期刊
GASTROENTEROLOGY
卷 139, 期 5, 页码 1602-+出版社
W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1053/j.gastro.2010.07.059
关键词
Adverse Effects of Hepatitis Therapy; Clinical Trial; Liver Disease; Blood Disorders
资金
- Schering-Plough
- Roche
- Gilead
- Merck Co
- Vertex Pharmaceuticals
- Biolex
- Bristol-Myers Squibb
- Coley Pharmaceuticals
- Conatus Pharmaceuticals
- GlaxoSmithKline
- GlobeImmune
- Idenix
- Johnson Johnson
- Pfizer
- Pharmassett
- Romark Laboratories
- Tibotec
- Valeant
- Wyeth
- ZymoGenetics
- Debio Pharmaceuticals
- Duke University Medical Center
- Peregrine Pharmaceuticals
- Beckman
BACKGROUND & AIMS: Hepatitis C virus (HCV) treatment is frequently complicated by anemia from ribavirin (RBV)-related hemolysis and peginterferon-alfa (PEG-IFN)-related bone marrow suppression. We investigated the relationships among treatment outcomes, anemia, and their management with RBV dose reduction and/or erythropoiesis-stimulating agents (ESAs). METHODS: We analyzed data from a trial conducted at 118 United States academic and community centers in treatment-naive patients with HCV genotype 1. Patients were treated for as many as 48 weeks with 1 of 3 PEG-IFN/RBV regimens. ESAs were permitted for anemic patients (hemoglobin [Hb] < 10 g/dL) after RBV dose reduction. Sustained virologic responses (SVR) were assessed based on decreases in Hb, anemia, and ESA use. RESULTS: While patients received treatment, 3023 had their Hb levels measured at least once. An SVR was associated with the magnitude of Hb decrease: >3 g/dL, 43.7%; <= 3 g/dL, 29.9% (P < .001). Anemia occurred in 865 patients (28.6%); 449 of these (51.9%) used ESAs. In patients with early-onset anemia (<= 8 weeks of treatment), ESAs were associated with higher SVR rate (45.0% vs 25.9%; P < .001) and reduced discontinuation of treatment because of adverse events (12.6% vs 30.1%, P < .001). ESAs did not affect SVR or discontinuation rates among patients with late-stage anemia. CONCLUSIONS: Among HCV genotype 1-infected patients treated with PEG-IFN/RBV, anemia was associated with higher rates of SVR. The effect of ESAs varied by time to anemia; patients with early-onset anemia had higher rates of SVR with ESA use, whereas no effect was observed in those with late-onset anemia. Prospective trials are needed to assess the role of ESAs in HCV treatment.
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