阿地福韦双酯对E抗原阴性患者表现持续有效(2005.5DDW)

zasxz

Adefovir Dipivoxil Demonstrates Sustained Efficacy in HBeAg-negative Chronic Hepatitis B Patients

Adefovir Dipivoxil/ADV (Hepsera) demonstrated efficacy and safety in 184 HBeAg-negative chronic hepatitis B (CHB) patients enrolled in a 96-week randomized, placebo -controlled trial.?Patients on ADV in the second 48 weeks were offered up to 3 additional years of ADV.

The aim of the current study was to evaluate the safety and efficacy of ADV over 192 weeks in HBeAg-negative CHB patients.

Baseline characteristics for patients randomized to receive ADV for 1st 96 weeks (n=79) and continuing open label ADV were as follows:?

?span style='font:7.0pt "Times New Roman"'> 81% male; 70% Caucasian; 26% Asian; median age 47 years;

?span style='font:7.0pt "Times New Roman"'> median serum HBV DNA 7.08 log10 copies/mL;

?span style='font:7.0pt "Times New Roman"'> median ALT: 99 IU/L (2.3 x ULN). 70 and 67 patients continued ADV up to week 144 and week 192 respectively.?

Results

?span style='font:7.0pt "Times New Roman"'> At week 192, the median HBV DNA change from baseline was ?3.71 Log10 copies/mL with 85% of patients achieving HBV undetectability by PCR (< 1,000 copies/mL).

?span style='font:7.0pt "Times New Roman"'> Eighty one percent of patients (44 of 54) normalized their ALT levels.

?span style='font:7.0pt "Times New Roman"'> Three patients had confirmed mild elevations in serum creatinine ?/span> 0.5 mg/dL over 192 weeks.?

?span style='font:7.0pt "Times New Roman"'> All resolved, one on treatment and two following discontinuation.

?span style='font:7.0pt "Times New Roman"'> No patients had phosphorus levels < 1.5 mg/dL over 192 weeks.

?span style='font:7.0pt "Times New Roman"'> The cumulative incidence of adefovir resistance at weeks 48, 96, 144 and 192 is 0 %, 3.0% and 11% and 18%, respectively using life table analysis.?

?span style='font:7.0pt "Times New Roman"'> HBsAg seroconversion was observed in 4 of 79 (5%) patients.

In conclusion, the authors write, 揟reatment with ADV 10 mg over 192 weeks resulted in significant and sustained reductions in HBV DNA levels with the majority of patients achieving prolonged HBV DNA suppression and sustained ALT normalization. ADV was generally well-tolerated with long-term treatment.?/span>

05/23/05

Reference S Hadziyannis and others. [Oral 322] Adefovir Dipivoxil (ADV) Demonstrates Sustained Efficacy in HBeAg Negative Chronic Hepatitis B (CHB) Patients Digestive Disease Week 2005. May 14-18, 2005. Chicago, IL.