Lamivudine: Positive Effects In Hepatitis B

BioChem Pharma's has announced results from a Phase II study of its antiviral lamivudine (3TC) in chronic hepatitis B patients which suggest that the agent can reduce viral DNA to undetectable levels. The data were presented at the annual meeting of the American Association for the Study of Liver Diseases in Chicago last week.

At a dose of 100-300mg/day, lamivudine reduced hepatitis B virus DNA to undetectable levels in all patients who received the drug. 32 patients were enrolled into the study from three study sites and received either 25mg/day, 100mg/day or 300mg/day lamivudine for three months and then followed up for six months thereafter. Reduction of HBV DNA was sustained throughout the follow-up period in six of 22 (27%) patients in the 100mg and 300mg group. Side effects of the treatment included headache, fatigue, nausea and abdominal pain.

Lamivudine was discovered by BioChem Pharma and is being developed by Glaxo under the terms of a license agreement signed between the two companies in January 1990. Additional studies are being conducted to evaluate further the clinical benefit of lamivudine in HBV infection. Glaxo has now advanced the drug into Phase III trials in the Far East, Canada and Europe, and additional patients will be enrolled in centers in the USA, China and Japan in early-1995.