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Telaprevir dosing regimen

A drug and stage technology, applied in the field of telaprevir, can solve the problem of no alternative treatment methods

Inactive Publication Date: 2011-06-01
JANSSEN PHARMA NV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In many parts of the world, no alternative treatment with proven superiority is currently available for patients who do not achieve SVR following Peg-IFN / RBV therapy

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0040] Randomized, double-blind, placebo-controlled trial of telaprevir in patients with chronic HCV genotype 1 infection refractory to prior therapy with Peg-IFN (Peg-IFN alfa-2a or Peg-IFNalfa-2b) plus RBV Research. The trial was designed to compare the efficacy, safety of two regimens of telaprevir combined with Peg-IFN alfa-2a and RBV (with and without delayed start) versus standard therapy (Peg-IFN alfa-2a and RBV) and tolerance.

[0041] The trial consisted of a screening period of approximately 4 weeks, a treatment period of 48 weeks, and a follow-up period of 24 weeks. figure 1 Displays a graphical overview of the experimental design.

[0042] Patients participating in this study meet any of the following criteria:

[0043] (1) Patients with undetectable HCV RNA levels at the end of a prior course of Peg-IFN / RBV therapy, but who did not achieve SVR (viral relapser), or

[0044] (2) Patients who never had undetectable HCV RNA levels at the end of or during the cours...

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PUM

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Abstract

This invention relates to the use of specific dosing regimens of telaprevir in combination with peg-IFN and RBV in the treatment of HCV patients, wherein the treatment comprises (a) a lead-in phase of administering to the subject pegylated interferon and ribavirin, and (b) a treatment phase of administering to the subject a combination of telaprevir, pegylated interferon and ribavirin.

Description

[0001] The invention relates to the use of telaprevir combined with peg-IFN and ribavirin (RBV) in treating HCV patients. In particular, the use of a specific dosing regimen of telaprevir in combination with peg-IFN and ribavirin. Background of the invention [0002] Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in a patient's blood. HCV, infecting 3.4 million people in the United States, is a serious public health problem that is transmitted through direct contact with the blood of infected individuals. While many people with HCV infection may not have symptoms, others may have symptoms such as jaundice, abdominal pain, fatigue, and fever. The burden of liver disease associated with HCV infection is increasing, and existing treatments typically have a sustained effect in fewer than half of patients with genotype 1 HCV, the most common species of the virus. [0003] Standard therapy for HCV patients consists of a combination of pegylated inte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/497A61K31/7056A61K47/48A61P31/14A61K38/21
CPCA61K31/7056A61K31/497A61K47/48215A61K47/48092A61K38/21A61K2300/00A61K47/60A61K47/549A61P1/16A61P31/14A61P43/00
Inventor M·G·比蒙特S·R·赫蒂纽斯G·R·皮基奥R·波洛R·S·考夫曼B·S·阿迪维贾亚V·加尔格
Owner JANSSEN PHARMA NV
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