Clinical and Virological Evaluation of the Drug "Stimforte" in Acute Hepatitis B

Abstract

Gamalei Str., Moscow, Russia, 123098; 4Closed 4Joint-Stock Company “SKY LTD”, 113/1, Leninsky avenue, Moscow, Russian Federation, 117108 Hepatitis B is a serious problem for global health. The incidence of acute hepatitis B in the Russian Federation in recent years was 2.2 per 100 000 people. In 5% of cases the infection can acquire chronic course, leading to the development of cirrhosis and hepatocellular carcinoma. Recently, there is increased interest in drugs of plant and animal origin which have immunomodulatory and antiviral activity. "Stimforte" is one out of such drugs. The aim of this work was to determine the as clinical and immunologic as virologic efficacy of the injectable form of the drug. The study included 30 patients and 22 subjects from the control group. Evaluation of treatment efficacy was performed on the results of clinical and laboratory examination and was determined in the terms of reverse development of acute viral hepatitis, dynamics and rate of downword in activity of biochemical parameters (ALT, AST, alkaline phosphatase), elimination of markers of acute hepatitis from the blood, the frequency of formation of chronic hepatitis. The investigation of immune and interferon status was performed. At the same time the possible occurrences of adverse reactions were taken into account. At the end of the study the use of "Stimforte " was shown to have a positive effect on the regression of clinical symptoms of the disease, by reducing their duration by 2-8 days, contributed to a more rapid normalization of indices of cytolysis (ALT, AST). Drug "Stimforte" has immunomodulatory effect, stimulated antiviral immune response to acute HBV-infection. Within 6 months of following up patients no chronic cases were observed. The drug was well tolerated by all patients with no incidence of adverse reactions.