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Friday, March 12, 1999

Indian patent plant for Hepatitis B virus

Vani Saraswathi  
Chennai, March 11: The much debated upon Indian medicinal plant Keezhanali (Phyllanthus Amarus) is all set to occupy the global position of pride as probably the most-effective treatment for Hepatitis B Virus (HBV) disorders.

Keezhanali is soon to be marketed nationally and subsequently launched in the international market, after a good 20 years of study and six years of clinical trials by the Madras University Dr A L Mudaliar Institute of Post Graduate Medical Sciences, which holds the patent for the plant.

HBV is now considered a more serious health threat than HIV/AIDS in developing countries, as its ``infectivity'' is as high as 33 per cent, against the HIV ``infectivity'' of 0.3 per cent. Mortality in case of HBV-related diseases is much higher.

Dr S P Thiagarajan who spearheaded the research at the University, explaining the potency of the plant to The Indian Express, said in acute HBV-related jaundice, four weeks of Keezhanali treatment can completely clear the virus.

InHBV related Chronic Liver Diseases (CLD) and asymptomatic carriers, with six months of treatment, the virus can be cleared in 30 per cent of the cases and becomes non-infectious in 55 per cent of the cases. Further research is being carried out to cover the balance 15 per cent. (Keezhanali traditionally has been administered to treat jaundice.)

The six clinical trials, including one at the Scottish Centre for Infection and Environment Health, Glasgow, have reproduced these observations. Multi-national, multi-centric clinical trials, between UK and India - a pre-requisite for internationally marketing the product - will be undertaken shortly. Marketing at a national level will be taken up within the next few weeks.

Though a couple of other drugs are available internationally, which are as effective in controlling the virus, Keezhanali's position is strengthened by the fact that it is affordable and free of the significant side-effects associated with the other drugs, like body pain, andhair-loss.

But more important than lack of side-effects and cost, is that it is a time-bound course. In case of the other two existing drugs, when the drugs are withdrawn, the virus returns and there are instances of resistance. The drugs have to be taken lifelong. However, for Keezhanali, once the course is completed, be it four weeks or six months, the virus does not return, Dr Thiagarajan says.

A cost-effective treatment for HBV is the need of the hour, as India with an incidence of 3.34 per cent, now in the intermediate zone (incidence 2-7 % of population) of the epidemic is rapidly heading towards the high prevalence zone (8 - 20 %), to join the likes of Africa, China, Taiwan and some Asia-Pacific countries.

In sheer numbers -- there are about 40 million HBV positives in the country, of whom 10 million are actively infectious.

The incidence among pregnant mothers is 4.22 per cent. Ante-natal transmission is 73.8 per cent against 33 per cent in case of HIV.

And though there is a vaccineavailable, India is still not among the 82 countries that have made it a component of mandatory vaccination. The projected annual cost of making it mandatory is Rs 6,400 crore, but experts feel it could be reduced to as low as Rs 640 crore. Yet, the country is a long way away from making it mandatory, and has only recently made HBV screening mandatory along with HIV testing.

The solid immunity of the vaccine is 98.6 per cent, making it the most potential vaccine after small pox vaccine. Studies in Taiwan have shown that chances of CLD in vaccinated children was drastically lower than in children who were not vaccinated.

Neo-natal vaccination can also prevent transmission from mother to child in 98 per cent of the cases, and thee need to be propagated aggressively. Local companies are now being encouraged to manufacture the vaccine at a lower cost.

Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.


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