Presented by: Jean Yoo-Campbell, Matthew Konerman, Monica Konerman, Jean Yoo Campbell, Christian Gocke, Eunpi Cho Donald Lynch

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1 Bass N.M., et. al. N Engl J Med 2010; 362: Presented by: Jean Yoo-Campbell, Matthew Konerman, Monica Konerman, Jean Yoo Campbell, Christian Gocke, Eunpi Cho Donald Lynch Faculty Advisor: Dr. Fred Brancati

2 Study Outline Hypothesis: Rifaximin can prevent episodes of acute hepatic encephalopathy Study Design: Randomized Control Trial (doubleblind, placebo-controlled) Setting: Multi-center in US, Canada, Russia Participants: 299 patients in remission from recurrent hepatic encephalopathy secondary to chronic liver disease Inclusion: Age >18, >2 eps of HE in previous 6 months, remission at enrollement, MELD <25 Exclusion: liver transplant expected w/in 1 month, GI bleed, TIPSS, Cr >2.0, Hg <8, electrolyte abnormality, infection, active SBP, respiratory insufficiency

3 Study Outline Data Collection: Conn score & Asterixis grade during clinic visits and phone interviews Conn: 1 = trivial lack of awareness, 2 = lethargy or apathy, 3 = somnolence to semistupor, 4 = coma Asterixis grade: 0 = no tremor, 1 = few flaps, 2 = occasional flap, 3 = frequent flaps, 4 = continuous flaps Data Analysis: Efficacy data through intention-totreat; Kaplan-Meier, Cox proportional-hazards Outcome: time to breakthrough HE episode, time to HE hospitalization, safety

4 Background Hepatic encephalopathy is a complication of hepatic cirrhosis HE based on clinical diagnosis of 1) impaired mental status (def by Conn score) and 2) impaired neuromotor function (hyperreflexia, rigidity, myoclonus and asterixis) Current standard of care is treatment with lactulose, nonabsorbable disaccharides (Sharma et al demonstrated lactulose effective in preventing HE compared to placebo) Sharma BC, Sharma P, Agrawal A, Sarin SK. Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology 2009;137:885-91, 91 e1.

5 Rifaximin Also reduces ammonia by decreasing the ammoniaproducing enteric bacteria w/o toxicity other Abx Min absorbed in gut, broad spectrum H/o randomized studies that demonstrated rifaximin was more effective than nonabsorbable disaccharides and equal or better than other Abx for treatment of HE Unknown efficacy for prevention of HE (until now )

6 Results Over a 6-month period, patients treated with rifaximin (550mg bid) maintained remission from hepatic encephalopathy more effectively than placebo. Patients in the rifaximin group also had longer time to HE related hospitalization.

7

8 Subgroup Analysis Bass NM et al. N Engl J Med 2010;362:

9 Adverse Events, According to Study Group Bass NM et al. N Engl J Med 2010;362:

10 Conclusions/Implications First RCT addressing prevention with rifaximin Rifaximin is effective in preventing first breakthrough episode of HE Patients already on lactulose 50% relative risk reduction Similar safety profiles Reduce cost, frequency of hospitalizations Seen in retrospective chart reviews already Small number needed to treat

11 Rifaximin in Hepatic Encephalopathy: Strengths Randomized, double-blind, placebo-controlled trial is the gold standard for evaluating a drug (protects against many potential biases) Kaplan-Meier Time-to-Event analysis most appropriate for this data set Included more concrete secondary endpoint of hospitalizations involving hepatic encephalopathy Included comparison of adverse effects between groups, demonstrating that Rifaximin may be better tolerated than antibiotics used previously for hepatic encephalopathy

12 Rifaximin in Hepatic Encephalopathy: Weaknesses Soft Primary Outcome Measure: Episodes of Hepatic Encephalopathy Conn score and asterixis grade are subjective measures Study not powered to assess impact on mortality Concomitant use of lactulose not well characterized Mean doses similar between groups but titration of doses unclear True placebo not used in this study --- proper interpretation is that rifaximin + lactulose is more effective at preventing HE than only lactulose Inclusion/Exclusion criteria limits generalizability of results Excluded patients with recent GI bleed, chronic renal insufficiency, anemia, etc. Involvement of Salix Pharmaceuticals does encourage more investigation into study s methods (i.e., how was randomization performed?, etc.)

13 Discussion Points Can we generalize this to our patients? Sicker patients/higher MELD less exclusions like intercurrent infection How long do you stay on rifaximin? Does it continue to prevent HE after a few months or do you get gut resistance? What about frequency of HE while still on rifaximin (ie, are you protected similarly for 2 nd, 3 rd episodes?) Can rifaximin be used alone to prevent HE? Compare lactulose to rifaximin in preventing over long periods

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