Details for Patent: 9,629,829

Title:	Methods of treating hepatic encephalopathy
Abstract:	The application describes treatment of hepatic encephalopathy using gastrointestinal specific antibiotics. One example of a gastrointestinal specific antibiotic is rifaximin.
Inventor(s):	Forbes; William (Raleigh, NC)
Assignee:	Salix Pharmaceuticals, Ltd (Bridgewater, NJ)
Filing Date:	Feb 03, 2015
Application Number:	14/612,697
Claims:	1. A method of reducing the frequency of hospitalization visits by an hepatic encephalopathy (HE) subject, comprising administering rifaximin daily for a period of about 12 months or longer to the subject suffering from HE. 2. The method of claim 1, wherein administration of rifaximin reduces hospitalization frequency by about 48%. 3. The method of claim 1, wherein administration of rifaximin reduces hospitalization frequency by from between about 13% to about 69%. 4. The method of claim 1, wherein 550 mg of rifaximin is administered to the subject two times per day (BID). 5. The method of claim 1, wherein 275 mg of rifaximin is administered to the subject four times per day. 6. The method of claim 1, wherein 275 mg of rifaximin is administered to the subject as two dosage forms two times per day. 7. The method of claim 1, wherein rifaximin is administered to the subject for one year. 8. The method of claim 1, wherein rifaximin is administered to the subject for two to three years. 9. The method of claim 1, wherein rifaximin is administered daily to the subject until the subject's death. 10. The method of claim 1, wherein a Conn score of the subject is improved over baseline following administration of rifaximina. 11. The method of claim 1, wherein a quality of life (QoL) measurement is improved from baseline following administration of rifaximin. 12. The method of claim 1, further comprising administering lactulose. 13. The method of claim 1, wherein a Conn score (mental state grade) of the subject decreases. 14. The method of claim 1, wherein time to a Conn score increase from baseline for the subject is increased. 15. The method of claim 14, wherein the delay in time to increase in Conn score of the subject is increased by about 54%. 16. The method of claim 14, wherein the delay in time to increase in Conn score is increased between about 30% to about 70%. 17. The method of claim 1, wherein there is an increase of time to an increase from baseline in an asterixis grade of the subject. 18. The method of claim 1, wherein there is a delay in the time to increase in asterixis grade. 19. The method of claim 1, wherein there is a decrease in blood ammonia concentration from baseline after administration of rifaximin to the subject. 20. The method of claim 19, wherein the decrease in blood ammonia concentration from baseline to 170 days is about 6 .mu.g/dL. 21. The method of claim 1, wherein there is an increase in critical flicker frequency values from baseline after administration of rifaximin to the subject. 22. The method of claim 1, wherein there is a shift in baseline in Conn scores over time after administration of rifaximin to the subject. 23. The method of claim 22, wherein the shift in baseline in Conn scores is from between about 1 to about 2. 24. The method of claim 1, wherein there is a shift from baseline in asterixis grades over time after administration of rifaximin to the subject. 25. The method of claim 1, wherein there is a change from baseline in Chronic Liver Disease Questionnaire (CLDQ) scores over time after administration of rifaximin to the subject. 26. The method of claim 1, wherein there is a change from baseline in Epworth Sleepiness Scale scores over time after administration of rifaximin to the subject. 27. The method of claim 1, wherein 550 mg of rifaximin is administered to the subject two times per day.