Durability of efficacy of adefovir dipivoxil in hepatitis B patients
As an extension of Study 412 (Phase II), patients were treated with adefovir dipivoxil 10 mg beyond 48 weeks.
In these patients there was a significant median reduction in serum HBV DNA of 3.40 log10 copies per ml (p < 0.0001) that remained durable through up to nearly 2 years (3.36 log10 copies per ml at 100 weeks, p < 0.0001). By week 100, HBV DNA was undetectable (< 400 copies/ml) in 70% of patients.
Over the course of the study, 21% of patients achieved seroconversion of the HBV “e” antigen.
No adefovir associated resistance mutations were noted in patients who received 72 to 136 weeks of adefovir dipivoxil treatment.