US2011236351A1PendingUtilityA1

Therapeutic Regimen Comprising PEG-Interferon, Ribavirin and VX-950 for the Treatment of Hepatitis

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Assignee: VERTEX PHARMAPriority: Sep 24, 2008Filed: Mar 24, 2011Published: Sep 29, 2011
Est. expirySep 24, 2028(~2.2 yrs left)· nominal 20-yr term from priority
Inventors:Robert KauffmanCyrill Jean Camille TiteuxRamon PoloRudolf Peter Gerhardt Van HeeswijkMaria Gloria BeumontGaston Rafael Picchio
A61P 31/20A61P 31/12A61P 43/00A61P 31/14A61K 38/212A61K 38/07A61K 31/7056A61P 1/18A61K 38/21
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Claims

Abstract

The present invention relates to antiviral therapies and compositions for treating or preventing Hepatitis C infections in patients and relates to other methods disclosed herein. The invention also relates to kits and pharmaceutical packs comprising compositions and dosage forms.

Claims

exact text as granted — not AI-modified
1 . A therapeutic regimen comprising administering to a patient peginterferon and ribavirin with VX-950 in an initial phase and administering peginterferon and ribavirin over a secondary phase, wherein the secondary phase occurs after the initial phase, and wherein VX-950 is administered in an amount of 1125 mg twice per day, peginterferon is administered once per week and ribavirin is administered once per day. 
     
     
         2 . A therapeutic regimen comprising administering to a patient peginterferon and ribavirin with VX-950 in an initial phase and administering peginterferon and ribavirin over a secondary phase, wherein the secondary phase occurs after the initial phase, and wherein VX-950 is administered in an amount of 1125 mg twice per day, peginterferon is administered in an amount of 180 micrograms per week and ribavirin is administered in an amount of 1000 to 1200 mg per day. 
     
     
         3 . The therapeutic regimen of  claim 2 , wherein at least 65% of patients have undetectable HCV RNA levels at week 4. 
     
     
         4 . The therapeutic regimen of  claim 3 , wherein at least 75% of patients have undetectable HCV RNA levels at week 4. 
     
     
         5 . The therapeutic regimen of  claim 4 , wherein at least 80% of patients have undetectable HCV RNA levels at week 4. 
     
     
         6 . The therapeutic regimen of  claim 5 , wherein at least 85% of patients have undetectable HCV RNA levels at week 4. 
     
     
         7 . The therapeutic regimen of  claim 2 , wherein at least 80% of patients have undetectable HCV RNA levels at week 12. 
     
     
         8 . The therapeutic regimen of  claim 7 , wherein at least 84% of patients have undetectable HCV RNA levels at week 12. 
     
     
         9 . The therapeutic regimen of  claim 8 , wherein at least 90% of patients have undetectable HCV RNA levels at week 12. 
     
     
         10 . The therapeutic regimen of  claim 9 , wherein at least 93% of patients have undetectable HCV RNA levels at week 12. 
     
     
         11 . The therapeutic regimen of  claim 2 , wherein VX-950 is administered every 12 hours. 
     
     
         12 . The therapeutic regimen of  claim 2 , wherein the peginterferon administered in the initial phase and in the secondary phase is peginterferon alfa 2a. 
     
     
         13 . The therapeutic regimen of  claim 2 , wherein the initial phase is for 12 weeks. 
     
     
         14 . The therapeutic regimen of  claim 2 , wherein the secondary phase is for 12 weeks or 36 weeks. 
     
     
         15 . A therapeutic regimen comprising administering to a patient peginterferon and ribavirin with VX-950 in an initial phase and administering peginterferon and ribavirin over a secondary phase, wherein the secondary phase occurs after the initial phase, and wherein VX-950 is administered in an amount of 1125 mg twice per days, peginterferon is administered in an amount of 1.5 micrograms per kilogram per week and ribavirin is administered in an amount of 800 to 1200 mg per day. 
     
     
         16 . The therapeutic regimen of  claim 15 , wherein at least 65% of patients have undetectable HCV RNA levels at week 4. 
     
     
         17 . The therapeutic regimen of  claim 16 , wherein at least 75% of patients have undetectable HCV RNA levels at week 4. 
     
     
         18 . The therapeutic regimen of  claim 17 , wherein at least 80% of patients have undetectable HCV RNA levels at week 4. 
     
     
         19 . The therapeutic regimen of  claim 18 , wherein at least 85% of patients have undetectable HCV RNA levels at week 4. 
     
     
         20 . The therapeutic regimen of  claim 15 , wherein at least 80% of patients have undetectable HCV RNA levels at week 12. 
     
     
         21 . The therapeutic regimen of  claim 20 , wherein at least 84% of patients have undetectable HCV RNA levels at week 12. 
     
     
         22 . The therapeutic regimen of  claim 21 , wherein at least 90% of patients have undetectable HCV RNA levels at week 12. 
     
     
         23 . The therapeutic regimen of  claim 22 , wherein at least 93% of patients have undetectable HCV RNA levels at week 12. 
     
     
         24 . The therapeutic regimen of  claim 15 , wherein VX-950 is administered every 12 hours. 
     
     
         25 . The therapeutic regimen of  claim 15 , wherein the peginterferon administered in the initial phase and in the secondary phase is peginterferon alfa 2b. 
     
     
         26 . The therapeutic regimen of  claim 15 , wherein the initial phase is for 12 weeks. 
     
     
         27 . The therapeutic regimen of  claim 15 , wherein the secondary phase is for 12 weeks or 36 weeks.

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