Combination therapy for treating alphavirus infection and liver fibrosis

• US 20070072181A1
• Filed: 02/26/2004
• Published: 03/29/2007
• Est. Priority Date: 02/28/2003
• Status: Abandoned Application

• Current Assignee: Three Rivers Pharmaceuticals LLC (Sanofi )
• Original Assignee: Three Rivers Pharmaceuticals LLC (Sanofi )
• Inventors: Blatt, Lawrence
• Application Number:
  US10/545,864
• Publication Number:
  US 20070072181A1
• Time in Patent Office: Days
• US Class Current: 435/6
• 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 31/4412 having oxo groups directly attached to the heterocyclic ring
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention provides methods for treating alphavirus infections; methods of treating hepatitis C virus (HCV) infections; methods of treating West Nile virus infection; methods of reducing liver fibrosis; methods of increasing liver function in an individual suffering from liver fibrosis; methods of reducing the incidence of complications associated with HCV and cirrhosis of the liver; and methods of reducing viral load, or reducing the time to viral clearance, or reducing morbidity or mortality in the clinical outcomes, in patients suffering from viral infection. The methods generally involve administering effective amounts of an interferon receptor agonist and pirfenidone in combination therapy.

Claims

1. A method of treating a hepatitis virus infection in an individual, the method comprising administering to the individual an effective amount of interferon alpha (IFN-α

) and an effective amount of pirfenidone or a pirfenidone analog.

2. The method of claim 1, wherein a sustained viral response is achieved.

3. The method of claim 1, wherein the IFN-α

is consensus interferon.

4. The method of claim 1, wherein the IFN-α

is selected from IFN-α

2a, IFN-α

2b, and IFN-α

2c.

5. A method of treating an alphaviral infection in an individual, the method comprising administering to the individual an effective amount of an interferon-alpha (IFN-α

) and an effective amount of pirfenidone or a pirfenidone analog.

6. The method of claim 5, wherein the method comprises administering to the individual a synergistically effective amount of IFN-α

and a pirfenidone analog.

7. The method of claim 5, wherein the method comprises administering to the individual an effective amount of IFN-α

and an amount of pirfenidone or a pirfenidone analog effective to reduce the incidence or severity of side effects ordinarily experienced by the individual in respones to IFN-α

monotherapy for treatment of alphaviral infection.

8. The method of claim 7, wherein the amount of IFN-α

administered to the individual is at least about 90% of the maximum tolerated dose (MTD) of the patient for IFN-α

in the context of IFN-α

monotherapy for treatment of the alphaviral infection.

9. The method of claim 8, wherein the amount of IFN-α

is at least about 100% of the MID.

10. The method of any one of claims 5-9, wherein the alphaviral infection is a hepatitis viral infection.

11. The method of claim 10, wherein the hepatitis viral infection is a hepatitis C viral infection.

12. The method of any one of claims 5-9, wherein the alphaviral infection is a West Nile viral infection.