After 5 Months of Therapy, Adefovir Dipivoxil Results in a Significant Reduction of HBV DNA in 72% of Patients with Lamivudine Resistance
Patients with chronic hepatitis B developing lamivudine (Epivir-HBV) resistance are at high risk of disease progression and death.
To assess the efficacy and safety of adefovir-dipivoxil, 46 patients with lamivudine resistance (43 men, 53 years, 42 HBeAg negative, 37 cirrhotics, 89% with HBV DNA >6 log10 copies/ml by HBV Roche Amplicor Monitor) were also given adefovir-dipivoxil (Hepsera) 10 mg/daily for 5 to 30 months (median 7).
Results
At month 5, HBV-DNA levels decreased from a median of 7.6 (range 3.8-9.3) to 3.7 log10 copies/ml. HBV-DNA was <2.3 log10 copies/ml in 21 (46%) patients, between 2.3 and 5.3 in 12 (26%) and >5.3 log in 13 (28%). 29 (63%) patients had normal ALT.
Patients with undetectable serum HBV-DNA at month 5 had pre-treatment lower HBV-DNA and higher levels of ALT than those with detectable HBV-DNA (6.7 vs 8.2 logs, p=0.011; 174 vs 74 U/l, p=0.045).
None of the patients showed a >1 log rebound of serum HBV-DNA. In two patients who had >4 log HBV-DNA despite 12 months of therapy, the adefovir-resistance associated rtN236T and rtA181V mutations were not identified.
Child-Pugh score improved by at least 2 points in 9 of 13 Child-Pugh B/C patients.
None of the patients had significant changes of renal function.
Conclusions
Adefovir dipivoxil resulted in a significant reduction of serum HBV DNA in 72% of patients with lamivudine resistant HBV after 5 months of therapy, according to the authors. High ALT and low HBV-DNA predicted a faster response to treatment, they concluded.
04/28/04
Reference
M Vigano and others. RESCUE TREATMENT WITH ADEFOVIR DIPIVOXIL IN LAMIVUDINE RESISTANT PATIENTS WITH CHRONIC HEPATITIS B. Abstract 448. 39th EASL. April 14-18, 2004. Berlin, Germany.
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