1
AGA Abstracts patients has not been examined. The objective of this analysis was to assess the efficacy and tolerability of rifaximin in maintaining remission from HE in cirrhotic patients with HCV. Methods: Breakthrough HE events and tolerability were assessed from a 6-month, random- ized, double-blind, placebo-controlled trial of RFX 550 mg BID in cirrhotic patients (n= 299) with a recent history of recurrent HE but in remission at enrollment (Conn Score [CS], 0 or 1). Breakthrough overt HE was defined as an increase in CS to 2, or an increase in both CS and asterixis score of 1 grade each for patients entering with a CS of 0. Lactulose was permitted throughout the study. The incidence of adverse events (AEs) was reported. Results: HCV was the etiology of advanced liver disease in 42.8% (128 of 299) of patients. Demographic and baseline characteristics were generally similar between HCV and non- HCV patients. In HCV patients, breakthrough HE events occurred in 26.2% (16 of 61) of RFX patients vs. 47.8% (32 of 67) of PBO patients, corresponding to relative reduction in risk of a breakthrough HE episode of 52.2% (Figure, P=0.014). In cirrhotic patients with other etiologies (eg, alcohol-related, NAFLD/NASH), there were also significant treatment- related differences, with 19.0% (15 of 79) of RFX patients experiencing a breakthrough HE event vs. 44.6% (41 of 92) of PBO patients (P ,0.001). In HCV patients, the most commonly reported AEs were nausea (RFX:18.0% of patients, PBO:19.4% of patients), fatigue (RFX:14.8%, PBO:13.4%), and peripheral edema (RFX:14.8%, PBO:7.5%). Conclusions: In patients with HCV and recurrent HE, RFX was efficacious and well-tolerated, with a clinical profile similar to that observed for cirrhotic patients with other etiologies of advanced liver disease. Maintenance of Remission in Patients with Hepatitis C and Other Etiologies of Advanced Liver Disease Su1301 Impact of Infection Type, Acute Kidney Injury, and Systemic Inflammatory Response Syndrome on Survival of Cirrhotic Patients With Bacterial Infections: A Population-Based Cohort Study Konstantina Sargenti, Hanne Prytz, Emma Nilsson, Sara Bertilsson, Evangelos Kalaitzakis Sepsis has been proposed as a prognostic factor in decompensated cirrhosis but the potential long-term prognostic significance of infections has not been validated in a population-based cirrhotic cohort. Nosocomial and health-care associated(HCA) infections are common in these patients. Acute kidney injury(AKI) and systemic inflammatory response syn- drome(SIRS) indicate poor prognosis in cirrhotics with an infection. Population-based data on the potential impact of these factors on long-term survival of patients with bacterial infections in different cirrhosis stages are lacking. Methods Hepatology practice in Sweden is almost exclusively public and hospital-based. All cirrhotic patients diagnosed in 2000- 2010 residing in an area of 250000 inhabitants were retrospectively evaluated. Medical records of all hospitals in the region were scrutinized and relevant data, eg hospitalizations for infections with/without SIRS or AKI(increase in s-creatinine .50%), were extracted. Patients were followed until death, transplant or end of 2011. Results 344 patients (34%F; 51% with alcoholic cirrhosis; 17% with viral cirrhosis; mean follow-up 50mo) were included. During follow-up 40(12%) patients had 70 infection episodes while compensated, 88(26%) 160 infections while decompensated and 231(67%) did not have any infection episode. The frequency of at least one nosocomial/HCA infection did not differ significantly between decompensated and compensated disease(67% vs 33%,p=0.83) but infection-related SIRS and AKI were more common in the former than the latter (63% vs 38%, p=0.008; 76% vs 24%, p=0.038 respectively). The occurrence of at least one infection episode during follow-up had a significant prognostic impact in decompensated but not compensated cirrhosis(figure 1 and 2). Survival analysis showed that the occurrence of infection episodes with AKI, SIRS or those due to nosocomial/HCA infections had an impact on survival mainly in decompen- sated(log-rank test p,0.05 for all) but not compensated cirrhosis(p .0.05 for all). After adjusting for confounders with Cox regression analysis, transplant-free survival of decompen- sated patients was independently related to the occurrence of nosocomial/HCA infections (Hazard ratio 2.52, 95% confidence interval(CI) 1.59-4) but not infection-related AKI or SIRS(p.0.05 for both). In Cox regression analysis neither infection type nor the occurrence of infections with AKI or SIRS was independently related to transplant-free survival in compensated cirrhotics(p.0.05 for all). Conclusion In a population-based cohort of cirrhotic patients, bacterial infections appeared to have prognostic significance mainly in decompen- sated and not compensated cirrhosis. Nosocomial/HCA infections appear to have a negative prognostic impact on survival in decompensated cirrhosis independent of the occurrence of infection-related SIRS or AKI. S-452 AGA Abstracts Figure 1 Transplant-free survival in patients with compensated cirrhosis with (continuous line) or without (dashed line) at least one infection episode during follow-up Figure 2 Transplant-free survival in patients with decompensated cirrhosis with (continuous line) or without (dashed line) at least one infection episode during follow-up Su1302 Predictors of Combined Liver and Kidney Transplantation and Post-Transplant Liver Graft, Kidney Graft, and Patient Survival: Comparison to Patients Receiving Listed for Kidney but Receiving Liver Alone Ashwani K. Singal, Yong Fang Kuo, Russell Wiesner Background: Data on patient and liver kidney graft survival following combined liver kidney (CLK) transplantation remain conflicting. Aim: To compare outcomes after CLK transplanta- tion to patients listed for liver and kidney but receiving only liver. Methods and Results: United Network for organ Sharing (UNOS) data used to select first deceased donor adult liver transplants with or without kidney during 1994 and 2011. Of 79,160 transplants, 4930 received CLK (441 kidney after liver [KAL], 770 liver after kidney [LAK], 3719 simultaneous liver kidney [SLK]) and 74,230 liver alone (2065 listed for kidney [LALK]). CLK as proportion of all transplants increased from 3.2% in 1994 to 9.5% in 2011 and proportion of LALK decreased from 4.8% in 1994 to 1.6% in 2011. CLK was more often performed in UNOS regions 1,3,6, and 7. Compared to LALK, patients with CLK transplants were a) older (52±9 vs. 49±10 yrs.); b) more likely to have higher MELD (29±9 vs. 24±12), renal insufficiency (RI) with creatinine . 2 mg/dl (85% vs. 33%) and diabetes (33% vs. 28%) but less likely to have HCC (2.5% vs. 7%); c) more likely to be on dialysis (65% vs. 17%) and in MELD era (78% vs. 53%). Once listed for kidney, odds of receiving CLK were 6 (5.4-7.6) for RI, 5 (4.2-5.7) for dialysis, and 2.3 for MELD era transplants (1.7-3). Hispanic race had 19% less likely to receive CLK compared to other races. Comparison of Kaplan Meier 5 yr. curves for LALK to KAL, LAK, and SLK, survival was lower for liver graft (67% vs. 68%, 74%, and 71% respectively; Log Rank P=0.0002) and similar for patient (77% vs. 76%, 74% and 77% respectively; P=0.1). Other predictors for patient survival were black race, on ventilator, dialysis, and RI. Kidney graft 5 yr. survival was lower for LAK compared to KAL and SLK (54% vs. 67% and 69% respectively, P ,0.0001). Amongst LAK transplants, 5 yr. outcomes were poor for patient and kidney graft if gap between receiving liver after kidney was .30 days (N=203) compared to 30 days (N=567): 67% vs. 77%; P=0.01 and 50% vs. 67%; P=0.0001 respectively). For KAL transplants, patient survival was poor for kidney received within 30 days after liver (N=383) compared to .30 days (N=83): 73% vs. 92%; P=0.0001. Controlling for patient demographics and other factors, LALK was a predictor for liver graft loss [1.32 (1.11-1.45)] and patient mortality [1.6 (1.3-2)]. Other predictors were being on ventilator, dialysis, RI, black race, and male gender. Conclusions: Proportion of CLK transplantation is increasing in the US. Guidelines are needed for patient selection to list for CLK transplantation balancing at optimizing use of kidneys and achieving good post transplant outcomes.

Su1302 Predictors of Combined Liver and Kidney Transplantation and Post-Transplant Liver Graft, Kidney Graft, and Patient Survival: Comparison to Patients Receiving Listed for Kidney

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Page 1: Su1302 Predictors of Combined Liver and Kidney Transplantation and Post-Transplant Liver Graft, Kidney Graft, and Patient Survival: Comparison to Patients Receiving Listed for Kidney

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spatients has not been examined. The objective of this analysis was to assess the efficacy andtolerability of rifaximin in maintaining remission from HE in cirrhotic patients with HCV.Methods: Breakthrough HE events and tolerability were assessed from a 6-month, random-ized, double-blind, placebo-controlled trial of RFX 550 mg BID in cirrhotic patients (n=299) with a recent history of recurrent HE but in remission at enrollment (Conn Score [CS],0 or 1). Breakthrough overt HE was defined as an increase in CS to ≥2, or an increase inboth CS and asterixis score of 1 grade each for patients entering with a CS of 0. Lactulosewas permitted throughout the study. The incidence of adverse events (AEs) was reported.Results: HCV was the etiology of advanced liver disease in 42.8% (128 of 299) of patients.Demographic and baseline characteristics were generally similar between HCV and non-HCV patients. In HCV patients, breakthrough HE events occurred in 26.2% (16 of 61) ofRFX patients vs. 47.8% (32 of 67) of PBO patients, corresponding to relative reduction inrisk of a breakthrough HE episode of 52.2% (Figure, P=0.014). In cirrhotic patients withother etiologies (eg, alcohol-related, NAFLD/NASH), there were also significant treatment-related differences, with 19.0% (15 of 79) of RFX patients experiencing a breakthrough HEevent vs. 44.6% (41 of 92) of PBO patients (P,0.001). In HCV patients, the most commonlyreported AEs were nausea (RFX:18.0% of patients, PBO:19.4% of patients), fatigue(RFX:14.8%, PBO:13.4%), and peripheral edema (RFX:14.8%, PBO:7.5%). Conclusions:In patients with HCV and recurrent HE, RFX was efficacious and well-tolerated, with aclinical profile similar to that observed for cirrhotic patients with other etiologies of advancedliver disease.

Maintenance of Remission in Patients with Hepatitis C and Other Etiologies of AdvancedLiver Disease

Su1301

Impact of Infection Type, Acute Kidney Injury, and Systemic InflammatoryResponse Syndrome on Survival of Cirrhotic Patients With BacterialInfections: A Population-Based Cohort StudyKonstantina Sargenti, Hanne Prytz, Emma Nilsson, Sara Bertilsson, Evangelos Kalaitzakis

Sepsis has been proposed as a prognostic factor in decompensated cirrhosis but the potentiallong-term prognostic significance of infections has not been validated in a population-basedcirrhotic cohort. Nosocomial and health-care associated(HCA) infections are common inthese patients. Acute kidney injury(AKI) and systemic inflammatory response syn-drome(SIRS) indicate poor prognosis in cirrhotics with an infection. Population-based dataon the potential impact of these factors on long-term survival of patients with bacterialinfections in different cirrhosis stages are lacking. Methods Hepatology practice in Swedenis almost exclusively public and hospital-based. All cirrhotic patients diagnosed in 2000-2010 residing in an area of 250000 inhabitants were retrospectively evaluated. Medicalrecords of all hospitals in the region were scrutinized and relevant data, eg hospitalizationsfor infections with/without SIRS or AKI(increase in s-creatinine .50%), were extracted.Patients were followed until death, transplant or end of 2011. Results 344 patients (34%F;51% with alcoholic cirrhosis; 17% with viral cirrhosis; mean follow-up 50mo) were included.During follow-up 40(12%) patients had 70 infection episodes while compensated, 88(26%)160 infections while decompensated and 231(67%) did not have any infection episode. Thefrequency of at least one nosocomial/HCA infection did not differ significantly betweendecompensated and compensated disease(67% vs 33%,p=0.83) but infection-related SIRSand AKI were more common in the former than the latter (63% vs 38%, p=0.008; 76% vs24%, p=0.038 respectively). The occurrence of at least one infection episode during follow-uphad a significant prognostic impact in decompensated but not compensated cirrhosis(figure 1and 2). Survival analysis showed that the occurrence of infection episodes with AKI, SIRSor those due to nosocomial/HCA infections had an impact on survival mainly in decompen-sated(log-rank test p,0.05 for all) but not compensated cirrhosis(p .0.05 for all). Afteradjusting for confounders with Cox regression analysis, transplant-free survival of decompen-sated patients was independently related to the occurrence of nosocomial/HCA infections(Hazard ratio 2.52, 95% confidence interval(CI) 1.59-4) but not infection-related AKI orSIRS(p.0.05 for both). In Cox regression analysis neither infection type nor the occurrenceof infections with AKI or SIRS was independently related to transplant-free survival incompensated cirrhotics(p.0.05 for all). Conclusion In a population-based cohort of cirrhoticpatients, bacterial infections appeared to have prognostic significance mainly in decompen-sated and not compensated cirrhosis. Nosocomial/HCA infections appear to have a negativeprognostic impact on survival in decompensated cirrhosis independent of the occurrenceof infection-related SIRS or AKI.

S-452AGA Abstracts

Figure 1 Transplant-free survival in patients with compensated cirrhosis with (continuousline) or without (dashed line) at least one infection episode during follow-up

Figure 2 Transplant-free survival in patients with decompensated cirrhosis with (continuousline) or without (dashed line) at least one infection episode during follow-up

Su1302

Predictors of Combined Liver and Kidney Transplantation and Post-TransplantLiver Graft, Kidney Graft, and Patient Survival: Comparison to PatientsReceiving Listed for Kidney but Receiving Liver AloneAshwani K. Singal, Yong Fang Kuo, Russell Wiesner

Background: Data on patient and liver kidney graft survival following combined liver kidney(CLK) transplantation remain conflicting. Aim: To compare outcomes after CLK transplanta-tion to patients listed for liver and kidney but receiving only liver. Methods and Results:United Network for organ Sharing (UNOS) data used to select first deceased donor adultliver transplants with or without kidney during 1994 and 2011. Of 79,160 transplants,4930 received CLK (441 kidney after liver [KAL], 770 liver after kidney [LAK], 3719simultaneous liver kidney [SLK]) and 74,230 liver alone (2065 listed for kidney [LALK]).CLK as proportion of all transplants increased from 3.2% in 1994 to 9.5% in 2011 andproportion of LALK decreased from 4.8% in 1994 to 1.6% in 2011. CLK was more oftenperformed in UNOS regions 1,3,6, and 7. Compared to LALK, patients with CLK transplantswere a) older (52±9 vs. 49±10 yrs.); b) more likely to have higher MELD (29±9 vs. 24±12),renal insufficiency (RI) with creatinine. 2 mg/dl (85% vs. 33%) and diabetes (33% vs.28%) but less likely to have HCC (2.5% vs. 7%); c) more likely to be on dialysis (65% vs.17%) and in MELD era (78% vs. 53%). Once listed for kidney, odds of receiving CLK were6 (5.4-7.6) for RI, 5 (4.2-5.7) for dialysis, and 2.3 for MELD era transplants (1.7-3). Hispanicrace had 19% less likely to receive CLK compared to other races. Comparison of KaplanMeier 5 yr. curves for LALK to KAL, LAK, and SLK, survival was lower for liver graft (67%vs. 68%, 74%, and 71% respectively; Log Rank P=0.0002) and similar for patient (77% vs.76%, 74% and 77% respectively; P=0.1). Other predictors for patient survival were blackrace, on ventilator, dialysis, and RI. Kidney graft 5 yr. survival was lower for LAK comparedto KAL and SLK (54% vs. 67% and 69% respectively, P,0.0001). Amongst LAK transplants,5 yr. outcomes were poor for patient and kidney graft if gap between receiving liver afterkidney was .30 days (N=203) compared to ≤ 30 days (N=567): 67% vs. 77%; P=0.01 and50% vs. 67%; P=0.0001 respectively). For KAL transplants, patient survival was poor forkidney received within 30 days after liver (N=383) compared to .30 days (N=83): 73%vs. 92%; P=0.0001. Controlling for patient demographics and other factors, LALK was apredictor for liver graft loss [1.32 (1.11-1.45)] and patient mortality [1.6 (1.3-2)]. Otherpredictors were being on ventilator, dialysis, RI, black race, and male gender. Conclusions:Proportion of CLK transplantation is increasing in the US. Guidelines are needed for patientselection to list for CLK transplantation balancing at optimizing use of kidneys and achievinggood post transplant outcomes.