Zeffix effective for HBV in children

BioChem Pharma says that its oral antiviral Zeffix (lamivudine),licenced to GlaxoSmithKline, is effective at suppressing hepatitis B in children. Data in adults have shown that the number of Zeffix-treated patients who achieve a complete virologic response, an indication of effective viral suppression, increases year-on-year, and at four years 75% of patients with active liver disease are able to stop treatment.

New data suggest this pattern may be mirrored in children. The studies show that after one year of treatment a CVR is seen in 23% of children with the disease, compared to 13% in the placebo group, and one-third of patients with more active disease heal from the active-replicative phase of the disease compared to 16% of controls. Even 18% of the patients with YMDD variant HBV, which has been shown in laboratory assays to have reduced susceptibility to Zeffix, derived some clinical benefit from treatment, said BioChem.

A regulatory application to extend the indication for the treatment of chronic hepatitis B in patients aged two years and above was submitted to the US Food and Drug Administration last year.