title: Prospective study on early virologic response to treatment with interferon alpha-2b plus ribavirin in patients with chronic hepatitis C genotype 1b.
abstract: To evaluate the predictive value of early virologic response (EVR) of achieving a sustained virologic response (SVR), an open, prospective trial including 42 patients with chronic hepatitis C genotype 1b was performed with directly observed 24-week treatment with interferon alpha-2b plus ribavirin. We assessed the predictive values of EVR at days 3, 7, 14, and weeks 4, 8, and 12 of the SVR. The SVR in an intention-to-treat analysis was 19.0%. Patients who reached SVR presented a significantly faster reduction in plasma viral load. Stepwise multiple logistic regression analysis of the factors (gender, age, IFN dosage, ribavirin dosage, HCV RNA, ISDR, and loss of HCV RNA at week 4) revealed that loss of HCV RNA at week 4 was the only independent variable of treatment outcome (P=0.0039). A viral load at treatment day 3 above 100kIU/ml, at day 7 above 50kIU/ml, and at day 14 above 10kIU/ml was 100% predictive for virologic non-response in all except 1 patient. The cutoff levels for HCV RNA at days 3 and 14 of treatment were associated with an algorithm of the failure to detect HCV RNA after 12 weeks of treatment. In conclusions, a very early virologic response assessment could be useful for prediction of later outcome of combination therapy in chronic hepatitis C genotype 1b.
authors.affiliation: First Department of Internal Medicine, Gifu University School of Medicine, 1-1 Yanagido, Gifu 501-1194, Japan.
authors.forename: Masahito
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authors.lastname: Nagaki
authors.forename: Motoaki
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authors.lastname: Imose
authors.forename: Takafumi
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authors.lastname: Naiki
authors.forename: Kiminori
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authors.lastname: Kimura
authors.forename: Hideki
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authors.lastname: Hayashi
authors.forename: Masaru
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authors.lastname: Shimizu
authors.forename: Hiroo
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authors.lastname: Ohnishi
authors.forename: Eiichi
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authors.lastname: Tomita
authors.forename: Jun'ichi
authors.initials: J
authors.lastname: Sugihara
authors.forename: Kazuo
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authors.lastname: Amano
authors.forename: Tsutomu
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authors.lastname: Sakai
authors.forename: Takao
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authors.lastname: Kojima
authors.forename: Naoki
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authors.lastname: Katsumura
authors.forename: Yoshimasa
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authors.lastname: Kondo
authors.forename: Masao
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authors.lastname: Fujimoto
authors.forename: Hisataka
authors.initials: H
authors.lastname: Moriwaki