Study on lamivudine

A team of researchers led by Dr Jules L Dienstag of Massachusetts General Hospital and Harvard Medical School in Boston that conducted a year-long study of lamivudine has reported that the drug appears to keep hepatitis B, the liver disease, under control without causing serious side effects. Lamivudine (150 mg twice daily) was initially found useful to treat HIV- (or AIDS-) infected people.

The report was published in the October 1999 issue of The New England Journal of Medicine. The study was conducted on 137 human subjects sufferring from chronic hepatitis B infection. The researchers randomly assigned 137 people to receive either lamivudine or an inactive placebo pill for a year. After 12 months, the participants were followed for another 16 weeks to see how long the effect of the drug lasted.

Of the 66 people who took lamivudine, 34 (52 per cent) experienced a significant improvement in their disease, Dienstag’s team reports. Among 71 subjects put on placebo, only 16 (23 per cent) improved as much.

In addition, based on the samples of liver tissue taken before and after the treatment, inflammation decreased in 64 per cent of people taking lamivudine, while a similar reduction was observed in only 34 per cent of the people taking the placebo. Scarring of the liver was five per cent in the lamivudine group compared to 20 per cent in the placebo group.

The report says one year of treatment appeared to be more effective in suppressing the hepatitis B virus than a shorter course of the drug, and hepatitis B levels remained significantly suppressed after the discontinuation of the treatment in the lamivudine group.

Earlier studies that tested lamivudine for three to six months showed that levels of the virus rebounded within two months after stopping the treatment, the report adds.

In comparison to interferon, the other known treatment for hepatitis B, the researchers noted, lamivudine did not cause serious side effects in the study "though it has to be taken for a longer period of time than interferon".

However, the researchers were unable to comment on which of the two drugs should be the first choice for treating HBV.