Glaxo India has launched lamivudine formulation for controlling chronic infection, the fourth largest killer disease in India. Lamivudine is the first oral anti-viral treatment for chronic hepatitis B. Interferon, an injectible, is the only other treatment for chronic hepatitis B, besides liver transplant.
Glaxo's product Hepitec, available in a 100-mg tablet form, is a unique Indianised pack, with information printed in Hindi and other regional languages. Each strip of Hepitec, costing Rs 1,218, contains 14 tablets and is available in pilfer-proof 'alu-alu double foil blister' packs.
Lamivudine is an original research product from Glaxo Wellcome and is internationally available as Zeffix. The drug was originally found useful in treating people infected with HIV (human immuno virus) – the virus that causes AIDS. Lately, lamivudine is also proven effective against HBV (hepatitis B virus).
A report published in the 21 October issue of The New England Journal of Medicine says lamivudine appears to keep hepatitis B under control without causing serious side effects. The study was conducted by a team of researchers led by Dr Jules L Dienstag, of the Massachusetts General Hospital and Harvard Medical School in Boston. They commented that one-year treatment appeared to be effective in suppressing HBV.
Hepatitis B is a potentially fatal liver disease. According to World Health Organisation data, approximately 350 million people around the world are long-term carriers of hepatitis B virus, including an estimated 48 million people in India. Its victims are often in the most productive age group of 15 to 45 years.
Unlike interferon, lamivudine is not known to cause serious side effects, but it has to be taken for a longer period of time. "However, it is still unclear which drug should be the first choice for treating HBV," Dr Dienstag and his colleagues say.
The dosage regimen for lamivudine is one tablet daily. Extensive controlled clinical trials by GlaxoWellcome have established that lamivudine has an excellent efficacy and safety profile across diverse patient groups in Asia, Europe and North America, a Glaxo release says.
Cipla is the only other manufacturer of lamivudine in India. The company markets it version under the brand name Lamivir. The product was launched in December 1999.