Nucleotide hemi-sulfate salt for the treatment of hepatitis c virus

Abstract

A hemi-sulfate salt of the structure: to treat a host infected with hepatitis C, as well as pharmaceutical compositions and dosage forms, including solid dosage forms, thereof.

1 . A pharmaceutical composition comprising an effective amount of a compound of the formula: 
       
         
           
           
               
               
           
         
       
       and an effective amount of an additional anti-viral compound selected from a protease inhibitor, a NS5B polymerase inhibitor, and a NS5A inhibitor in a pharmaceutically acceptable carrier. 
     
     
         2 . The pharmaceutical composition of  claim 1  comprising a compound of the formula: 
       
         
           
           
               
               
           
         
       
     
     
         3 . The pharmaceutical composition of  claim 1  comprising a compound of the formula: 
       
         
           
           
               
               
           
         
       
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the additional anti-viral compound is a protease inhibitor. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the protease inhibitor is a NS3/4A protease inhibitor 
     
     
         6 . The pharmaceutical composition of  claim 1 , wherein the additional anti-viral compound is a NS5A inhibitor. 
     
     
         7 . The pharmaceutical composition of  claim 1 , wherein the additional anti-viral compound is a NS5B polymerase inhibitor. 
     
     
         8 . The pharmaceutical composition of  claim 1 , in an oral dosage form. 
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein the oral dosage form is a solid dosage form. 
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the solid dosage form is a tablet or capsule. 
     
     
         11 . The pharmaceutical composition of  claim 8 , wherein the oral dosage form is a liquid dosage form. 
     
     
         12 . The pharmaceutical composition of  claim 11 , wherein the liquid dosage form is a suspension or solution. 
     
     
         13 . The pharmaceutical composition of  claim 1 , in an intravenous formulation. 
     
     
         14 . The pharmaceutical composition of  claim 1 , in a parenteral formulation. 
     
     
         15 . The pharmaceutical composition of  claim 2 , wherein the additional anti-viral compound is a protease inhibitor. 
     
     
         16 . The pharmaceutical composition of  claim 15 , wherein the protease inhibitor is a NS3/4A protease inhibitor 
     
     
         17 . The pharmaceutical composition of  claim 2 , wherein the additional anti-viral compound is a NS5A inhibitor. 
     
     
         18 . The pharmaceutical composition of  claim 2 , wherein the additional anti-viral compound is a NS5B polymerase inhibitor. 
     
     
         19 . The pharmaceutical composition of  claim 2 , in an oral dosage form. 
     
     
         20 . The pharmaceutical composition of  claim 19 , wherein the oral dosage form is a solid dosage form. 
     
     
         21 . The pharmaceutical composition of  claim 20 , wherein the solid dosage form is a tablet or capsule. 
     
     
         22 . The pharmaceutical composition of  claim 19 , wherein the oral dosage form is a liquid dosage form. 
     
     
         23 . The pharmaceutical composition of  claim 22 , wherein the liquid dosage form is a suspension or solution. 
     
     
         24 . The pharmaceutical composition of  claim 2 , in an intravenous formulation. 
     
     
         25 . The pharmaceutical composition of  claim 2 , in a parenteral formulation. 
     
     
         26 . The pharmaceutical composition of  claim 3 , wherein the additional anti-viral compound is a protease inhibitor. 
     
     
         27 . The pharmaceutical composition of  claim 26 , wherein the protease inhibitor is a NS3/4A protease inhibitor 
     
     
         28 . The pharmaceutical composition of  claim 3 , wherein the additional anti-viral compound is a NS5A inhibitor. 
     
     
         29 . The pharmaceutical composition of  claim 3 , wherein the additional anti-viral compound is a NS5B polymerase inhibitor. 
     
     
         30 . The pharmaceutical composition of  claim 3 , in an oral dosage form. 
     
     
         31 . The pharmaceutical composition of  claim 30 , wherein the oral dosage form is a solid dosage form. 
     
     
         32 . The pharmaceutical composition of  claim 31 , wherein the solid dosage form is a tablet or capsule. 
     
     
         33 . The pharmaceutical composition of  claim 30 , wherein the oral dosage form is a liquid dosage form. 
     
     
         34 . The pharmaceutical composition of  claim 33 , wherein the liquid dosage form is a suspension or solution. 
     
     
         35 . The pharmaceutical composition of  claim 3 , in an intravenous formulation. 
     
     
         36 . The pharmaceutical composition of  claim 3 , in a parenteral formulation.