Adefovir Dipivoxil in Chronic Hepatitis B Dose Selection
Doses of 5-125 mg evaluated in chronic hepatitis B
- 3 - 4 log10 copies/mL reduction in HBV DNA at all doses > 5 mg at 4-12 weeks
Adefovir dipivoxil 60 and 120 mg in HIV
10 and 30 mg selected for evaluation in HBV
Sustained HBV DNA reduction and increased ALT normalization up to 136 weeks
- No adefovir-associated resistance mutations identified (n=27)
- Renal laboratory abnormalities at 30 mg
10 mg target dose for registration