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EFFICACY AND SAFETY OF PEGINTERFERON ALFA-2a OR -2b PLUS RIBAVIRIN IN THE ROUTINE DAILY TREATMENT OF CHRONIC HEPATITIS C PATIENTS IN GERMANY: THE PRACTICE STUDY
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T. Witthoeft1, D. Hueppe2, C. John3, J. Goelz4, U. Meyer5, R. Heyne6, B. Moeller6, R. Link7, G. Teuber8, S. Sworszt9, A. Herrmann10, A. Wollschlaeger11, A. Baumgarten12, K.G. Simon13, H.-J. Cordes14, G. Moog15, N. Dikopoulos16, S. Mauss17
1 Medical Department I, Div. of Gastroenterology, University Hospital Schleswig-Holstein Campus Luebeck, Luebeck, 2 Center of Gastroenterology, Herne, 3 Center of Gastroenterology, Berlin, 4 Praxiszentrum Kaiserdamm, Berlin, 5 Center of Internal Medicine, Berlin, 6 Center of Gastroenterology and Livercenter, Berlin, 7 Internal Medicine, St. Josefs-Krankenhaus, Offenburg, 8 Johann Wolfgang Goethe-
Universitaet, Frankfurt, 9 General Practice, Gelsenkirchen, 10 Friedrich Schiller-Universitaet, Jena, 11 Krankenhaus Dresden Friedrichstadt, Dresden, 12 General Practice, Berlin, 13 Center of Gastroenterology, Leverkusen, 14 Vitanus GmbH, Frankfurt/Main, 15 Center of Gastroenterology, Kassel, 16 Klinik Fu_r Innere Medizin I, Universitaetsklinikum Ulm, Ulm, 17 Center For HIV and Hepatogastrenterology Duesseldorf, Germany
ABSTRACT
Background and Aims: PRACTICE, a retrospective study analysing response to hepatitis C treatment between 2000 and 2007 in 23 German centres with high treatment rates (>20/year). In particular, the efficacy and safety of peginterferon alfa-2a/RBV (A) was compared to peginterferon alfa-2b/RBV (B).
Methods: Results were analysed by ITT and by matched pair (MP) analysis. Parameters for MP I analysis were: age; genotype; BL viral load; BMI; prior treatment history, history of drug addiction and HIV-coinfection. A second MP II analysis included cumulative RBV dosage.
Results: 3470 patients received treatment. Mean age was 42.3 yrs, 58.9% male, BMI 24.9 kg/m2, naive/relapse/non-responder 89/6/5%, source of infection (>1 answer possible): iv drug use 35.5%, medical action 6.1%, transfusion 17.8%, unknown 32.9%. See Table for virological responses. Reasons for discontinuation were non-response (58.0% in A, 65.1% in B), tolerability (18.4% in A, 14.3% in B), patient request (10.1% in A, 10.4% in B) and compliance issues (9.1% in A, 4.2% in B).
Conclusions: For a valid comparison of peginterferon regimes it is important to match patient groups by BL factors and also by cumulative RBV dose. In our MP analysis significantly more patients were cured with peginterferon alfa-2a (40KD) compared to peginterferon alfa-2b (12KD) in a real-life setting.
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