Transcript ELPA Symposium Compassionate Use in Hepatitis C Saving

ELPA Symposium
Compassionate Use in Hepatitis C
Saving lives of patients who cannot wait
Thomas Berg
Section of Hepatology
Clinic for Gastroenterology and Rheumatology
Department of Internal Medicine
University Clinic Leipzig
Liver- and Study Center Checkpoint, Berlin
ELPA Symposium - AGENDA
Compassionate Use in Hepatitis C
Saving lives of patients who cannot wait
The view from….
EASL (Prof. D. Prati)
Patients with HCV/HIV (L. Mendao)
EMA (F. Josephson)
Infectious Disease Specialist (Prof. M. Puoti)
Bulgarian Ministry of Health (D. Dimitrova)
A living example (I. Gardini)
Summary and Recommendations (Prof. T. Berg)
Panel Discussion
Worldwide HCV Prevalence
Global chronic HCV infections in Mill.
North America
4,0
Europe
7,0
Asien
+
Pacific
80
Latein-Amerika
7,0
Africa +
Middle EAST
72
Estimated HCV infections worldwide
170 Million
World Health Organization hepatitis C prevalence 2000 and United Nations global population
Increasing HCV-associated mortality in the US
Yearly age-adjusted mortality rate due to HBV-, HIV- and HCV-infection in the
US between 1999 and 2007
7
HIV
Rate per 100.000 Persons
6
5
4
Hepatitis C
3
2
Hepatitis B
1
0
1999
2000
2001
2002
2004
2003
Year
2005
2006
2007
Ly et al. Ann Intern Med 2012; 156: 271
Effect of achieving a SVR on the
HCV-induced mortality
Backus LI et al. Clin Gastroenterol Hepatol 2011; 9: 509
HCV Type 1
SVR = sustained virologic response
Future HCV treatment strategies
Phase III
Treatment-naive
Next wave of triple/quadruple regimens
Asunaprevir (PI)
Peg-IFNacontaining
regimens
2nd Gen. PI Triple
MK5172 (PI)
Faldaprvir,
Simeprevir
MK7009 (PI)
NUC Triple
Sofosbuvir
HCV type 1 and 4-6
2013
2014
Phase III
Interferon
-free
regimens
Daclatasvir (NS5A)
GS8558 (NS5A)
Daclatasvir + Asunaprevir
GS5885 + GS9451
2015
2016
2017
Next wave of all-oral regimens
NUC + RBV
ABT-450/r (PI/r)+ABT-267 (NS5A)+ABT-333 (NNUC)+RBV
Sofosbuvir
HCV type 2 and 3
Faldaprevir + BI 207127 + RBV
Daclatasvir (NS5A) + Sofosbuvir (NUC) ± RBV
GS5885 (NS5A) + Sofosbuvir (NUC) + RBV
GS9669 (Non-NUC) + Sofosbuvir (NUC) RBV
Asunaprevir (PI) + Daclatasvir (NS5A) + BMS791325
PI = Protease Inhibitor, NUC = nucleosidic polymerase (NS5B) inhibitor, NS5A = NS5A Inhibitor, PI/r ritonavir boosted PI, RBV = Ribavirin
Access to HCV treatment
North America
4,0
Europe
7,0
Asien
+
Pacific
80
Africa +
Middle EAST
72
Latein-Amerika
7,0
Global chronic HCV infections in Millions
Access to HCV treatment
North America
4,0
Europe
7,0
Asien
+
Pacific
Limited access to new treatment options in countries with the highest HCV 80
prevalence
Africa +
Middle EAST
72
Latein-Amerika
7,0
Global chronic HCV infections in Millions