Composition for treatment of and method of monitoring hepatitis C virus using interferon-tau

Abstract

A method of monitoring treatment of HCV by oral administration of ovine IFN-τ is disclosed. The method includes measuring the blood levels of 2′,5′-oligoadenylate synthetase prior to and after such oral administration, and if necessary, adjusting the dose of IFN-τ until a measurable increase in blood 2′,5′-oligoadenylate synthetase level, relative to the level observed prior to administration, is observed. Also disclosed are oral-delivery compositions for use in treating HCV in an HCV-infected patient comprising ovine IFN-τ, in a dosage effective to stimulate bloodstream levels of 2′,5′-oligoadenylate synthetase.

1 . An oral-delivery composition for use in treating HCV in a HCV-infected patient comprising ovine IFN-τ, in a dosage effective to stimulate bloodstream levels of 2′,5′-oligoadenylate synthetase.  
     
     
         2 . The oral-delivery composition of  claim 1 , which further comprises an oral-delivery vehicle containing IFN-τ, wherein said oral-delivery vehicle is effective to release the IFN-τ in active form in the digestive tract.  
     
     
         3 . The composition of  claim 2 , wherein the vehicle is effective to release ovine IFN-τ in the stomach or intestines.  
     
     
         4 . The composition of  claim 1  wherein the dosage of ovine IFN-τ is between 10 8 -10 10  Units/day.  
     
     
         5 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 1×10 8  Units/day.  
     
     
         6 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 2×10 8  Units/day.  
     
     
         7 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 4×10 8  Units/day.  
     
     
         8 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 1×10 9  Units/day.  
     
     
         9 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 4×10 9  Units/day.  
     
     
         10 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ is greater than about 7×10 9  Units/day.  
     
     
         11 . The composition of  claim 1 , wherein the dosage of ovine IFN-τ avoids the  tunica mucosa oris.    
     
     
         12 . The composition of  claim 1 , in combination with ribavirin.  
     
     
         13 . A pharmaceutical composition for the treatment of HCV comprising: 
 ovine IFN-τ as an effective ingredient, wherein said composition avoids the absorption of ovine IFN-τ through the  tunica mucosa oris.      
     
     
         14 . A method of monitoring treatment of HCV by oral administration of ovine IFN-τ comprising: 
 measuring the blood levels of 2′,5′-oligoadenylate synthetase prior to and after such oral administration, and if necessary    adjusting the dose of IFN-τ until a measurable increase in blood 2′,5′-oligoadenylate synthetase level, relative to the level observed prior to administration, is observed.    
     
     
         15 . The method of  claim 14 , wherein said adjusting includes increasing the dose above 10 8  units.