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Agent for the treatment of hepatitis C virus

一种丙型肝炎、慢性丙型肝炎的技术，应用在医药领域，能够解决未提出戊二酸单酰基组胺病毒性肝炎、不知道戊二酸单酰基组胺组合等问题

Inactive Publication Date: 2015-01-14
OBSCHESTVO S OGRANICHENNOI OTVETSTVENNOSTIYU (PHARMENTERPRISES)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Previously, glutaryl histamine was not proposed for the treatment of viral hepatitis
Also, the combination of glutaryl histamine with pegylated interferon and ribavirin was not previously known

Method used

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  • Agent for the treatment of hepatitis C virus
  • Agent for the treatment of hepatitis C virus
  • Agent for the treatment of hepatitis C virus

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] The aim of this study was to determine the antiviral activity of glutaryl histamine in an experimental model of hepatitis C virus infection in cell culture.

[0037] This study was performed in a cytopathic subtype 1b hepatitis C virus (HCV) strain. The strain was isolated from the serum of a patient with chronic hepatitis C and identified as a hepatitis C virus. The infectious HCV dose used was equal to 10.0 tissue cytopathic dose (TCID 50 ) / 20 μL.

[0038] Primary fibroblasts, which are highly sensitive to the cytopathic effects of HCV, were obtained after trypsinization of 9-day-old chicken embryos (FEC), and cultures of porcine embryonic kidney cells (SPEV) were obtained from Collection of Cell Cultures of the Institute of Virology RAMS. They are used as 1-day monolayers of cells grown in 24-well plastic plates. SPEV and FEC cell cultures were grown in Medium 199 with 10% fetal calf serum, supplemented with glutamine and antibiotics (100 U / ml).

[0039] The glu...

Embodiment 2

[0060] The aim of this study was to determine the clinical and laboratory effects of glutaryl histamine in patients with hepatitis C virus during combination antiviral therapy (AVT) with pegylated interferon and ribavirin. potency.

[0061] Patient inclusion criteria were as follows: 1) presence of symptoms of HCV infection in the patient - detection of anti-HVC antibodies by enzyme immunoassay (EIA); presence of HCV RNA of genotype 1b in serum (qualitative test); 2) general blood test WBC level was 3.9×10 9 / L to 3.0×10 9 / L, neutrophil level was 2.0×10 9 / L to 1.5×10 9 / L; 3) There is no hepatitis B surface antigen; 4) There is no antibody to human immunodeficiency virus; 5) There is no other clinically significant liver disease (alcoholic liver disease, administration of hepatotoxic drug preparations, autoimmune chronic hepatitis, hemochromatosis); and 6) the absence of cirrhosis.

[0062] Patients were administered a dose of 100 μg (or 1.5 μg / kg) of peg-interferon-α2b...

Embodiment 3

[0100] The aim of this study was to determine the effect of glutaryl histamine (dicarbamine) on the efficacy of antiviral therapy in patients with chronic HCV genotype 1b infection with initially reduced levels of leukocytes and neutrophils .

[0101] 86 patients with CHC (anti-HCV "+", HCV RNA "+", genotype 1b) aged between 20 and 52 years (mean age 32±1.2 years) were observed. Among them, 46 (53.5%) patients were male and 40 (46.5%) patients were female.

[0102] In order to achieve the aforementioned purpose, all patients were divided into two groups with comparable gender and age according to the treatment plan: Group 1 (n=44) administered peg-interferon-α2b+ribavirin; Group 2 (n=42) Receive peg-interferon-α2b + ribavirin + dicarbamine. Peg-interferon-α2b was administered subcutaneously at a dose of 100 μg (or 1.5 μg / kg) once a week, and ribavirin was administered daily at a dose of 1000 mg for 48 weeks. Dicarbamine was administered at a dose of 100 mg once a day for 9 ...

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Abstract

The invention relates to medicine and comprises an agent for the treatment of a viral hepatitis C, which is glutaryl histamine or a pharmaceutically acceptable salt thereof. This agent can also be administered in combination with a pegylated interferon and ribavirin. The invention further relates to a pharmaceutical composition for the treatment of a viral hepatitis C. This invention solves the problem of providing a novel agent, which is effective in the treatment of a viral hepatitis C and makes it possible to produce a sustained virologic response.

Description

technical field [0001] The invention relates to the field of medicine, in particular to the use of glutaryl histamine or a pharmaceutically acceptable salt thereof for treating hepatitis C virus. Background technique [0002] Hepatitis C virus remains one of the most real problems in healthcare worldwide. Large number of infected people (almost 200 million people), high risk (60%-80%) of developing chronic infection which leads to liver cirrhosis or hepatocellular carcinoma (15%-25%), developing systemic disease of human organs and tissues Extrahepatic lesions and the lack of vaccines to prevent the development and spread of infection are reasons for the development of effective treatments for hepatitis C (Abdurakhmanov D.T. Prospects of the treatment of chronic hepatitis C. / / The Clinical Hepatology, 2010; 3: 3-11 ). [0003] Modern treatment of hepatitis C with pegylated interferon α2a or α2b in combination with ribavirin allows sustained virologic response (SVR) in 54%...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/05A61K39/39A61P1/16A61P31/14
CPCA61K31/7056A61K38/05A61K38/21A61K31/417A61K38/212A61P1/16A61P31/14A61K2300/00
Inventor 弗拉迪米尔·叶夫根尼耶维奇·涅博利辛德米特里·尤里耶维奇·康斯坦丁诺夫拉里莎·列昂尼多夫娜·波波娃叶连娜·阿列克谢夫娜·斯特列布科娃彼得·格里戈里耶维奇·杰里亚宾
Owner OBSCHESTVO S OGRANICHENNOI OTVETSTVENNOSTIYU (PHARMENTERPRISES)
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