Session Title: Category 5g. VIRAL HEPATITIS: g. HEPATITIS C - CLINICAL (THERAPY)
Presentation Date: Apr 15, 2010
COMPARISON OF EFFICACY BETWEEN PEGINTERFERON ALFA-2A OR -2B PLUS RIBAVIRINE IN THE TREATMENT OF CHRONIC HEPATITIS C PATIENTS IN DAILY ROUTINE: RESULTS FROM PRACTICE
T. Witthoeft1*, S. Mauss2, D. Hueppe3, C. John4, R. Heyne5, B. Moeller5, R. Link6, A. Herrmann7, A. Baumgarten4, A. Dikopoulos8, G. Teuber9
1Center of Gastroenterology, Stade, 2Center for HIV and Hepatogastroenterology, Duesseldorf, 3Center for Gastroenterology, Herne, 4Center of Gastroenterology, Practice of Internal Medicine, 5Center of Gastroenterology and Livercenter, Berlin, 6Internal Medicin, St. Josefs-Krankenhaus, Offenburg, 7Internal Medicine II, Friedrich-Schiller-Universitaet, Jena, 8Klinik fuer Innere Medizin I, Universitaetsklinikum Ulm, Ulm, 9Interdisziplinäres Facharztzentrum Sachsenhausen, Frankfurt/Main, Germany. *firstname.lastname@example.org
Background: PRACTICE, a retrospective study analysing response to hepatitis C treatment between 2000 and 2007 in 24 German centres. In last time several direct comparisons between efficacy of peginterferon alfa-2a/RBV (A) and peginterferon alfa-2b/RBV (B) were presented (Sulkowski et al, Ascione et al, Rumi et al.) but RBV assignment and composition of genotypes was different.
Methods: Data of G1 patients were analysed by three matched pair (MP) analysis. Parameters for MP I analyses were: age; BL viral load; BMI; prior treatment history, history of drug addiction and HIV-co-infection. MP II analysis included additionally to MP I cumulative RBV dose (≤60% / >60%-80% / >80%-100% / > 100%) as defined by prescribing information. MP III was matched by the criteria of Matched Pairs I plus initial RBV dose, which included evaluation of any dose reductions and dose reduction strategy. Potential effect of body weight on RBV starting dose was controlled as patients were matched for BMI.
Results: See Table for SVR rates. Majority of patients in MP III (90.2% in Group A and 87.2% in Group B) did not require RBV dose reduction; the extent of dose reduction with ≥400 mg or in 200 mg steps was comparable. Even the average time to the first dose reduction was similar (92.1 days in group A, 94.5 days in B)
Conclusions: For a valid comparison of peginterferon regimes it is important to match patient groups by BL factors. Further impact on SVR originates from the RBV dose. Real life data show that the kind of dose adjustment of ribavirin is very similar in daily routine. Since the approved regimes are different in this respect, data comparing A and B have to be evaluated carefully.
| ||A: Peginterferon alfa-2a (40KD) ||B: Peginterferon alfa-2b (12KD) |
|Virological Response ||Matched Pairs I (N=733) ||Matched Pairs II (N=554) ||Matched Pairs III (N=579) ||Matched Pairs I (N=733) ||Matched Pairs II (N=554) ||Matched Pairs III (N=579) |
|SVR, % ||48.7* ||49.6# ||49.9§ ||49.9§ ||43.7# ||44.6§ |
|* p = 0.075; # p = 0.047; § p = 0.068 |