Early access programme offers adefovir for treatment of HBV
Graham McKerrow, HIV i-Base
Gilead Sciences is introducing an early access programme to make adefovir available on a named patient basis to people in the UK with hepatitis B who are experiencing lamivudine resistance.
The programme provides early access to adefovir (ADV, PMEA, Preveon) 10mg daily to patients with chronic hepatitis B that is resistant to treatment with lamivudine (3TC, Epivir).
Gilead sciences says the programme is aimed at benefiting people who have limited treatment options and are in need of additional therapeutic intervention in order to suppress HBV DNA replication and to prevent progressive liver disease.
A statement from the company says data from three completed phase I-II studies, and interim data from ongoing studies, including two phase III placebo-controlled studies, demonstrate significant anti-HBV activity following treatment with adefovir dipivoxil in patients with HBeAg positive chronic hepatitis B, presumed precore mutant hepatitis B (HBeAg-/anti-HBe+/HBV DNA+), and lamivudine resistant hepatitis B.
An Adefovir Dipivoxil Call Centre has been set up to assist physicians wishing to include a patient in the programme. It is available on 01223 897300, or fax 01223 897282.