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Biomarkers for predicting rapid response to HCV treatment

A technology of HCV-1 and HCV-4, applied in the field of biomarkers, can solve the problems of undetermined identification and difficult extrapolation to humans

Inactive Publication Date: 2012-10-03
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the identification of prodrugs remains an undefined and challenging practice
Furthermore, evaluating the pharmacokinetic properties of potential prodrugs is a challenging and expensive endeavor
Pharmacokinetic results from animal models may be difficult to extrapolate to humans

Method used

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  • Biomarkers for predicting rapid response to HCV treatment
  • Biomarkers for predicting rapid response to HCV treatment
  • Biomarkers for predicting rapid response to HCV treatment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Example 1: Phase II clinical trial involving RO4588161

[0088] This is Phase 2A, multicenter, randomized, double-blind (RO4588161 and ribavirin are double-blind and Pegasys is open labeled), active-controlled, with ongoing parallel group studies test. The treatment portion of the trial ( figure 1 ). The HCV genotype and HCV RNA titer of each patient were determined during screening, and only untreated patients with HCV genotype-1 and HCV RNA titer > 50,000 IU / mL were enrolled.

[0089] 107 male and female patients aged 18 to 66 were enrolled in the study. Patients were randomized into 4 treatment groups:

[0090] Group A / Dual 1500 [twice a day, oral RO45881611500 mg + once a week, subcutaneous Pegasys 180 μg] for 4 weeks - 21 patients,

[0091] Group B / Dual 3000 [twice a day, oral RO45881613000mg + once a week, subcutaneous Pegasys 180μg] for 4 weeks - 34 patients,

[0092] Group C / Triple 1500 [twice a day, oral RO45881611500mg + once a week, subcutaneous Pegas...

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Abstract

The present invention relates to biomarkers that are useful for predicting the response of hepatitis C virus infected patients to pharmacological treatment.

Description

technical field [0001] The present invention relates to biomarkers for predicting response to drug therapy in patients infected with hepatitis C virus. Background of the invention [0002] Hepatitis C virus (HCV) is a major health problem and a major cause of chronic liver disease worldwide (Boyer, N. et al., J. Hepatol. 2000 32:98-112). Patients infected with HCV are at risk of progression to cirrhosis and subsequent hepatocellular carcinoma; therefore, HCV is the main indication for liver transplantation. [0003] According to the World Health Organization, there are more than 200 million infected individuals worldwide, and at least 3 to 4 million people are infected each year. Once infected, about 20% of people clear the virus, but the rest can carry HCV for life. Ten to 20 percent of chronically infected individuals eventually develop cirrhosis or cancer that destroys the liver. The viral disease is transmitted parenterally by contaminated blood and blood products, by...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576C12Q1/70G01N33/68
CPCG01N33/5767G01N2800/60G01N2333/186G01N2800/52G01N33/6863G01N33/68G01N33/569C12Q1/70
Inventor S-H·邱Y·朱
Owner F HOFFMANN LA ROCHE & CO AG