Claims for Patent: 10,786,518

Summary for Patent: 10,786,518

Title:	Compositions and methods of treating HIV
Abstract:	The disclosure is directed to methods of treating subjects infected with HIV, once daily, with single unit dosage forms that include darunavir (or a hydrate or solvate thereof), cobicistat, emtricitabine, and a tenofovir prodrug, or salt thereof.
Inventor(s):	Boven; Katia (Titusville, NJ), De Smedt; Goedele (Geel, BE), Driesen; Regina (Kessel, BE), Henrist; Dominiek (Zoersel, BE), Kauwenberghs; Greet (Schoten, BE), Mathur; Sandeep (Furlong, PA), McCallister; Scott (San Francisco, CA), Mertens; Roel (Balen, BE), Nettles; Richard (New Hope, PA), Opsomer; Magda (Sint-Pieters-Leeuw, BE), Pyrz; William (Belmont, CA), Zia; Vahid (Palo Alto, CA)
Assignee:	Janssen Sciences Ireland UC (Co Cork, IE) Gilead Sciences, Inc. (Foster City, CA)
Application Number:	16/040,324
Patent Claims:	1. A method of treating a subject infected with an HIV virus comprising orally administering to the subject, once daily, a single unit dosage form comprising darunavir, or a hydrate or solvate thereof; cobicistat; emtricitabine; and tenofovir alafenamide, or a pharmaceutically acceptable salt thereof; wherein the subject is treatment experienced and was administered a first anti-retroviral regimen that has been discontinued; and wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/mL) after at least 24 weeks of the once-daily administration of the single unit dosage form. 2. The method of claim 1, wherein the single unit dosage form comprises darunavir ethanolate. 3. The method of claim 1, wherein the single unit dosage form comprises tenofovir alafenamide fumarate. 4. The method of claim 1, wherein the single unit dosage form comprises tenofovir alafenamide hemifumarate. 5. The method of claim 1, wherein the first anti-retroviral regimen comprises a boosted protease inhibitor; emtricitabine; and tenofovir, a tenofovir prodrug, a pharmaceutically acceptable salt of tenofovir, or a pharmaceutically acceptable salt of a tenofovir prodrug. 6. The method of claim 5, wherein the boosted protease inhibitor is darunavir, or a hydrate or solvate thereof, and ritonavir; darunavir, or a hydrate or solvate thereof, and cobicistat; atazanavir, or a pharmaceutically acceptable salt thereof, and ritonavir; atazanavir, or a pharmaceutically acceptable salt thereof, and cobicistat; or lopinavir and ritonavir. 7. The method of claim 1, wherein the first anti-retroviral regimen comprises tenofovir disoproxil fumarate. 8. The method of claim 1, wherein the single unit dosage form is administered with food. 9. The method of claim 1, wherein the subject is infected with HIV-1. 10. The method of claim 1, wherein the subject does not harbor any darunavir resistance-associated mutations in HIV-1 protease or a K65R mutation in HIV-1 reverse transcriptase. 11. The method of claim 1, wherein the subject harbors darunavir resistance-associated mutations in HIV-1 protease or a K65R mutation in HIV-1 reverse transcriptase. 12. The method of claim 1, wherein the subject's has hepatic impairment and the hepatic impairment is Child-Pugh Class A or Child Pugh Class B. 13. The method of claim 1, wherein the subject does not exhibit detectable amounts of hepatitis B virus prior to the administration of the single unit dosage form. 14. The method of claim 1, wherein the subject exhibits detectable amounts of hepatitis B virus prior to the administration of the single unit dosage form. 15. The method of claim 1, wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/mL) prior to the administration of the single unit dosage form. 16. The method of claim 1, wherein the single unit dosage form comprises about 800 mg of darunavir. 17. The method of claim 1, wherein the single unit dosage form comprises about 150 mg of cobicistat. 18. The method of claim 1, wherein the, single unit dosage form comprises about 200 mg of emtricitabine. 19. The method of claim 1, wherein the single unit dosage form comprises about 10 mg of tenofovir alafenamide. 20. The method of claim 1, wherein the single unit dosage form comprises about 11.2 mg of tenofovir alafenamide fumarate. 21. The method of claim 1, wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/mL) after at least 48 weeks of once daily administration of the second anti-retroviral regimen. 22. The method of claim 1, wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (<50c/mL) after at least 96 weeks of once daily administration of the single unit dosage form. 23. The method of claim 1, wherein the subject exhibits the same or an improved cluster of differentiation (CD) 4+ cell count after at least 24 weeks, at least 48 weeks, or at least 96 weeks, of once daily administration of the single unit dosage form, as compared to the subject's CD4+ count prior to the administration. 24. The method of claim 1, wherein the subject does not exhibit an emergent resistance-associated mutation in an HIV virus after at least 24 weeks, at least 48 weeks, or at least 96 weeks, of once daily administration of the single unit dosage form. 25. The method of claim 5, wherein the pharmaceutically acceptable salt of a tenofovir prodrug is tenofovir disoproxil or tenofovir disoproxil fumarate.