ADV对E抗原－表现持续有效性(2005.4.26)

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Adefovir Demonstrates Sustained Effectiveness in HBeAg-negative Chronic HBV Patients?

Adefovir dipivoxil/ADV (Hepsera) demonstrated efficacy and safety in 184 HBeAg-negative 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 present study was to evaluate the safety and efficacy of ADV over 192 weeks.?

Results

Baseline characteristics for patients randomized to receive ADV for 1st 96 weeks (n=79) and continuing open label ADV: 81% male; 70% Caucasian; 26% Asian; median age 47 years; median serum HBV DNA 7.08 log10 copies/mL; median ALT: 99 IU/L (2.3 x ULN). 70 and 67 patients continued ADV up to week 144 and week 192 respectively.?

?span style='font:7.0pt "Times New Roman"'> Three patients had confirmed elevations in serum creatinine ≥ 0.5 mg/dL over 192 weeks.?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 (n=184), 96 (n=134), 144 (n=123) and 192 (n=67) 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 patients (5%).牋

Conclusions

The authors conclude, 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>

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Henry Dunant Hospital, Athens, Greece, Western Attica Hospital, Athens, Greece, National Cheng Kung Hospital, Taipei, Taiwan, Toronto Western Hospital, Toronto ON, Canada, Georgios Papanikolaou Hospital, Thessaloniki, Greece, Azienda Ospedaliera San Giovanni Battista, Torino, Italy, Hopital Beaujon, Clichy, France, National University, Singapore, Singapore, Gilead Sciences, Inc., Foster City CA, USA.

04/25/05

Reference S Hadziyannis and others. ADEFOVIR DIPIVOXIL?(ADV) DEMONSTRATES SUSTAINED EFFICACY IN HBEAG-CHRONIC HEPATITIS B (CHB) PATIENTS. Abstract 492. 40th EASL. April 13-17, 2005. Paris, France.