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Claims for Patent: 6,472,373

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Claims for Patent: 6,472,373

Title: Combination therapy for eradicating detectable HCV-RNA in antiviral treatment naive patients having chronic hepatitis C infection
Abstract:Methods for treating an antiviral treatment naive patient having chronic hepatitis C infection to eradicate detectable HCV-RNA involving administering a therapeutically effective amount of a combination therapy of ribavirin and interferon-alpha for a time period of from 20 up to 50 weeks are disclosed.
Inventor(s): Albrecht; Janice K. (Winter Park, FL)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:09/311,487
Patent Claims: 1. A method of treating antiviral treatment naive patients having chronic hepatitis C ("HCV") infection comprising identifying antiviral treatment naive patients having HCV genotype 1 and an initial viral load of greater than 2 million copies/ mL of serum HCV-RNA as measured by HCV-RNA/ quantitative Polymerase Chain Reaction ("qPCR") and then administering to said antiviral treatment naive patients a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of about 40 to about 50 weeks and identifying antiviral treatment naive patients having an HCV genotype 1 and an initial viral load of less than or equal to 2 million copies/ mL of serum HCV-RNA as measured by HCV-RNA/ quantitative Polymerase Chain Reaction ("qPCR") and then administering to said antiviral treatment naive patients a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of about 20 to about 24 weeks.

2. The method of claim 1, wherein the antiviral treatment naive patients known to be HCV-genotype 1 are treated for about 48 weeks, and the effective amount of ribavirin administered is from about 800 to about 1200 mg per day.

3. The method of claim 1, wherein the interferon-alpha is selected from interferon alpha-2a, interferon alpha 2b, a consensus interferon, a purified interferon alpha product, a pegylated interferon alpha-2a, or a pegylated interferon alpha 2b.

4. The method of claim 1, wherein the interferon-alpha is selected from interferon alpha-2a, interferon alpha 2b, a consensus interferon, or a purified interferon alpha product, and the amount of interferon-alpha administered is from about 2 to about 10 million International United ("IU") per week on a weekly, three times a week ("TIW"), five times a week ("QOD") or daily basis.

5. The method of claim 1, wherein the interferon-alpha is interferon alpha 2b, and the amount of interferon-alpha administered is from about 3 million IU TIW.

6. The method of claim 1, wherein the interferon-alpha administered is consensus interferon and the amount of interferon-alpha administered is from about 1 to about 20 micrograms per week on a weekly, TIW, QOD or daily basis.

7. The method of claim 1, wherein the interferon-alpha administered is a pegylated interferon alpha-2b and the amount of interferon-alpha administered is from about 0.5 to about 2.0 micrograms/kilogram per week on a weekly, TIW, QOD or daily basis.

8. The method of claim 1, wherein the interferon-alpha administered is a pegylated interferon alpha-2a and the amount of interferon-alpha administered is from about 20 to about 250 micrograms/kilogram per week on a weekly, TIW, QOD or daily basis.

9. A method of treating antiviral treatment naive patients having chronic hepatitis C ("HCV") infection comprising identifying antiviral treatment naive patients having an HCV genotype 1 and an initial viral load of greater than 2 million copies/ ML of serum HCV-RNA as measured by HCV-RNA/ quantitative Polymerase Chain Reaction ("qPCR") and then administering to said antiviral treatment naive patients a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of about 48 weeks and identifying antiviral treatment naive patients having an HCV genotype 1 and an initial viral load of less than or equal to 2 million copies/mL of serum HCV-RNA as measured by HCV-RNA/ quantitative Polymerase Chain Reaction ("qPCR") and then administering to said antiviral treatment naive patients therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of at least about 24 weeks and up to about 48 weeks.

10. A method of treating antiviral treatment naive patients having chronic hepatitis C ("HCV") infection comprising identifying antiviral treatment naive patients having an HCV genotype 2 or 3 and administering to said antiviral treatment naive patients a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of at least about 20 weeks to about 24 weeks.

11. A method of treating antiviral treatment naive patients having chronic hepatitis C ("HCV") infection comprising identifying antiviral treatment naive patients having an HCV genotype 2 or 3 and administering to said antiviral treatment naive patients a therapeutically effective amount of ribavirin and a therapeutically effective amount of interferon-alpha for a time period of at least about 24 weeks.

12. The method of claim 10 or 11, wherein the antiviral treatment naive patients known to be HCV-genotype 2 or 3 are treated for about 24 weeks, and the effective amount of ribavirin administered is from about 800 to about 1200 mg per day.

13. The method of claims 9 or 10 or 11, wherein the interferon-alpha is selected from interferon alpha-2a, interferon alpha 2b, a consensus interferon, a purified interferon alpha product, a pegylated interferon alpha-2a, or a pegylated interferon alpha 2b.

14. The method of claims 9 or 10 or 11, wherein the interferon-alpha is selected from interferon alpha-2a, interferon alpha 2b, a consensus interferon, or a purified interferon alpha product, and the amount of interferon-alpha administered is from 2 to 10 million IU per week on a weekly, TIW, QOD, or daily basis.

15. The method of claims 9 or 10 or 11, wherein the interferon-alpha is interferon alpha 2b, and the amount of interferon-alpha administered is from 3 million IU, TIW.

16. The method of claims 9 or 10 or 11, the interferon-alpha administered is consensus interferon and the amount of interferon-alpha administered is from 1 to 20 micrograms per week on a weekly, TIW, QOD or daily basis.

17. The method of claims 9 or 10 or 11, wherein the interferon-alpha administered is a pegylated interferon alpha-2b and the amount of interferon-alpha administered is from 0.5 to about 2.0 micrograms/kilogram per week on a weekly, TIW, QOD or daily basis.

18. The method of claims 9 or 10 or 11, wherein the interferon-alpha administered is a pegylated interferon alpha-2a and the amount of interferon-alpha administered is from 20 to about 250 micrograms/kilogram per week on a weekly, TIW, QOD or daily basis.

19. The method of claims 9 or 10 or 11, wherein the effective amount of ribavirin administered is from about 800 to about 1200 mg per day.
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