Z Gastroenterol 2011; 49 - P349
DOI: 10.1055/s-0031-1285619

Effectiveness and safety of telbivudine in field practice: A multicenter german real-life observational study

J Petersen 1, A Zipf 2, E Schott 3, M Wiese 4, H Loehr 5, K Boeker 6, B Moeller 7, KE Pfaff 8, R Heyne 7, C John 4, JC Arnold 9, D Hueppe 10, S Mauss 11, P Buggisch 1
  • 1IFI Institute for Interdisciplinary Medicine, Asklepios Clinics St. Georg Hamburg, Hamburg, Germany
  • 2Gastro Office, Mannheim, Germany
  • 3Medicine Charité Campus Virchow, Berlin, Germany
  • 4Gastro Office, Leipzig, Germany
  • 5Gastro Office, Wiesbaden, Germany
  • 6Hepatologische Schwerpunkt Praxis, Hannover, Germany
  • 7Leberzentrum Checkpoint, Berlin, Germany
  • 8Gastro Office, Gießen, Germany
  • 9Department of Medicine, Diakonie Klinikum, Rotenburg/Wumme, Germany
  • 10Gastro Office, Herne, Germany
  • 11Hepatology Center, Düsseldorf, Germany

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 600mg 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 41yrs, 26% were pretreated. 101 patients completed the twelve month survey up to end of sept 2010. Average viral load at baseline was 1.6×108 copies (HBeAg+), 1×107 copies (HBeAg-). After 48 weeks of treatment the mean reduction in viral load was 2×104 copies in HBeAg+ and 5×103 copies in HBeAg- patients. With this reduction, 74% of all patients became HBV DNA undetectable (<300 copies/ml), with no differences between pre-treated (26%) 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 6/24 patients (25%). ALT levels decreased from 76±8.2 to 36±1.6 U/I (p<0.001). Pooled safety assessment revealed no substantial new findings compared to core data sheet.

Conclusion: Telbivudine suppressed HBV replication to undetectable levels in most NUC naive and pretreated patients in field practive in Germany 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.