It is an ayurvedic medicine that claims to be as effective as allopathic drugs in the treatment of Hepatitis B, a liver disease that impacts over 40 million Indians a year and kills as many as 100,000 from related chronic disease such as cirrhosis and liver cancer.
The Himalaya Drug Company, which recently developed Liv.52 HB, a completely new drug for the treatment of Hepatitis B. Liv.52 HB is not a variant of Liv.52 and claims that about 27 per cent of more than 1,000 participants in clinical trials held across the country showed sustained virological after using the new product over six months. SVR refers to the non-recurrence of viral infection six to 12 months after the treatment has stopped.
The company claims the drug exerts antiviral activity that enhances the immunity of liver patients and suppresses the replication of viral DNA found in the Hepatitis B virus (HBV) in order to eliminate it.
Himalaya is optimistic that Liv.52 HB will be successful in the market mainly because, at a little under Rs 5,000 for a six-month course, it costs a fraction of conventional drugs such as antivirals, immunoglobals and interferons. Himalaya says standard therapy could cost as much as Rs one lakh for the same duration and also comes with serious side effects to the kidneys, blood and other organs.
Says Philipe Haydon, CEO, Pharmaceuticals, Himalaya: “Interferons and antivirals come with serious side effects that include neuro-vegetative symptoms, nephrotoxicity and anemia. A lot of patients withdraw from treatment due to the severity of the side effects. Liv.52 HB is a phytopharmaceutical formulation that is completely devoid of side effects.”
Haydon said Liv.52 HB would be promoted both as a prescription drug and as an over-the-counter formulation, and that the company had also not applied for USFDA approval, however, in a few years, we will look at launching this drug in other international markets after fulfilling the regulatory requirements.
The response of the medical fraternity to this new drug has been mixed.
Jay Sanghvi, a Gujarat-based naturopath and ayurved, says he has prescribed Liv.52 HB to his patients and is optimistic it will work. Says he: "We recommended this new formulation since it is quite cheap, and results show up in about three weeks."
Others are not so optimistic. Jayprakash Hebbar, a Mumbai-based general practitioner, says,"We are still cynical about it and need some time to assess the medicine's effectiveness. I would continue to prescribe supplementary medicines along with this if I have to for now."
Others are unaware about the drug and are wary of prescribing something new without assured clinical research. However, the company claims that clinical research has been undertaken for Liv.52 HB and its reports have been published in leading indigenous and international publications, including Antiviral Research.
Paramveer Singh, a Gurgaon-based gastroenterologist says he does not recommend alternative drugs to patients.
Raju Kanakia, a gastro at Mumbai's Lilavati Hospital is also unaware of Liv.52 HB.
Himalaya confirmed that it had not yet started a full-fledged marketing campaign for Liv.52 HB. Yet, it is widely available across the country. "We are promoting the drug ethically through medical representatives across the country, like all our pharmaceutical product," the company official said.