Claims for Patent: 6,849,254

Summary for Patent: 6,849,254

Title:	HCV combination therapy
Abstract:	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.
Inventor(s):	Brass; Clifford A. (Scotch Plains, NJ), Glue; Paul W. (Flemington, NJ), Piken; Edward (Palos Verdes Estates, CA)
Assignee:	Schering Corporation (Kenilworth, NJ)
Application Number:	09/551,341
Patent Claims:	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 .mu.g/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.

Details for Patent 6,849,254

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132	06/04/1986		2019-04-19
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2019-04-19
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2019-04-19