Treatment of hepatitis c in the asian population with interferon-beta

A technology of interferon and population, applied in the field of viral diseases, can solve problems such as poor clinical efficacy

Inactive Publication Date: 2008-02-13
MERCK SERONO SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] Intramuscular injection of IFN-β (3 MU three times per week (tiw)) has been shown to have poor clinical efficacy in HCV patients of non-Asian ethnicity (Perez R. et al., 1995)

Method used

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  • Treatment of hepatitis c in the asian population with interferon-beta
  • Treatment of hepatitis c in the asian population with interferon-beta
  • Treatment of hepatitis c in the asian population with interferon-beta

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0127] Example 1: Interferon-beta-1a (Liby  ) early viral response to treatment: 12-week results of a multicenter, randomized, placebo-controlled trial

[0128] Purpose

[0129] The primary purpose of this study was to evaluate and compare the effect of IFN-β-1a versus placebo on sustained viral response (SVR) in Asian patients with chronic hepatitis C infection not treated with IFN-α.

[0130] The second main objective of this study was to evaluate and compare the effect of interferon-β-1a and interferon-α-1a / ribavirin combination on SVR.

[0131]Another objective of this study was to evaluate and compare the effects of interferon-beta-1a on therapeutic viral load and clearance, alanine aminotransferase (ALT) levels, liver histology, and treatment safety and tolerability, including effects on hematological and biochemical parameters and development of neutralizing antibodies.

[0132] The present example presents the results of an analysis of the first 12 weeks of treatme...

Embodiment 2

[0187] Example 2 Sustained Viral Response to Interferon-beta-1a (Liby(R)) Treatment in Asian Hepatitis C Patients: 24 and 48 Week Results of a Multicenter, Randomized, and Placebo-Controlled Trial

[0188] Study Design and Materials and Methods:

[0189] The research design and materials and methods used are as in Example 1.

[0190] result:

[0191] Patient demographics and baseline disease characteristics are as in Example 1.

[0192] 128 subjects received interferon-beta-1a, 15 (11.7%) subjects withdrew before 48 weeks. All study subjects who received placebo during the double-blind period completed the first 12 weeks of the study. Two power analysis sets are analyzed: the full analysis set and the per-protocol set. The full analysis set was defined as all study subjects randomized and treated (ie, receiving at least one study drug) with at least one efficacy or safety value for a treatment-based measure. Subjects with no viral load (HCV RNA) at week 12 were also inclu...

Embodiment 3

[0212] Example 3 Combination therapy of interferon-beta-1a (Ribi(R)) and ribavirin in Asian patients with hepatitis C: 24-week and 48-week results of a multicentre, randomized and placebo-controlled trial

[0213] The final experimental data analysis has been carried out, and the results of the IFN-β and ribavirin combination treatment group in the draft statistical report are shown below.

[0214] Table 9 Week 48 SVR Summary, Full Analysis Set

[0215] IFN-β-1a

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PUM

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Abstract

The invention relates to the use of IFN-beta in the manufacture of a medicament for the treatment of an HCV infection in a treatment-nave patient belonging to the Asian population.

Description

technical field [0001] The present invention relates to the field of viral diseases. More specifically, it relates to the use of IFN-beta in the preparation of a medicament for the treatment of HCV-infected Asian population patients who have not been treated with interferon-alpha. technical background [0002] Hepatitis viruses are a family of viruses that include hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis G virus and hepatitis E virus. [0003] At least 80% of post-transfusion hepatitis cases and most cases of sporadic acute hepatitis are caused by HCV. It also occurs in many cases of chronic hepatitis, latent sclerosis, and hepatocellular carcinoma unrelated to HBV. The most common is through blood-acquired infection from blood transfusions or intravenous administration of medicines. A small proportion of apparently healthy individuals are chronic HCV carriers, often with subclinical symptoms of chronic hepatitis or even cirrho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61P31/14
CPCA61K38/215A61P1/16A61P31/14A61P43/00A61K38/21
Inventor I·帕森斯黄迪仁
Owner MERCK SERONO SA
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