Methods of treating retroviral infections and related dosage regimes

Abstract

The present invention relates to compounds and methods for treating retroviral infections and/or Hepatitis B viral infections. Some compounds of the invention are described by Formula I: or a stereoisomer, a diastereomer, an enantiomer or racemate thereof.

1 - 9 . (canceled) 
     
     
         10 . A method of treating a retroviral infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a pharmaceutically acceptable salt of a compound having the formula: 
       
         
           
           
               
               
           
         
         wherein M +  is K + , Na + , Ca 2+ , Mg 2+ , or [NR 1 R 2 R 3 R 4 ] + , wherein R 1 , R 2 , R 3 , and R 4  are each independently hydrogen or C 1-5  alkyl, and 
         wherein the compound is administered daily or weekly in an amount of about 400 mg to about 2000 mg. 
       
     
     
         11 . The method of  claim 10 , wherein the subject is infected with HIV. 
     
     
         12 . The method of  claim 10 , wherein the compound is administered daily. 
     
     
         13 . The method of  claim 10 , wherein the compound is administered weekly. 
     
     
         14 . The method of  claim 10 , wherein the compound is administered in an amount of about 450 mg, about 500 mg, about 1000 mg, about 1500 mg or about 2000 mg. 
     
     
         15 . The method of  claim 10 , further comprising concurrently administering to the subject one or more additional antiviral agents with the compound. 
     
     
         16 . The method of  claim 15 , wherein the one or more additional antiviral agents are selected from HIV-protease inhibitors, nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors, entry inhibitors, fusion inhibitors, maturation inhibitors, and combinations thereof. 
     
     
         17 . The method of  claim 15 , wherein the one or more additional antiviral agents are selected from lamivudine, abacavir, zidovudine, stavudine, zalcitabine, didanosine, emtricitabine, tenofovir, delavirdine, efavirenz, etravirine, nevirapine, amprenavir, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir, maraviroc, enfuvirtide, raltegravir and combinations thereof. 
     
     
         18 . The method of  claim 15 , wherein the one or more additional antiviral agents are selected from the group consisting of raltegravir, ribavirin, indinavir, retrovir and combinations thereof. 
     
     
         19 . The method of  claim 10 , wherein the subject is infected with HBV. 
     
     
         20 . The method of  claim 10 , wherein the subject is infected with HIV and HBV. 
     
     
         21 . The method of  claim 10 , wherein the daily dose is divided into two to four doses per day.