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Impact of high-dose interferon induction and ribavirin therapy in patients with chronic hepatitis C relapsing after or not responding to interferon monotherapy

Authors


  • *Austrian Hepatitis Study Group:
    Principal investigators:
    Ferenci P. and Steindl-Munda P. (Univ. of Vienna); Vogel W (Univ. of Innsbruck)
    Clinical investigators:
    Hofer H, Jessner W, Gangl A, Müller C, Österreicher C, Novacek G, Penner E, Peck- Radosavljevic M (Univ. of Vienna); Hentschel E, Scharf C, Schütze W. (Hanusch-Hospital, Vienna); Hartmann G, Sebesta EC, (Donau-Hospital, Vienna), Gschwantler M, (Rudolfs-Hospital, Vienna); Bognar K, Brunner H, Kopty C, Rosenbeiger M, (Hospital Lainz, Vienna); Dragosics B, (Gesundheitszentrum Süd, Vienna); Hackl F (Elisabethinnen-Hospital, Linz); Hubmann R. (General Hospital, Linz); Buder R. (Barmherzige Brüder, Linz); Nitsche D (Barmherzige Schwestern, Linz); Marzy H, Haidinger R. (Steyr); Schneeweiss B. (Kirchdorf); Renner F. (Ried); Allinger S, Knoflach P, Stadler B, (Wels); Stetter M, (Amstetten); Datz C, Raffelsberger R. (St. Johann Hospital, Salzburg); Herrmann R (Zell/See); Stingl W. (Eggenburg); Begic-Karup S, Jaritz B. (Mistelbach); Kutilek M, Ptacek-Wegerer K, (St.Pölten); Goldsteiner H, Kotlan P, Taschner H. (Wr. Neustadt); Spahits E., Stockenhuber F. (Oberpullendorf); Stangl W. (Oberwart); Fickert P; Hegenbarth K; Krejs GJ, Stauber R, Trauner M, (Univ. of Graz); Bauer B. (Hörgas); Rainer W. (Knittelfeld); Pristautz H. (Wagna); Edis GC, Nachbaur K, (Univ. of Innsbruck); Erhart K. (Bregenz); Dertinger S, Reichsöllner F (Feldkirch); Eritscher-Tinhofer C,W. Grimm G, Türk H, (Klagenfurt); Siebert F. (St.Veit); Lin W (Villach) Virology: Hofmann H, Watkins-Riedl Th, (Univ. of Vienna), Kessler H (Univ. of Graz) Pathology: Wrba F (Univ. of Vienna), Denk H (Univ. of Graz), Offner F. (Univ. of Innsbruck), Dietze O (Salzburg) Biometry: Neumann K (Vienna) Statistics: Frommlet F (Vienna)

Petra Steindl-Munda, MD, Department of Internal Medicine IV, Division of Gastroenterology and Hepatology, Waehringer Guertel 18-20, A-1090 Vienna/Austria.
Tel: +43 1 40400 4741.
e-mail: petra.munda@akh-wien.ac.at

Abstract

Background/aims: Initial high-dose interferon-α induction therapy in combination with ribavirin improves sustained response rates in treatment-naïve patients. This prospective, randomized, controlled study tested whether non-responders or relapsers to interferon monotherapy also benefit from induction therapy.

Methods: Patients with chronic hepatitis C who had not responded to (n=75) or relapsed (n=80) after previous interferon therapy were randomized to receive three different interferon doses during the first 14 weeks of therapy (A: 10 MU IntronA®/day for 2 weeks, followed by 10 MU/2 days for 12 weeks; B:5 MU/d for 14 weeks; C: 5 MU/2 days for 14 weeks) followed in all by 5 MU/2 days for 24 weeks. All patients received 1–1.2 g ribavirin/day throughout the whole study.

Results: The rates of viral clearance at any time on treatment were similar in all groups. Sustained response rates were also not different among the groups in interferon nonresponders (A 32%, B 29%, C 31%) and relapsers (A 64%, B 68%, C 71%), respectively, as well as in patients with different genotypes. As expected, sustained response rates were higher in patients with genotype non-1 than in those with genotype 1.

Conclusion: High-dose induction therapy does not improve the outcome of interferon/ribavirin therapy in interferon nonresponders or relapsers.

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