Use of dronabinol for treatment of side effects of Hepatitis C therapy

• US 20060258738A1
• Filed: 05/12/2006
• Published: 11/16/2006
• Est. Priority Date: 05/12/2005
• Status: Abandoned Application

• Current Assignee: Icahn School of Medicine at Mount Sinai
• Original Assignee: Icahn School of Medicine at Mount Sinai
• Inventors: Dieterich, Douglas
• Application Number:
  US11/433,378
• Publication Number:
  US 20060258738A1
• Time in Patent Office: Days
• US Class Current: 514/454
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/7056 containing five-membered rings with nitrogen as a ring hetero atom
• CPC Class Codes: A61K 38/21 Interferons [IFN]

Abstract

The present invention provides methods for treating and preventing the gastrointestinal side effects associated with anti-HCV therapy comprising administering delta-9-tetrahydrocannabinol.

Claims

1. A method of treating or preventing gastrointestinal side effects of anti-Hepatitis C Virus (anti-HCV) therapy comprising administering delta-9-tetrahydrocannabinol (delta-9-THC) to a patient in need of such treatment or prevention.

2. The method of claim 1 wherein the patient is undergoing treatment of HCV with interferon.

3. The method of claim 1 wherein the patient is undergoing treatment of HCV with interferon and ribavirin.

4. The method of claim 1 wherein said delta-9-THC is dronabinol.

5. The method of claim 1 wherein said delta-9-THC is administered by oral, intranasal, transdermal, sublingual or rectal administration, injection or inhalation.

6. The method of claim 1 wherein said delta-9-THC is administered by oral administration.

7. The method of claim 4 wherein said dronabinol is administered orally at a dose of 1.0 mg to 50 mg per day.

8. The method of claim 4 wherein said dronabinol is administered orally at a dose of 2.5 mg to 30 mg per day.

9. The method of claim 4 wherein said dronabinol is administered orally at a dose of 10 mg to 20 mg per day.

10. A method of treating Hepatitis C Virus (HCV) comprising administering interferon and ribavirin to a patient infected with HCV and further comprising administering delta-9-THC to said patient.

11. The method of claim 10 wherein said patient is co-infected with HIV.

12. The method of claim 11 wherein said patient is not co-infected with HIV.

13. The method of claim 10 wherein said delta-9-THC is dronabinol.

14. The method of claim 10 wherein said delta-9-THC is administered by oral, intranasal, transdermal, sublingual or rectal administration, injection or inhalation.

15. The method of claim 10 wherein said delta-9-THC is administered by oral administration.

16. The method of claim 13 wherein said dronabinol is administered orally at a dose of 1.0 mg to 50 mg per day.

17. The method of claim 13 wherein said dronabinol is administered orally at a dose of 2.5 mg to 30 mg per day.

18. The method of claim 13 wherein said dronabinol is administered orally at a dose of 10 mg to 20 mg per day.

19. A kit containing RBV, IFN and delta-9-THC.

20. The kit of claim 19 wherein IFN is formulated for injection and RBV and delta-9-THC are each formulated for oral administration.

21. The kit of claim 19 wherein delta-9-THC is dronabinol.

22. The kit of claim 21 wherein dronabinol is formulated as a soft gelatin capsule.