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 infection in a subject comprising:
(a) intramuscularly administering to the subject once every month±7 days a dosage regimen comprising a 2-mL injection of 400 mg of cabotegravir and a separate 2-mL injection of 600 mg of rilpivirine (once-monthly dosing);
(b) replacing said once-monthly dosing with oral antiretroviral therapy comprising cabotegravir and rilpivirine, wherein the first dose of said oral antiretroviral therapy is administered 1 month ±7 days after the last administration of said once-monthly dosing;
(c) discontinuing said oral antiretroviral therapy; and
(d) wherein if 2 months or less has passed between the last injection of said once-monthly dosing and the last day of said oral antiretroviral therapy, resuming said once-monthly dosing on the last day of said oral antiretroviral therapy; or
wherein if greater than 2 months has passed between the last injection of said once-monthly dosing and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (reinitiation injections) on the last day of said oral antiretroviral therapy and then resuming said once-monthly dosing one month ±7 days after said reinitiation injections.
2 . The method of claim 1 , further comprising intramuscularly administering to the subject one month±7 days prior to said once-monthly dosing of step (a) a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections).
3 . The method of claim 2 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per ml of blood plasma (<50c/mL) after at least 48 weeks of said treatment.
4 . The method of claim 1 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said once-monthly dosing of step (a).
5 . The method of claim 2 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
6 . The method of claim 3 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
7 . The method of claim 1 , wherein 2 months or less has passed between the last injection of said once-monthly dosing and the last day of said oral antiretroviral therapy.
8 . The method of claim 7 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) after at least 48 weeks of said treatment.
9 . The method of claim 8 , further comprising intramuscularly administering to the subject one month±7 days prior to said once-monthly dosing of step (a) a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections).
10 . The method of claim 9 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
11 . The method of claim 1 , wherein greater than 2 months has passed between the last injection of said once-monthly dosing and the last day of said oral antiretroviral therapy.
12 . The method of claim 11 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) after at least 48 weeks of said treatment.
13 . The method of claim 12 , further comprising intramuscularly administering to the subject one month±7 days prior to said once-monthly dosing of step (a) a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections).
14 . The method of claim 13 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
15 . A method of treating HIV-1 infection in a subject comprising:
(a) intramuscularly administering to the subject a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections);
(b) initiating administration of an oral antiretroviral therapy comprising cabotegravir and rilpivirine to the subject, wherein the first dose of said oral antiretroviral therapy is administered 1 month±7 days after said initiation injections;
(c) discontinuing said oral antiretroviral therapy; and
(d) wherein if 2 months or less has passed between said initiation injections and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject once every month±7 days a dosage regimen comprising a 2-mL injection of 400 mg of cabotegravir and a separate 2-mL injection of 600 mg of rilpivirine (once-monthly dosing) starting on the last day of said oral antiretroviral therapy; or
wherein if greater than 2 months has passed between said initiation injections and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (reinitiation injections) on the last day of said oral antiretroviral therapy and then initiating said once-monthly dosing one month±7 days after said reinitiation injections.
16 . The method of claim 15 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per ml of blood plasma (<50c/mL) after at least 48 weeks of said treatment.
17 . The method of claim 15 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
18 . The method of claim 16 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
19 . The method of claim 15 , wherein 2 months or less has passed between the last injection of said once-monthly dosing and the last day of said oral antiretroviral therapy.
20 . The method of claim 19 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) after at least 48 weeks of said treatment.
21 . The method of claim 20 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.
22 . The method of claim 15 , wherein greater than 2 months has passed between said initiation injections and the last day of said oral antiretroviral therapy.
23 . The method of claim 22 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) after at least 48 weeks of said treatment.
24 . The method of claim 23 , wherein the subject exhibits a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/ml) prior to said initiation injections.