AIM:To analyzes the decision whether patients with chronic hepatitis C virus (HCV) infection are treated or not.METHODS:This prospective cohort study included 7658 untreated patients and 6341 patients receiving pegylated interferon α 2a/ribavirin, involving 434 physicians/institutions throughout Germany (377 in private practice and 57 in hospital settings). A structured questionnaire had to be answered prior to the treatment decision, which included demographic data, information about the personal life situation of the patients, anamnesis and symptomatology of hepatitis C, virological data, laboratory data and data on concomitant diseases. A second part of the study analyzes patients treated with pegylated interferon α2a. All questionnaires included reasons against treatment mentioned by the physician.RESULTS:Overall treatment uptake was 45%. By multivariate analysis, genotype 1/4/5/6, HCV-RNA ≤ 520,000 IU/mL, normal alanine aminotransferase (ALT), platelets ≤ 142,500/μL, age > 56 years, female gender, infection length > 12.5 years, concomitant diseases, human immunodeficiency virus co-infection, liver biopsy not performed, care in private practice, asymptomatic disease, and unemployment were factors associated with reduced treatment rate. Treatment and sustained viral response rates in migrants (1/3 of cohort) were higher than in German natives although 1/3 of migrants had language problems. Treatment rate and liver biopsy were higher in clinical settings when compared to private practice and were low when ALT and HCV-RNA were low.CONCLUSION:Some reasons against treatment were medically based whereas others were related to fears, socio-economical problems, and information deficits both on the side of physicians and patients.

Background and Aims: Due to a high proportion of an Asian patient population in the GLOBE-study, effectiveness and safety data for Caucasian patients treated with Telbivudine for CHB in a real life setting are limited.We present here the 48 week interim analysis from study CLDT600ADE01 in Germany.Methods: Prospective ongoing multicenter non-interventional observational study from academic centers and private practices.Patients were treated for CHB with 600 mg telbivudine daily.Study documentation consisted of baseline demographics, virological data, medical history, as well as follow-up visits for virology, safety and treatment success at month 3, 6, 9, 12, and optional at month 24.Results: 273 CHB patients were enrolled into the study at date of interim analysis, 76% were HBeAg-, 62% male, median age 41 yrs, 73% were pretreated.101 patients completed the twelve month survey up to end of sept 2010.Average viral load at baseline was 1.6×10 8 log copies (HBeAg+), 1.2×10 7 log copies (HBeAg-).After 48 weeks of treatment the mean reduction in viral load was 2×10 4 log copies in HBeAg+ and 4.5×10 3 log copies in HBeAgpatients.With this reduction, 73% of all patients became HBV DNA undetectable (<300 copies/ml), with no differences between pretreated (73%) and naive patients (74%).Patients who became HBV DNA undetectable at week 24 remained negative in 97% of cases at week 48.48 week treatment with telbivudine resulted in HBeAg loss in 6/25 patients (25%).ALT levels decreased from 53±8.2 to 35±1.6 U/l (p < 0.001).Pooled safety assessment revealed no substantial new findings compared to core data sheet, AE consisted predominantly of some muscle pain.Conclusion: Telbivudine suppressed HBV replication to undetectable levels in most NUC naive and pretreated patients in field practice in Germany with good safety and tolerability profile and showed relative high HBeAg loss rates although this subgroup consists of relatively small patient numbers.It appears that European patients with lower viremia and in majority HBeAg negative CHB demonstrate a favourable outcome during Telbivudine therapy.

S. Mauss1, E. Zehnter2, D. Hueppe3, K. Kaiser4, K. Boeker5, T. Lutz6, R. Heyne7, C. John9, G. Moog9, A. Schober10, R. Pfaff11, A. Zipf12, S. Racky13, J. Lohmeyer14, B. Bokemeyer15, B. Kallinowski16, T. Witthoeft17, U. Alshuth18. 1Center For HIV and Hepatogastrenterology, Duesseldorf, 2Center of Gastroenterology, Dortmund, 3Center of Gastroenterology, Herne, 4Klinikum der Eberhard-Karls-Universitat, Tuebingen, 5Center of Gastroenterology, Hannover, 6 Infektiologikum, Frankfurt, 7Center of Gastroenterology and Livercenter, Berlin, 8Center of Gastroenterology, Berlin, 9Center of Gastroenterology, Kassel, 10Center of Gastroenterology, Goettingen, 11Center of Gastroenterology, Giessen, 12Center of Gastroenterology, Mannheim, 13Center of Gastroenterology, Bad Schwalbach, 14Justus Liebig-Universitat Giessen, Giessen, 15Gastroenterology Practice, Minden, 16Center of Gastroenterology, Schwetzingen, 17Medical Department I, Div. of Gastroenterology, University Hospital Schleswig-Holstein Campus, Luebeck, 18Roche Pharma AG, Grenzach-Wyhlen, Germany E-mail: stefan.mauss@center-duesseldorf.de