Regimens for treating hiv infections and aids

Abstract

A method of treating HIV comprising intramuscular administration once every 4 weeks or less frequently of a combination of cabotegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof, including the option of discontinuing administration of a first oral anti-retroviral regimen and intramuscularly administering, once four weeks or less often said combination of cabotegravir and rilpivirine.

1 - 16 . (canceled) 
     
     
         17 . A combination kit comprising either:
 400 mg of cabotegravir or a pharmaceutically acceptable salt thereof and 600 mg of rilpivirine or a pharmaceutically acceptable salt thereof in two separate 2-mL injections presented in two separate packages; or   600 mg of cabotegravir or a pharmaceutically acceptable salt thereof and 900 mg of rilpivirine or a pharmaceutically acceptable salt thereof in two separate 3-mL injections presented in two separate packages.   
     
     
         18 . The combination kit according to  claim 17 , wherein the two separate packages comprise two separate containers. 
     
     
         19 . The combination kit according to  claim 18 , wherein the two separate containers are ampoules or vials. 
     
     
         20 . The combination kit according to  claim 19 , wherein the two separate containers are sealed. 
     
     
         21 . The combination kit according to  claim 18 , wherein the two separate containers are unit-dose containers. 
     
     
         22 . The combination kit according to  claim 17 , wherein the combination kit comprises 400 mg cabotegravir and 600 mg rilpivirine in two separate 2-mL injections, presented in two separate containers. 
     
     
         23 . The combination kit according to  claim 17 , wherein the combination kit comprises 600 mg cabotegravir and 900 mg rilpivirine in two separate 3-mL injections, presented in two separate containers. 
     
     
         24 . The combination kit according to  claim 17 , further comprising dosage and administration instructions. 
     
     
         25 . The combination kit according to  claim 24 , wherein the dosage and administration instructions are for a method of treating HIV comprising intramuscular administration to a subject in need thereof using a dosage regimen consisting of either
 (a) the 400 mg of cabotegravir or a pharmaceutically acceptable salt thereof and the 600 mg of rilpivirine or a pharmaceutically acceptable salt thereof every four weeks or once a month, or   (b) the 600 mg of cabotegravir or a pharmaceutically acceptable salt thereof and the 900 mg of rilpivirine or a pharmaceutically acceptable salt thereof every eight weeks or once every two months.   
     
     
         26 . The combination kit according to  claim 24 , wherein the dosage and administration instructions are for a method of modifying an anti-HIV dosage regimen for a subject in need thereof comprising:
 discontinuing administration of a first oral anti-HIV regimen to the subject; and   intramuscular administration to the subject, once every month or four weeks a dosage form consisting of:
 the 600 mg rilpivirine, or a pharmaceutically acceptable salt thereof; and 
 the 400 mg cabotegravir, or a pharmaceutically acceptable salt thereof. 
   
     
     
         27 . The combination kit according to  claim 24 , wherein the dosage and administration instructions are for a method of modifying an anti-HIV dosage regimen for a subject in need thereof comprising:
 discontinuing administration of a first oral anti-HIV regimen to the subject; and   intramuscular administration to the subject, once every two months or eight weeks a dosage form consisting of:
 the 900 mg rilpivirine, or a pharmaceutically acceptable salt thereof; and 
 the 600 mg cabotegravir, or a pharmaceutically acceptable salt thereof.