Claims for Patent: 12,447,170

Summary for Patent: 12,447,170

Title:	Use of maribavir in treatment regimens
Abstract:	Characterization of drug-drug interaction properties and pharmacological properties of maribavir is useful to inform potential drug-drug interactions and dosing strategies when administering with co-medications.
Inventor(s):	Heng Song, Kefeng SUN, Matthew Crouthamel, Grace Chen, Andy Z. X. ZHU, Ingrid Nicolle Michon, Howard James Burt, Zoe Elizabeth Barter, Sibylle Neuhoff
Assignee:	Takeda Pharmaceutical Co Ltd
Application Number:	US18/990,486
Patent Claims:	1. A method of treating cytomegalovirus (CMV) infection in a patient suffering therefrom, the method comprising administering maribavir in an amount of 1200 mg orally twice daily to the patient, wherein the patient is a transplant recipient concomitantly exposed to or receiving an anticonvulsant and an immunosuppressant, and wherein the amount of maribavir is selected to counteract the effect of the anticonvulsant from an efficacy perspective; wherein the method further comprises monitoring immunosuppressant drug levels in blood throughout treatment with maribavir, wherein the patient is an adult, or a child of 12 years of age or older and weighing at least 35 kg, and wherein the patient is refractory to treatment with one or more of ganciclovir, valganciclovir, cidofovir, or foscarnet. 2. The method of claim 1, wherein the anticonvulsant is phenytoin. 3. The method of claim 2, wherein phenytoin is administered to the patient in an amount of 300 mg once daily. 4. The method of claim 2, wherein the immunosuppressant is cyclosporine. 5. The method of claim 2, wherein the immunosuppressant is everolimus. 6. The method of claim 2, wherein the immunosuppressant is sirolimus. 7. The method of claim 2, wherein the immunosuppressant is tacrolimus. 8. The method of claim 7, wherein tacrolimus is administered as a stable dose, twice daily, with a total daily dose between 0.5 to 16 mg. 9. The method of claim 1, wherein the anticonvulsant is phenobarbital. 10. The method of claim 9, wherein phenobarbital is administered to the patient in an amount of 100 mg once daily. 11. The method of claim 9, wherein the immunosuppressant is cyclosporine. 12. The method of claim 9, wherein the immunosuppressant is everolimus. 13. The method of claim 9, wherein the immunosuppressant is sirolimus. 14. The method of claim 9, wherein the immunosuppressant is tacrolimus. 15. The method of claim 14, wherein tacrolimus is administered to the patient as a stable dose, twice daily, with a total daily dose between 0.5 to 16 mg. 16. The method of claim 1, wherein the monitoring comprises monitoring immunosuppressant drug levels following initiation, and after discontinuation, of treatment with maribavir in the patient. 17. A method of treating cytomegalovirus (CMV) infection in a patient suffering therefrom, the method comprising administering maribavir in an amount of 800 mg orally twice daily to the patient, wherein the patient is a transplant recipient concomitantly exposed to or receiving an anticonvulsant and an immunosuppressant, wherein the amount of maribavir is selected to counteract the effect of the anticonvulsant from an efficacy perspective; wherein the method further comprises monitoring immunosuppressant drug levels in blood throughout treatment with maribavir, wherein the patient is an adult, or a child of 12 years of age or older and weighing at least 35 kg, and wherein the patient is refractory to treatment with one or more of ganciclovir, valganciclovir, cidofovir, or foscarnet. 18. The method of claim 17, wherein the anticonvulsant is carbamazepine. 19. The method of claim 18, wherein carbamazepine is administered to the patient in an amount of 400 mg once daily. 20. The method of claim 18, wherein the immunosuppressant is cyclosporine. 21. The method of claim 18, wherein the immunosuppressant is everolimus. 22. The method of claim 18, wherein the immunosuppressant is sirolimus. 23. The method of claim 18, wherein the immunosuppressant is tacrolimus. 24. The method of claim 23, wherein tacrolimus is administered to the patient as a stable dose, twice daily, with a total daily dose between 0.5 to 16 mg. 25. The method of claim 17, wherein the monitoring comprises monitoring immunosuppressant drug levels following initiation, and after discontinuation, of treatment with maribavir in the patient.