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Compositions and methods for treating hepatitis b virus infection

A technology of hepatitis B virus and composition, applied in the directions of antiviral agents, pharmaceutical formulations, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2012-10-17
周晓剑
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, comparing the treatment results of lamivudine combined with adefovir with lamivudine alone, published data show that lamivudine combined with adefovir has not been observed so far in patients who have not received anti-HBV treatment. Initial treatment with fovir dipivoxil had additive or synergistic antiviral activity and was not sufficient to prevent the emergence of lamivudine resistance (Lok et al., American Association for the Liver Diseases AASLD Treatment Guidelines, Chronic Hepatitis B: 2009 Update, Hepatology , 50(3):1-35, 2009)

Method used

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  • Compositions and methods for treating hepatitis b virus infection
  • Compositions and methods for treating hepatitis b virus infection
  • Compositions and methods for treating hepatitis b virus infection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0147] Implementation Example 1. Formulation

[0148] Although lamivudine and adefovir dipivoxil can be co-administered as bulk drugs, they are preferably administered via a pharmaceutical composition of these compounds that is convenient for patient use. Table 1 lists the dosage examples of each of lamivudine and adefovir dipivoxil used to prepare pharmaceutical composition preparations.

[0149] Table 1. Examples of respective unit doses used in the preparation of lamivudine and adefovir dipivoxil pharmaceutical compositions

[0150]

[0151] Prepare examples of each lamivudine dose, such as 405, 460, 510, 550, 600 and 900 mg / unit dose, and each example of adefovir dipivoxil dose, such as 3, 5, 8 and 10 mg / unit dose, Pharmaceutical composition preparations, 24 kinds of composition preparations with different dosage strengths can be obtained.

[0152] Each dosage strength listed in Table 1 can be prepared into conventional pharmaceutical preparations with appropriate pharmaceutical...

Embodiment 2

[0156] Implementation example 2. Virus kinetic analysis and Emax model

[0157] HBV DNA data

[0158] The HBV DNA data used in the unique viral kinetic analysis during the lamivudine treatment disclosed here is derived from the published lamivudine quantitative-effect curve ( figure 1 ) (Johnson et al. Clinical pharmacokinetics of lamivudine, Clin Pharmacokinet 1999, 36(1): 41-66). figure 1 The data points shown to 29 days were obtained by scanning and digitizing. Given that the HBVDNA value is too close to the off-line of quantitative methods, the data on the 22nd and 29th days of the high-dose group is not reliable. Therefore, virus kinetic analysis only used data up to 15 days.

[0159] Virus kinetic analysis

[0160] Convert the digitized data into the percentage change from the baseline (V t -V 0 ) / V 0 It is further expressed as V t / V 0 ; Where V 0 And Vt are the HBV DNA values ​​at baseline and t time after the start of treatment, respectively. Use the following virus kinet...

Embodiment 3

[0180] Implementation example 3. Clinical data

[0181] A preliminary observational study initiated by doctors to evaluate the clinical efficacy of the optimal dose of lamivudine combined with low-dose adefovir dipivoxil in HBeAg-positive chronic hepatitis B patients is ongoing. The results of the interim case report of 6 months of treatment are summarized below.

[0182] TMS is a 46-year-old male of Chinese descent. When he saw a doctor on April 11, 2010, he stated that he had a history of chronic hepatitis B (CHB) for several years and had recently felt weakness and decreased appetite.

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Abstract

The invention generally relates to compositions and methods for treating hepatitis B virus infection. More particularly, the invention relates to treating hepatitis B virus infection and related conditions in humans using unique and synergistic combinations of lamivudine and adefovir that maximize favorable therapeutic outcomes while minimizing or preventing viral resistance, which commonly occurs from using lamivudine or adefovir alone, and reducing the side effects of adefovir.

Description

[0001] This application claims the priority of US Provisional Patent Application No. 61 / 291,728 filed on December 31, 2009. For all purposes, the entire content of this application is incorporated herein by reference. Technical field [0002] The present invention generally relates to compositions and methods for treating hepatitis B virus infection. The present invention particularly relates to the use of a unique and synergistic pharmaceutical composition of lamivudine and adefovir to treat human hepatitis B virus infection and related diseases, in order to obtain the greatest beneficial effect and minimize or prevent When lamivudine or adefovir is used alone, viral resistance is common, and the side effects of adefovir are reduced. Background technique [0003] Hepatitis B is a disease caused by the hepatitis B virus (HBV). Hepatitis B virus infects the human liver, causing liver inflammation and hepatitis. Hepatitis B is a major health care problem worldwide, especially in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7068A61K31/506A61K31/675A61P31/20
CPCA61K31/675A61K31/513A61K31/7068A61P31/20A61K2300/00A61K31/506
Inventor 周晓剑
Owner 周晓剑
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