Method for treating HIV with Cabotegravir and Rilpivirine

Abstract

Invented are methods for treating HIV in a human in need thereof which comprises the administration of a therapeutically effective amount of a combination of cabotegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof, to such human.

1 . A method of treating HIV-1, comprising
 regularly administering intramuscular injections of cabotegravir or a salt thereof and rilpivirine or a salt thereof,   subsequent to at least one said intramuscular injection of each of cabotegravir or a salt thereof and rilpivirine or a salt thereof, discontinuing one or both of said regularly administered intramuscular injections, and   replacing the one or more discontinued intramuscular injection with regularly administered oral therapy.   
     
     
         2 . The method of  claim 1 , wherein the intramuscular injections of cabotegravir or a salt thereof and rilpivirine or a salt thereof are administered separately. 
     
     
         3 . The method of  claim 2 ,
 wherein the cabotegravir or salt thereof is administered as a 400 mg intramuscular injection once per month, and   wherein the rilpivirine or salt thereof is administered as a 600 mg intramuscular injection once per month.   
     
     
         4 . The method of  claim 3 ,
 wherein the cabotegravir or salt thereof is administered as a 600 mg intramuscular injection once and then a 400 mg intramuscular injection once per month thereafter, and   wherein the rilpivirine or salt thereof is administered as a 900 mg intramuscular injection once and then as a 600 mg intramuscular injection once per month thereafter.   
     
     
         5 . The method of  claim 2 ,
 wherein the cabotegravir or salt thereof is administered as a 600 mg intramuscular injection once per 2 months, and   wherein the rilpivirine or salt thereof is administered as a 900 mg intramuscular injection once per 2 months.   
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 1 , wherein said regular administration is once every month+/−7 days or once every 2 months+/−7 days. 
     
     
         8 . (canceled) 
     
     
         9 . The method of  claim 1 , wherein oral lead-in doses of both cabotegravir or a salt thereof and rilpivirine or a salt thereof are provided prior to regularly administering intramuscular injections. 
     
     
         10 . The method of  claim 1 , wherein intramuscular administration of cabotegravir or a salt thereof is discontinued and replaced with one 30-mg tablet of cabotegravir or salt thereof once daily. 
     
     
         11 . The method of  claim 1 , wherein intramuscular administration of rilpivirine or a salt thereof is discontinued and replaced with one 25-mg tablet of rilpivirine or salt thereof once daily. 
     
     
         12 . The method of  claim 10 , wherein regular intramuscular administration of said cabotegravir or a salt thereof is reinitiated after said oral therapy of said cabotegravir or a salt thereof. 
     
     
         13 . A method of treating HIV-1, comprising
 regularly administering intramuscular injections of cabotegravir or a salt thereof and rilpivirine or a salt thereof,   subsequent to at least one said intramuscular injection of each of cabotegravir or a salt thereof and rilpivirine or a salt thereof, discontinuing one or both of said regularly administered intramuscular injections, and   reestablishing intramuscular administration of the one or both cabotegravir or a salt thereof and rilpivirine or a salt thereof, by first administering a loading dose of the discontinued cabotegravir or a salt thereof and/or rilpivirine or a salt thereof, and then continuing the regular administration of the intramuscular injections.   
     
     
         14 . The method of  claim 13 , where the intramuscular injections of cabotegravir or a salt thereof and rilpivirine or a salt thereof are administered separately. 
     
     
         15 . The method of  claim 13 ,
 wherein the regularly administered injections comprise the cabotegravir or salt thereof administered as a 400 mg intramuscular injection once per month, and   wherein the rilpivirine or salt thereof administered as a 600 mg intramuscular injection once per month.   
     
     
         16 . The method of  claim 13 ,
 wherein the loading dose comprises cabotegravir or salt thereof administered as a 600 mg intramuscular injection once and/or   rilpivirine or salt thereof administered as a 900 mg intramuscular injection once.   
     
     
         17 . The method of  claim 13 ,
 wherein the regularly administered injections comprise the cabotegravir or salt thereof administered as a 600 mg intramuscular injection once per 2 months, and   wherein the rilpivirine or salt thereof administered as a 900 mg intramuscular injection once per 2 months.   
     
     
         18 . (canceled) 
     
     
         19 . The method of  claim 13 , wherein said regular administration is once every month+/−7 days or once every 2 months+/−7 days. 
     
     
         20 . (canceled) 
     
     
         21 . The method of  claim 13 , wherein an oral lead-in doses of both cabotegravir or a salt thereof and rilpivirine or a salt thereof are provided prior to regularly administering intramuscular injections. 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . (canceled) 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . (canceled) 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . (canceled) 
     
     
         40 . (canceled) 
     
     
         41 . (canceled) 
     
     
         42 . (canceled) 
     
     
         43 . The method of  claim 11 , wherein regular intramuscular administration of said rilpivirine or a salt thereof is reinitiated after said oral therapy of said rilpivirine or a salt thereof. 
     
     
         44 . The method of  claim 10 , wherein intramuscular administration of rilpivirine or a salt thereof is discontinued and replaced with one 25-mg tablet of rilpivirine or salt thereof once daily. 
     
     
         45 . The method of  claim 44 , wherein regular intramuscular administration of said cabotegravir or a salt thereof and/or rilpivirine or a salt thereof is reinitiated after said oral therapy of said cabotegravir or a salt thereof and/or rilpivirine or a salt thereof. 
     
     
         46 . The method of  claim 15 , wherein the loading dose comprises cabotegravir or salt thereof administered as a 600 mg intramuscular injection once and/or rilpivirine or salt thereof administered as a 900 mg intramuscular injection once. 
     
     
         47 . The method of  claim 17 , wherein the loading dose comprises cabotegravir or salt thereof administered as a 600 mg intramuscular injection once and/or rilpivirine or salt thereof administered as a 900 mg intramuscular injection once.