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发表于 2004-4-21 11:18
HBV Patients Unresponsive to Lamivudine (Epivir-HBV) May Be Switched Directly to Therapy with Entecavir 1.0 Mg Daily
Hepatic flares have been reported in patients who have been abruptly discontinued from anti-HBV therapy.?In a phase II, multinational, double-blind, randomized, 4-arm, dose-ranging trial, ALT elevations and hepatic adverse events were analyzed in 181 lamivudine (LVD)-refractory patients (87% with YMDD mutations) switched directly to entecavir (ETV) at one of three doses (0.1, 0.5, 1.0 mg daily) or continued on LVD therapy (100mg daily).?
Post-switch ALT flares were defined as ALT>2x baseline (BL) and >10x upper limit of normal (ULN). Patients were treated for up to 85 weeks.
Results
Eleven patients (6%) developed ALT flares during study treatment: 3 on 1.0mg, 1 on 0.5mg, 2 on 0.1mg ETV and 5 on continued LVD.?
All 4 patients on either 0.5 or 1.0 mg ETV had transient ALT flares that?resolved while on continued blinded ETV therapy; all had declines in HBV bDNA
揙n-treatment ALT elevations accompanied by viral load reductions may reflect a favorable response to therapy.?/span>
04/19/04
Reference
R G Gish and others. LAMIVUDINE-REFRACTORY HEPATITIS B PATIENTS CAN BE SAFELY SWITCHED DIRECTLY TO ENTECAVIR 1 MG DAILY THERAPY. Abstract 428.?39th EASL. April 14-18, 2004. Berlin, Germany.
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