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发表于 2004-4-17 03:38
After 144 Weeks of Adefovir Therapy in Chronic HBV Patients, Drug Resistance Emerges with Low Frequency
Lamivudine (Epivir-HBV) resistance occurs in 24% and 70% of CHB patients after 1 and 4 years.?ADV resistance mutations, rtN236T and rtA181V, were observed in 0% of patients after 48 weeks and 2% of patients after 96 weeks.
In this study, researchers in the US, Greece and France sought to determine the incidence of adefovir/ADV (Hepsera) resistance after 144 weeks (approx 3 years).
This analysis included 629, 293, and 167 patients who received ADV through 48, 96 and 144 weeks, respectively. At baseline, patients had either wild-type or YMDD mutant HBV.
The majority received ADV monotherapy.
Most (>90%) patients with YMDD mutant HBV continued on lamivudine after addition of ADV. HBV RT was sequenced for all samples with detectable HBV DNA by PCR (≥1000 copies/mL). The cumulative probability of ADV resistance was calculated using the Life Table method.
Results
In addition to the patients who developed rtN236T (n=4) or rtA181V (n=2) at week 96, three additional patients developed rtN236T (n=2) or rtA181V (n=1) at week 144.
All rtN236T and rtA181V mutants emerged during ADV monotherapy. All patients with the rtN236T and 2 of 3 patients with the rtA181V experienced confirmed serum HBV DNA rebound (≥1 log10 increase from nadir).
Two novel conserved site mutations (rtA211P, rtS202G) were observed once each in single patients at week 144 but were not associated with HBV DNA rebound; in vitro phenotypic analysis of these mutations is ongoing.
The authors conclude, ?/span>ADV resistance mutations (rtN236T and rtA181V) emerged at a delayed rate and with a low frequency (cumulative probability of 3.9%) after 144 weeks of therapy in all patients in this analysis.?/span>
04/16/04
Reference
S Xiong and others. Long-Term Incidence of Adefovir Dipivoxil Resistance in Chronic Hepatitis B Patients after 144 Weeks of Therapy. Abstract 57 (oral). 39th EASL. April 14-18, 2004. Berlin, Germany.
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