Lamivudine Improves Liver Histology In Hepatitis B

Glaxo Wellcome and BioChem Pharma have reported the results of a PhaseIII study of lamivudine in patients with hepatitis B virus infection. The study, involving 358 patients with chronic hepatitis B from centers in Hong Kong, Singapore and Taiwan, showed that lamivudine was more effective than placebo in improving liver histology.

Lamivudine is already available in a higher dosage form for the treatment of HIV infection in many countries, but a hepatitis B indication would dramatically increase the sales potential of the drug. Analysts have suggested that the HBV indication could add between L175 million ($285 million) and L300 million a year to total sales of the drug by the year 2000. Sales of the drug in 1996 were just under L200 million, and are estimated to rise to over L1 billion by 2000 (Marketletter March 17).

Far East Trial Out of the 385 patients, 72 were given placebo, 142 were on 25mg lamivudine once-daily and 143 took 100mg/day. Most patients were infected within the first two years of birth, and had not taken interferon alpha (the only current therapy) for some time. The primary endpoint was liver histology, to give an indicator on the severity of liver disease, while secondary endpoints were lamivudine's effect on levels of hepatitis B e antigen (HBeAg), and HBV DNA in the blood.