HCV combination therapy
View Patent ↗Methods of treating patients having susceptible viral infections, especially chronic hepatitis C infection by administering to said patient a therapeutically effective amount of a combination therapy of interferon-alfa and ribavirin for a time sufficient to lower HCV-RNA in association with a therapeutically effective amount of an antioxidant for a time sufficient to ameliorate ribavirin-related hemolysis are disclosed.
1. A method of treating a patient having chronic HCV infection which comprises administering to said patient a therapeutically effective amount of a combination therapy of interferon-alfa and ribavirin for a time sufficient to substantially lower HCV-RNA in association with a therapeutically effective amount of Vitamin E and Vitamin C for a time sufficient to ameliorate ribavirin-related hemolysis wherein the therapeutically effective amounts of Vitamin E and of Vitamin C are in the range of about ten to about one hundred times the recommended daily dietary allowance of Vitamin E and of Vitamin C.
2. The method of claim 1 wherein the interferon alfa is interferon alfa-2a, interferon-alfa-2b, pegylated interferon alfa-2a, pegylated interferon alfa-2b, or a consensus interferon or a purified interferon alfa product.
3. The method of claim 1 wherein Vitamin E is a water soluble Vitamin E derivative.
4. The method of claim 3 wherein the water soluble Vitamin E derivative is an alpha-tocopheryl polyethylene glycol ester.
5. The method of claim 4 wherein the water soluble Vitamin E derivative is an alpha-tocopheryl polyethylene glycol succinate ester.
6. The method of claim 1 wherein the combination therapy comprising 3 Million International Units (“MIU”), three times a week (“TIW”) of interferon alfa-2b and about 600 mg to about 1600 mg/day, orally (“PO”) of ribavirin is administered for a first time period of at least about 24 weeks.
7. The method of claim 1 wherein the combination therapy is administered for time period at least about 48 weeks.
8. The method of claim 6 which further comprises administering about 600 to about 1600 mg per day of ribavirin in association with the Vitamin E and Vitamin C for a second time period of at least about 24 weeks after the end of the first time period.
9. The method of claim 7 which further comprises administering about 600 to about 1600 mg/day of ribavirin in association with the Vitamin E and Vitamin C for a third time period of at least about 24 weeks after the end of the first time period.
10. The method of claim 1 wherein the combination therapy comprises about 0.5 to about 1.5 μg/kg, once a week (“QW”) of pegylated interferon alfa-2b and about 600 to about 1600 mg/day of ribavirin.
11. The method of claim 1 wherein the combination therapy comprises induction dosing amount of interferon alfa-2b and ribavirin.
12. The method of claim 1 wherein the combination therapy comprises induction therapy dosing of pegylated interferon alfa and ribavirin.
13. A method of treating a patient having chronic HCV infection which comprises administering to said patient a therapeutically effective amount of a combination therapy of pegylated interferon-alfa and ribavirin for a time sufficient to substantially lower HCV-RNA in association with a therapeutically effective amount of Vitamin E and Vitamin C for a time sufficient to ameliorate ribavirin-related hemolysis wherein the therapeutically effective amounts of Vitamin E and of Vitamin C are in the range of about ten to about one hundred times the recommended daily dietary allowance of Vitamin E and of Vitamin C.
14. The method of claim 13 wherein the pegylated interferon alfa is pegylated interferon alfa-2a.
15. The method of claim 13 wherein the pegylated interferon alfa is pegylated interferon alfa-2b.
16. The method of claim 13 wherein the time for administering the combination therapy in association with the therapeutically effective amount of Vitamin E and Vitamin C is a period of at least about 24 weeks.
17. The method of claim 13 wherein the time for administering the combination therapy in association with the therapeutically effective amount of Vitamin E and Vitamin C and is a period of at least about 48 weeks.
18. A method of treating a patient having a chronic HCV infection which comprises administering to said patient for a time period of at least about 24 weeks a therapeutically effective amount of a combination therapy of pegylated interferon alfa and ribavirin sufficient to lower detectable HCV-RNA in association with a therapeutically effective amount of Vitamin E and Vitamin C sufficient to ameliorate ribavirin-related hemolysis wherein the therapeutically effective amounts of Vitamin E and of Vitamin C are in the range of about ten to about one hundred times the recommended daily dietary allowance of Vitamin E and of Vitamin C.
19. The method of claim 18 wherein the patient has a HCV genotype 2 or 3 infection.
20. The method of claim 18 wherein the patient has a HCV genotype 1 infection, and the time period is about 48 weeks.