Gilead's adefovir effective in HBV

Gilead Sciences has announced positive data from a Phase III trial whichevaluated its investigative antiviral agent adefovir dipivoxil 10mg as a monotherapy for chronic hepatitis B virus infection. Gilead had previously dropped adefovir from development as Preveon for the treatment of HIV when it failed to get approval from a US Food and Drug Administration advisory panel (Marketletter December 13, 1999).

The new data, presented at the European Association for the study of the Liver meeting, held in Prague, Czech Republic, showed a virologic response to the 10mg dose of adefovir in patients with lamivudine-resistant HBV and HIV co-infection, no significant changes in serum electrolytes or renal function in these patients after 42 weeks of treatment and a reduction at 24 weeks in HBV DNA in lamivudine-resistant HBV-infected liver transplant patients.

John Martin, chief executive of Gilead, said the new results "demonstrate the potential safety and antiviral activity of adefovir dipivoxil, as well as a favorable resistance profile of the drug beyond one year of therapy." Based on these data, the company intends to file for regulatory approval of adefovir for treating chronic HBV infection in the USA and Europe in the first half of 2002.