Regimens for treating HIV infections and aids
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.
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.