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Claims for Patent: 6,524,570

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Claims for Patent: 6,524,570

Title: Polyethylene glycol modified interferon therapy
Abstract:A method comprising administering a PEG.sub.12000 -IFN alpha conjugate to an individual afflicted with a viral infection susceptible of treatment with interferon alpha, preferably chronic hepatitis C, is disclosed.
Inventor(s): Glue; Paul (Flemington, NJ), Cutler; David L. (Morristown, NJ), Affrime; Melton B. (Flemington, NJ)
Assignee: Schering Corporation (Kanilworth, NJ)
Application Number:09/699,663
Patent Claims: 1. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient a conjugate comprising polyethylene glycol (PEG) and an alpha interferon once per week in an amount effective to treat the infection.

2. The method of claim 1 wherein said interferon is interferon alpha-2a.

3. The method of claim 1 wherein said interferon is interferon alpha-2b.

4. The method of claim 1 wherein said interferon comprises consensus alpha interferon.

5. The method of claim 1 wherein said interferon comprises naturally occurring alpha interferon.

6. The method of claim 1 wherein said interferon comprises recombinant alpha interferon.

7. The method of claim 1 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

8. The method of claim 1 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

9. The method of claim 1 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

10. The method of claim 1 wherein said PEG is conjugated to said alpha interferon via an epsilon amino group of a lysine residue in said alpha interferon.

11. The method of claim 1 wherein said PEG is conjugated to free amino groups of said alpha interferon via a urethane linkage.

12. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient a conjugate comprising polyethylene glycol (PEG) and an alpha interferon once or twice per week in an amount effective to treat the infection.

13. The method of claim 12 wherein said interferon is interferon alpha-2a.

14. The method of claim 12 wherein said interferon is interferon alpha-2b.

15. The method of claim 12 wherein said interferon comprises consensus alpha interferon.

16. The method of claim 12 wherein said interferon comprises naturally occurring alpha interferon.

17. The method of claim 12 wherein said interferon comprises recombinant alpha interferon.

18. The method of claim 12 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

19. The method of claim 12 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

20. The method of claim 12 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

21. The method of claim 12 wherein said PEG is conjugated via an epsilon amino group of a lysine residue in said interferon alpha.

22. The method of claim 12 wherein said PEG is conjugated to free amino groups of said interferon alpha via a urethane linkage.

23. The method of claim 12 wherein said conjugate is administered to said patient twice per week.

24. A method of treating a patient suspected of having hepatitis C infection, comprising administering to the patient in combination, ribavirin and a conjugate comprising polyethylene glycol (PEG) and an alpha-interferon, each in amounts effective to treat the infection, wherein the conjugate is administered once or twice per week.

25. The method of claim 24 wherein said interferon is interferon alpha-2a.

26. The method of claim 24 wherein said interferon is interferon alpha-2b.

27. The method of claim 24 wherein said interferon comprises consensus alpha interferon.

28. The method of claim 24 wherein said interferon comprises naturally occurring alpha interferon.

29. The method of claim 24 wherein said interferon comprises recombinant alpha interferon.

30. The method of claim 25 wherein the amount of the conjugate administered is 0.5 .mu.g/kg.

31. The method of claim 25 wherein the amount of the conjugate administered is 2.0 .mu.g/kg.

32. The method of claim 25 wherein the amount of the conjugate administered is 0.5, 1.0, or 1.5 .mu.g/kg.

33. The method of claim 25 wherein said PEG is conjugated to said alpha interferon via an epsilon amino group of a lysine residue in said alpha interferon.

34. The method of claim 25 wherein said PEG is conjugated to free amino groups of said alpha interferon via a urethane linkage.

35. The method of claim 24 wherein the conjugate is administered once per week.

36. The method of claim 24 wherein the conjugate is administered twice per week.
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