期刊
HEPATOLOGY
卷 52, 期 3, 页码 822-832出版社
WILEY
DOI: 10.1002/hep.23743
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资金
- Gilead
- Novartis
- Onyx-Bayer
- Roche
- Biolex
- Conatus
- Human Genome Sciences
- Romark
- Valeant
- Vertex
- Zymogenetics
- GlaxoSmithKline
- Globeimmune
- Idenix
- Johnson Johnson
- Wyeth
- Schering-Plough
- Merck
- Human Genome Science
- Abbott
- Anadys
- Bristol-Myers Squibb
- Idera
- Intarcia Therapeutics
- Medarex
- Medtronic
- Pharmasset
- Virochem
- Sundise
- Excalenz
Interferon lambda 1 (IFN-lambda 1) is a type III IFN that produces intracellular responses similar to those of IFN-alpha but in fewer cell types because of differences in the receptor distribution pattern, and this could potentially result in an improved safety profile. This was an open-label three-part study of patients with chronic hepatitis C virus (HCV) genotype 1 infection. Part 1 evaluated single-agent pegylated interferon lambda (PEG-IFN-lambda) at 1.5 or 3.0 mu g/kg administered every 2 weeks or weekly for 4 weeks in patients who had relapsed after previous IFN-alpha-based treatment. Part 2 evaluated weekly doses of PEG-IFN-lambda ranging from 0.5 to 2.25 mu g/kg in combination with ribavirin (RBV) for 4 weeks in treatment-relapse patients. Part 3 evaluated weekly PEG-IFN-lambda at 1.5 mu g/kg in combination with RBV for 4 weeks in treatment-naive patients. Fifty-six patients were enrolled: 24 patients in part 1, 25 patients in part 2, and 7 patients in part 3. Antiviral activity was observed at all PEG-IFN-lambda dose levels (from 0.5 to 3.0 mu g/kg). Two of seven treatment-naive patients (29%) achieved rapid virological response. Treatment was well tolerated with minimal flu-like symptoms and no significant hematologic changes other than RBV-associated decreases in hemoglobin. The most common adverse events were fatigue (29%), nausea (12%), and myalgia (11%). Six patients experienced increases in aminotransferases that met protocol-defined criteria for dose-limiting toxicity (DLT) or temporarily holding therapy with PEG-IFN-lambda. Most DLT occurred in patients with high PEG-IFN-lambda exposure. Conclusion: Weekly PEG-IFN-lambda with or without daily RBV for 4 weeks is well tolerated with minimal adverse events and hematologic effects and is associated with clear antiviral activity across a broad range of doses in patients with chronic HCV. (HEPATOLOGY 2010;52:822-832)
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