Claims for Patent: 6,824,768

Summary for Patent: 6,824,768

Title:	Ribavirin-pegylated interferon alfa induction HCV combination therapy
Abstract:	There is disclosed a method for treating antiviral treatment naives patient having chronic hepatitis C infection to eradicate detectable HCV-RNA involving a combination therapy using (1) a therapeutically effective inducing amount of ribavirin and a therapeutically effective induction dosing amount of pegylated interferon-alfa, e.g, pegylated interferon-alfa-2b for a first treatment time period sufficient to substantially lower detectable HCV-RNA, followed by (2) administering a therapeutically effective amount of ribavirin and an therapeutically effective amount of pegylated interferon-alfa, e.g., pegylated interferon alfa-2b for a second treatment time period sufficient to eradicate detectable HCV-RNA at least by end of the second treatment time period and to maintain no detectable HCV-RNA for at least 24 weeks after the end of the second treatment time period.
Inventor(s):	Stalgis; Carlos O. (Millington, NJ), Albrecht; Janice K. (Winter Park, FL), Glue; Paul W. (Flemington, NJ)
Assignee:	Schering Corporation (Kenilworth, NJ)
Application Number:	09/464,426
Patent Claims:	1. A method of treating a patient having a chronic hepatitis C infection to eradicate detectable HCV-RNA as measured by quantitative PCR ("qPCR") which comprises (1) administering to the patient in a first treatment time period of at least about four weeks up to about twelve weeks, about 400-1600 mg per day of ribavirin and about 1.5 micrograms per kilogram of pegylated interferon-alfa-2b twice a week, followed by (2) administering to the patient in a second treatment time period of about thirty-six weeks up to about forty-four weeks, about 800-1200 mg per day of ribavirin and about 0.5 to about 1.5 micrograms per kilogram of pegylated interferon-alfa-2b once a week, wherein the patient has no detectable HCV-RNA as measured by qPCR at the end of the second treatment time period and no detectable HCV-RNA as measured by qPCR for at least 24 weeks after the end of the second treatment time period. 2. The method of claim 1, wherein the amount of ribavirin administered in the first treatment time period is from 600 to 1600 mg per day. 3. The method of claim 1, wherein the amount of ribavirin administered in the second treatment time period is from 1000 to 1600 mg per day. 4. The method of claim 1, wherein the first treatment time period is four weeks and the second period is forty-four weeks. 5. The method of claim 1, wherein the amount of pegylated interferon alfa-2b administered in second treatment time period is 1.5 micrograms/kilogram once a week. 6. The method of claim 1, wherein the amount of ribavirin administered in the first and second treatment time periods is from about 800 to 1200 mg per day. 7. The method of claim 1 wherein the amount of ribavirin administered in the first and second treatment time period is about 1000 to 1200 mg/kg per day. 8. A method of treating a patient having a chronic hepatitis C infection to eradicate detectable HCV-RNA as measured by qPCR which comprises (1) administering to the patient, in a first treatment time period week of about four weeks, about 400-1600 mg per day of ribavirin and 1.5 micrograms per kilogram of pegylated interferon-alfa-2b twice a week, followed by (2) administering to the patient, in a second treatment time period of about forty-four weeks, about 800-1200 mg per day of ribavirin and about 0.5 to 1.5 micrograms per kilogram of pegylated interferon-alfa-2b once a week wherein the patient has no detectable HCV-RNA as measured by qPCR at the end of the second treatment time period and no detectable HCV-RNA as measured by qPCR for at least 24 weeks after the end of the second treatment time period. 9. The method of claim 8, wherein the amount of ribavirin administered in the first treatment time period is from 600 to 1600 mg per day. 10. The method of claim 8, wherein the amount of ribavirin administered in the second treatment time period is from 1000 to 1600 mg per day. 11. The method of claim 8, wherein the amount of ribavirin administered in the first and second treatment time periods is from about 800 to 1200 mg per day. 12. The method of claim 8 wherein the patient having chronic hepatitis C infection is a treatment naive patient having HCV genotype 1, 2 or 3. 13. The method of claim 8, wherein the amount of pegylated interferon alfa-2b administered in second time period is 1.5 micrograms/kilogram once a week. 14. The method of claim 8, wherein the amount of pegylated interferon alfa-2b administered in second time period is 1.0 micrograms/kilogram once a week. 15. The method of claim 8, wherein the amount of pegylated interferon alfa-2b administered in second time period is 0.5 micrograms/kilogram once a week.

Details for Patent 6,824,768

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		2018-12-18
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2018-12-18
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2018-12-18
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	06/04/2004		2018-12-18
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	06/13/2008		2018-12-18