Session Title: Parallel Session:
HEPATITIS C: CLINICAL ADVANCES AND THERAPY
Presentation Date: Apr 16, 2010
COMPLETELY INDIVIDUALIZED TREATMENT DURATIONS (24, 30, 36, 42, 48, 60 OR 72 WEEKS) WITH PEGINTERFERON-ALFA-2B AND RIBAVIRIN IN HCV GENOTYPE 1-INFECTED PATIENTS (INDIV-2 STUDY)
C. Sarrazin1, S. Schwendy2, B. Möller3, N. Dikopoulos4, P. Buggisch5, J. Encke6, G. Teuber1, T. Goeser7, R. Thimme8, H. Klinker9, W.O. Boecher10, E. Schulte-Frohlinde11, R. Prinzing2, T. Berg12, S. Zeuzem1
1Medizinische Klinik 1, J. W. Goethe-University Hospital, Frankfurt/Main, 2University Hospital Munich, Munich, 3Leberzentrum Checkpoint, Berlin, 4University Hospital Ulm, Ulm, 5Institut für Interdisziplinäre Medizin, Hamburg, 6Johanna Etienne Krankenhaus, Neuss, 7Imterdisziplinäres Facharztzentrum, Frankfurt/Main, 8University Hospital Cologne, Cologne, 9University Hospital Freiburg, Freiburg im Breisgau, 10University Hospital Würzburg, Würzburg, 11University Hospital Mainz, Mainz, 12Klinikum Freising, Freising, 13Essex Pharma, Munich, 14University Hospital Leipzig, Leipzig, Germany. *firstname.lastname@example.org
Introduction: Shortening of treatment with peginterferon and ribavirin to 24-weeks in patients with chronic hepatitis-C genotype-1, low baseline viral load and rapid-virologic-response (RVR) is approved in Europe. It is unknown whether complete individualized treatment durations according to baseline viral load and initial viral decline are possible.
Methods: 398 treatment-naïve HCV genotype-1 patients were enrolled in a multicenter, randomized trial with peginterferon-alfa-2b and ribavirin. Patients received individualized treatment durations for 24,30,36,42,48,60 or 72 weeks according to low or high baseline viral load (LVL/HVL, cut-off 800.000IU/ml) and undetectable HCV-RNA at week 4,6,8,12 and 24 by a highly sensitive assay (TMA). Sustained virologic response (SVR) rates were compared to 224 patients treated for 48 weeks.
Results: Overall SVR rates were similar in patients treated with individualized durations and the control group (53% vs. 48%). SVR rates of groups with individualized treatment durations and patients with HCV-RNA negativity after identical treatment durations but 48 weeks treatment were not statistically different. Patients with HVL and LVL and first time HCV-RNA negativity at week 24 and 30, respectively were treated for 72 weeks and achieved 50% SVR rates. The remaining patients are shown in the Table.
Conclusion: For treatment of patients with chronic hepatitis C genotype 1 infection with pegylated interferon 2b and ribavirin complete individualization and optimization of treatment duration is possible according to baseline viral load and first time HCV RNA negativity at week 4, 6, 8, 12 and 24. Complete individualized treatment durations may also be useful for STAT-C triple treatment schedules.
[Sustained virologic response (SVR) based on ITT]
| ||Treatment duration INDIV-2 (n=398) ||SVR INDIV-2 ||Treatment duration control (n=224) ||SVR control |
|neg. wk. 4 (RVR) + LVL ||24 weeks (n=41) ||88% ||48 weeks (n=30) ||93% |
|neg. wk. 4 (RVR) + HVL ||30 weeks (n=7) ||86% ||48 weeks (n=3) ||100% |
|neg. wk. 6 + LVL ||30 weeks (n=23) ||91% ||48 weeks (n=18) ||77% |
|neg. wk. 6 + HVL ||36 weeks (n=13) ||85% ||48 weeks (n=13) ||78% |
|neg. wk. 8 + LVL ||42 weeks (n=29) ||72% ||48 weeks (n=8) ||100% |
|neg. wk. 8 + HVL ||48 weeks (n=22) ||82% ||48 weeks (n=8) ||88% |
|neg. wk. 12 + LVL ||48 weeks (n=33) ||82% ||48 weeks (n=16) ||88% |
|neg. wk. 12 + HVL ||60 weeks (n=39) ||56% ||48 weeks (n=24) ||42% |
|neg. wk 24 + LVL ||60 weeks (n=43) ||56% ||48 weeks (n=19) ||42% |