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562 Performance Feedback Impacts Quality Measures in the Management of Cirrhosis James T. Kwiatt, Parin N. Desai, Samer Gawrieh, Kia Saeian Introduction: Quality improvement (QI) is an emerging area of importance in health care. The Medicare Physician Quality Reporting Initiative, AASLD, and AGA recommend tracking, reporting, and training in QI measures for gastroenterologists and hepatologists (1,2). Vac- cination for viral hepatitis, management of esophageal varices (EV), and screening for hepato- cellular carcinoma (HCC) are areas of potential QI that have been identified in the manage- ment of cirrhosis (3). Our group previously reported baseline deficiencies in vaccination for hepatitis A & B, EV screening, and HCC screening at DDW 2008. Performance feedback is one approach to possibly increase adherence to these measures. Aim: Assess if performance feedback improved adherence to guidelines and if so, see if adherence sustained over one year. Methods: Design- Retrospective and prospective chart review at a tertiary academic medical center. Participants- Health care providers in an outpatient hepatology clinic caring for 2311 cirrhotics. Data regarding appropriate HCC screening, EV screening/surveillance, and documented immunity to hepatitis A and hepatitis B was obtained utilizing chart review and a database. At the start of the study, providers were given retrospective data on previous 3 years of performance on addressing health maintenance. After having providers review past performance, prospective adherence to health maintenance measures was tracked and assessed at 60 days and 365 days in all patients seen in clinic by chart review. Results: Retrospective assessment revealed baseline deficiencies in recommended health maintenance (See Table). After giving performance feedback, medical records of all cirrhotics seen in clinic were assessed for recommended health maintenance compliance. 60 days after performance feedback, documentation of immunity to hepatitis A improved to 81%, immunity to hepatitis B to 91 %, screening for HCC 100%, and EV management to 98% (p<0.001 compared to retrospective data). Performance improvement was sustained after 1 year (p=NS comparing 60 day and 365 day data). At one year, documentation of immunity to hepatitis A was 85%, immunity to hepatitis B 85%, screening for HCC 100%, and EV management 97%. Discussion: Performance feedback to health care providers can improve adherence to health maintenance guidelines in managing cirrhotics. When providers are aware that performance is being tracked, improvement is sustained over 1 year. Systems to provide performance feedback can be an important part of QI initiatives. References 1. AGA Institute Press. PQRI Updates. GI Quality and Practice Management News 2008; 9:12 2. AASLD, ACG, AGA Institute, ASGE. The Gastroenterology Core Curriculum. May 2007 3. Kanwal,F. et.al. An Explicit Quality Indicator Set for Measurement of Quality of Care in Patients With Cirrhosis. Clin Gastro Hep.2010;8:709-717 Quality Improvement in Cirrhosis Health Mainanence Performance feedback resulted in sustained improvement in adherence to QI indicators. 563 Effectiveness of Hepatitis C Virus (HCV) Antiviral Treatment in Veterans With HIV-HCV Coinfection Jennifer R. Kramer, Fasiha Kanwal, Minghua Mei, Thomas P. Giordano, Hashem El-Serag Background: Efficacy of antiviral treatment for hepatitis C virus (HCV) in patients with HCV and HIV coinfection in achieving sustained viral response (SVR) rates has been shown to be between 28% and 44% in randomized controlled trials. However, effectiveness in a community-based practice setting can be much lower and is influenced by other factors related to access, adherence, and representation of low response groups (e.g. blacks, HCV genotype, and drug and alcohol use). We determined the effectiveness of HCV treatment in veterans with HCV-HIV coinfection in the United States. Methods: We conducted a retrospective cohort study of veterans with HCV viremia and HIV (positive antibody or viral load test) from the nationwide Veterans Affairs HCV Clinical Case Registry during 2000 to 2006. We identified patients who had at least one prescription for pegylated-interferon and ribavirin and calculated the duration of treatment and the proportions of patients completing treatment (at least 44 for genotypes 1 or 4 or 22 weeks for 2 or 3). The effectiveness of treatment was measured as the proportions of patients who achieved an SVR (negative test for HCV RNA at least 12 weeks after the end of treatment) in the overall coinfected cohort and among both patients who initiated and completed treatment. We also stratified by genotype and race/ethnicity. Results: We identified 6,137 patients coinfected with HCV and HIV. Of those, 896 (14.6%) had at least one released prescription for any antiviral treatment and 638 (10.4%) received pegylated-interferon with ribavirin. Of the 638 patients on com- bination therapy, 72.3% had genotype 1, 22.1% had genotype 2 or 3, and 5.6% were not tested for genotype. One-third completed at least 44 weeks of treatment for genotype 1 while almost three-fourths completed at least 22 weeks of treatment for genotype 2 or 3. Absolute or relative contraindications were documented in only 61.5% of patients who did not receive treatment. SVR was documented in 33.6% and 65.7% of those who completed treatment, 18.7% and 56.0% of those who initiated treatment, and 2.6% and 15.6% of the entire coinfected cohort for genotype 1 and 2 or 3, respectively. Black and Hispanic patients were significantly less likely to achieve an SVR compared to whites for both genotypes (1: 10.2% and 5.9% vs. 24.7%; 2 or 3: 46.7% and 45.5% vs. 58.3%). Overall, only 2.8% of the entire coinfected cohort had documented SVR. Conclusions: Treatment effectiveness for HCV in HIV coinfected veterans is low. Compared to previously published VA data in an HCV cohort (with and without HIV), treatment effectiveness is lower for coinfected veterans for HCV genotype 1, but higher for coinfected veterans with genotype 2 or 3. Other than S-895 AASLD Abstracts fixed factor such as race and virus genotype, the drop in effectiveness is due to low antiviral treatment initiation and treatment completion. 564 Truncated Therapy Based on Rapid Virologic Response is a Cost Effective Treatment Paradigm for Chronic Hepatitis C Ziad F. Gellad, Shelby Reed, Andrew J. Muir, John McHutchison, William Sievert, Ala I. Sharara, Kimberly Ann A. Brown, Robert Flisiak, Ira M. Jacobson, David Kershenobich, Michael P. Manns, Kevin A. Schulman BACKGROUND & AIMS: Shorter courses of treatment with pegylated interferon and ribavirin for patients with hepatitis C who achieve rapid virologic response (RVR) have been shown to be effective in appropriately selected patients. However, truncated therapy may result in a higher rate of relapse than standard therapy and necessitate retreatment. The aim of this study was to evaluate the cost effectiveness of truncated therapy as compared to the standard of care. METHODS: We developed a decision model for chronic hepatitis C that combined a decision tree and Markov cohort model. In the decision tree, we modeled two treatment strategies; the first modeled the standard of care which included 48 weeks of therapy with pegylated interferon and ribavirin for individuals with genotypes 1 and 4 and 24 weeks of therapy for individuals with genotypes 2 and 3; the second strategy consisted of shortening therapy by 50% in individuals with RVR. Individuals who failed to achieve SVR with truncated therapy were retreated with the standard of care. Lifetime costs and quality- adjusted life-years (QALYs) were estimated using a Markov cohort model and compared between the two treatment strategies. We performed a probabilistic sensitivity analysis to assess parameter uncertainty and multiple univariate and bivariate sensitivity analyses to test model assumptions. All costs and benefits were discounted at a rate of 3% per year as recommended by the US Panel on Cost-Effectiveness in Health and Medicine. RESULTS: In the base case, the average lifetime cost was $43,950 (± 1,906) in the standard arm and $39,717 (±1,914) in the truncated therapy arm resulting in a savings of $4,233 (± 325) in favor of truncated therapy. Average lifetime QALYs were similar with 17.04 (± 0.69) in the standard arm as compared to 17.09 (± 0.69) in the truncated therapy arm; thus, truncated therapy dominated standard therapy. In a probabilistic sensitivity analysis using a Monte Carlo simulation of 10,000 trials, the probability of truncated therapy being dominant (i.e. cost-saving and QALY increasing) was 78%. When stratified by genotype, truncated therapy remained cost effective (i.e. dominant or cost per QALY < $5000) as compared to standard therapy. One-way sensitivity analyses revealed that the results were insensitive to variations in costs, utilities, transition probabilities and baseline characteristics of the study cohort, including age, genotype distribution and baseline fibrosis. CONCLUSIONS: Truncated ther- apy based on RVR is likely to be cost effective when compared to standard of care for individuals with chronic hepatitis C. These findings are applicable to populations of indi- viduals with hepatitis C as well as those stratified by genotype. Decision analysis may be helpful in optimizing resource allocation in the era of personalized therapy for chronic hepatitis C. 565 Factors Associated With Immunoprophylaxis Failure in Infants Born to HBsAg Positive Mothers: A Retrospective Study Huaibin Zou, Yu Chen, Zhongping Duan, Hua Zhang, Calvin Pan Background and Aim Despite the active-passive immunization, immunoprophylaxis failure occurs in infants born to mothers with hepatitis B virus (HBV). Prior studies showed HBeAg(+) and DNA > 1×108 c/ml are the major risk for immunoprophlaxi failure, but the lower DNA level or other risk factors have not been fully explored, we evaluate the risk factors associated with the immunoprophylaxis failure. Methods Infants born to HBsAg+ mothers with >7 month follow up in 1/2007-3/2010 at our center were eligible. Infants from mothers with co-infection, antiviral use, missed immunoprophylasix were excluded. Maternal and infants clinical and laboratory data was collected by chart review. HBV serology of all infant was assessed by microparticle enzyme immunoassy technique (Abbott kits,USA),HBV DNA at birth was measure by RT-PCR. HBV immunoprophylaxis failure was defined as infant with HBsAg(+) and anti-HBs (-) at 7-12 months of age. Results Among 3536 infants born to 3521 HBsAg+ mother, 1045 infants were eligible. 8 infants were excluded (1 co-infection, 4 anti-HBV drug use, 3 missed vaccines). 1037 infants from 1031 mothers were analyzed. All infants received HBIG 200 IU and HBV vaccine 10 mcg within 6 hours of birth, and a second injection of HBIG at week 2, the vaccine were given again at 1 and 6 months. Among 1031 mothers, HBeAg(+) in 573(55.6%), detectable HBV DNA in 689 (66.8%), maternal DNA levels at 3.0-5.9 logs, 6-7.9 logs and >or = 8 logs were 151, 457 and 81 respectively; The correspondent infant prophylaxis failure rates were 0%, 5.3% and 7.4%, respectively. The trend test chi-square = 15.785 (P<0.001). Among 1037 infants, 30 failed immunoprophy- laxis were selected as cases and the rest as controls. The rate of immunoprophylaxis failure was 2.9% vs 5.8% in the infants born to HBeAg-negative vs HBeAg positive mothers, respectively. Clinical presentation and possible related factors of cases and controls were listed on Table 1. The factors with statistically significant differences between two groups on univariate analysis were: maternal HBeAg+, maternal HBV DNA > 6×log10 c/ml, HBV DNA detectable in core blood. Conclusions Our study showed infants' HBV immunoprophyl- axis failure was associated with maternal DNA level > 6 log10 c/ml, HBeAg+, and HBV DNA detectable in core blood. Further prospective studies needed to verify the finding and provide more aggressive intervention in patients with the above risk factors. Characteristics of the patients AASLD Abstracts

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562

Performance Feedback Impacts Quality Measures in the Management ofCirrhosisJames T. Kwiatt, Parin N. Desai, Samer Gawrieh, Kia Saeian

Introduction: Quality improvement (QI) is an emerging area of importance in health care.The Medicare Physician Quality Reporting Initiative, AASLD, and AGA recommend tracking,reporting, and training in QI measures for gastroenterologists and hepatologists (1,2). Vac-cination for viral hepatitis, management of esophageal varices (EV), and screening for hepato-cellular carcinoma (HCC) are areas of potential QI that have been identified in the manage-ment of cirrhosis (3). Our group previously reported baseline deficiencies in vaccinationfor hepatitis A & B, EV screening, and HCC screening at DDW 2008. Performance feedbackis one approach to possibly increase adherence to these measures. Aim: Assess if performancefeedback improved adherence to guidelines and if so, see if adherence sustained over oneyear. Methods: Design- Retrospective and prospective chart review at a tertiary academicmedical center. Participants- Health care providers in an outpatient hepatology clinic caringfor 2311 cirrhotics. Data regarding appropriate HCC screening, EV screening/surveillance,and documented immunity to hepatitis A and hepatitis B was obtained utilizing chart reviewand a database. At the start of the study, providers were given retrospective data on previous3 years of performance on addressing health maintenance. After having providers reviewpast performance, prospective adherence to health maintenance measures was tracked andassessed at 60 days and 365 days in all patients seen in clinic by chart review. Results:Retrospective assessment revealed baseline deficiencies in recommended health maintenance(See Table). After giving performance feedback, medical records of all cirrhotics seen in clinicwere assessed for recommended health maintenance compliance. 60 days after performancefeedback, documentation of immunity to hepatitis A improved to 81%, immunity to hepatitisB to 91 %, screening for HCC 100%, and EV management to 98% (p<0.001 compared toretrospective data). Performance improvement was sustained after 1 year (p=NS comparing60 day and 365 day data). At one year, documentation of immunity to hepatitis A was85%, immunity to hepatitis B 85%, screening for HCC 100%, and EV management 97%.Discussion: Performance feedback to health care providers can improve adherence to healthmaintenance guidelines in managing cirrhotics. When providers are aware that performanceis being tracked, improvement is sustained over 1 year. Systems to provide performancefeedback can be an important part of QI initiatives. References 1. AGA Institute Press. PQRIUpdates. GI Quality and Practice Management News 2008; 9:12 2. AASLD, ACG, AGAInstitute, ASGE. The Gastroenterology Core Curriculum. May 2007 3. Kanwal,F. et.al. AnExplicit Quality Indicator Set for Measurement of Quality of Care in Patients With Cirrhosis.Clin Gastro Hep.2010;8:709-717Quality Improvement in Cirrhosis Health Mainanence

Performance feedback resulted in sustained improvement in adherence to QI indicators.

563

Effectiveness of Hepatitis C Virus (HCV) Antiviral Treatment in Veterans WithHIV-HCV CoinfectionJennifer R. Kramer, Fasiha Kanwal, Minghua Mei, Thomas P. Giordano, Hashem El-Serag

Background: Efficacy of antiviral treatment for hepatitis C virus (HCV) in patients with HCVand HIV coinfection in achieving sustained viral response (SVR) rates has been shown tobe between 28% and 44% in randomized controlled trials. However, effectiveness in acommunity-based practice setting can be much lower and is influenced by other factorsrelated to access, adherence, and representation of low response groups (e.g. blacks, HCVgenotype, and drug and alcohol use). We determined the effectiveness of HCV treatmentin veterans with HCV-HIV coinfection in the United States. Methods: We conducted aretrospective cohort study of veterans with HCV viremia and HIV (positive antibody or viralload test) from the nationwide Veterans Affairs HCV Clinical Case Registry during 2000 to2006. We identified patients who had at least one prescription for pegylated-interferon andribavirin and calculated the duration of treatment and the proportions of patients completingtreatment (at least 44 for genotypes 1 or 4 or 22 weeks for 2 or 3). The effectiveness oftreatment was measured as the proportions of patients who achieved an SVR (negative testfor HCV RNA at least 12 weeks after the end of treatment) in the overall coinfected cohortand among both patients who initiated and completed treatment. We also stratified bygenotype and race/ethnicity. Results: We identified 6,137 patients coinfected with HCV andHIV. Of those, 896 (14.6%) had at least one released prescription for any antiviral treatmentand 638 (10.4%) received pegylated-interferon with ribavirin. Of the 638 patients on com-bination therapy, 72.3% had genotype 1, 22.1% had genotype 2 or 3, and 5.6% were nottested for genotype. One-third completed at least 44 weeks of treatment for genotype 1while almost three-fourths completed at least 22 weeks of treatment for genotype 2 or 3.Absolute or relative contraindications were documented in only 61.5% of patients who didnot receive treatment. SVR was documented in 33.6% and 65.7% of those who completedtreatment, 18.7% and 56.0% of those who initiated treatment, and 2.6% and 15.6% of theentire coinfected cohort for genotype 1 and 2 or 3, respectively. Black and Hispanic patientswere significantly less likely to achieve an SVR compared to whites for both genotypes (1:10.2% and 5.9% vs. 24.7%; 2 or 3: 46.7% and 45.5% vs. 58.3%). Overall, only 2.8% ofthe entire coinfected cohort had documented SVR. Conclusions: Treatment effectiveness forHCV in HIV coinfected veterans is low. Compared to previously published VA data in anHCV cohort (with and without HIV), treatment effectiveness is lower for coinfected veteransfor HCV genotype 1, but higher for coinfected veterans with genotype 2 or 3. Other than

S-895 AASLD Abstracts

fixed factor such as race and virus genotype, the drop in effectiveness is due to low antiviraltreatment initiation and treatment completion.

564

Truncated Therapy Based on Rapid Virologic Response is a Cost EffectiveTreatment Paradigm for Chronic Hepatitis CZiad F. Gellad, Shelby Reed, Andrew J. Muir, John McHutchison, William Sievert, Ala I.Sharara, Kimberly Ann A. Brown, Robert Flisiak, Ira M. Jacobson, David Kershenobich,Michael P. Manns, Kevin A. Schulman

BACKGROUND&AIMS: Shorter courses of treatment with pegylated interferon and ribavirinfor patients with hepatitis C who achieve rapid virologic response (RVR) have been shownto be effective in appropriately selected patients. However, truncated therapy may result ina higher rate of relapse than standard therapy and necessitate retreatment. The aim of thisstudy was to evaluate the cost effectiveness of truncated therapy as compared to the standardof care. METHODS: We developed a decision model for chronic hepatitis C that combineda decision tree and Markov cohort model. In the decision tree, we modeled two treatmentstrategies; the first modeled the standard of care which included 48 weeks of therapy withpegylated interferon and ribavirin for individuals with genotypes 1 and 4 and 24 weeks oftherapy for individuals with genotypes 2 and 3; the second strategy consisted of shorteningtherapy by 50% in individuals with RVR. Individuals who failed to achieve SVR withtruncated therapy were retreated with the standard of care. Lifetime costs and quality-adjusted life-years (QALYs) were estimated using a Markov cohort model and comparedbetween the two treatment strategies. We performed a probabilistic sensitivity analysis toassess parameter uncertainty and multiple univariate and bivariate sensitivity analyses totest model assumptions. All costs and benefits were discounted at a rate of 3% per year asrecommended by the US Panel on Cost-Effectiveness in Health and Medicine. RESULTS:In the base case, the average lifetime cost was $43,950 (± 1,906) in the standard arm and$39,717 (±1,914) in the truncated therapy arm resulting in a savings of $4,233 (± 325) infavor of truncated therapy. Average lifetime QALYs were similar with 17.04 (± 0.69) in thestandard arm as compared to 17.09 (± 0.69) in the truncated therapy arm; thus, truncatedtherapy dominated standard therapy. In a probabilistic sensitivity analysis using a MonteCarlo simulation of 10,000 trials, the probability of truncated therapy being dominant (i.e.cost-saving and QALY increasing) was 78%. When stratified by genotype, truncated therapyremained cost effective (i.e. dominant or cost per QALY < $5000) as compared to standardtherapy. One-way sensitivity analyses revealed that the results were insensitive to variationsin costs, utilities, transition probabilities and baseline characteristics of the study cohort,including age, genotype distribution and baseline fibrosis. CONCLUSIONS: Truncated ther-apy based on RVR is likely to be cost effective when compared to standard of care forindividuals with chronic hepatitis C. These findings are applicable to populations of indi-viduals with hepatitis C as well as those stratified by genotype. Decision analysis may behelpful in optimizing resource allocation in the era of personalized therapy for chronichepatitis C.

565

Factors Associated With Immunoprophylaxis Failure in Infants Born to HBsAgPositive Mothers: A Retrospective StudyHuaibin Zou, Yu Chen, Zhongping Duan, Hua Zhang, Calvin Pan

Background and Aim Despite the active-passive immunization, immunoprophylaxis failureoccurs in infants born tomothers with hepatitis B virus (HBV). Prior studies showedHBeAg(+)and DNA > 1×108 c/ml are the major risk for immunoprophlaxi failure, but the lower DNAlevel or other risk factors have not been fully explored, we evaluate the risk factors associatedwith the immunoprophylaxis failure. Methods Infants born to HBsAg+ mothers with >7month follow up in 1/2007-3/2010 at our center were eligible. Infants from mothers withco-infection, antiviral use, missed immunoprophylasix were excluded. Maternal and infantsclinical and laboratory data was collected by chart review. HBV serology of all infant wasassessed by microparticle enzyme immunoassy technique (Abbott kits,USA),HBV DNA atbirth was measure by RT-PCR. HBV immunoprophylaxis failure was defined as infant withHBsAg(+) and anti-HBs (-) at 7-12 months of age. Results Among 3536 infants born to3521 HBsAg+ mother, 1045 infants were eligible. 8 infants were excluded (1 co-infection,4 anti-HBV drug use, 3 missed vaccines). 1037 infants from 1031 mothers were analyzed.All infants received HBIG 200 IU and HBV vaccine 10 mcg within 6 hours of birth, and asecond injection of HBIG at week 2, the vaccine were given again at 1 and 6 months. Among1031 mothers, HBeAg(+) in 573(55.6%), detectable HBV DNA in 689 (66.8%), maternalDNA levels at 3.0-5.9 logs, 6-7.9 logs and >or = 8 logs were 151, 457 and 81 respectively;The correspondent infant prophylaxis failure rates were 0%, 5.3% and 7.4%, respectively.The trend test chi-square = 15.785 (P<0.001). Among 1037 infants, 30 failed immunoprophy-laxis were selected as cases and the rest as controls. The rate of immunoprophylaxis failurewas 2.9% vs 5.8% in the infants born to HBeAg-negative vs HBeAg positive mothers,respectively. Clinical presentation and possible related factors of cases and controls werelisted on Table 1. The factors with statistically significant differences between two groupson univariate analysis were: maternal HBeAg+, maternal HBV DNA > 6×log10 c/ml, HBVDNA detectable in core blood. Conclusions Our study showed infants' HBV immunoprophyl-axis failure was associated with maternal DNA level > 6 log10 c/ml, HBeAg+, and HBV DNAdetectable in core blood. Further prospective studies needed to verify the finding and providemore aggressive intervention in patients with the above risk factors.Characteristics of the patients

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