Peginterferon-α-2a (40kD) and Ribavirin in Patients with Chronic Hepatitis CA Phase II Open-Label Study
作者:
Mark Sulkowski,
Robert Reindollar,
David L. Thomas,
Sherilyn Brinkley-Laughton,
Martha Hudson,
Jian Yu,
期刊:
BioDrugs
(ADIS Available online 2002)
卷期:
Volume 16,
issue 2
页码: 105-109
ISSN:1173-8804
年代: 2002
出版商: ADIS
关键词: Antivirals, therapeutic use;Hepatitis C, treatment;Interferons, therapeutic use;PEG interferon alpha 2a, therapeutic use;Research and development;Ribavirin, therapeutic use
数据来源: ADIS
摘要:
Background and aimsAddition of a 40kD polyethylene glycol moiety to interferon-α-2a [peginterferon-α-2a (40kD)] improves pharmacokinetic properties over those of standard interferon. We conducted a phase II study to assess the safety and initial efficacy of peginterferon-α-2a (40kD) plus ribavirin combination therapy in patients with chronic hepatitis C (CHC).MethodsTwenty patients received open-label 180μg peginterferon-α-2a (40kD) subcutaneously once weekly and oral ribavirin 1000 or 1200mg daily for patients weighing <75 or ≥75kg, respectively, for a period of 24 weeks. Patients with hepatitis C virus (HCV) genotype 1 and a virological response at week 24 received study drugs for an additional 24 weeks.ResultsA sustained virological response, defined as undetectable HCV RNA 24 (i.e. <100 copies/ml) weeks after completing the therapy, was achieved in 50% of patients in an intent-to-treat analysis (6/16 genotype 1 and 4/4 genotype non-1). Adverse events were similar to those reported with unmodified interferon plus ribavirin combination therapy. Anaemia led to ribavirin dose reduction in five patients. Neutropenia led to dose reduction in three patients treated with peginterferon-α-2a (40kD).ConclusionsThe addition of ribavirin to a once-weekly peginterferon-α-2a (40kD) regimen should be investigated in larger clinical trials.
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