Zusammenfassung
EINLEITUNG: Mit der heute zur Verfügung stehenden Standardtherapie der chronischen Hepatitis C bestehend aus pegyliertem Interferon und Ribavirin erreichen in randomisierten und kontrollierten Studien bis 60% der Patienten eine dauerhafte Viruselimination (SVR). Die Reproduzierbarkeit der Ergebnisse in der klinischen Praxis ist unklar, deshalb untersuchten wir alle konsekutiven, therapienaiven Patienten an unserer Abteilung um die Wirksamkeit der Standardtherapie in der klinischen Routine zu überprüfen. MATERIAL UND METHODIK: Insgesamt wurden 219 Patienten mit pegyliertem Interferon Alpha (2a oder 2b) und Ribavirin (800–1200 mg/Tag) in den Jahren 2000 und 2006 behandelt. 34.8% der Genotyp 1/4/6 und 18.4 % der Genotyp 2/3 Patienten wiesen eine Fibrose Grad 3 oder 4 auf. Die Patienten wurden gemäß der gängigen Ein- und Ausschlusskriterien für klinische Studien in zwei Gruppen geteilt. Die Therapieergebnisse dieser beiden Gruppen wurden getrennt analysiert. ERGEBNISSE: 44.3 % der Patienten erreichten eine dauerhafte Viruselimination. Jene mit einer niedrigen Fibrose (F0 – F2) erreichten in 52.5 % und jene mit einer Fibrose F3 – F4 erreichten in 20.8 % einen SVR. Die SVR-Rate für Patienten mit Genotyp 1/4/6 betrug 35.4 % (SVR: F0 – F2 47.7; F3 – F4 19.6 %) und für Genotyp 2/3 67.8 %. In der Gruppe der Patienten, mit ungünstigen Voraussetzungen für die Therapie war die SVR-Rate signifikant niedriger (32.4 % vs. 50 %; p = 0.017), zudem war in dieser Gruppe die Non-Responder-Rate deutlich erhöht (30.9 % vs. 13.8 %). SCHLUSSFOLGERUNG: Bis zu einem Drittel der Patienten weisen ungünstige, zu schlechteren Therapieergebnissen führende, Voraussetzungen, für eine antivirale Therapie auf. Der Therapieerfolg ist durch Patientenselektion, Schweregrad der zu Grunde liegenden Lebererkrankung und Anteil der Patienten mit fortgeschrittener Lebererkrankung beeinflusst.
Summary
OBJECTIVE: Pegylated interferon plus ribavirin is the standard treatment for chronic hepatitis C. Sustained virological response (SVR) rates of up to 60% are reported in randomized controlled trials, but it is unclear whether the results from such trials are reproducible in the clinical routine setting. We investigated consecutive treatment-naïve chronic hepatitis C patients at our center to examine the efficacy of treatment with pegylated interferon plus ribavirin in clinical routine. MATERIALS AND METHODS: Between 2000 and 2006 we treated a total of 219 patients with pegylated interferon alpha (2a or 2b) and ribavirin (800–1200 mg/d). Among them, 34.8% of patients infected with HCV genotypes 1/4/6 and 18.4% of those with genotypes 2/3 had advanced fibrosis or cirrhosis (F3–F4). For analysis of outcome we subdivided our series into two groups of patients: those who fulfilled standard inclusion criteria in randomized controlled trials and those who did not. RESULTS: The overall SVR rate was 44.3%. In patients with F0–F2 an SVR was achieved in 52.5%; in those with F3–F4 the SVR rate was 20.8%. In patients infected with genotypes 1/4/6 the SVR rate was 35.4% (SVR: F0–F2 47.7%; F3–F4 19.6%); in those with genotypes 2/3 the rate was 67.8%. The SVR rate in patients with unfavorable baseline factors was significantly lower (32.4% vs. 50%; P = 0.017) and they were more likely to be non-responders (30.9% vs. 13.8%). CONCLUSION: In everyday clinical practice, up to one-third of patients show unfavorable baseline factors for antiviral therapy, resulting in worse therapeutic outcome. Differences in therapeutic outcome are influenced by patient selection and by the proportion and severity of the underlying liver disease.
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Maieron, A., Metz-Gercek, S., Hackl, F. et al. Antiviral treatment of chronic hepatitis C in clinical routine. Wien Klin Wochenschr 122, 237–242 (2010). https://doi.org/10.1007/s00508-010-1364-7
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DOI: https://doi.org/10.1007/s00508-010-1364-7