Lamivudine 3TC: Phase III; awaiting marketing approval

BCHE reported data from trials comparing the combination of lamivudine with Intron A versus either alone. A total of 226 patients were randomized to received 100 mg lamivudine once daily for 52 weeks, 10 MU Intron A three times weekly for 16 weeks or lamivudine for 8 weeks followed by combination treatment for 16 weeks. Patients were followed to week 64.

The primary end point was seroconversion rate (i.e., loss of antigen, gain of antibody and loss of HBV DNA). Secondary end points included histological response, HBV DNA loss and normalization of the liver enzyme ALT, an indicator of liver function. ...