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.

1 . (canceled) 
     
     
         2 . (canceled) 
     
     
         3 . A method of decreasing a subject's risk of a hepatic encephalopathy (HE) breakthrough episode comprising administering rifixamin to a subject suffering from HE. 
     
     
         4 . The method of  claim 3 , wherein the risk of the episode for subjects having a last HE episode equal to, or greater than, 90 days prior to the administration is reduced by about 58% or between about 30% to 70% or between about 40% to about 70%. 
     
     
         5 . (canceled) 
     
     
         6 . The method of  claim 3 , wherein the risk of the episode for subjects having a last HE episode greater than 90 days prior to the administration is decreased by between about 60% or between about 2% to 80%. 
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 3 , wherein the risk of the episode for subjects having two or fewer HE episodes in the six months prior to the administration is reduced by about 56%, or between about 20% to 70%. 
     
     
         9 . (canceled) 
     
     
         10 . The method of  claim 3 , wherein the risk of the episode for subjects having greater than two HE episodes in the six months prior to rifaximin administration is reduced by about 63% or between about 30% to about 80%. 
     
     
         11 .- 13 . (canceled) 
     
     
         14 . A method of maintaining remission of HE in a subject comprising administering rifaximin to a subject suffering from HE. 
     
     
         15 . A method of reducing the frequency of hospitalization visits by an HE patient, comprising administering rifaximin to a subject suffering from HE. 
     
     
         16 . The method of  claim 15 , wherein administration of rifaximin reduces hospitalization frequency by about 48% or from between about 13% to about 69%. 
     
     
         17 .- 19 . (canceled) 
     
     
         20 . The method of  claim 15 , wherein 550 mg of rifaximin is administered to the subject two times per day (BID) or 275 mg of rifaximin is administered to the subject four times per day or 275 mg of rifaximin is administered to the subject as two dosage forms two times per day. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . The method of  claim 3 , wherein the GI specific antibiotic is administered to the subject for six months, one year, two to three years, or until the subject's death. 
     
     
         24 .- 26 . (canceled) 
     
     
         27 . The method of  claim 3 , wherein a Conn score or the quality of life (QoL) measurement of the subject is improved over baseline following administration of rifaximin. 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 3 , further comprising administering one or more of align, alinia, lactulose, pentasa, cholestyramine, sandostatin, vancomycin, lactose, amitiza, flagyl, zegerid, prevacid, or miralax. 
     
     
         30 .- 37 . (canceled) 
     
     
         38 . The method of  claim 3 , wherein there is an increase in time to a first HE-related hospitalization of the subject, an increase in the time to development of spontaneous bacterial peritonitis (SBP) of the subject or an increase in critical flicker frequency values from baseline after administration of rifaximin to the subject. 
     
     
         39 . (canceled) 
     
     
         40 . The method of  claim 3 , wherein there is a decrease in blood ammonia concentration from baseline or a decrease in daily lactulose consumption from baseline over time after administration of rifaximin to the subject. 
     
     
         41 .- 46 . (canceled) 
     
     
         47 . The method of  claim 3 , wherein there is a shift in baseline in Conn scores, in asterixis grades, in Chronic Liver Disease Questionnaire (CLDQ) scores or in Epworth Sleepiness Scale scores over time after administration of rifaximin to the subject. 
     
     
         48 .- 51 . (canceled) 
     
     
         52 . The method of  claim 3 , wherein subjects having a meld level of between about 1 to 24 respond to treatment with rifaximin. 
     
     
         53 .- 74 . (canceled) 
     
     
         75 . A method of increasing the time between breakthrough events for a patient suffering from hepatic encephalopathy, comprising administering to the patient an effective amount of rifaximin that extends the time between hepatic encephalopathy breakthrough events. 
     
     
         76 . The method of  claim 75 , wherein the time between breakthrough events for the patient is extended to greater than six months or greater than 12 months. 
     
     
         77 .- 96 . (canceled)