Claims for Patent: 12,636,285

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Summary for Patent: 12,636,285

Title:	Method for treating HIV with cabotegravir and rilpivirine
Abstract:	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.
Inventor(s):	Herta Maria Ludovica CRAUWELS, Susan L. FORD, David Andrew MARGOLIS, Stefaan Louis F. ROSSENU, William Robert SPREEN, Rodica Mihaela VAN SOLINGEN-RISTEA, Peter Evan Owen WILLIAMS
Assignee:	Janssen Pharmaceutica NV , Janssen Sciences Ireland ULC , ViiV Healthcare Co
Application Number:	US19/227,593
Patent Claims:	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.