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BACKGROUND &AIMS: Treatment with adefovir dipivoxil for 48 weeks resulted in clinicalimprovement in patients with hepatitis B e antigen (HBeAg)-negative chronichepatitis B that was lost when treatment was discontinued. We investigated theefficacy, safety, and resistance profile of adefovir dipivoxil treatment for upto 240 weeks. METHODS: HBeAg-negative patients were treated double blind with placeboor adefovir dipivoxil 10 mg once daily for 48 weeks, followed by adefovirdipivoxil from week 49 to 96. At week 97, 125 patients enrolled in a 144-week,open-label phase. Patients received adefovir dipivoxil for up to 192 or 240weeks. RESULTS: Serum hepatitis B virus (HBV) DNA levels were less than 1000copies per milliliter in 67% of patients, and alanine aminotransferase (ALT)levels normalized in 69% after 240 weeks. After 192 or 240 weeks of treatment,over 83% of patients had improvement in necroinflammation, and over 73% hadimprovement in fibrosis. Ishak fibrosis scores improved compared with baselinein 35%, 55%, and 71% of patients after 48, 192, and 240 weeks of adefovirdipivoxil, respectively. After 240 weeks, the cumulative probability of HBVpolymerase mutations was 29%, but the cumulative probability of mutations withvirologic resistance was 20% and of mutations, virologic resistance, and ALTelevations was 11%. Slight elevations in creatinine were confirmed in 4 (3%)patients. CONCLUSIONS: Treatment with adefovir dipivoxil for up to 240 weekswas well tolerated and produced significant, increasing improvement in hepaticfibrosis, durable suppression of HBV replication, normalization of liverenzymes, and delayed development of resistance.Leggil'articolo