Phase I Clinical Trial on treatment of chronic Hepatitis B using Immune Assist TM brand Dietary Supplement as an adjunct with Lamivudine [ Epivirtm ]

Presented here are the results of a clinical trial conducted on 60 subjects over a two year period evaluating the efficacy of Immune-AssistTM as an adjuvant for the treatment of hepatitis B with the antiviral drug Lamivudine [EpivirTM]. Immune-AssistTM is an immune-active blend of complex non-linear, HMW heteropolysaccharides and 1,31,6 beta-glucans with a triple right hand helix tertiary conformation. Immune-AssistTM is manufactured by Aloha Medicinals Inc. of Carson City, Nevada, USA and widely marketed as a dietary supplement for immune enhancement. The results of this trial clearly shows that greater effectiveness can be achieved with the addition of ImmuneAssistTM to the standard treatment protocols than can be provided by the conventional therapy alone in patients suffering from chronic hepatitis B. these results suggest that further research is indicated to determine what added value Immune-AssistTM could add in treating other viral diseases, such as different types of hepatitis or HIV/AIDS. Introduction: The discovery in the early 1970’s of immune-active polysaccharides in a number of higher basidiomyces fungi (mushrooms) stimulated considerable research into the structures and mechanisms of action of this class of compound, leading to the development of immune modulator drugs of the 1,3-1,6 beta-glucan class such as Lentinan. These immune-modulator compounds are used as adjuncts and adjuvants for conventional treatments for a number of diseases, including viral infections such as Hepatitis. Lentinan was introduced in 1977, and is the first and prototypical drug of this class. Early research suggested that it was the chemical composition of the compound 1,3-1,6 beta-glucans that triggered the immune responses seen with the use of Lentinan. This would be good news if it were true, since bakers and brewers yeast, Saccharomyces cerevisiae, is low cost and readily available as a byproduct of many industries. However, as research in immune-active polysaccharides advanced, it became obvious that it was not the composition of the compounds that conferred biological activity so much as the tertiary structure. This is the shape that the molecule takes in three dimensional space. The studies on yeast-derived beta-glucans have generally yielded poor results in humans although they are known to increase immunity in fish and crustaceans. Immune Assist Hepatitis Trial 2 The city of Lishui, which lies in the south-west of Zhejiang province, is one of the major mushroom cultivation districts in China and has rich resources of these edible fungi. It is a long-standing tradition for the populace of this area and other parts of China to use the edible fungi as part of their medicine. While researching the traditional medicine and folk recipes of the people of this area, there is found a widespread belief that edible fungi can protect the liver, reduce obesity and improve overall immunity. In accordance with this traditional belief, this study was designed using modern extraction methods in the preparation of a mushroom polysaccharide mixture according to the formula of ImmuneAssist Critical Care FormulaTM, a proprietary health supplement developed as a joint project between the Government of Zhejiang province and a privately held American company, Aloha Medicinals Inc. of Maui, Hawaii. This mixture is manufactured and distributed in the United States of America by Aloha Medicinals Inc. The formula is composed of purified alcohol-precipitated hot water extracts of six species of medicinal mushrooms: Lentinula edodes, Agaricus blazei, Grifola frondosa, Coriolus [Trametes] versicolor, Ganoderma lucidum and two types of Cordyceps sinensis extracts, one from the mycelium and one from the culture broth of liquid-fermented Cordyceps sinensis. We tested this mixture concurrently with the accepted drug lamivudine in the cure of chronic hepatitis. With lamivudine therapy alone, the rate of hepatitis Be antigen convertion from positive to negative is 10%-20% with a one year course of therapy, and this antibody seroconversion to negative increases by continued use of lamivudine past the first year. Because of this long treatment period, there is concern that the virus will induce genetic variation, as well as the possibility of some subjects discontinuing the therapy after time due to attrition or economic hardship. From February 2000 to August 2001, our research group used the Immune AssistTM formula and lamivudine together to treat hepatitis B for a period of nine months. From April in 2001 to May in 2002, we also used this formula and lamivudine together to treat hepatitis B compounded with hyperlipidemia, with good results. This trial was performed under the guidelines of informed consent and good clinical practice. The Peoples Republic of China clinical trial sanction number for this trial was 99-118.