|
The effect of nucleoside free HAART on the treatment of chronic HCV infection
M. Vogel1, G. Ahlenstiel1, G. Klausen2, T. Lutz3, D. Schürmann4, C. Stephan5, C. Mayr6, A. Baumgarten7, P. Buggisch8, H. Klinker9, C. John10, J. Gölz11, P. Khaykin5, M. Bickel5, J. Rockstroh1
1Bonn University, Bonn, Germany, 2Practice Hintsche / Klausen, Berlin, Germany, 3Infektiologikum Frankfurt, Frankfurt / Main, Germany, 4Charite University Medical Center, Berlin, Germany, 5University of Frankfurt, Frankfurt / Main, Germany, 6Ärzteforum Seestrasse, Berlin, Germany, 7Praxis Dupke / Baumgarten / Carganico, Berlin, Germany, 8Institut für Interdisziplinäre Medizin (ifi), Hamburg, Germany, 9University of Würzburg, Würzburg, Germany, 10Practice John, Berlin, Germany, 11Praxiszentrum Kaiserdamm, Berlin, Germany
Background: The impact of nucleoside analogues on the treatment of chronic HCV infection with pegylated interferon and ribavirin is controversially discussed.
Methods: Prospective, partially randomized multicenter study. HIV-negative patients (group A) were compared to HIV-positive patients without HAART (group B) and with HAART (group C). Group C was randomized to nucleoside-free HAART (double PI or PI/NNRTI, group C1) and nucleoside containing HAART (group C2). HIV-positive patients were treated with 180 µg pegylated interferon alfa-2a and 800 mg ribavirin; treatment duration was 24 weeks for genotypes 2 or 3 and 48 weeks for genotypes 1 or 4. After amendment I genotype 2 and 3 infections were treated 48 weeks (17/40 patients) and after amendment II weight based ribavirin was prescribed for genotype 1 or 4 infections (49/61 patients).
Results: 152 patients (group A = 48, B = 41, C1 = 19, C2 = 44) received at least one dose of pegylated interferon / ribavirin and were evaluated by intent to treat analysis (missing=failure) with regard to sustained virological response (SVR). Interestingly, comparable SVR rates were reached among HIV- and HIV+ in 55% of cases in both groups. Whereas the rate of SVR was not different between groups B and C (59% vs. 52%) a significant difference was observed between C1 and C2 (74 vs. 43%; p=0.031). Post-hoc multivariate analysis of group C according to SVR-status revealed low baseline HCV-RNA, HCV genotype 2 or 3, and no abacavir as predictors for SVR. However restricting analysis to genotype 1 or 4 and weight adapted ribavirin only HCV-RNA remained a significant predictor.
Conclusions: High SVR-rates, comparable to HIV-negative patients, were reached in 55% of HIV-positive patients. NUC-free HAART resulted in higher SVR-rates compared to NUC-containing HAART. This effect was most likely due to use of abacavir in patients with low doses of ribavirin.
Download the e-Poster
|