Method for treating HIV with Cabotegravir and Rilpivirine
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)
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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.