Adefovir dipivoxil: Phase III

GILD said that in a subset of 131 post-liver transplant, lamivudine-resistant chronic hepatitis B virus (HBV) patients in an international 230-patient open-label Phase III trial (Study 435), 10 mg of Adefovir gave a median reduction in HBV DNA of 3.7 log10 copies/mL at week 24 (p<0.0001) and 4.6 log10 copies/mL (p<0.0001) at week 48. Statistically significant improvements in ALT, bilirubin and albumin levels (clinical markers of liver function) were seen at weeks 24 and 48 compared to baseline.

GILD also reported interim data from an international Phase III trial run in collaboration with GlaxoSmithKline plc (GSK; LSE:GSK, London, U.K.), which markets lamivudine for HIV and HBV. Data from the 131-patient study showed the addition of 10 mg Adefovir to ongoing lamivudine therapy resulted in a median reduction in HBV DNA of 3.9 log10 copes/mL from baseline after 24 weeks of treatment (p<0.001). Markers for liver disease indicated improvements in liver function from baseline to week 24. ...