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Optimal dosing frequency of pegylated interferon alfa-2b monotherapy for chronic hepatitis C virus infection.

Lurie, Y; Rouzier-Panis, R; Webster, GJM; Dusheiko, GM; Laughlin, M; Jackson, ML; Oren, R; (2005) Optimal dosing frequency of pegylated interferon alfa-2b monotherapy for chronic hepatitis C virus infection. Clin Gastroenterol Hepatol , 3 (6) pp. 610-615.

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Abstract

BACKGROUND & AIMS: Pegylated interferon alfa-2b (PEG-IFN-alfa 2b ) has been shown to provide superior efficacy to IFN-alfa 2b in patients with chronic hepatitis C (predominantly genotype 1) infection as measured by viral clearance. This study was conducted to determine the optimal dosing regimen of PEG-IFN-alfa 2b required to obtain a maximum decrease of hepatitis C viral RNA. METHODS: This was a 24-week, open-label, multicenter, parallel-group, randomized, active-controlled trial in the United Kingdom, France, and Israel. Individuals (n = 61) with chronic hepatitis C infection, genotype 1, received IFN-alfa 2b 3 mIU 3 times weekly for 24 weeks, or PEG-IFN-alfa 2b 1.5 or 3.0 microg/kg/wk, as total weekly full or split doses, for 12 weeks. At week 12, serum RNA titer was measured, and all PEG-IFN-alfa 2b patients continued with 1.5 microg/kg/wk for a further 12 weeks. RESULTS: Mean serum hepatitis C RNA levels decreased in all groups at weeks 12 and 24. PEG-IFN-alfa 2b 1.5 microg/kg/wk was superior to IFN-alfa 2b in decreasing mean serum hepatitis C RNA ( P < .05 at week 12). The efficacy of split-dose PEG-IFN-alfa 2b 1.5 or 3.0 microg/kg/wk regimens was not significantly different from full-dose PEG-IFN-alfa 2b 1.5 microg/kg/wk. However, there was a significant decrease in neutrophil count in groups receiving PEG-IFN-alfa 2b 3.0 microg/kg/wk or lower, multiple-dose per week regimens. CONCLUSIONS: PEG-IFN-alfa 2b 1.5 microg/kg once weekly is the optimal dosing frequency for patients with chronic hepatitis C with predominantly genotype 1 infection. More frequent dosing or increasing the dose to 3.0 microg/kg/wk did not result in improved antiviral effects, but did decrease neutrophil counts.

Type: Article
Title: Optimal dosing frequency of pegylated interferon alfa-2b monotherapy for chronic hepatitis C virus infection.
Location: United States
Keywords: Adolescent, Adult, Aged, Antiviral Agents, Dose-Response Relationship, Drug, Female, Follow-Up Studies, France, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Interferon-alpha, Israel, Male, Middle Aged, Polyethylene Glycols, RNA, Viral, Recombinant Proteins, Reverse Transcriptase Polymerase Chain Reaction, Safety, Treatment Outcome, United Kingdom, Virulence
UCL classification: UCL > School of Life and Medical Sciences
UCL > School of Life and Medical Sciences > Faculty of Medical Sciences
URI: http://discovery.ucl.ac.uk/id/eprint/40558
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