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 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 2 months±7 days a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (every-2-month injection 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 once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (reinitiation injections) starting on the last day of said oral antiretroviral therapy and then initiating said every-2-month injection dosing 2 months±7 days after last injection of said reinitiation injections.
2 . 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) after at least 48 weeks of said treatment.
3 . 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 initiation injections.
4 . 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.
5 . The method of claim 1 , wherein 2 months or less has passed between said initiation injections and the last day of said oral antiretroviral therapy.
6 . The method of claim 5 , 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.
7 . The method of claim 6 , 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.
8 . The method of claim 1 , wherein greater than 2 months has passed between said initiation injections and the last day of said oral antiretroviral therapy.
9 . The method of claim 8 , 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.
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 . A method of treating HIV-1 infection in a subject comprising:
(a) intramuscularly administering to the subject once every 2 months±7 days a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (every-2-month injection dosing);
(b) replacing said every-2-month injection dosing with oral antiretroviral therapy comprising cabotegravir and rilpivirine, wherein the first dose of said oral antiretroviral therapy is administered 2 months±7 days after the last administration of said every-2-month injection dosing;
(c) discontinuing said oral antiretroviral therapy; and
(d) wherein if 3 months or less has passed between the last injection of said every-2-month injection dosing and the last day of said oral antiretroviral therapy, resuming said every-2-month injection dosing on the last day of said oral antiretroviral therapy; or
wherein if greater than 3 months has passed between the last injection of said every-2-months injection dosing and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (reinitiation injections) starting on the last day of said oral antiretroviral therapy and then resuming said every-2-month injection dosing 2 months±7 days after the last injection of said reinitiation injections.
12 . The method of claim 11 , further comprising intramuscularly administering to the subject once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections) starting 3 months±7 days prior to said every-2-month injection dosing of step (a).
13 . 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.
14 . 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) prior to said every-2-month injection dosing of step (a).
15 . The method of claim 12 , 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.
16 . The method of claim 11 , wherein 3 months or less has passed between the last injection of said every-2-month injection dosing and the last day of said oral antiretroviral therapy.
17 . 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) after at least 48 weeks of said treatment.
18 . The method of claim 17 , further comprising intramuscularly administering to the subject once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections) starting 3 months±7 days prior to said every-2-month injection dosing of step (a).
19 . The method of claim 18 , 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.
20 . The method of claim 11 , wherein greater than 3 months has passed between the last injection of said every-2-months injection dosing and the last day of said oral antiretroviral therapy.
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) after at least 48 weeks of said treatment.
22 . The method of claim 21 , further comprising intramuscularly administering to the subject once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (initiation injections) starting 3 months±7 days prior to said every-2-month injection dosing of step (a).
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) prior to said initiation injections.
24 . A method of treating HIV-1 infection in a subject comprising:
(a) intramuscularly administering to the subject monthly±7 days for two months a dosage regimen comprising 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 2 months±7 days after the last administration of said initiation injections;
(c) discontinuing said oral antiretroviral therapy; and
(d) wherein if 3 months or less has passed between the last injection of said initiation injections and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject once every 2 months±7 days a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (every-2-month injection dosing) starting on the last day of said oral antiretroviral therapy; or
wherein if greater than 3 months has passed between the last injection of said initiation injections and the last day of said oral antiretroviral therapy, intramuscularly administering to the subject once every month±7 days for 2 months a dosage regimen comprising a 3-mL injection of 600 mg of cabotegravir and a separate 3-mL injection of 900 mg of rilpivirine (reinitiation injections) starting on the last day of said oral antiretroviral therapy and then initiating said every-2-months injection dosing 2 months±7 days after the last administration of said reinitiation injections.
25 . The method of claim 24 , 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.
26 . The method of claim 25 , 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.
27 . The method of claim 24 , wherein 3 months or less has passed between the last injection of said initiation injections and the last day of said oral antiretroviral therapy and 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 treatment.
28 . The method of claim 27 , 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.
29 . The method of claim 24 , wherein greater than 3 months has passed between the last injection of said initiation injections and the last day of said oral antiretroviral therapy and 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.
30 . The method of claim 29 , 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.