Study 435Summary
Efficacy
- Change in HBV DNA and ALT similar to pivotal studies
- Normalization of albumin, bilirubin, and prothrombin time
- Stabilization or improvement in CPT Score
- No adefovir-associated resistance mutations identified through 48 weeks (n=55)
Safety
- Safety profile consistent with advanced liver disease and co-morbidities
- Renal function should be monitored closely before and during therapy