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发表于 2004-4-17 03:34
Three Year Study of Adefovir Dipivoxil Demonstrates Sustained Efficacy in Presumed Precore Mutant Chronic Hepatitis B PatientsT
HBeAg- CHB patients were previously enrolled in a randomized, placebo-controlled trial of ADV for 96 weeks. Patients receiving adefovir/ADV (Hepdera) in the second 48 weeks were offered up to 3 additional years of ADV.
The aim of this study was to evaluate safety and efficacy of ADV over 96 and 144 weeks.
Results
Baseline (in original study) for patients entering LTSES: 81% male; 70% Caucasian; 26% Asian; median age 47 years; median HBV DNA 7.08 log10 copies/mL; median ALT: 99 (2.3 x ULN).
The rtN236T and A181V mutations were associated with resistance to ADV. The rate of either mutation at weeks 48, 96, and 144 is 0 %, 3.0% and 5.9%, respectively. Three patients had confirmed elevations in serum creatinine = 0.5 mg/dL over 144 weeks. All resolved, one on treatment and two following discontinuation.
Conclusions
The authors draw four primary conclusions from the results of this study:
· Treatment with ADV 10mg over 144 weeks resulted in significant and continued reductions in HBV DNA levels with increasing proportion of patients achieving HBV DNA undetectability;
· ALT change and normalization was sustained;
· The safety profile of ADV during three years of treatment was similar to that seen in the first and second year; and
· Resistance is delayed and infrequent.
04/16/04
Reference
S Hadziyannis and others. Three Year Study of Adefovir Dipivoxil Demonstrates Sustained Efficacy in Presumed Precore Mutant Chronic Hepatitis B Patients in A Long Term Safety and Efficacy Study. Abstract 46 (oral). 39th EASL. April 14-18, 2004. Berlin, Germany.
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