Hepsera (adefovir dipivoxil) Is an Effective

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Treatment for Patients with Chronic Hepatitis B Failing Epivir-HBV (lamivudine) Therapy


Abstract Summary

Lamivudine (LAM)-resistant HBV develops in 16-32% of patients after one year and up to 69% after 5 years of LAM therapy.

Conducted in France, the aim of the current study was to evaluate the safety and efficacy of adefovir dipivoxil (ADV; Hepsera) 10mg in CHB patients with LAM-resistant HBV enrolled in the French early access program for adefovir10mg.

473 patients with chronic hepatitis B (CHB) failing >24 weeks LAM therapy, HBV DNA >105 copies/mL by PCR or positive by molecular hybridization, ALT >1.2 X ULN and METAVIR fibrosis score >F2 or activity score >A3 (>A2 for HIV/HBV co-infected patients) were enrolled.

Median treatment duration was 5.25 months (0.3 to 60 months) ; 88% male; 24% HIV/HBV co-infected; median age 49 years; 11% > 65 years. Five (1%) discontinued ADV: one for disease progression and four deaths unrelated to ADV.

Seventeen (3.6%) patients reported adverse drug reactions (ADRs) ; the most common were gastrointestinal (1.3%). No serious ADRs were reported.

Conclusion: Treatment with ADV 10 mg daily was well tolerated and resulted in significant reduction in serum HBV DNA, and ALT normalization in CHB patients with LAM-resistant HBV regardless of age or baseline fibrosis score.

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03/21/03

Reference
F Zoulim?and others. ADEFOVIR DIPIVOXIL (ADV) FOR THE TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS B (CHB) FAILING LAMIVUDINE (LAM) THERAPY. Abstract 3626.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL).