Long term treatment of HIV-infection with TMC278
This invention relates to the use of a parenteral formulation comprising an anti-virally effective amount of TMC278 or a pharmaceutically acceptable acid-addition salt thereof, and a carrier, for the manufacture of a medicament for the treatment of a subject being infected with HIV, wherein the formulation is to be administered intermittently at a time interval of at least one week.
1. A method of treating HIV in a subject comprising administering to the subject a solution comprising
an amount of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile (TMC278) or a pharmaceutically acceptable acid-addition salt thereof, and a carrier,
wherein the solution is administered intermittently by subcutaneous or intramuscular administration at a time interval that is once every one month or once every four weeks,
and wherein the amount of TMC278, or the pharmaceutically acceptable acid-addition salt thereof, is effective in keeping a minimum blood plasma level of TMC278 in the subject during the time interval.
2. The method according to claim 1 , wherein the solution is administered intramuscularly.
3. The method according to claim 1 , wherein the minimum blood plasma level is about 5 ng/mL to about 500 ng/mL.
4. The method according to claim 1 , wherein the minimum blood plasma level is about 5 ng/mL to about 200 ng/mL.
5. The method according to claim 1 , wherein the minimum blood plasma level is about 5 ng/mL to about 100 ng/mL.
6. The method according to claim 1 , wherein the minimum blood plasma level is about 10 ng/mL to about 50 ng/mL.
7. The method according to claim 1 , wherein the subject's HIV viral load is below about 200 copies/mL, prior to administration of the solution.
8. The method according to claim 1 , wherein the solution is an aqueous solution.
9. The method according to claim 1 , wherein the time interval is once every four weeks.
10. The method according to claim 1 , wherein the time interval is once every one month.
11. The method according to claim 1 , wherein the TMC278 is E-TMC278.
12. The method according to claim 1 , wherein the carrier comprises polyethyleneglycol.
13. The method according to claim 8 , wherein the carrier comprises polyethyleneglycol.