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Method for inhibiting development of liver cancer and increasing survival in chronic hepadnavirus infection

A chronic infection, hepatitis B virus technology, applied in the direction of pharmaceutical formulations, organic active ingredients, medical preparations containing active ingredients, etc., can solve problems such as inability to evaluate

Inactive Publication Date: 2001-01-10
CORNELL RES FOUNDATION INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These short-term in vivo studies cannot assess the effect of 3TC on the prevention of HCC-related hepatocellular carcinoma (HCC) in human HBV-infected patients

Method used

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  • Method for inhibiting development of liver cancer and increasing survival in chronic hepadnavirus infection
  • Method for inhibiting development of liver cancer and increasing survival in chronic hepadnavirus infection
  • Method for inhibiting development of liver cancer and increasing survival in chronic hepadnavirus infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] This example shows the development of chronically infected woodchucks. The woodchuck is the offspring of female and male mice raised in the laboratory, and the parents were seronegative for WHV infection markers when they gave birth. At the age of 3 days, each woodchuck was subcutaneously inoculated with 100 μl of 10-fold diluted WHV7-P-1 woodchuck hepatitis virus. At 3 months old, the woodchuck was tested positive for WHV surface antigen (WHs); at 6 months old, it was confirmed to still be WHs antigenemia. As additional markers of chronic infection, each woodchuck in the lifetime study tested positive for serum WHV DNA and anti-WHV core antibodies at six months of age. Before 3TC treatment, the baseline level of serum activity of liver enzyme γ-glutamyl transpeptidase (GGT) was determined to be lower than 5IU / L. According to the above criteria, two groups of 20 chronic WHV carrier woodchucks aged 7 to 8 months were selected and divided into treatment group and contro...

Embodiment 2

[0028] This example illustrates a 3TC dosing regimen for the treatment of chronically infected woodchucks.

[0029] At first, it was used by Raymond F. 3TC synthesized by Dr. Schinazi. Later, a commercially available 3TC (from Glaxo Wellcome) was used. 3TC was orally administered as an aqueous solution to each woodchuck in the treatment group. A control group of woodchucks received water as a placebo. To ensure ingestion, water or 3TC was added to 2-3ml semi-liquid diet, given via oral feeding syringe. The amount of 3TC or placebo was adjusted each time the woodchucks were weighed during the study to reflect changes in body weight. The treatment group received 3TC orally at a dose of 5 mg / kg body weight / day from the beginning of the study to the 42nd week of treatment. After week 42, the treatment group received a dose of 15 mg / kg / day.

Embodiment 3

[0031] This example illustrates the effect of treatment of chronically infected woodchucks with 3TC or placebo on body weight and parameters measured in post-treatment blood samples. Such as figure 1 As shown, there was no difference in mean body weight between the placebo group (•) and the treatment group (o) during the first 136 weeks of the study. Both groups showed a gradual increase in body weight, with a slight decrease after week 40, consistent with a normal annual rhythm.

[0032] During the first 64 weeks of the study, ALT ( Figure 2A ) and AST ( Figure 2B ) average serum levels were slightly higher, but the increase from the 64th week to the 88th week was more significant. Then, at weeks 96 and 104, mean AST and ALT activities decreased in the control group. In the group receiving 3TC, it was seen that the activities of both enzymes continued to increase at 96 weeks. Then, at week 104, the mean serum activity of both ALT and AST decreased in the 3TC group. Th...

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Abstract

A method of inhibiting the development and growth of hepatocellular carcinoma in a individual chronically infected with Hepatitis B virus involves prolonged administration of a prophylactically effective amount of 3TC to the chronically infected individual. Additionally, the method includes prolonged administration of 3TC in combination with another antiviral agent having activity against Hepatitis B virus.

Description

[0001] The invention was supported by the government, and was supported by the NO1-AI-35164 fund of the National Institute of Metamorphosis and Infectious Diseases. The government has certain rights in this invention. field of invention [0002] The present invention relates to new uses of β-L(-)-nucleotide analogues. More specifically, the present invention relates to methods of inhibiting the development and growth of hepatocellular carcinoma using β-L(-)-nucleotide analogues in hepatitis B infection. Background of the invention [0003] Hepatitis B virus (HIV) is a partially double-stranded DNA virus belonging to the family Hepadnaviridae. Most HBV-infected patients develop self-limited acute infection. However, in some patients the viral infection persists, resulting in chronic persistent hepatitis or chronic active hepatitis. Chronic viral hepatitis leads to progressive liver disease (eg, cirrhosis); and is associated with the development of hepatocellular carcinoma ...

Claims

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Application Information

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IPC IPC(8): A61K31/70
CPCA61K31/70
Inventor B·C·坦南特S·F·皮克
Owner CORNELL RES FOUNDATION INC
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