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|Title:||Administration of HCV protease inhibitors in combination with food to improve bioavailability|
|Abstract:||Methods of treating, preventing or ameliorating one or more symptoms of hepatitis C in a subject comprising the step of administering at least one HCV protease inhibitor in combination with food are provided. Also provided are methods of increasing bioavailability of an HCV protease inhibitor and methods of increasing serum levels of an HCV protease inhibitor in a subject. All methods comprise adminstering at least one HCV protease inhibitor in combination with food, the at least one HCV protease inhibitor selected from the group consisting of compounds of Formulae I-XXVI, described herein. Administration of compounds of the present invention in combination with food provides improved bioavailability and increased peak serum levels of the compounds as compared to administration without food.|
|Inventor(s):||Zhang; Jenny (Cranbury, NJ), Gupta; Samir K. (East Brunswick, NJ)|
|Assignee:||Schering Corporation (Kenilworth, NJ)|
1. A method of increasing the bioavailability of a compound in a subject in need thereof, comprising administering to the subject an effective amount of at least one of the
following compounds ##STR01476## ##STR01477## ##STR01478## or a pharmaceutically acceptable salt thereof, in combination with food comprising high or low fat food, wherein said compound is administered concurrently with, up to ninety minutes after or up
to 30 minutes before administration of said food and, wherein the bioavailability achieved is higher compared to that when the compound is administered without food.
2. The method of claim 1, wherein the total amount of the at least one compound administered over twenty-four hours is between 50 mg and 3,000 mg.
3. The method of claim 2, wherein the one or more discrete dosages are in oral dosage form.
4. The method of claim 1 wherein the at least one compound is administered in oral dosage form and is administered concurrently with consumption of food.
5. The method of claim 1 wherein the at least one compound is administered in oral dosage form and is administered up to thirty minutes before or up to thirty minutes after consumption of food.
6. The method of claim 1 wherein over 30% of the calories in the food are from fat.
7. The method of claim 1 wherein the at least one compound is administered in combination with at least one antiviral agent which is different from the at least one compound and/or an immunomodulatory agent.
8. A method of increasing bioavailability of the compound in a subject in need thereof of Formula Ia ##STR01479## or a salt thereof, comprising administering to the subject an effective amount of said compound in combination with food, said food comprising high or low fat food.
9. A method of increasing bioavailability of the compound in a subject in need thereof of the structural formula ##STR01480## or a salt thereof, comprising administering to the subject an effective amount of said compound in combination with food, said food comprising high or low fat food.
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