Method for treating hepatitis C virus with omega interferon

• US 7,727,519 B2
• Filed: 11/05/2004
• Issued: 06/01/2010
• Est. Priority Date: 11/03/2000
• Status: Active Grant

• Current Assignee: Intarcia Therapeutics, Inc.
• Original Assignee: Intarcia Therapeutics, Inc.
• Inventors: Moran, Mark Stanford
• Primary Examiner(s): Landsman; Robert
• Assistant Examiner(s): Hissong; Bruce D
• Application Number:
  US10/982,532
• Publication Number:
  US 20050201980A1
• Time in Patent Office: 2,034 Days
• Field of Search: None
• US Class Current: 424/85.4
• CPC Class Codes: A61K 38/00 Medicinal preparations containing peptides peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/06 for tuberculosis
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 31/14 for RNA viruses
• CPC Class Codes: A61P 31/22 for herpes viruses
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 35/02 specific for leukemia
• CPC Class Codes: A61P 37/00 Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Methods for the treatment of interferon-response disorders by administration of an interferon alone or in combination with adjunctive therapy are described. The invention encompasses providing to a patient both a formulation of an interferon that is suitable for short-term administration and a formulation of an interferon associated with a sustained release delivery system that is suitable for long-term administration. A principal advantage of the method is that responsiveness to treatment can be ascertained with short-term dosimetric techniques using one formulation of an interferon, which permits the appropriate selection of a dose that is both effective and safe for long-term administration using the second formulation.

Claims

1. A method of treating hepatitis C virus (HCV) infection in a subject in need of such treatment, wherein the HCV infection exhibits primary or secondary resistance to treatment with alpha interferon, comprising

administering a therapeutically effective amount of omega interferon protein to the subject, the administering selected from the group consisting of:

(i) is at a controlled rate over time and the therapeutically effective amount of omega interferon is an amount of omega interferon selected from the group consisting of between 48 and 194 micrograms per week, between 23 and 388 micrograms per week, and between 23 and 623 micrograms per week, and

(ii) is by injection and the therapeutically effective amount of omega interferon is an amount of omega interferon selected from the group consisting of between about 1 and about 210 micrograms per week and between about 22.5 and about 360 micrograms per week.

2. The method of claim 1, wherein the therapeutically effective amount of omega interferon is administered by injection.

3. The method of claim 2, wherein the therapeutically effective amount of omega interferon is administered by one or more daily injections.

4. The method of claim 2, wherein the therapeutically effective amount of omega interferon is administered by one or more injections given at selected dosing intervals.

5. The method of claim 4, wherein the dosing interval comprises three injections per week.

6. The method of claim 2, wherein the method of injection is selected from the group consisting of subcutaneous injection, intramuscular injection, and bolus intravenous injection.

7. The method of claim 6, wherein the omega interferon is administered by subcutaneous injection.

8. The method of claim 1, wherein the omega interferon is administered by infusion.

9. The method of claim 8, wherein the method of infusion is chronic intravascular infusion.

10. The method of claim 1, wherein the omega interferon is administered at a controlled rate over time.

11. The method of claim 10, wherein a device is used to administer the omega interferon.

12. The method of claim 11, wherein the device comprises a pump.

13. The method of claim 12, wherein the device is either implanted in or external to the subject.

14. The method of claim 13, wherein the device is implanted.

15. The method of claim 14, wherein the device comprises an osmotic pump.

16. The method of claim 10, wherein two or more implantable devices are used to administer the omega interferon.

17. The method of claim 1, wherein the therapeutically effective amount of injected omega interferon is between about 1 and about 210 micrograms per week.

18. The method of claim 1, wherein the therapeutically effective amount of injected omega interferon is between about 22.5 and about 360 micrograms per week.

19. The method of claim 1, wherein the therapeutically effective amount of omega interferon administered at a controlled rate over time is between 23 and 623 micrograms per week.

20. The method of claim 1, wherein the omega interferon is a recombinant omega interferon.

21. The method of claim 1, wherein the treatment with alpha interferon further comprises treatment with ribavirin.

22. A method of treating hepatitis C virus (HCV) infection in a subject in need of such treatment, wherein the HCV infection exhibits primary or secondary resistance to treatment with alpha interferon, comprising

administering a therapeutically effective amount of omega interferon protein to the subject, the administering selected from the group consisting of:

(i) is at a controlled rate over time and the therapeutically effective amount of omega interferon is an amount of omega interferon selected from the group consisting of between 48 and 194 micrograms per week, between 23 and 388 micrograms per week, and between 23 and 623 micrograms per week, and

(ii) is by injection and the therapeutically effective amount of omega interferon is an amount of omega interferon selected from the group consisting of between about 1 and about 210 micrograms per week and between about 22.5 and about 360 micrograms per week;

wherein the therapeutically effective amount of omega interferon protein is administered over at least about one month.