Mauss S et al., AASLD 2011, # 1338

1. LONG-TERM OUTCOME OF INTERFERON/RIBAVIRIN TREATMENT IN GERMAN REAL-LIFE SETTING: DURABLE SVR ASSOCIATED WITH LOW RATES OF LIVER-RELATED EVENTS S. Mauss1; J. Petersen2; T. Witthoeft3; H. W. Busch4; S. Christensen4; E. Zehnter5; C. John6; J. Goelz7; K. Nowok8; M. Bilzer8; D. Hueppe9 Center of HIV and Hepatogastroenterology, Duesseldorf, Germany ifi Institute, Hamburg, Germany Center of Gastroenterology, Stade, Germany Center for Interdisciplinary Medicine (CIM), Muenster, Germany Gastroenterological Practice, Dortmund, Germany Center of Gastroenterology, Berlin, Germany Center of Gastroenterology, Berlin, Germany MSD GmbH, Haar, Germany Center of Gastroenterology, Herne, Germany Mauss S et al., AASLD 2011, # 1338

2. Background & Aim Limited data exist regarding long-term durability of SVR and incidence of liver-related morbidity after treatment with peginterferon-based therapies in the real-life setting Aim: To conducted a non-interventional follow-up survey in German gastroenterological practices to determine long-term clinical outcome after interferon-based treatments in the real-life setting Mauss S et al., AASLD 2011, # 1338

3. Methods • Patients with chronic hepatitis C who achieved SVR/Non-SVR after IFN-based treatment ≥3 years ago and who are still under routine medical observation were enrolled by 45 gastroenterological centers in Germany • Significant clinical events related to progression of liver disease (liver transplant, signs of decompensated liver disease [ascites, variceal bleeding, encephalopathy], and hepatic malignancy) were recorded • Patients with documented SVR after at least 6 months following termination of IFN-based therapy were assessed for durability of undetectable serum HCV RNA Mauss S et al., AASLD 2011, # 1338

4. Patient characteristics and duration of long-term follow-up after achieving SVR / Non-SVR • From May 2009 until October 2010 N=1355 patients (male 58.0%, mean age 49.2 ±11.48 yrs) infected with G1 (62.4%), G2 (8.1%), G3 (26.3%) and G4/other (3.2%) have been enrolled • Median follow up was 4 yrs (range 3 to 8 yrs). 42 and 1313 pts were treated with conventional/pegylated IFN and ribavirin Mauss S et al., AASLD 2011, # 1338

5. Results • In total 759/1355 (56%) achieved SVR after first therapy • Only 3 SVR patients (0.4%) developed a liver-related clinical event in contrast to 31 (6.2%) Non-SVR patients • Of the 34 pts patients who had significant hepatic-related clinical events, 24 (including the 3 pts with SVR) had baseline cirrhosis Mauss S et al., AASLD 2011, # 1338

6. Frequency of liver cirrhosis before HCV-therapy and at the end of long-term follow-up Mauss S et al., AASLD 2011, # 1338

7. Liver-related events and liver transplantation during follow-up of patients with/without SVR • Interestingly, only 3 patients (0.4%) with SVR and preexisting cirrhosis developed a liver-related clinical event in contrast to 33 events (6.6%) in patients who did not achieve SVR • In addition only one patient with SVR received liver transplantation (LTX) while another patient was prepared for LTX in contrast to 6 and 13 patients in the treatment failure group Mauss S et al., AASLD 2011, # 1338

8. Patients negative for HCV-RNA at last follow-up visit • Most patients who achieved SVR after first HCV treatment continued to have undetectable HCV-RNA after a mean follow-up of 2.4±1.5 years • Similar results were obtained in the subgroup of intravenous drug user after a mean follow-up of 2.5 years. Only 5 patients became HCV-RNA detectable after a mean of 1.8 yrs (range 1 to 3 years) Mauss S et al., AASLD 2011, # 1338

9. Conclusions • SVR following treatment with conventional / pegylated IFN ± ribavirin is durable in the real-life setting, in particular also for the majority of patients under opioid maintenance • In addition, SVR almost completely eliminates morbidity by liver-related clinical events suggesting cure of chronic hepatitis C Mauss S et al., AASLD 2011, # 1338