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Completely individualized treatment durations with peginterferon-alfa-2b and ribavirin in HCV genotype 1-infected patients and importance of IL28B genotype (INDIV-2 study)

C. Sarrazin; S. Schwendy; B. Moeller; N. Dikopoulos; P. Buggisch; J. Encke; G. Teuber; T. Goeser; R. Thimme; H. Klinker; W. O. Boecher; E. Schulte-Frohlinde; R. Prinzing; T. Berg; S. Zeuzem

Introduction: Tailoring treatment duration according to baseline viral load and virologic response during treatment is recommended by current treatment guidelines. The possibility of further individualization of treatment durations to 24, 30, 36, 42, 48, 60 and 72 weeks in genotype 1 patients was shown in the INDIV-2 study. The potential importance of IL28B genotype for precise determination of treatment duration is unknown.

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). The results were compared to a historical control (n=224) with identical treatment for 48 weeks. Treatment response (SVR, Relapse, Non-Response) was analyzed according to IL28B genotype (rs129797860)

Results: Overall SVR rates of 55% and 48% were obtained in patients treated with individualized durations and 48 weeks standard duration, respectively. IL28B genotype was obtainable in 305/398 patients which completed therapy. SVR rate of patients who completed therapy was 65%.
In non-responders 96% (65/68) are CT and TT IL28B genotypes. SVR was achieved in 85%, 58% and 46% of patients with CC, CT and TT IL28B genotype. However, overall relapse rates are similar for CC, CT and TT IL28B genotypes (13%, 19%, 21%, respectively). In patients with LVL at baseline relapse was uncommon for CC genotype (1/29, 3%) and equally frequent in CT and TT genotypes (18% and 23%, respectively) while for patients with HVL relapse was equally frequent in CC and CT genotypes (17% and 22%, respectively). Thus, longer treatment durations probably would have been required in these patients to prevent relapse. IL28B genotypes of patients who received standard treatment duration of 48 weeks will be presented at the meeting.

Conclusion: High SVR rates can be achieved in chronic hepatitis C genotype 1 infection with a complete individualized treatment schedule (24,30,36,42,48,60,72 weeks) with pegylated interferon 2b and ribavirin. In addition to baseline viral load and HCV RNA negativity during treatment IL28B genotype may be used to determine treatment duration.


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