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Details for Patent: 7,304,043

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Details for Patent: 7,304,043

Title:.beta.-L-2'-deoxy-nucleosides for the treatment of hepatitis B
Abstract: This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2'-deoxy-.beta.-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2'-deoxy-.beta.-L-erythro-pentofuranonucleoside has the formula: ##STR00001## wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2'-deoxy-.beta.-L-eythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2'-deoxy-.beta.-L-erythro pentofuranonucleoside or in combination with another anti-hepatitis B agent.
Inventor(s): Gosselin; Gilles (Montpellier, FR), Imbach; Jean-Louis (Montpellier, FR), Bryant; Martin L. (Carlisle, MA)
Assignee: Idenix Pharmaceuticals, Inc. (Cambridge, MA) Centre National de la Recherche Scientifique (Paris, FR) L'Universite Montpellier II (Montpellier, FR)
Filing Date:Sep 22, 2005
Application Number:11/232,818
Claims:1. A method for the treatment of a hepatitis B virus infection in a human comprising administering an effective amount of .beta.-L-2'-deoxythymidine, or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable carrier that provides controlled release of the .beta.-L-2'-deoxythymidine.

2. The method of claim 1, wherein the .beta.-L-2'-deoxythymidine is at least 95% in its designated enantiomeric form.

3. The method of claim 1, wherein the carrier is in the form of an implant.

4. The method of claim 1, wherein the carrier is a microencapsulated delivery system.

5. The method of claim 1, wherein the carrier comprises a biocompatible biodegradable polymer.

6. The method of claim 5, wherein the biodegradable polymer comprises an ethylene vinyl acetate polymer.

7. The method of claim 5, wherein the biodegradable polymer comprises a polyanhydride polymer.

8. The method of claim 5, wherein the biodegradable polymer comprises a polyglycolic acid polymer.

9. The method of claim 5, wherein the biodegradable polymer comprises a polyorthoester polymer.

10. The method of claim 5, wherein the biodegradable polymer comprises a polyacetic acid polymer.

11. The method of claim 5, wherein the biodegradable polymer comprises collagen.

12. A method for the treatment of a hepatitis B virus infection in a human comprising administering an effective amount of .beta.-L-2'-deoxycytidine, or a pharmaceutically acceptable salt thereof in a pharmaceutically acceptable carrier that provides controlled release of the .beta.-L-2'-deoxycytidine.

13. The method of claim 12, wherein the .beta.-L-2'-deoxycytidine is at least 95% in its designated enantiomeric form.

14. The method of claim 12, wherein the carrier is in the form of an implant.

15. The method of claim 12, wherein the carrier is a microencapsulated delivery system.

16. The method of claim 12, wherein the carrier comprises a biocompatible biodegradable polymer.

17. The method of claim 16, wherein the biodegradable polymer comprises an ethylene vinyl acetate polymer.

18. The method of claim 16, wherein the biodegradable polymer comprises a polyanhydride polymer.

19. The method of claim 16, wherein the biodegradable polymer comprises a polyglycolic acid polymer.

20. The method of claim 16, wherein the biodegradable polymer comprises a polyorthoester polymer.

21. The method of claim 16, wherein the biodegradable polymer comprises a polyacetic acid polymer.

22. The method of claim 16, wherein the biodegradable polymer comprises collagen.

23. The method of claim 1 wherein the .beta.-L-2'-deoxythymidine is administered in combination or alternation with an effective amount of a compound selected from the group consisting of .beta.-L-2-hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane (3TC), cis-2-hydroxymethyl-5-(5-fluorocytosin-1 -yl)-1,3-oxathiolane (FTC), .beta.-L-2'-fluoro-5-methyl-arabinofuranolyl-uridine (L-FMAU), .beta.-D-2,6-diaminopurine diaxolane (DAPD), famciclovir, penciclovir, 2-amino-1,9-dihydro-9-[4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl- ]-6H-purin-6-one (entecavir, BMS-200475), 9-[2-(phosphono-methoxy)ethyl]adenine (PMEA, adefovir, dipivoxil); lobucavir, ganiciclovir and ribavirin.

24. The method of claim 12 wherein the .beta.-L-2'-deoxycytidine is administered in combination or alternation with an effective amount of a compound selected from the group consisting of .beta.-L-2-hydroxymethyl-5 -(cytosin-1-yl)-1,3-oxathiolane (3TC), cis-2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane (FTC), .beta.-L-2'-fluoro-5-methyl-arabinofuranolyl-uridine (L-FMAU), .beta.-D-2,6-diaminopurine diaxolane (DAPD), famciclovir, penciclovir, 2-amino-1,9-dihydro-9-[4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl- ]-6H-purin-6-one (entecavir, BMS-200475), 9-[2-(phosphono-methoxy)ethyl]adenine (PMEA, adefovir, dipivoxil); lobucavir, ganiciclovir and ribavirin.
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