Prevention of hiv-infection

Abstract

This invention relates to the use of a parenteral formulation comprising the NNRTI TMC278 for the long term prevention of HIV infection in a subject at risk of being infected by HIV, which comprises the intermittent administration of the said formulation at long time intervals.

1 . The use of a parenteral formulation comprising an effective amount of TMC278 or a pharmaceutically acceptable acid-addition salt thereof, and a carrier, for the manufacture of a medicament for the long term prevention of HIV infection in an individual at risk of being infected by HIV, wherein the formulation is administered intermittently at a time interval of at least one week. 
     
     
         2 . The use according to  claim 1  wherein the formulation is administered once every two weeks. 
     
     
         3 . The use according to  claim 1  wherein the formulation is administered once every month. 
     
     
         4 . The use according to  claim 1  wherein the effective amount of TMC278 in the parenteral formulation is selected such that the blood plasma concentration of TMC278 is kept during a prolonged period of time at a level comprised between a maximum blood plasma level which is the blood plasma level that causes significant side effects and the minimum blood plasma level that is the lowest blood plasma level that causes the HIV inhibitor to provide effective prevention of HIV infection. 
     
     
         5 . The use according to  claim 4  wherein the blood plasma level is kept at a level equal to or above about 15 ng/ml, in particular equal to or above about 20 ng/ml. 
     
     
         6 . The use according to any of  claims 1 - 5 , wherein the formulation is administered subcutaneously or intramuscularly. 
     
     
         7 . The use according to any of  claims 1 - 6 , wherein the TMC278 is in base-form. 
     
     
         8 . A method for the long term prevention of HIV infection in an individual at risk of being infected by HIV, said method comprising administering an effective amount of TMC278 or a pharmaceutically acceptable acid-addition salt thereof, and a carrier, to said individual, wherein the formulation is administered intermittently at a time interval of at least one week. 
     
     
         9 . The method of  claim 8  wherein the formulation is administered as specified in  claim 2  or  3 , or the blood plasma concentration is as specified in  claim 4  or  5 , or the formulation is administered as specified in  claim 6 .