SOEDAK2009 --- PREPARE FOR THE LONG RUN

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Titel
The influence of nucleoside free HAART on the treatment of chronic hepatitis C with pegylated interferon / ribavirin combination treatment
Autor
Martin Vogel1, Golo Ahlenstiel1, Gerd Klausen2, Thomas Lutz3, Dirk Schürmann4, Christoph Stephan5, Christoph Mayr6, Axel Baumgarten7, Peter Buggis
Abstract
Introduction: Concomitant use of nucleosides (NUC) as part of HAART and ribavirin may lead to enhanced toxicity during treatment of hepatitis C in HIV-coinfected patients, possibly compromising treatment outcome of hepatitis C therapy.
Methods: Prospective, partially randomized controlled trial. HIV-negative (A), HIV-positive without HAART (B), and HIV-positive on HAART (C) were enrolled. Group C was randomized to NUC-free (double PI or PI/NNRTI, C1) or NUC-containing HAART (NRTI at choice of investigator, C2). Patients were treated with pegylated interferon alfa-2a 180 µg/week and ribavirin (800 mg in genotype 2/3, 1000/1200 mg in genotype 1/4). Treatment duration was 24 weeks for HCV-genotypes 2 and 3 and 48 weeks for genotypes 1 and 4. After a protocol amendment all patients were treated for 48 weeks.
Results: 152 patients (group A = 48, B = 41, C1 = 19, C2 = 44) received at least one dose of pegylated interferon / ribavirin ribavirin and were evaluated by intent to treat analysis (missing=failure). In HIV+ patients median CD4-cellcount was 494/µl, and of those off HAART HIV-RNA was 3.9 log10. HCV-genotypes were 1 (n=78), 2 (n=9), 3 (n=52), 4 (n=8) and double infections (n=5). In HCV-monoinfected patients an end of treatment response (ETR) was reached in 73% of patients and was sustained (negative HCV-RNA 24 weeks after the end of therapy, SVR) in 55% of patients. In HIV-coinfected patients, ETR was observed in 72% of patients and was sustained in 55% of cases (Group B 59%, C 52%). Interestingly, the difference between groups C1 and C2 was significant for SVR (C1 74%, C2 43%; p=0.031), but not for age, gender, baseline ALT, CD4-cellcount, HIV-RNA, HCV-RNA, or distribution of HCV-genotypes.
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.
Datei SOEDAK_09_OSE1.pdf