Claims for Patent: 8,822,496

Summary for Patent: 8,822,496

Title:	Dosage regimens for HCV combination therapy
Abstract:	The present invention relates to therapeutic combinations comprising (a) Compound (1), or a pharmaceutically acceptable salt thereof, as herein described, (b) an interferon alfa and (c) ribavirin and particular regimens for administering this combination. Compound (1) is a selective and potent inhibitor of the HCV NS3 serine protease. The present invention also relates to methods of using such therapeutic combinations for treating HCV infection or alleviating one or more symptoms thereof in a patient.
Inventor(s):	Haefner; Carla (Neu-Ulm, DE), Steinmann; Gerhard (Erbach, DE), Stern; Jerry O. (New Fairfield, CT), Yong; Chan-Loi (Brookfield, CT)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	12/913,323
Patent Claims:	1. A method of treating hepatitis C viral (HCV) infection in a patient comprising administering to the patient a therapeutic combination comprising: (a) Compound (1) or a pharmaceutically acceptable salt thereof: ##STR00005## (b) an interferon alpha; and (c) ribavirin, wherein the first dose of Compound (1), or a pharmaceutically acceptable salt thereof, that is administered to the patient is double in quantity by weight to the subsequent doses thereof and wherein Compound (1), or a pharmaceutically acceptable salt thereof, is administered at a dosage of about 240 mg to about 480 mg in the first dose, and at a dosage of about 120 mg to about 240 mg in subsequent doses. 2. A method according to claim 1, wherein Compound (1), or a pharmaceutically acceptable salt thereof, is administered at a dosage of about 240 mg in the first dose, and at a dosage of about 120 mg in subsequent doses. 3. A method according to claim 1, wherein Compound (1), or a pharmaceutically acceptable salt thereof, is administered at a dosage of about 480 mg in the first dose, and at a dosage of about 240 mg in subsequent doses. 4. The method according to claim 1, wherein the HCV infection is genotype 1. 5. The method according to claim 1, wherein said patient is a treatment-naive patient. 6. The method according to claim 1, wherein said patient is non-responsive to a combination therapy using ribavirin and an interferon alpha. 7. The method according to claim 1, wherein said interferon alpha is a pegylated interferon alfa. 8. The method according to claim 1, wherein said interferon alfa is pegylated interferon alfa-2a or pegylated interferon alfa-2b. 9. The method according to claim 1, wherein on the first day of treatment with Compound (1), or a pharmaceutically acceptable salt thereof, the Compound (1), or a pharmaceutically acceptable salt thereof, is administered at a dose of 480 mg and on subsequent days at a dose of 240 mg per day. 10. The method according to claim 1, wherein on the first day of treatment with Compound (1), or a pharmaceutically acceptable salt thereof, the Compound (1), or a pharmaceutically acceptable salt thereof, is administered at an initial dose of 480 mg and at subsequent doses of 240 mg twice per day. 11. The method according to claim 1, wherein on the first day of treatment with Compound (1), or a pharmaceutically acceptable salt thereof, the Compound (1), or a pharmaceutically acceptable salt thereof, is administered at a dose of 240 mg and on subsequent days at a dose of 120 mg per day.

Details for Patent 8,822,496

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		2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	For Injection	103132			2039-02-26
Merck Sharp & Dohme Corp.	INTRON A	interferon alfa-2b	Injection	103132			2039-02-26
Hoffmann-la Roche Inc.	PEGASYS COPEGUS COMBINATION PACK	peginterferon alfa-2a and ribavirin		125083	06/04/2004		2039-02-26
Schering Corporation A Subsidiary Of Merck & Co., Inc.	PEGINTRON/ REBETOL COMBO PACK	peginterferon alfa-2b and ribavirin		125196	06/13/2008		2039-02-26