Method of treating hepatitis C infection

• US 20050031589A1
• Filed: 07/26/2004
• Published: 02/10/2005
• Est. Priority Date: 06/08/1998
• Status: Abandoned Application

• Current Assignee: Friederike Zahm
• Original Assignee: Friederike Zahm
• Inventors: Zahm, Friederike
• Application Number:
  US10/899,726
• Publication Number:
  US 20050031589A1
• Time in Patent Office: Days
• US Class Current: 424/85.700
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/7056 containing five-membered rings with nitrogen as a ring hetero atom
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 47/642 the peptide or protein in the drug conjugate being a cytokine, e.g. IL2, chemokine, growth factors or interferons being the inactive part of the conjugate
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention provides the use of PEG-IFN-α conjugates in association with ribavirin for the treatment of chronic hepatitis C infections. The present invention also provides a method for treating chronic hepatitis C infections in patients in need of such treating comprising administering an amount of PEG-IFN-α conjugate in association with an amount of ribavirin effective to treat hepatitis C.

Claims

1-5. -5. (Cancelled)

6. (Originally presented) A method for treating chronic hepatitis C infections comprising administering a PEG-IFN-α

conjugate having the formula;

7. The method according to claim 6 wherein the PEG-IFN-α

2A conjugate is administered in in an amount of about 33 to about 540 mcg per week.

8. The method according to claim 7 wherein the ribavirin is administered in an amount of about 400 to about 1200 mg daily.

9. The method according to claim 6 wherein at least one daily dose of ribavirin is administered within the same week as at least one dose of the PEG-IFN-α

2A conjugate.

11. The method according to claim 8 wherein from about 150 μ

g to about 250 μ

g of the PEG-IFN-α

2A conjugate is administered once a week for at least one week and from about 800 mg to about 1200 mg of ribavirin is administered daily during the same at least one week the PEG-IFN-α

2A conjugate is administered.

12. The method according to claim 8 wherein about 180 μ

g of the PEG-IFN-α

2A conjugate is administered once a week for 48 weeks and from about 400 mg to about 600 mg of ribavirin is administered twice daily during the same 48 weeks the PEG-IFN-α

2A conjugate is administered.

10. (Cancelled)

13. A method for treating chronic hepatitis C infections comprising:

a) administering a PEG-IFN-α

conjugate having the formula;

where R and R′

are methyl, X is NH, and n and n′

are individually or both either 420 or 520, wherein the PEG-IFN-α

2A conjugate is administered once a week in a dosage of from about 150 μ

g to about 250 μ

g of and co-administering ribavirin daily in a dosage of from about 800 mg to about 1200 mg of ribavirin per day;

b) continuing the administration of drug in accordance with a) for a period of 12 weeks;

c) testing the patient treated in accordance with b) for HCV-RNA titer or serum ALT; and

d) continuing the administration of drug in accordance with a) to only those patients tested in c) who have at least a one (1) log 10 unit decrease in viral titer or who have a 50% decrease in or normalization of serum ALT levels until a total treatment period of 48 weeks has been completed.