Epoetin alfa maintains ribavirin dose in HCV-infected patients: a prospective, double-blind, randomized controlled study |
| |
Authors: | Afdhal Nezam H Dieterich Douglas T Pockros Paul J Schiff Eugene R Shiffman Mitchell L Sulkowski Mark S Wright Teresa Younossi Zobair Goon Betty L Tang K Linda Bowers Peter J;Proactive Study Group |
| |
Institution: | Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. nafdhal@caregroup.harvard.edu |
| |
Abstract: | BACKGROUND & AIMS: Combination therapy with interferon alpha (IFN-alpha) and ribavirin (RBV) or pegylated IFN-alpha (PEG-IFN-alpha)/RBV for chronic hepatitis C virus (HCV) infection often causes anemia, prompting RBV dose reduction/discontinuation. This study assessed whether epoetin alfa could maintain RBV dose, improve quality of life (QOL), and increase hemoglobin (Hb) in anemic HCV-infected patients. METHODS: HCV-infected patients (n = 185) on combination therapy who developed anemia (Hb < or = 12 g/dL) were randomized into a U. S. multicenter, placebo-controlled, clinical trial of epoetin alfa, 40,000 U subcutaneously, once weekly vs. matching placebo. The study design used an 8-week, double-blind phase (DBP) followed by an 8-week, open-label phase (OLP), in which placebo patients were crossed over to epoetin alfa. RESULTS: At the end of the DBP, RBV doses were maintained in 88% of patients receiving epoetin alfa vs. 60% of patients receiving placebo (P < 0.001). Mean QOL scores at the end of the DBP improved significantly on all domains of the Linear Analog Scale Assessment (LASA) and on 7 of the 8 domains of the Short Form-36, version 2 (SF-36v2). Mean Hb increased by 2.2 +/- 1.3 g/dL (epoetin alfa) and by 0.1 +/- 1.0 g/dL (placebo) in the DBP (P < 0.001). Similar results were demonstrated in patients who switched from placebo to epoetin alfa in the OLP. Epoetin alfa was well tolerated; the most common adverse effects were headache and nausea. CONCLUSIONS: Epoetin alfa maintained RBV dose and improved QOL and Hb in anemic HCV-infected patients receiving combination therapy. |
| |
Keywords: | AE adverse event DBP double-blind phase EA/EA epoetin alfa/epoetin alfa EVR early virologic response Hb hemoglobin HCV hepatitis C virus IFN-α interferon α LDH lactate dehydrogenase OLP open-label phase P/EA placebo/epoetin alfa PEG-IFN-α pegylated interferon α QOL quality of life RBV ribavirin SAE serious adverse event SVR sustained virologic response |
本文献已被 ScienceDirect PubMed 等数据库收录! |
|