015, 22, (Suppl. S1), 1 5

14 Treatment rate in particular countries in 2013 treatment rate = number of treated annualy / estimated total number of viremic Razavi H et al. J Viral Hepat 2014;21 Suppl 1: Hatzakis A et al. J Viral Hepat Submitted for publication 30 July

15 HCV RNA prevalence and treatment rate Treatment rate is high in countries with relatively low infecation rate 6.0% Treatment rate 5.0% 4.0% France Germany Netherlands Austria England Luxembourg 3.0% Sweden Norway Czech Republic Spain 2.0% Poland New Zealand Canada Greece Finland Switzerland Belgium Australia 1.0% Ireland Israel Turkey Mexico Portugal Brazil Denmark India Argentina South Africa 0.0% 0.0% 1.0% 2.0% Egypt Russia 3.0% 4.0% Mongolia 5.0% 6.0% 7.0% 8.0% HCV RNA prevalence Dore GJ, Ward JW., Thursz. J Viral Hepatitis, 2014, 21, (Suppl. S1), 1 4 Wedemeyer H, Dore GJ, Ward JW. J Viral Hepatitis, 2015, 22, (Suppl. S1),

16 Cascade of HCV care, based on 2013 data Sweden France 81% 68% 2.8% Germany 57% 4.8% England 35% 3.8% Curtuesy of Sarah Blech from Center of Disease Analysis 5.2% Spain 48% 2.4% Poland 15% 2.0% 16

17 Fold increase in annual diagnosis rate required to achieve HCV elimination (>90% reduction) by

18 A treatment rate of approximately 10%/year is necessary to achieve HCV elimination (>90% reduction) by 2030 that mean 2-15 fold increase of treatment rate 18

19 Approved HCV drugs in the European Union in

20 National treatment guidelines 20

21 Therapeutic options reimbursed by public health care 1) 2) 3) IFN-free regimen reimbursed for patients with decompensated cirrhosis Triple therapy reimbursed for selected professional groups Expected by the end of

22 Priority to reimbursed treatment Opinions collected from national pharma representatives 22

23 Predicted costs of reimbursed HCV treatment in Poland EUR Flisiak R. Forum Zakaźeń, April 2015 IFN dual IFN triple IFN-free 1st line 2015 IFN-free 2nd line

24 Conclusions 1. Recent epidemiological data from Europe represents good quality but it is not a case in all countries. 2. Europe can be divided into regions of low prevalence western, central and northern, moderate prevalence southern and high prevalence eastern part of the continent. 3. Predominant genotypes are 1 and Reimbursement of HCV treatment according to EASL guidelines is very divergent across the region, from reimbursement of PegIFN/RBV treatment only to IFN-free regimen for all patients. 24