1. 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

2. 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

3. Worldwide HCV Prevalence World Health Organization hepatitis C prevalence 2000 and United Nations global population Global chronic HCV infections in Mill. North America 4,0 Europe 7,0 Latein-Amerika 7,0 Africa + Middle EAST 72 Asien + Pacific 80 Estimated HCV infections worldwide 170 Million

4. 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 Ly et al. Ann Intern Med 2012; 156: 271 5 Rate per 100.000 Persons 4 3 2 1 0 1999 HIV Year 2000 2001 2002 2003 2004 2005 2006 2007 6 7 Hepatitis C Hepatitis B

5. 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

6. 2nd Gen. PI Triple Interferon -free regimens 20172016 2015 2014 Peg-IFNa- containing regimens PI = Protease Inhibitor, NUC = nucleosidic polymerase (NS5B) inhibitor, NS5A = NS5A Inhibitor, PI/r ritonavir boosted PI, RBV = Ribavirin 2013 Next wave of triple/quadruple regimens NUC Triple Phase III Treatment-naive MK5172 (PI) MK7009 (PI) Daclatasvir (NS5A) GS8558 (NS5A) Asunaprevir (PI) Faldaprvir, Simeprevir Sofosbuvir NUC + RBV Sofosbuvir ABT-450/r (PI/r)+ABT-267 (NS5A)+ABT-333 (NNUC)+RBV Daclatasvir (NS5A) + Sofosbuvir (NUC) ± RBV Next wave of all-oral regimens GS5885 (NS5A) + Sofosbuvir (NUC) + RBV GS9669 (Non-NUC) + Sofosbuvir (NUC) RBV Faldaprevir + BI 207127 + RBV Phase III HCV type 2 and 3 Asunaprevir (PI) + Daclatasvir (NS5A) + BMS791325 HCV type 1 and 4-6 Daclatasvir + Asunaprevir GS5885 + GS9451 Future HCV treatment strategies

7. North America 4,0 Europe 7,0 Latein-Amerika 7,0 Africa + Middle EAST 72 Asien + Pacific 80 Access to HCV treatment Global chronic HCV infections in Millions

8. North America 4,0 Europe 7,0 Latein-Amerika 7,0 Africa + Middle EAST 72 Asien + Pacific 80 Access to HCV treatment Global chronic HCV infections in Millions Limited access to new treatment options in countries with the highest HCV prevalence