Low dose therapy for treating viral infections

Abstract

A method of treating viral infections, particularly Hepatitis B (HBV) and Human Immunodeficiency Virus (HIV), by administering a low dose of Elvucitabine to a patient suffering viral infection, is provided herein. The Elvucitabine dosages provided herein for effective anti-viral therapy are approximately 10-fold less than the effective dosages of currently marketed reverse transcriptase inhibitors. The Elvucitabine dosage may be given BID, daily, once ever 48 hours, or once weekly. Also provided herein are packaged pharmaceutical formulations comprising Elvucitabine and instructions for treating a viral infection by administering a low BID, daily, once/48 hour period, or weekly dosage of Elvucitabine. The low dose Elvucitabine formulations provided herein have the additional benefit of improving patient compliance with anti-viral therapy.

1 . A method of treating an HIV infection comprising administering about 2.5 mg to about 10 mg Elvucitabine per day to a patient suffering from an HIV infection. 
     
     
         2 . The method of  claim 1  wherein about 5 mg Elvucitabine is administered BID. 
     
     
         3 . The method of  claim 1  wherein about 5 mg Elvucitabine is administered once per day. 
     
     
         4 . The method of  claim 1  wherein about 7.5 mg Elvucitabine is administered once per day. 
     
     
         5 . The method of  claim 1  wherein about 10 mg Elvucitabine is administered once per day. 
     
     
         6 - 14 . (canceled) 
     
     
         15 . The method of  claim 1  wherein the Elvucitabine is administered as an oral dosage. 
     
     
         16 . The method of  claim 15  wherein the oral dosage is in the form of a tablet or capsule. 
     
     
         17 . A packaged pharmaceutical formulation comprising a pharmaceutical formulation containing Elvucitabine and instructions for using the formulation for treating an HIV infection by administering about 2.5 mg to about 10 mg Elvucitabine per day to a patient suffering from an HIV infection. 
     
     
         18 . A packaged pharmaceutical formulation comprising a pharmaceutical formulation containing Elvucitabine and instructions for using the formulation for treating a viral infection by administering about 5 mg to about 20 mg Elvucitabine once per 48 hour interval or about 40 to about 100 mg Elvucitabine once per one week interval to a patient suffering from a viral infection. 
     
     
         19 . The packaged pharmaceutical formulation of  claim 18  where the instructions are instructions for using the formulation for treating an HIV or HBV infection. 
     
     
         20 . The pharmaceutical formulation of  claim 17  wherein the formulation comprises an oral dosage form. 
     
     
         21 - 25 . (canceled) 
     
     
         26 . A method of treating an HIV infection or HBV infection in a patient comprising administering an amount of elvucitabine to the patient so that AUC at steady state for a 24 hour period is at least 300 μg·h/L and C min  is from about 2 μg/L to about 23 μg/L. 
     
     
         27 . A method of treating HIV infection or HBV infection in a patient comprising administering an effective amount of elvucitabine to the patient once every 2 to 7 days. 
     
     
         28 . The method of  claim 27 , wherein from about 5 mg to about 100 mg elvucitabine are administered to the patient. 
     
     
         29 . The method of  claim 27 , wherein about 20 mg elvucitabine are administered to the patient once every 2 to 7 days.