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saccuracy of such measurement. However, after accounting for automated data and medicalrecord reviews, vaccinations, liver biopsy, and antiviral treatment rates in the VA left roomfor improvement.

Tu1011

Quality of Varices-Related Care in Patients With CirrhosisPaula Buchanan, Jennifer R. Kramer, Hashem El-Serag, Youssef Assioun, Fasiha Kanwal

Background: Variceal bleeding is the second most common complication of cirrhosis. AASLDPractice guidelines define the criteria and standards of care in patients with cirrhosis whoare at risk for or develop variceal bleeding. However, the extent to which patients meetthese standards is largely unknown in clinical practice. We evaluated the quality of varices-related care that patients with cirrhosis receive and factors associated with receipt of suchcare. Methods: We conducted a retrospective cohort study of 1650 patients with cirrhosisin 3 VA facilities between 2000 and 2007. Using an administrative and clinical database,we assessed quality of varices-related care that patients received as measured by ten explicitDelphi panel-derived quality indicators (QIs) in cirrhosis. Of these patients 599 were eligiblefor at least one QI. We utilized a generalized linear mixed model to examine patientdemographic (age, race), clinical (MELD, serum albumin, Deyo comorbidity index), andhealth care utilization (seen by specialists, seen in academic facility) factors that may predictreceipt of care. We also conducted a structured implicit review of patients' medical recordsto explore the role of patient refusal, outside care, or other justifiable exclusions to careprocesses as explanations for non-adherence to the quality measures. Results: Quality scoresvaried across individual indicators (Table), ranging from 17.6% for repeat endoscopy withinone year of varices diagnosis to 87.5% for testing for complete blood cell counts, level ofelectrolytes, and INR at the time of variceal bleeding. Overall, fewer than 12.8% (95% CI,10.2%-15.5%) of patients received all recommended care. On average, patients received47.3% (95% CI, 44.9%-49.7%) of the care they were eligible for. Patients who sought careat the academic facility (odds ratio [OR]= 1.27, 95% CI, 1.03 - 1.56) and those who wereseen by a gastroenterologist (OR=1.54, 95% CI,1.09-2.18) had higher odds of receivingbetter quality of varices-related care. Higher albumin (≥3 mg/dl vs. <2.2 mg/dl, OR=0.66,95% CI, 0.46-0.94, and albumin 2.2-2.99 mg/dl vs. <2.2 mg/dl, OR=0.64, 95% CI, 0.49-0.82) was significantly associated with lower quality, MELD score or Deyo index did nothave an effect on quality score. Most patients did not have a documented explanation intheir medical records for non-adherence to the recommended QI. Conclusion: Quality ofcare provided to patients at-risk for or those who develop variceal bleeding leaves room forimprovement. Patients who were seen by specialists and in academic facility received thebest care. Most of the shortfalls in quality of varcies-related care were unexplained bycomorbidity or chart documented patient preferences.Rate of Varices Related Quality Indicators

Tu1012

Optimizing Medical Care for NAFLD: A Structured Assessment of MedicalProvidersAmanda K. Camp, Kiran Bambha

Background: Nonalcoholic fatty liver disease (NAFLD) is a leading cause of chronic liverdisease in the U.S. Despite its prevalence, there are currently no cohesive guidelines for thediagnosis and management of NAFLD, and medical providers (MPs) from an array of clinicaldisciplines outside of Gastroenterology and Hepatology (GI/Hep) are caring for patients whohave, or are at risk for, NAFLD. Aim: To assess perceptions and practice patterns of MPsoutside of GI/Hep with respect to approaches to the diagnosis and management of patientswho have, or are at risk for, NAFLD. Methods: An anonymous, online survey consisting

S-1010AASLD Abstracts

of 39 closed-ended questions and case-based scenarios was administered to outpatient MPsin Internal Medicine (IM) and Endocrinology at a large academic medical center. The surveyaddressed: providers' facility and comfort levels with diagnosing and managing NAFLD;triggers for referrals to a GI/Hep; and specific managements being applied by MPs. Results:The response rate was 62.5% (N=50 responses from 80 solicitations), with 68% being female,53% IM, 40% Endocrine, and 8% Other Specialties; 82% were Practicing Physicians, 12%Fellows, 4% Nurse Practitioners, and 2% Physician Assistants. 40% of MPs specialized indiabetes care. Diabetes and the metabolic syndrome were the two most common reasonsfor providers to check baseline liver enzymes (30%), but 30% of MPs do not check baselineliver enzymes for any reason. Thresholds for abnormal liver enzymes that triggered furtherliver workup varied considerably, with 49%, 40% and 11% using >1x, >2x or >3x ULN asthe thresholds, respectively. While 55% of MPs stated they were comfortable diagnosingNAFLD, 30% were not. Only 28% of MPs were comfortable managing NAFLD, with 51%of MPs referring patients with suspected NAFLD to GI/Hep. Common reasons for referralto GI/Hep included: patient education (53%); opportunities for participation in clinical trials(51%); and monitoring for liver-related complications (49%). The most commonly usedmedications by MPs specifically for management of NAFLD were metformin and HMGCoAReductase Inhibitors. Vitamin E was infrequently used. Imaging demonstrating hepaticsteatosis with normal liver enzymes was not evaluated further by 42% of MPs. The majorityof providers (86%) recognize NASH histology as predisposing their patients to progressiveliver disease. Conclusion: Medical providers outside the fields of GI/Hep frequently encoun-ter patients with known or suspected NAFLD. There is considerable variation in how thesepatients are being clinically assessed and managed, with some high risk patients likely beingundiagnosed. Medical providers overwhelmingly express a need for further education toassist them with the care of their NAFLD patients, presenting an opportunity for interventionand optimization of NAFLD patient care.

Tu1013

Does Increasing Health Care Expenditure Improve Health Related Outcomesin Patients With Esophageal Variceal Bleeding (Evb)? an Analysis of NationalTrends in US From 2000 to 2009Venu Gopala Reddy Gangireddy, Subbaramiah Sridhar, Akash Nabh, Teresa Coleman,Alphonso Brown

Background: Esophageal variceal bleeding (EVB) is a medical and a surgical emergency anda major complication in patients with cirrhosis and portal hypertension. Over the past twodecades there have been major advances in the diagnosis and management of varicealbleeding. It is unclear as to whether these advances have made any impact on health relatedoutcomes in patients with bleeding varices. Objective: The aim of this study was to evaluate1) the trends in the incidence, mortality, mean hospital charges and mean length of hospitalstay associated with EVB using the national inpatient sample database (NISD). 2) To examinethe impact of patient's demographics on health related outcomes (HRO). Methods: Weanalyzed the NISD for all patients with the principle discharge diagnosis of EVB (ICD-9code: 456.0) between 2000 to 2009. The primary outcome measures studied were incidenceof EVB, in-patient mortality, mean hospital charges &mean length of hospital stay. Secondaryoutcomes studied were the age of patients (18-44, 45-64 & 65-84), gender (M vs F),size of the hospital (small, medium & large), location of patients (Metropolitan vs nonmetropolitan), region (North east, Midwest, South and West) of the hospital and payer(Medicare,Medicaid, Private insurance and Uninsured) characteristics. Mean Hospital chargeswere adjusted for Medical cost inflation rates between 2000 & 2009. Chi- square testingwas used to determine the trend and linear regression models were performed for eachvariable. Results: During the study period from 2000 to 2009, there were a total of 40,586admissions with a discharge diagnosis of EVB. The total admissions in year 2009 havedecreased by 13.8% (P=0.03) compared to the year 2000. The Mean hospital charges haveincreased by 42.3% (p<0.01). There has been no statistically significant difference in thein-patient mortality rate or mean length of hospital stay in any of the secondary outcomevariables. The biggest increase in mean hospital charges were seen in metropolitan (40%,P<0.01) and large hospitals (54.9%, P<0.01); and in Northeast region (112.9%, P<0.01).The expenditure in Non-metropolitan, small and medium hospitals showed no statisticallysignificant increase in health care expenditure. Discussion: During the study period of 2000to 2009, the health care costs have significantly increased, but there has been no differencein the in-patient mortality or mean length of hospital stay for EVB. The biggest increase inexpenditure was seen in metropolitan areas and large hospitals. This may be related toincrease in endoscopic procedures and ICU stays during the study period. Overall, increasesin health care expenditure does not necessarily mean better HRO in patients with EBV.Better diagnosis, triage and treatment plans are needed for the cost effective managementof this serious disease.Table 1: Comparison of health related outcomes in patients with esophageal variceal bleeding.

NA = Data not available.

Tu1014

Real-World Evaluation of the Economic Impact of Duration of Drug Therapyin the Treatment of Hepatitis C Virus (HCV): an UpdateJeffrey S. McCombs, Janet Shin, Patricia Hines, Sammy Saab, Yong Yuan

Background: New therapies for hepatitis C [HCV] are under development which will likelyaugment the standard treatment regimen of pegylated interferon-alpha plus ribavirin [P/R]to improve patient outcomes and possibly shorten P/R duration. However, few studies haveevaluated the economic implications associated with P/R treatment duration in real worldpractice. Objective: To estimate the impact of P/R treatment duration on health care costsin real-world clinical practice. Methods: Paid claims data for 2003-2010 were retrieved froma large U.S. health insurance company and 148, 176 HCV patients were identified. Only7,840 HCV patients received P/R treatment [5.3%]. Patients were then screened for aminimum of 6 months of data prior and 24 months of data after the start of P/R drugtherapy. Patients with a pre-treatment diagnosis for HIV, hepatitis B, cirrhosis, liver canceror a liver transplantation were also excluded. The impact of treatment duration on cost andadverse event risk was estimated by comparing patients with 24-48 weeks and 48+ weeksof therapy to patients with < 24 weeks of continuous P/R therapy. Multivariable statisticalanalyses were used to estimate the incremental effects of 24-48 and 48+ weeks of P/R therapycontrolling for each patient's baseline demographics, and diagnostic and prescription drugprofile. Results: 1,856 patients were identified who used P/R therapy and had two years ofpost-treatment data. Genotype data were available for 519 treated patients [27%], of whom76% were HCV genotype 1 or 4. 35.8% and 21.7% of all treated patients completed 24-48 weeks or 48+ weeks of drug therapy, respectively. Relative to the patients treated <24weeks, drugs costs associated with 24-48 weeks of therapy were +$10,671 in the first year[p<0.0001] which were partially offset by reduced medical costs [-$3,247; p>0.05]. Firstyear drug costs for patients with 48+ weeks of treatment were +$27,116 [p<0.0001] whichwere partially offset by medical costs savings of -$6,194 [p<0.01]. In the second year,duration of P/R therapy for between 24 and 48 weeks achieved in year 1 was associatedwith reductions total costs of -$6,171 [p<0.05]. Patients achieving 48+ weeks of treatmentin the first year experienced a reduction in total second-year healthcare costs of -$8,130[p<0.01]. Conclusions: Patients with genotype 1 HCV infections require 48 weeks of P/Rtherapy; however, less than 22% of patients achieved this goal. While estimated savings infirst year medical costs associated with duration of therapy of 24-48 weeks and >48 weekswere not sufficient to offset drug costs, these results were reversed in year 2. This suggeststhat a full course of P/R therapy may reduce total cost over time. More research is neededto determine if year 2 savings associated with compliance with drug therapy continues onbeyond year 2.

Tu1015

Relationships Between Exercise Performance, Metabolic Measures andInflammatory Markers in Patients With Chronic Liver Disease (CLD)Anthony Loria, Lei Wang, Katherine Doyle, Guoqing Diao, Aybike Birerdinc, Lynn Gerber,Zobair M. Younossi

Background and Aim: Clinical variables such as etiology of liver disease, body mass index(BMI) and cardio-respiratory status do not consistently predict distance walked in the sixminute walk test (6MWT). We aimed to examine the ability of various biological variablesto predict walk distance in subjects with CLD. Methods: Patients with histologically provennon-alcoholic fatty liver disease (NAFLD) or chronic hepatitis C (HCV) and a BMI≥25 wereenrolled prospectively. Patients with cirrhosis, receiving anti-viral therapies, uncontrolledhypertension or cardiac-related comorbidities were excluded. Prior to 6MWT, fasting morn-ing blood was obtained and used to determine levels of aspartate transaminase (AST), alaninetransaminase (ALT), glucose (GLU), C-peptide insulin (CPI), total cholesterol (TC), highdensity lipoprotein (HDL) and low density lipoprotein(LDL). Serum was used to assess thelevels of the interleukin-6 (IL-6), interleukin-8 (IL-8), and TNFa using the R&D SystemsELISA kits (Minneapolis, MN, USA). Laboratory values were categorized as being within oroutside the normal ranges based on accepted values and were scored as 0 or 1 accordingly.We performed cluster analysis by summing these scores, using the convention that highersummed scores indicated healthier individuals. The summed dichotomous comparison fromabnormal scores was Spearman correlated to distance walked. In addition, Mann-Whitneyinter-quartile analysis and stepwise linear regressions were used. Results: Complete datawere available for thirty subjects for 6MWT and fasting blood values of interest (40% Female,66% HCV, 34% NAFLD, age=52±7 years, BMI=32.02±5.70). No individual Spearman cor-relations of a biological variable was significant when ranked with distance walked. Thefollowing variables were analyzed by distance from abnormal values: CPI, GLU, IL-6, IL-8,TNF-a, AST/ALT, AST, ALT, TRG, LDL and HDL. The summed distance of biologicalvariables from abnormal was correlated to distance walked (r=.405, p<.05). Interquartile

S-1011 AASLD Abstracts

analysis showed differences between 25th and 75th percentile in the summed distance fromabnormal scores (W=68.0, z=-1.907, p=.057). Variables from the cumulative Spearmancorrelation were fed into a stepwise linear regression model predicting distance walked andwas significant (R=.793, R2=.629 and F change=.015). Conclusions: Overall distance walkedis an important objective measure of functionality. In subjects with CLD, longer distanceswalked are associatedwith bettermetabolic (lower fasting glucose and insulin) and inflammat-ory profiles (lower pro-inflammatory cytokines). Physical performance, as defined by distancewalked in 6 minutes, is influenced by both metabolic and inflammatory measures.

Tu1016

Prevalence of Liver Disease in Individuals With Human ImmunodeficiencyVirus (HIV) InfectionBrian P. Lam, Maria Stepanova, Nila Rafiq, Fatema Nader, Manirath K. Srishord, ZobairM. Younossi

Background and aims: Chronic Liver Diseases (CLD), especially Hepatitis C (HCV), arebecoming a major cause of morbidity and mortality in patients with HIV infection. Our aimwas to assess the prevalence of different types of CLD in HIV positive individuals. Methods:We utilized the National Health and Nutrition Examination Survey (five continuous cyclesconducted in 1999-2008). In eligible NHANES participants (18-49 years), HIV infectionwas defined as positive anti-HIV by enzyme immunoassay further confirmed by Westernblot. The diagnosis of CLD included HCV Ab positivity, HB-surface antigen positivity,elevated liver enzymes or excessive alcohol consumption (>2 drinks per day). Clinico-demographic and laboratory parameters were used to assess differences between those withand without HIV infection. Logistic regression was used to identify independent predictorsof CLD in HIV positive individuals as well as in the general population. All data analyseswere run using SAS 9.1 and SUDAAN 10.0 (SAS Institute Inc., Cary, NC). Results: Weincluded 13,547 eligible adults with available testing for HIV. Of those, 0.43±0.08% wasHIV-positive. Individuals with HIV positive tests were more commonly male (79.91±4.94%vs. 49.09±0.45%, p=0.0001) and African-American (48.10±7.73% vs. 11.89±1.03%,p<0.0001). Of the study population, 14.95±0.45% had evidence of CLD, including28.24±6.13% in HIV-positive individuals and 14.89±0.46% in HIV-negative controls (p=0.03). The distribution of CLD in HIV+ vs. HIV- was as follows: HCV (7.50±2.90% vs.2.00±0.18%, p=0.06), HBV (0% vs. 0.29±0.05%, p<0.0001), Alcohol-related liver disease(3.89±2.36% vs. 2.44±0.20%, p=0.53) and other liver diseases such as NAFLD/drug-inducedliver disease (defined as elevated liver enzymes without any known cause) (19.30±5.76%vs. 10.94±0.39%, p=0.15). In the entire cohort, independent predictors of CLD were HIVpositivity [OR:1.87 (0.96 - 3.65), p=0.06], older age [OR: 1.02 (1.02 - 1.03), p<0.0001],male gender [OR: 2.21 (1.94 - 2.51), p<0.0001] and obesity [OR: 2.22 (1.92 - 2.57)<0.0001], while African American race was associated with lower risk for CLD [OR: 0.71(0.6 - 0.83), p<0.0001]. Conclusions: CLD is common in individuals who are HIV positive,predominantly due to high rate of HCV and NAFLD/drug-induced liver disease. Withsuccessful long term treatment of HIV, management of chronic liver disease will continueto remain very important, in these patients.

Tu1017

What is the Most Cost-Effective Strategy for the Management of ChronicHepatic Encephalopathy (HE)?Navin Paul, Edward S. Huang, Eric Esrailian, Vandana Khungar, Brennan M. Spiegel

Background:HE causes significant morbidity andmortality among patients with liver disease.The most commonly used medications include rifaximin, a nonabsorbable antibiotic, whichis costly, and lactulose, an inexpensive nonabsorbable disaccharide limited by side effects.In a previous decision analysis (Huang et al APT;2007) we concluded that a hybrid strategyreserving rifaximin only for those failing lactulose was most cost-effective. However, morestudies, including a large multi-center trial (Bass et al. NEJM;2010) have been publishedsince then. In this setting, a re-analysis including newly available data and updated costs isrequired. Methods: We performed a decision analysis using Markov modeling to test thecost-effectiveness of 4 strategies for a cohort of 50 year old patients with overt HE: 1)rifaximin monotherapy 2) lactulose monotherapy 3) rifaximin and lactulose combination 4)initiation with lactulose and crossover to rifaximin in case of inadequate response or intoler-ance to lactulose (“rifaximin salvage”). Since previously used agents such as neomycin, andlactitol are no longer widely used, they were excluded, as was the “do nothing” strategy.Probability estimates were derived from a systematic literature review to identify RCTs ofHE with follow-up >4 weeks. Each estimate was varied over a wide range in sensitivityanalysis. We adopted a third-party payer's perspective and included cost estimates fromMedicare and the Red Book for a comprehensive list of management costs which a patientwith cirrhosis and HE would accrue. The primary outcome was discounted cost per lifeyears (LY) gained. Results: In a limited 6-month model (similar to Bass et al), lactulosemonotherapy was dominated by all rifaximin arms; rifaximin salvage was the overall dominantstrategy. During the first year there were 1.3 vs 0.8 hospitalizations for the lactulose andrifaximin arms, respectively (62% difference). When expanded to a lifetime horizon, lactulosemonotherapy was least effective (2.1 discounted LY) and rifaximin salvage was most effective(2.5 LY). Lactulose monotherapy was least expensive ($61,300 total lifetime combined costof care), and rifaximin monotherapy was most expensive ($65,800). The lower long-termcost of lactulose reflected higher mortality (costs stop accruing with death). When balancingcosts and effectiveness, there were 2 relevant strategies to compare: rifaximin monotherapyand rifaximin salvage. Of these, rifaximin salvage was both more effective and less expensive,and therefore the dominant and preferred approach. Conclusions: At current prices, rifaxi-min monotherapy is not cost-effective as a first line agent for HE. A hybrid “salvage” strategyreserving rifaximin for patients failing lactulose monotherapy continues to be the most cost-effective treatment strategy for chronic management of patients with HE.

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