IP Library Patent Application 11005881
Patent Application
App. No. 11/005,881

Biomarkers for interferon-alpha response in hepatitis C virus infected patients

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Quick Facts
Patent No.
US None
App. No.
11/005,881
Abstract

The present invention relates to the identification of prognostic markers useful in determining the response of hepatitis c virus (HCV) infected patients to interferon alpha (IFN-α) treatment. The studies provide biomarkers that can be used to discern sustained responders and non-responders of IFN-α treatment. This information should enable treating physicians to help patients to make more informed decisions.

Claims (29)

1 . A method of selecting an HCV infected individual for treatment with IFN-α, comprising:

(a) exposing cells obtained from the individual to IFN-α in vitro; and

(b) detecting the altered expression of at least 3 markers as listed in Table 4, as compared to cells obtained from the individual prior to IFN-α exposure;

wherein altered expression of said markers is correlated with a positive response to IFN-α treatment of the HCV infection.

2 . The method of claim 1 wherein the cells are exposed to IFN-α in vitro for 1-20 hours.

3 . The method of claim 1 , wherein the cells are peripheral blood mononuclear cells.

4 . The method of claim 1 , wherein the markers whose expression is altered are ADAR, IFI27, IFI44, OAS3, MX1, MX2, PRKR, IFIT4, TRIM22, and G1P2.

5 . The method of claim 1 , wherein the cells are obtained from the individual prior to any in vivo IFN-α administration in said individual.

6 . The method of claim 1 , wherein the level of expression of the marker is altered at least 2 fold relative to their expression levels in cells obtained prior to their exposure to IFN-α in vitro.

7 . A method of identifying an HCV infected individual for continued treatment with IFN-α, comprising:

(a) obtaining cells from an HCV infected individual who has received in vivo administration of IFN-α; and

(b) detecting the altered expression of at least 3 markers as listed in Table 4, as compared to cells obtained from the individual prior to IFN-α exposure;

wherein altered expression of said markers is correlated with a positive response to IFN-α treatment of the HCV infection.

8 . The method of claim 7 , wherein the cells are obtained from the individual 2-72 hours after in vivo administration of IFN-α

9 . The method of claim 7 , wherein the cells are peripheral blood mononuclear cells.

10 . The method of claim 7 , wherein the markers whose expression is altered are ADAR, IFI27, IF144, OAS3, MX1, MX2, PRKR, IFIT4, TRIM22, and G1P2.

11 . The method of claim 7 , wherein the level of expression of the marker is altered at least 2 fold relative to their expression levels in cells obtained prior to their exposure to IFN-α in vivo.

12 . A method of treating an HCV-infected individual, comprising administering a therapeutically effective amount of IFN-α in said individual, whose cells have been shown in an in vitro assay to exhibit altered expression of at least 3 markers as listed in Table 4.

13 . The method of claim 12 , wherein the cells are peripheral blood mononuclear cells.

14 . The method of claim 12 , wherein the markers whose expression is altered are ADAR, IFI27, IF144, OAS3, MX1, MX2, PRKR, IFIT4, TRIM22, and G1P2.

15 . The method of claim 12 , wherein the level of expression of the marker is altered at least 2 fold relative to their expression levels in cells obtained prior to their exposure to IFN-α.

16 . A method of identifying an HCV infected individual for discharge from treatment with IFN-α, comprising:

(b) exposing cells obtained from an HCV infected individual with IFN-α in vitro; and

(b) detecting a lack of altered expression of at least 3 markers as listed in Table 4, as compared to cells obtained from the individual prior to IFN-α exposure;

wherein altered expression of said markers is correlated with a positive response to IFN-α treatment of the HCV infection.

17 . The method of claim 16 , wherein the level of expression of the markers is altered 1.5 fold or less relative to their expression levels in cells obtained prior to their exposure to IFN-α in vitro.

18 . A kit comprising reagents for detecting the expression of at least 3 markers as listed in Table 4.

19 . The kit of claim 18 , wherein the reagents further comprise amplification primers.

20 . The kit of claim 18 , wherein the reagents further comprise hybridization probes.

Assignments (4)
CHANGE OF NAME Recorded Feb 26, 2010
From: APPLERA CORPORATION
To: APPLIED BIOSYSTEMS INC.
Reel/Frame 023994/0538 →
MERGER Recorded Feb 26, 2010
From: APPLIED BIOSYSTEMS INC.
To: APPLIED BIOSYSTEMS, LLC
Reel/Frame 023994/0587 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2008
From: APPLERA CORPORATION
To: CELERA CORPORATION
Reel/Frame 021561/0124 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 19, 2005
From: CHANG, SHENG-YUNG; MARTIN, JOHN
To: APPLERA CORPORATION
Reel/Frame 016652/0443 →