Drug composition for preventing or treating HIV (human immunodeficiency virus) infection and application thereof

A drug and amino acid technology, applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, peptide/protein components, etc., can solve problems such as high risk

Inactive Publication Date: 2011-11-23
TIANJIN FUSOGEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In other words, when the viral load rebounds, if the original treatment drug is not changed, the risk of drug resistance is greater

Method used

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  • Drug composition for preventing or treating HIV (human immunodeficiency virus) infection and application thereof
  • Drug composition for preventing or treating HIV (human immunodeficiency virus) infection and application thereof
  • Drug composition for preventing or treating HIV (human immunodeficiency virus) infection and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Embodiment 1-preparation of the pharmaceutical composition containing antiviral peptide FS-01

[0110] This example introduces the pharmaceutical composition of antiviral peptide FS-01 and the preparation method of injection powder preparation. According to the ratio shown in Table 1, the specified amount of filler, pH regulator and antiviral peptide are weighed, and the Appropriate amount of water for injection is used to completely dissolve it, after sterilization filtration, membrane filtration, and finally freeze-drying to obtain a powder preparation containing FS-01.

[0111]Table 1. Antiviral peptide composition prescription for injection (weight / weight)

[0112]

Embodiment 2-HI

[0113] The test of embodiment 2-HIV infected person's continuous subcutaneous injection containing the pharmaceutical composition of FS-01

[0114] 19 HIV-infected patients were randomly divided into two groups, and they were given pharmaceutical compositions containing 10 mg and 20 mg FS-01 respectively, subcutaneously injected once a day, for a total of 28 days. Analyzed together with the data in Example 4.

[0115] The test results show that the safety of the pharmaceutical composition of the present invention is good. No obvious side effects were found. After 14 days of administration, in the 20mg group, the viral load in plasma of HIV-infected patients whose viral load was figure 1 ), and for infected patients with pre-medication viral load >10,000c / ml, it is recommended to use it in combination with other antiviral drugs, such as antiretroviral inhibitors or protease inhibitors. The half-life of FS-01 in HIV-infected patients in the 20 mg group was 39 hours.

[0116] ...

Embodiment 3-F

[0117] The human trial of the drug combination of embodiment 3-FS-01 and HAART

[0118] 107 qualified subjects were randomly divided into two groups according to 2:1 (Table 2). The subjects in the control group were given lopinavir / ritonavir, lamivudine ) and didanosine (didanosine) HAART; FS-01 test group subjects were given a drug combination, including the above drugs and FS-01. The two groups of subjects were administered continuously for 24 weeks.

[0119] Table 2. Experimental design of HIV-infected patients receiving HAART combined with FS-01 composition

[0120]

[0121] Preliminary research results show (Table 3), continuous administration for 24 weeks, at each stage of treatment, the drug combination of the present invention can significantly promote the effect of antiviral treatment ( image 3 ). After 24 weeks of administration, 46.4% of the subjects in the FS-01 test group had their viral load reduced to an undetectable level, and 31.0% of the subjects' vira...

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PUM

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Abstract

The invention relates to a drug composition containing an antiviral peptide, application thereof in prevention or treatment of HIV (human immunodeficiency virus) infection and preparation of the corresponding drugs, and a method for preventing or treating HIV infection by using the drug composition.

Description

technical field [0001] The present invention relates to a drug combination containing antiviral peptides, the application of the drug combination for preventing or treating HIV infection and preparation of corresponding drugs, and a method for using the drug combination to prevent or treat HIV infection. Background technique [0002] 1. Epidemics of Human Immunodeficiency Virus and AIDS [0003] Human immunodeficiency virus (HIV) can cause pathogenic retrovirus infection and cause acquired immunodeficiency syndrome (AIDS, AIDS) (Barre-Sinossi, F. et al., 1983, Science (Science) 220:868- 870). Although macrophages, nerve cells, and various other cells can also be infected by HIV (Maddon et al., 1986, Cell (Cell) 47:333-48), HIV has an affinity for CD4 molecules on the surface of CD4+ cells, so CD4+ T lymphocytes are the major target cells of HIV (Dalgleish, A. et al., 1984, Nature 312:767-8). After a person is infected by HIV, a large number of CD4+ T lymphocytes are destr...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61P31/18A61K31/426A61K31/513A61K31/708
Inventor 周根发张晓滨
Owner TIANJIN FUSOGEN BIOTECH CO LTD
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