bluuebunny/crossref_metadata_2025_split huggingface dataset:
1013 The Effect of Steatosis on the Clinical Course of Autoimmune Hepatitis
Authors: Davis Ashley , Assis David , Celli Romulo , Gurung Ananta , Dhanpat Jain 
Published: October 2019

INTRODUCTION:
Nonalcoholic Fatty Liver Disease (NAFLD) is a common liver disease in western developed countries. NAFLD is increasingly encountered alongside other chronic liver diseases, such as autoimmune hepatitis (AIH). The impact of NAFLD on the clinical course of AIH is unclear and one recent single center study suggested a worse clinical outcome for patients with AIH and concurrent steatohepatitis. We aimed to determine the frequency of steatosis and steatohepatitis in patients with AIH and the effect on treatment outcomes.

METHODS:
The cohort consisted of 61 AIH patients from a single, large, tertiary referral center with pre-treatment liver biopsies and available clinical data. Biliary overlap syndromes were excluded. Two liver pathologists recorded histological findings, including quantification of steatosis and steatohepatitis. One clinical reviewer recorded 96 clinical/laboratory variables. Non-parametric (Spearman rho) tests were used and correlations with P < 0.05 were deemed significant. Non parametric t-tests were used to compare various degrees of steatosis (none, mild/moderate) with clinical variables and P < 0.05 were deemed significant.

RESULTS:
Patients were followed for mean of 3.1 ± 3 years after diagnosis. Mean age at diagnosis was 49.9 ± 19.1 years and mean BMI at diagnosis was 28.3 ± 7. In this cohort, 31.7% of patients had steatosis on histology, and out of those 75.0% had mild and 25.0% had moderate degree of steatosis. Strikingly, there were no cases of steatohepatitis. The degree of steatosis was positively correlated with increasing age and BMI, (r = 0.44, CI 0.17-0.65, P ≤ 0.001and r = 0.49, CI 0.15-0.73, P = 0.01, respectively). However, there was no correlation between degree of steatosis and initial treatment failure, ALT at 12 months of treatment, chances of biochemical remission, development of cirrhosis, or the dose of steroid required for biochemical remission. Furthermore, there was no difference in these outcomes when those with versus without steatosis were compared.

CONCLUSION:
Data from this single center study suggest that AIH patients with mild and moderate steatosis have the same clinical course and response to treatment as those without steatosis.. The increasing prevalence of superimposed NAFLD in AIH warrants longitudinal observational multi-center studies focused on the frequency of steatohepatitis, and the impact of steatosis on the natural history of AIH.
1015 Fibroscan Is a Feasible and Useful Point-Of-Care Tool to Assess Nonalcoholic Fatty Liver Disease Severity in Children Texas Liver Institute, University of Texas (UT) Health San Antonio, San Antonio, TX
Authors: Cummings-John Oladuni D. , Geistweidt Stephenie , Okubote Toluwalase C. , Ascher Bartlett Johanna M. , Filo Jean , Betancourt Amanda , Alkhouri Naim , Lawitz Eric , Angueira Candice 
Published: October 2019

INTRODUCTION:
Estimating the severity of liver steatosis by controlled attenuation parameter (CAP) and liver fibrosis by transient elastography (TE) using the FibroscanTM machine provides a noninvasive method to establish the presence of nonalcoholic fatty liver disease (NAFLD) and assess its severity. The use of CAP/TE is becoming routine practice in adults yet limited data exists in children with suspected NAFLD. The aim of this study was to assess the feasibility and utility of measuring CAP/TE by FibroscanTM in a cohort of children with suspected NAFLD.

METHODS:
All children referred with a clinical suspicion of NAFLD (elevated alkaline phosphatase (ALT) or fatty infiltration on ultrasonography) who had CAP/TE measured were included. FibroscanTM testing was performed on a standardized machine with an experienced operator utilizing a medium (M) or extra-large (XL) probe. Standard criteria for having valid measurements were applied (IQR < 30% with >70% success rate). Severity of steatosis was evaluated based on the following cutoffs for CAP: <225 db/m (no steatosis), 225-250 db/m (mild steatosis), 250-300 db/m (moderate steatosis), >300 db/m (severe steatosis). Severity of liver stiffness was evaluated using the following TE cutoffs: <6 kPa (no fibrosis), 6-10 kPa (mild to moderate fibrosis), >10 kPa (advanced fibrosis). Baseline clinical and laboratory parameters were also collected.

RESULTS:
119 children with suspected NAFLD were referred to the clinic between May 2017 and April 2019. The mean age at time of assessment was 13.0 (± 3.0) years. The majority were males (68%), obese (87%) and of Hispanic ethnicity (77%). The M probe was used to successfully complete 64% of scans whereas the XL probe was required for 36% of scans. 4/116 (3%) had a CAP < 225 indicating no steatosis. 15/116 (13%) of patients fell within the mild steatosis range (CAP 225-250), 31/116 (27%) with moderate steatosis (CAP 250-300) and the majority, 66/116 (57%), of patients having severe steatosis with CAP values > 300. On TE, 50% had no fibrosis, 45% with mild to moderate fibrosis and 7% with advanced fibrosis. Linear regression analysis demonstrated a weakly positive correlation between baseline ALT and TE measurements (correlation coefficient (r) was 0.24; P value < 0.05; Figure 1.1).

CONCLUSION:
CAP/TE provides a reliable way to confirm the diagnosis of NAFLD and assess its severity in children. Larger pediatric studies that assess the correlation with liver histology and disease progression are needed.
1016 Lusutrombopag Is a Safe Treatment Option for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing a Scheduled Invasive Procedure: Pooled Safety Analysis From 3 Studies
Authors: Brown Robert S. , Izumi Namiki , Kano Takeshi , Ochiai Toshimitsu , Kurosaki Masayuki , Violi Francesco , Shrestha Pomy 
Published: October 2019

INTRODUCTION:
Lusutrombopag is a thrombopoietin receptor agonist (TPO-RA) approved in Japan (2015) and the US (2018) for treatment of thrombocytopenia (TCP), and in the EU (2019) for severe TCP, associated with chronic liver disease (CLD) in patients undergoing a planned invasive procedure. In an integrated analysis of two Phase 3 studies, lusutrombopag reduced the need for platelet transfusions compared to placebo. Treatment with TPO-RAs has been associated with an increased risk of thrombotic events in patients with CLD; thus, a thorough safety assessment of new agents is critical. A pooled retrospective analysis of 3 clinical studies was performed to assess safety of lusutrombopag.

METHODS:
Safety data from 3 double-blind, randomized, placebo-controlled studies in patients with CLD and TCP undergoing a planned invasive procedure (Phase 2b: M0626 [Japan; JapicCTI-121944], Phase 3: L-PLUS 1 [Japan; JapicCTI-132323] and L-PLUS 2 [global; NCT02389621]) were pooled. Adults with platelet counts <50 × 109/L at baseline received lusutrombopag 3 mg or placebo for up to 7 days before a procedure planned 9-14 days after randomization. Platelet transfusion was given if the platelet count remained <50 × 109/L no more than 2 days prior to procedure. Adverse event (AE) data were collected from signing of informed consent until the end of the post-treatment period or early termination.

RESULTS:
The pooled safety population included 341 patients (n = 171, lusutrombopag; n = 170, placebo). Approximately 65% of patients in the lusutrombopag and placebo groups experienced an AE (Table 1). Thrombotic and thromboembolic AEs occurred in 1.8% (3/171) of lusutrombopag patients (cardiac ventricular thrombosis, n = 1 [patient had prior history of cardiac ventricular thrombosis]; portal vein thrombosis, n = 2) and 2.4% (4/170) of placebo patients (mesenteric vein thrombosis, n = 2; portal vein thrombosis, n = 2). Overall, bleeding-related AEs occurred in less lusutrombopag vs placebo patients (15 [8.8%] vs 27 [15.9%]), respectively. The 3 AEs leading to death among patients taking lusutrombopag were not considered treatment-related but due to the progression of underlying disease.

CONCLUSION:
In this pooled safety analysis, lusutrombopag was safe and well-tolerated in patients with TCP and CLD undergoing planned invasive procedures. Approximately 50% fewer bleeding-related AEs and no increased risk of thrombotic and thromboembolic AEs were observed in patients treated with lusutrombopag vs placebo.
1018 Patients With Cirrhosis Have Worse Outcomes When Hospitalized With Influenza
Authors: Sobotka Lindsay , Hinton Alice , Mumtaz Khalid , Conteh Lanla 
Published: October 2019

INTRODUCTION:
The Centers for Disease Control and Prevention estimates that approximately 48 million patients were affected by influenza during the 2017 and 2018 flu season, resulting in 100,000 hospitalizations and 80,000 deaths. Previous studies on infections in patients with decompensated cirrhosis noted worse hospital outcomes as compared to patients without cirrhosis. This study aims to evaluate hospital outcomes in patients with cirrhosis who are hospitalized for influenza.

METHODS:
Utilizing the Nationwide Inpatient Sample, a retrospective database analysis was performed on adult patients admitted with influenza between 2005 and 2013. Patients were identified by ICD-9 codes. Multivariate analyses assessed patient and hospital outcomes including length of stay, inpatient mortality, cost of admission and influenza complications in patients with cirrhosis as compared to those without liver disease. Further, a subset analysis was conducted among patients with cirrhosis to evaluate the impact of decompensated cirrhosis on influenza outcomes.

RESULTS:
A total 236,513 patients were included, 234,960 without liver disease and 1,553 with cirrhosis. On multivariable analysis, patients with cirrhosis had higher costs [$1,030, 95% CI 710, 1,351] and longer length of stay [0.24 days, 95% CI 0.07, 0.41] however no significant differences were observed for mortality or influenza complications. Of the patients with cirrhosis, 76% (n: 1,176) had compensated cirrhosis and 24% (n: 377) had decompensated cirrhosis. After adjusting for confounders, patients with decompensated cirrhosis were noted to have a longer length of stay [1.92 days, 95% CI 1.63, 2.21], higher costs [$5,005, 95% CI 4,459, 5,551], and increased rates of influenza complications [OR 2.56, 95% CI 1.32, 4.93].

CONCLUSION:
Patients with decompensated cirrhosis have worse outcomes when admitted with influenza than patients with compensated cirrhosis. Further studies should be completed to determine interventions that can improve influenza outcomes within the population of patients with decompensated cirrhosis.
1020 The Effect of Metabolic Syndrome Components on Liver Stiffness Measurement Values After HCV Eradication
Authors: Asaad Imad , Eisa Mohamed , Lee Tae Hoon , Hamid Osama , Sandhu Annumeet A. , Calderon Amy 
Published: October 2019

INTRODUCTION:
The availability of noninvasive fibrosis measures coupled with high sustained viral response (SVR) rates has shifted the paradigm in the management of HCV infection in the direct-acting antiviral (DAA) era. Although these noninvasive tests are valuable in evaluating hepatic fibrosis prior to HCV therapy, use of these measures in monitoring fibrosis regression after HCV eradication is currently limited. There is evidence that patients who achieve SVR after therapy have a reduced risk of liver-related complications.1 This is likely attributed to the regression of fibrosis after HCV eradication.2 Other comorbidities, such as obesity, nonalcoholic steatohepatitis and diabetes mellitus may also contribute to liver-related complications.3-4 The aim of this study is to evaluate the effect of metabolic syndrome components on liver stiffness measurement (LSM) after HCV eradication.

METHODS:
A retrospective study of 65 HCV monoinfected patients who received DAA and achieved SVR located in a safety net hospital in Cleveland. All Patients had pretreatment LSM of more than 7k Pa. Patient’s with Fibrosis stage F4 had CP class A. Fibrosis was evaluate within 12 months before treatment and 12-24 months after SVR using Transient Elastography. Other collected parameters included BMI, history of DM, HLD and HTN, HbA1c, LDL, HDL and TGs. Demographics and hepatitis C genotype (GT) were also collected. Statistical analysis was performed using descriptive analysis, Anova, Univariate regression and Multivariate regression to compare variables for statistical significance.

RESULTS:
Among all subjects (n = 65). 64.6% were male. 61.5% had Genotype 1a, 26.2% had genotype 1b and 6.2% had genotype 2. 33.8% were diabetic, 64.6% had hyperlipidemia, and 66.2% patients had hypertension. The mean pre-treatment LSM was 14.4kPa (SD 10.0) and the mean post-treatment LSM was 9.33 kPa (SD 5.3). The mean of delta-stiffness was 5.1 kPa (SD 9.7). 53.8% patients dropped their LSM by 3 kPa or more after SVR. In univariate logistic regression, age (P = 0.675), race (P = 0.11), genotype (P = 0.688), BMI (P = 0.709), diabetes (P = 0.661), hyperlipidemia (P = 0.743), and hypertension (P = 0.545) failed to show any significant correlation with significant drop (≥3kPa) in liver stiffness measurement.

CONCLUSION:
Sustained viral response after direct-acting antiviral (DAA) therapy leads to significant improvement in LSM within 48 months of therapy completion. Metabolic syndrome components has no significant effect on LSM improvement after SVR.
1026 High SVR Rates in HCV-Infected Patients With Multiple Co-Morbid Medical Conditions Treated With HCV DAAs in Community Practice Using a Specialized Pharmacy Team
Authors: Hanysak Bryan , Mann Jena , Ramirez Ruben , Kim Jae , Guerrero Richard , Van Frank Timothy , Mitchell Robert , Hinojosa Kim , Christensen Kimberley , Landaverde Carmen , Loo Nicole , Alkhouri Naim , Wells Jennifer , Rodas Fabian , Lawitz Eric , Pedicone Lisa D. , Poordad Fred 
Published: October 2019

INTRODUCTION:
Approved HCV DAA regimens can cure nearly all patients; however, barriers to care in community practices include patients with a large number of medical co-morbidities, advanced liver damage and insurance approval of DAA regimens. This study assesses medical conditions, liver staging methods, and the drug prior auth process in HCV-infected patients managed in community practices partnered with a dedicated pharmacy team with expertise in liver disorders.

METHODS:
This IRB-approved, ongoing study captures outcomes on a cohort of 705 patients from community practices across Texas. Patients had chronic hepatitis C and were treated with DAA regimens selected by the physician. Insurance carrier and prior auth process data were also captured.

RESULTS:
96% of prior auth requests to Medicare and Medicaid were accepted upon first request; however, only 84% of requests to private insurance were accepted upon first request and did not require an appeal. This cohort included many patients with complicated medical histories including HCC (4.4%), ESRD (2.7%), liver transplant (2.1%) and seizure disorders (4.5%). Liver staging was done via Fibrotest (71%), Fibroscan (22%), Fibrosure (13%) and liver biopsy (0.6%). Medicaid patients had proportionately more advanced disease (79% F3/F4) and were less likely to be previously treated with DAA therapy (1.6%). The most common co-morbid conditions were hypertension (66%), diabetes (28%), GERD (23%), depression (20%), anxiety (16%) dyslipidemia (16%), renal disease (9%) and COPD (9%). Medicaid patients had the highest rates of dyslipidemia, obesity, renal disease and COPD. Overall, 90% of patients had undetectable virus at week 4, 96.7% completed follow-up and 97% achieved SVR, regardless of health insurance type. All patients with ESRD or with seizure disorders treated with oxcarbazepine achieved SVR as did 87% of patients with prior liver transplant. SVR was also achieved in 86% of patients with a history of HCC.

CONCLUSION:
HCV treatment in the community setting resulted in 97% cure. This cohort includes a wide variety of patients including those on dialysis or post-liver transplant. Partnership with a dedicated and liver focused pharmacy team resulted in 90% approval of first-time prior auth requests. Knowledge of and management of co-morbid conditions is critical for maximizing overall patient adherence, compliance and outcomes. Close monitoring through a chronic care management model can lead to better overall patient management.
1028 Treatment of Chronic HBV in African American Patients With and Without Co-Infection With HIV
Authors: Rahim Usman , Benjaram Sindhuri , Ameen Wadah , Ehrinpreis Murray N. , Mutchnick Milton , Naylor Paul 
Published: October 2019

INTRODUCTION:
TThe prevalence of Hepatitis B virus (HBV) infection in the US is estimated at 2 million and remains a public health challenge. The incidence of HBV is high in African Americans (AA), but most studies on HBV are in Asian population. Majority of patients in our Gastroenterology academic clinics are AA. We aimed to evaluate characteristics and treatment outcomes of chronic HBV in AA patients with or without co-infection with HIV.

METHODS:
We identified 149 patients with a visit between 2016-2018. Majority (124/149 = 83%) of patients had one previous visit at least two years prior, such that outcomes of treatment could be evaluated (25 patients excluded). All HIV-HBV co-infected patients were treated with tenofovir containing HART regimens and the majority of mono-infected were also treated with tenofovir.

RESULTS:
There were 62 AA and 2 non-AA patients with HIV coinfection, and 53 AA, 14 Asian, and 18 non-AA/non-Asian patients who were treated. Coinfected patients were more likely to be male (90% vs. 54%). The liver relevant data at entry for the 115 AA patients reported in this study is shown in Table 1. Co-infected and Mono-infected had patients who were on treatment or projected to be treated had had greater degrees of elevated HBV DNA, Inflammation, and fibrosis compared to HBV patients who were not subsequently treated. Co-infected and mono-infected patients were equally likely to be treated. In evaluation of response to treatment, only patients treated for at least 2 years were included (18 patients were excluded). Response to treatment is shown in Table 2. The number of patients with HBV DNA >2000 I.U. (Hi HBV DNA) and high ALT declined significantly in both treatment groups. Fibrosis defined by APRI and FIB-4 also declined but was only statistically significant in the co-infected patients. When correlating decline with time on therapy, only ALT (P < 0.01) declined in HIV-HBV co infected patients. ALT, APRI and FIB-4 all declined with time on treatment in mono-infected patients, although only Fib-4 was significant at P < 0.05

CONCLUSION:
AA individuals with HBV, regardless of co-infection with HIV, respond to anti-viral therapy with a decline in HBV DNA, ALT, APRI and FIB-4. Further studies evaluating outcomes as defined by continued assessment of liver by ultrasound, serum based fibrosis specific assays, and fibroscan are required to more accurately define the positive effects of anti-viral therapy, especially in HIV coinfected AA.
1030 Screening for Steatosis and Fibrosis in a General Population With Fatty Liver Using Transient Elastography (Fibroscan)
Authors: Wong Peter W. , Dharel Narayan , Wong Corinne C. 
Published: October 2019

INTRODUCTION:
Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are increasingly common in the United States and the Western World. In the United States, NAFLD and NASH are estimated to affect 1/3 and 1/10 Americans, respectively putting large proportion of the U.S. population at risk of advanced liver disease, cirrhosis and liver cancer. Transient Elastography or Fibroscan was approved in the United States in 2013 by the FDA as a non-invasive diagnostic test for the detection of steatosis and fibrosis in a variety of liver diseases including NAFLD. Until recently, access to Fibroscan has been limited primarily to academic research centers and tertiary care hospitals with the true status of NAFLD in the community and general U.S. population largely unknown. In this study, we report the status of NAFLD in a suburban community practice as identified by Fibroscan.

METHODS:
In this retrospective study, steatosis and fibrosis scores were analyzed in 489 NAFLD patients that had a Fibroscan (Fibroscan Compact 530) in a community hospital from February to November 2018. All the patients were referred for Fibroscan by gastroenterologists due to a fatty liver found on prior imaging studies by abdominal ultrasounds and / or CT scans. Patients with significant alcohol use (more than 2 drinks a day) and chronic liver disease (hepatitis B, Hepatitis C, autoimmune liver diseases and etc) were excluded from the analysis.

RESULTS:
Number of patient (percentage %). 1. *Steatosis score : S0 = 46 (9.40%), S1 = 15 (3.06%), S2 = 37 (7.56%) and S3 = 391 (79.95%). 2.** Fibrosis score : F0-F1 = 205 (41.92%), F2 = 148 (30.26%), F3 = 68 (13.90%) and F4 = 68 (13.90%). *Steatosis scoring: S0 = no fat, S1 = mild fat, S2 = moderate fat, S3 = severe fat. **Fibrosis scoring: F0-F1 = none to minimal scarring, F2 = moderate scarring, F3 = severe scarring, F4 = advanced fibrosis / cirrhosis.

CONCLUSION:
In this general population with incidental fatty liver, an alarming number of patients of nearly 80% have severe fatty liver disease (S3) and nearly a third (27.80%) have severe to advanced fibrosis / cirrhosis. With the higher than expected significant abnormal findings from this observational study, we recommend Transient Elastography (Fibroscan) as a screening tool to all clinicians managing patients with fatty liver disease. To confirm the validity of advanced liver disease found on Fibroscan, a liver biopsy should be considered in patients with severe or advanced (S3/4) liver fibrosis.