Combination therapy for eradicating detectable HCV-RNA in patients having chronic hepatitis C infection

Abstract

There is disclosed a method for treating a patient having chronic hepatitis C infection to eradicate detectable HCV-RNA involving a combination therapy using a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of from 20 up to 80 weeks.

1 . A method of treating a patient having chronic hepatitis C infection having HCV genotype 1 and having a viral load of greater than 2 million copies/mL of serum HCV-RNA as measured by HCV-RNA/qPCR comprising administering to the patient a therapeutically effective combination of ribavirin and interferon-alpha for a time period of about 40 to about 50 weeks, wherein the patient has fewer than about 100 copies/mL of serum HCV-RNA at the end of said period and also has less than about 100 copies/mL of serum HCV-RNA for at least 24 weeks after the end of said period.  
     
     
         2 . The method of  claim 1 , wherein the amount of ribavirin administered is from about 400 to about 1200 mg per day.  
     
     
         3 . The method of  claim 2 , wherein the amount of ribavirin administered is from about 800 to about 1200 mg per day.  
     
     
         4 . The method of  claim 1 , wherein the interferon-alpha administered is selected from interferon alpha-2a, interferon alpha-2b, a consensus interferon, a purified interferon alpha product or a pegylated interferon-alpha.  
     
     
         5 . The method of  claim 2 , wherein the interferon-alpha administered is selected from interferon alpha-2a, interferon alpha-2b or a purified interferon alpha product and the amount of the interferon-alpha administered is from about 2 to about 10 million international units (IU) per week on a weekly, three times a week (EW), every other day (QOD) or daily basis.  
     
     
         6 . The method of  claim 5 , wherein the amount of the interferon-alpha administered is about 3 million IU TIW.  
     
     
         7 . The method of  claim 6 , wherein the interferon-alpha administered is interferon alpha-2b.  
     
     
         8 . The method of  claim 2 , wherein the interferon-alpha administered is consensus interferon and the amount of the interferon-alpha administered is from about 1 to about 20 micrograms per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         9 . The method of  claim 2 , wherein the interferon-alpha administered is pegylated interferon alpha-2b and the amount of the interferon-alpha administered is from about 0.5 to about 2.0 micrograms/kilogram per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         10 . The method of  claim 2 , wherein the interferon-alpha administered is pegylated interferon alpha-2a and the amount of the interferon-alpha administered is from about 20 to about 250 micrograms/kilogram per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         11 . The method of  claim 2 , wherein the patient had previously been treated with interferon-alpha monotherapy.  
     
     
         12 . The method of  claim 3 , wherein the interferon-alpha administered is selected from interferon alpha-2a, interferon alpha-2b or a purified interferon alpha product and the amount of the interferon-alpha administered is from about 2 to about 10 million international units (IU) per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         13 . The method of  claim 12 , wherein the amount of the interferon-alpha administered is about 3 million IU TIW.  
     
     
         14 . The method of  claim 13 , wherein the interferon-alpha administered is interferon alpha-2b.  
     
     
         15 . The method of  claim 3 , wherein the interferon-alpha administered is consensus interferon and the amount of the interferon-alpha administered is from about 1 to about 20 micrograms per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         16 . The method of  claim 3 , wherein the interferon-alpha administered is pegylated interferon alpha-2b and the amount of the interferon-alpha administered is from about 0.5 to about 2.0 micrograms/kilogram per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         17 . The method of  claim 3 , wherein the interferon-alpha administered is pegylated interferon alpha-2a and the amount of the interferon-alpha administered is from about 20 to about 250 micrograms/kilogram per week on a weekly, three times a week (TIW), every other day (QOD) or daily basis.  
     
     
         18 . The method of  claim 3 , wherein the patient had previously been treated with interferon-alpha monotherapy.