1
AASLD Abstracts and/or HBeAg seroconversion (developed anti-HBe) are shown in Figure 1. Cumulative rates of alternative therapy due to suboptimal response at months 12, 24, and 36 were 1.5%, 22.6%, and 26.3%, respectively. No patients experienced adverse events or developed genotypic resistance to ETV. Conclusions: In clinical settings, ETV is well tolerated and highly potent at suppressing HBV viremia; however, rates of HBeAg seroconversion appear much lower than those reported in registration trials. Figure 1. Cumulative proportion of patients treated with entecavir 0.5 mg daily who had loss of HBeAg or HBeAg seroconversion Su1009 Treatment of Chronic Hepatitis B Patients According to Current Guidelines: A Community-Based Study Shu Zhang, Jessica T. Ristau, Huy N. Trinh, Ruel T. Garcia, Huy A. Nguyen, Brian S. Levitt, Mindie H. Nguyen PURPOSE: Prior studies have found that a significant proportion of chronic hepatitis B (CHB) patients do not receive antiviral therapy. Our goals were to characterize CHB patients by treatment eligibility and actual treatment status by current published guidelines and to examine reasons for lack of antiviral treatment in patients who are treatment eligible by current treatment guidelines. METHODS: We conducted a retrospective study of patients who were first evaluated for CHB at two community gastroenterology clinics between April 2007 and February 2009. Treatment eligibility was determined for patients using clinical and laboratory data from the first six months of presentation. Treatment status was followed in the patients who were found to be treatment eligible and reasons for non-treatment were identified. US Panel 2008 eligibility requirements are as follows: ALT >30 IU/mL for males, >19 IU/mL for females and HBV DNA >2,000 IU/mL for HBeAg negative patients, >20,000 IU/mL for HBeAg positive patients. AASLD 2009 eligibility included ALT >60 IU/mL for males, >38 IU/mL for females and HBV DNA >20,000 IU/mL regardless of HBeAg status. RESULTS: A total of 612 consecutive CHB patients were identified and included in the analysis. Mean age was 44±13 years, 54% were male, and almost all were Asian (99%). About half of the patients (51% ) were treatment eligible by US Panel guidelines (Table 1). Of these patients, 47% also met AASLD guidelines (Table 1). The latter were more likely to be younger, hepatitis B e antigen positive, and had higher median alanine aminotransferase (ALT) and HBV DNA levels. Overall, treatment was initiated in 50% of eligible patients: 29% of US Panel eligible only patients and 72% of AASLD eligible patients (Table 1). On multivariate analysis, independent predictors for actual treatment initiation were higher ALT in AASLD eligible patients and higher ALT and older age in US Panel eligible only patients. The leading reason for non-treatment was further observation as desired by the physicians. CONCLUSIONS: Approximately half of treatment eligible patients did not receive antiviral therapy for CHB as recommended by either AASLD or US Panel guidelines. Substantial undertreatment of CHB is observed especially in patients eligible only by US Panel guideline and additional research should further examine this finding. Table 1: Characteristics of Treatment Eligible Patients According to Guidelines a a Values expressed as mean ± standard deviation, median (range) or proportion. ALT=Alanine Aminotransferase, HBV DNA=Hepatitis B Virus DNA, HBeAg=Hepatitis B e Antigen. Su1010 Following AASLD Guidelines for HCC Screening in HBV is Limited by Adherence and Results in Additional Tests With Potential Radiation Risk Christie Choi, Nancy Reau, Krysta Drop, Helen S. Te, Andrew Aronsohn, Smruti R. Mohanty, Donald M. Jensen Intro: HCC surveillance is recommended for patients at high risk to develop hepatocellular carcinoma (HCC). However screening is only effective if patients are adherent. Imaging may have risks or benefits other than early identification of HCC. Aim: To evaluate physician implementation and patient adherence to current HCC surveillance guidelines in HBV patients from 1997 to 2010. Secondary aims include the calculation of radiation exposure risks incurred during HCC screening and the determination of any downstream imaging required by initial screening results. Methods: 148 HBV patient charts were retrospectively S-932 AASLD Abstracts reviewed. Patients meeting AASLD criteria for HCC surveillance (Asian male 40, Asian female 50, African 20, or cirrhosis) or considered high risk for HCC were included. Patients presenting with HCC were excluded. All abdominal imaging was logged and categor- ized as “surveillance” or “other” if done for non-screening purposes. Patients were considered compliant if imaging was done within a 12 month interval. Radiation dose deposited in abdomen during abdominal CTs was calculated by average effective dose of 8 millisieverts (mSv) as presented in the literature (N Engl J Med 2009;361:849-57) to approximate overall risk of radiation. Pelvic and chest concurrent radiation was not included as this was variable. Results: 81 patients were eligible for HCC surveillance. 79% male. Screening was recom- mended in 94% of patients with an average interval between imaging of 289.8(±303.7) days, however 47% were non-adherent and received imaging greater than 12 months apart. 32 patients had only ultrasounds as a screening modality, 3 had only CTs, 39 had both, and 7 had none although screening was recommended. 76% of all images were done for surveillance. 16 patients had further imaging prompted by initial screening, 12 of which had further CT radiation. Average # CTs for all patients from 1997 to present: 1.94 (± 3.23). Average effective dose in radiation from CTs: 15.51 (±25.87) mSv. Average annual effective dose per person: 0.86 (± 1.44) mSv. Conclusions: HBsAg positive patients at high risk to develop HCC as defined by AASLD guidelines are consistently counseled to obtain screening, yet adherence is poor. Physicians use CT prominently for HCC surveillance making radiation risk a serious concern. In addition, 23% of patients required follow-up imaging increasing radiation exposure. Table 1. Su1011 Increased Vitamin D Levels Are Associated With Undetectable Viral Loads in Patients With Chronic Hepatitis B Katherine Small, Marion-Anna Protano, Douglas T. Dieterich, Marie-Louise C. Vachon Background: Low serum 25-hydroxyvitamin D (25[OH]D) levels have recently been found to be independently associated with lower rates of sustained virologic response in patients with hepatitis C virus (HCV). In hepatocyte cell culture, 25(OH)D has been shown to directly inhibit HCV RNA replication. In patients with chronic hepatitis B virus (HBV), the relationship of 25(OH)D level to HBV viral load has not been described. Methods: A retrospective database review of patients seen in the liver practice at a large university medical center between 6/2008 and 9/2010 was performed via electronic query using ICD-9 codes for HBV. Patients co-infected with hepatitis C virus or human immunodeficiency virus were excluded. Demographics, metabolic and lipid parameters, and hepatitis serologies and therap- ies were abstracted. Serum 25(OH)D levels were analyzed according to hepatitis B viral load by Mann-Whitney U test. Results: 417 patients with hepatitis B were identified of whom 51 were hepatitis B surface antigen positive for >6 months. Of these 51 patients, 29 had serum 25(OH)D measurements performed. Average age of these patients was 41.4 ± 12.8 years and 18 (62%) of the patients were male. 12 patients (41%) had detectable HBV DNA with an average viral load of 75,000,000 ± 200,000,000 copies/mL. Blood pressure was 119 ± 15/78 ± 9 mm Hg. Creatinine measured 1.0 ± 0.4 mg/dL and platelet count was 204,000 ± 49,500/mm3. Average 25(OH)D level was 24.1 ± 10.6 ng/mL. 22 patients (76%) were classified as vitamin D insufficient (25[OH]D level <30 ng/mL) while 3 patients (10%) had vitamin D deficiency (25[OH]D level <10 ng/mL). 25(OH)D levels in patients with undetectable viral loads were significantly higher compared to 25(OH)D levels in patients with detectable viral loads (29.1 ± 9.9 vs. 17.0 ± 7.0 ng/mL, p=0.003). 5 of the 29 patients were receiving vitamin D supplementation and 4 of those patients had undetectable viral loads. Only 5 of 29 patients were not receiving anti-viral therapy for HBV, 2 of whom had detectable viral loads and 3 had undetectable viral loads. Conclusion: In this study of patients with chronic HBV, vitamin D insufficiency is common. Increased 25(OH)D levels are associated with undetectable viral loads. Given the prevalence of vitamin D insufficiency (76%), supplementation of vitamin D may be an important therapeutic intervention to increase the likelihood of achieving an undetectable viral load. This needs to be examined in a prospective trial in chronic HBV patients.

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sand/or HBeAg seroconversion (developed anti-HBe) are shown in Figure 1. Cumulative ratesof alternative therapy due to suboptimal response at months 12, 24, and 36 were 1.5%,22.6%, and 26.3%, respectively. No patients experienced adverse events or developedgenotypic resistance to ETV. Conclusions: In clinical settings, ETV is well tolerated andhighly potent at suppressing HBV viremia; however, rates of HBeAg seroconversion appearmuch lower than those reported in registration trials.

Figure 1. Cumulative proportion of patients treated with entecavir 0.5 mg daily who hadloss of HBeAg or HBeAg seroconversion

Su1009

Treatment of Chronic Hepatitis B Patients According to Current Guidelines: ACommunity-Based StudyShu Zhang, Jessica T. Ristau, Huy N. Trinh, Ruel T. Garcia, Huy A. Nguyen, Brian S.Levitt, Mindie H. Nguyen

PURPOSE: Prior studies have found that a significant proportion of chronic hepatitis B(CHB) patients do not receive antiviral therapy. Our goals were to characterize CHB patientsby treatment eligibility and actual treatment status by current published guidelines and toexamine reasons for lack of antiviral treatment in patients who are treatment eligible bycurrent treatment guidelines. METHODS: We conducted a retrospective study of patientswho were first evaluated for CHB at two community gastroenterology clinics between April2007 and February 2009. Treatment eligibility was determined for patients using clinicaland laboratory data from the first six months of presentation. Treatment status was followedin the patients who were found to be treatment eligible and reasons for non-treatment wereidentified. US Panel 2008 eligibility requirements are as follows: ALT >30 IU/mL for males,>19 IU/mL for females and HBV DNA >2,000 IU/mL for HBeAg negative patients, >20,000IU/mL for HBeAg positive patients. AASLD 2009 eligibility included ALT >60 IU/mL formales, >38 IU/mL for females and HBV DNA >20,000 IU/mL regardless of HBeAg status.RESULTS: A total of 612 consecutive CHB patients were identified and included in theanalysis. Mean age was 44±13 years, 54% were male, and almost all were Asian (99%).About half of the patients (51% ) were treatment eligible by US Panel guidelines (Table 1).Of these patients, 47% also met AASLD guidelines (Table 1). The latter were more likelyto be younger, hepatitis B e antigen positive, and had higher median alanine aminotransferase(ALT) and HBV DNA levels. Overall, treatment was initiated in 50% of eligible patients:29% of US Panel eligible only patients and 72% of AASLD eligible patients (Table 1). Onmultivariate analysis, independent predictors for actual treatment initiation were higher ALTin AASLD eligible patients and higher ALT and older age in US Panel eligible only patients.The leading reason for non-treatment was further observation as desired by the physicians.CONCLUSIONS: Approximately half of treatment eligible patients did not receive antiviraltherapy for CHB as recommended by either AASLD or US Panel guidelines. Substantialundertreatment of CHB is observed especially in patients eligible only by US Panel guidelineand additional research should further examine this finding.Table 1: Characteristics of Treatment Eligible Patients According to Guidelinesa

aValues expressed as mean ± standard deviation, median (range) or proportion. ALT=AlanineAminotransferase, HBV DNA=Hepatitis B Virus DNA, HBeAg=Hepatitis B e Antigen.

Su1010

Following AASLD Guidelines for HCC Screening in HBV is Limited byAdherence and Results in Additional Tests With Potential Radiation RiskChristie Choi, Nancy Reau, Krysta Drop, Helen S. Te, Andrew Aronsohn, Smruti R.Mohanty, Donald M. Jensen

Intro: HCC surveillance is recommended for patients at high risk to develop hepatocellularcarcinoma (HCC). However screening is only effective if patients are adherent. Imaging mayhave risks or benefits other than early identification of HCC. Aim: To evaluate physicianimplementation and patient adherence to current HCC surveillance guidelines in HBVpatients from 1997 to 2010. Secondary aims include the calculation of radiation exposurerisks incurred during HCC screening and the determination of any downstream imagingrequired by initial screening results. Methods: 148 HBV patient charts were retrospectively

S-932AASLD Abstracts

reviewed. Patients meeting AASLD criteria for HCC surveillance (Asian male ≥40, Asianfemale ≥50, African ≥20, or cirrhosis) or considered high risk for HCC were included.Patients presenting with HCC were excluded. All abdominal imaging was logged and categor-ized as “surveillance” or “other” if done for non-screening purposes. Patients were consideredcompliant if imaging was done within a 12 month interval. Radiation dose deposited inabdomen during abdominal CTs was calculated by average effective dose of 8 millisieverts(mSv) as presented in the literature (N Engl J Med 2009;361:849-57) to approximate overallrisk of radiation. Pelvic and chest concurrent radiation was not included as this was variable.Results: 81 patients were eligible for HCC surveillance. 79% male. Screening was recom-mended in 94% of patients with an average interval between imaging of 289.8(±303.7)days, however 47% were non-adherent and received imaging greater than 12 months apart.32 patients had only ultrasounds as a screening modality, 3 had only CTs, 39 had both,and 7 had none although screening was recommended. 76% of all images were done forsurveillance. 16 patients had further imaging prompted by initial screening, 12 of whichhad further CT radiation. Average # CTs for all patients from 1997 to present: 1.94 (± 3.23).Average effective dose in radiation from CTs: 15.51 (±25.87) mSv. Average annual effectivedose per person: 0.86 (± 1.44) mSv. Conclusions: HBsAg positive patients at high risk todevelop HCC as defined by AASLD guidelines are consistently counseled to obtain screening,yet adherence is poor. Physicians use CT prominently for HCC surveillance making radiationrisk a serious concern. In addition, 23% of patients required follow-up imaging increasingradiation exposure.Table 1.

Su1011

Increased Vitamin D Levels Are Associated With Undetectable Viral Loads inPatients With Chronic Hepatitis BKatherine Small, Marion-Anna Protano, Douglas T. Dieterich, Marie-Louise C. Vachon

Background: Low serum 25-hydroxyvitamin D (25[OH]D) levels have recently been foundto be independently associated with lower rates of sustained virologic response in patientswith hepatitis C virus (HCV). In hepatocyte cell culture, 25(OH)D has been shown to directlyinhibit HCV RNA replication. In patients with chronic hepatitis B virus (HBV), the relationshipof 25(OH)D level to HBV viral load has not been described. Methods: A retrospectivedatabase review of patients seen in the liver practice at a large university medical centerbetween 6/2008 and 9/2010 was performed via electronic query using ICD-9 codes forHBV. Patients co-infected with hepatitis C virus or human immunodeficiency virus wereexcluded. Demographics, metabolic and lipid parameters, and hepatitis serologies and therap-ies were abstracted. Serum 25(OH)D levels were analyzed according to hepatitis B viral loadby Mann-Whitney U test. Results: 417 patients with hepatitis B were identified of whom51 were hepatitis B surface antigen positive for >6 months. Of these 51 patients, 29 hadserum 25(OH)D measurements performed. Average age of these patients was 41.4 ± 12.8years and 18 (62%) of the patients were male. 12 patients (41%) had detectable HBV DNAwith an average viral load of 75,000,000 ± 200,000,000 copies/mL. Blood pressure was 119± 15/78 ± 9 mm Hg. Creatinine measured 1.0 ± 0.4 mg/dL and platelet count was 204,000± 49,500/mm3. Average 25(OH)D level was 24.1 ± 10.6 ng/mL. 22 patients (76%) wereclassified as vitamin D insufficient (25[OH]D level <30 ng/mL) while 3 patients (10%)had vitamin D deficiency (25[OH]D level <10 ng/mL). 25(OH)D levels in patients withundetectable viral loads were significantly higher compared to 25(OH)D levels in patientswith detectable viral loads (29.1 ± 9.9 vs. 17.0 ± 7.0 ng/mL, p=0.003). 5 of the 29 patientswere receiving vitamin D supplementation and 4 of those patients had undetectable viralloads. Only 5 of 29 patients were not receiving anti-viral therapy for HBV, 2 of whom haddetectable viral loads and 3 had undetectable viral loads. Conclusion: In this study ofpatients with chronic HBV, vitamin D insufficiency is common. Increased 25(OH)D levelsare associated with undetectable viral loads. Given the prevalence of vitamin D insufficiency(76%), supplementation of vitamin D may be an important therapeutic intervention toincrease the likelihood of achieving an undetectable viral load. This needs to be examinedin a prospective trial in chronic HBV patients.