Claims for Patent: 12,178,815

Summary for Patent: 12,178,815

Title:	Regimens for treating HIV infections and aids
Abstract:	A method of treating HIV comprising intramuscular administration once every 4 weeks or less frequently of a combination of cabotegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof, including the option of discontinuing administration of a first oral anti-retroviral regimen and intramuscularly administering, once four weeks or less often said combination of cabotegravir and rilpivirine.
Inventor(s):	Herta CRAUWELS, David Margolis, William R. SPREEN, Andrew Spaltenstein, Peter Williams
Assignee:	Janssen Pharmaceutica NV , Janssen Cilag Ltd , Janssen Sciences Ireland ULC , ViiV Healthcare Co
Application Number:	US18/762,939
Patent Claims:	1. A method of treating HIV-1 infection in a subject in need thereof, comprising intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine resulting in the subject having a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (≤50 c/mL) in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine result in the subject having the viral load of ≤50 c/mL and comprise 400 mg of cabotegravir in a 2-mL injectable formulation and 600 mg of rilpivirine in a separate 2-mL injectable formulation administered once every four weeks or once a month. 2. The method of claim 1, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every four weeks. 3. The method of claim 1, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every month. 4. The method of claim 1, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every four weeks or once a month, with a 14-day dosing window. 5. The method of claim 1, wherein the subject received oral anti-HIV therapy which was discontinued prior to the intramuscular administration. 6. The method of claim 5, wherein the oral anti-HIV therapy comprised once daily administration of cabotegravir or a pharmaceutically acceptable salt thereof and/or once daily administration of rilpivirine or a pharmaceutically acceptable salt thereof. 7. The method of claim 6, wherein the oral anti-HIV therapy comprised once daily administration of an amount by weight of the pharmaceutically acceptable salt of cabotegravir equivalent to 30 mg of cabotegravir and/or once daily administration of an amount by weight of the pharmaceutically acceptable salt of rilpivirine equivalent to 25 mg of rilpivirine. 8. The method of claim 1, wherein the method comprises intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine resulting in the subject having a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50 c/mL) in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine result in the subject having the viral load of <50 c/mL and comprise 400 mg of cabotegravir in a 2-mL injectable formulation and 600 mg of rilpivirine in a separate 2-mL injectable formulation administered once every four weeks or once a month. 9. A method of treating HIV-1 infection in a subject in need thereof, comprising intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine resulting in the subject having a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (≤50 c/mL) in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine result in the subject having the viral load of ≤50 c/mL and comprise 600 mg of cabotegravir in a 3-mL injectable formulation and 900 mg of rilpivirine in a separate 3-mL injectable formulation administered every once eight weeks or once every two months. 10. The method of claim 9, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every eight weeks. 11. The method of claim 9, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every two months. 12. The method of claim 9, wherein the effective amounts of cabotegravir and rilpivirine which result in the subject having the viral load of ≤50 c/mL are administered once every eight weeks or once every 2 months, with a 14-day dosing window. 13. The method of claim 9, wherein the subject received oral anti-HIV therapy which was discontinued prior to the intramuscular administration. 14. The method of claim 13, wherein the oral anti-HIV therapy comprised once daily administration of cabotegravir or a pharmaceutically acceptable salt thereof and/or once daily administration of rilpivirine or a pharmaceutically acceptable salt thereof. 15. The method of claim 14, wherein the oral anti-HIV therapy comprised once daily administration of an amount by weight of the pharmaceutically acceptable salt of cabotegravir equivalent to 30 mg of cabotegravir and/or once daily administration of an amount by weight of the pharmaceutically acceptable salt of rilpivirine equivalent to 25 mg of rilpivirine. 16. The method of claim 9, wherein the method comprises intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine resulting in the subject having a viral load of less than 50 copies of HIV-1 virus particles per mL of blood plasma (<50 c/mL) in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine result in the subject having the viral load of <50 c/mL and comprise 600 mg of cabotegravir in a 3-mL injectable formulation and 900 mg of rilpivirine in a separate 3-mL injectable formulation administered once every eight weeks or once every two months. 17. A method of treating HIV-1 infection in a subject in need thereof, comprising intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine which do not result in an emergent resistance-associated mutation in an HIV virus in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine comprise 400 mg of cabotegravir in a 2-mL injectable formulation and 600 mg of rilpivirine in a separate 2-mL injectable formulation administered every four weeks or once a month. 18. The method of claim 17, wherein the effective amounts of cabotegravir and rilpivirine are administered once every four weeks. 19. The method of claim 17, wherein the effective amounts of cabotegravir and rilpivirine are administered once every month. 20. The method of claim 17, wherein the effective amounts of cabotegravir and rilpivirine are administered once every four weeks or once a month, with a 14-day dosing window. 21. The method of claim 17, wherein the subject received oral anti-HIV therapy which was discontinued prior to the intramuscular administration. 22. The method of claim 21, wherein the oral anti-HIV therapy comprised once daily administration of cabotegravir or a pharmaceutically acceptable salt thereof and/or once daily administration of rilpivirine or a pharmaceutically acceptable salt thereof. 23. The method of claim 22, wherein the oral anti-HIV therapy comprised once daily administration of an amount by weight of the pharmaceutically acceptable salt of cabotegravir equivalent to 30 mg of cabotegravir and/or once daily administration of an amount by weight of the pharmaceutically acceptable salt of rilpivirine equivalent to 25 mg of rilpivirine. 24. A method of treating HIV-1 infection in a subject in need thereof, comprising intramuscularly administering into a gluteus medius muscle of the subject effective amounts of cabotegravir and rilpivirine which do not result in an emergent resistance-associated mutation in an HIV virus in the subject after at least 96 weeks of administration, wherein the effective amounts of cabotegravir and rilpivirine comprise 600 mg of cabotegravir in a 3-mL injectable formulation and 900 mg of rilpivirine in a separate 3-mL injectable formulation administered once every eight weeks or once every two months. 25. The method of claim 24, wherein the effective amounts of cabotegravir and rilpivirine are administered once every eight weeks. 26. The method of claim 24, wherein the effective amounts of cabotegravir and rilpivirine are administered once every two months. 27. The method of claim 24, wherein the effective amounts of cabotegravir and rilpivirine are administered once every eight weeks or once every 2 months, with a 14-day dosing window. 28. The method of claim 24, wherein the subject received oral anti-HIV therapy which was discontinued prior to the intramuscular administration. 29. The method of claim 28, wherein the oral anti-HIV therapy comprised once daily administration of cabotegravir or a pharmaceutically acceptable salt thereof and/or once daily administration of rilpivirine or a pharmaceutically acceptable salt thereof. 30. The method of claim 29, wherein the oral anti-HIV therapy comprised once daily administration of an amount by weight of the pharmaceutically acceptable salt of cabotegravir equivalent to 30 mg of cabotegravir and/or once daily administration of an amount by weight of the pharmaceutically acceptable salt of rilpivirine equivalent to 25 mg of rilpivirine.