Publications by authors named "Amit G Singal"

269 Publications

What Survivorship Means to Liver Transplant Recipients-Qualitative Groundwork for A Survivorship Conceptual Model.

Liver Transpl 2021 May 3. Epub 2021 May 3.

Department of Medicine, Division of Gastroenterology and Hepatology, University of North Carolina (UNC) School of Medicine, Chapel Hill, NC, United States.

Background & Aims: Survivorship is a well-established concept in the cancer care continuum with a focus on disease recurrence, quality of life, and minimizing competing risks for mortality; however, this has not been well studied in liver transplantation (LT). We aimed to investigate what survivorship means to LT patients and identify motivations and coping strategies for overcoming challenges after LT.

Approach & Results: Twenty in-depth home interviews were conducted among adults 3 to 6 months after LT. Interviews were conducted by trained qualitative research experts, coded and analyzed using an inductive approach. A majority of LT recipients (75%) identified themselves as survivors. Integral to the definition of survivorship was overcoming hardship (including experiences on the waitlist) and the unique experience of being given a "second chance" at life. Motivations to survive included: 1) honoring a new chance at life (55%), 2) family (40%), 3) spirituality/faith (30%), and 4) fear of rejection (15%). LT recipients and caregivers identified multiple strategies to cope with post-LT challenges including relying on a large network of community, spiritual, and virtual support. These findings informed a conceptual model of LT survivorship based on socioecological theory, which identified the following variables influencing survivorship: 1) pre-transplant experiences, 2) individual attributes and challenges, 3) interpersonal relationships with caregivers and other social support, 4) community relationships, and, 5) largescale factors including neighborhood and financial issues.

Conclusions: LT recipients identify themselves as survivors, and post-LT identities were greatly influenced by pre-LT experiences. These perspectives informed an in depth conceptual model of survivorship after transplantation. We identified sources of motivation and coping strategies used in LT recovery that could be targets of survivorship interventions aimed at improving post-LT outcomes.
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http://dx.doi.org/10.1002/lt.26088DOI Listing
May 2021

High Neutrophil-Lymphocyte Ratio and Delta Neutrophil-Lymphocyte Ratio Are Associated with Increased Mortality in Patients with Hepatocellular Cancer.

Dig Dis Sci 2021 May 3. Epub 2021 May 3.

Division of Digestive and Liver Diseases, Department of Internal Medicine, UT Southwestern Medical Center, 5959 Harry Hines Blvd, POB 1, Suite 420, Dallas, TX, 75390-8887, USA.

Background: The neutrophil-lymphocyte ratio (NLR) has been proposed as a prognostic biomarker for cirrhosis and non-liver malignancies. We aimed to evaluate the prognostic value of NLR in a diverse cohort of patients with hepatocellular carcinoma (HCC).

Methods: We performed a retrospective study of patients diagnosed with HCC between 2008 and 2017 at two large US health systems. We used Cox proportional hazard and multivariable ordinal logistic regression models to identify factors associated with overall survival and response to first HCC treatment, respectively. Primary variables of interest were baseline NLR and delta NLR, defined as the difference between pre- and post-treatment NLR.

Results: Among 1019 HCC patients, baseline NLR was < 5 in 815 (80.0%) and ≥ 5 in 204 (20.0%). Patients with NLR ≥ 5 had a higher proportion of infiltrative tumors (36.2% vs 22.3%), macrovascular invasion (39.6% vs 25.5%), metastatic disease (20.6% vs 11.4%), and AFP > 200 ng/mL (45.6% vs 33.8%). Baseline NLR ≥ 5 was independently associated with higher mortality (median survival 4.3 vs 15.1 months; adjusted HR 1.70, 95%CI 1.41-2.06), with differences in survival consistent across BCLC stages. After adjusting for baseline covariates including NLR, delta NLR > 0.26 was also independently associated with increased mortality (HR 1.42, 95%CI 1.14-1.78). In a secondary analysis, high NLR was associated with lower odds of response to HCC treatment (20.2% vs 31.6%; adjusted OR 0.55, 95%CI 0.32-0.95).

Conclusions: In a large Western cohort of patients with HCC, high baseline NLR and delta NLR were independent predictors of mortality.

Impact: NLR is an inexpensive test that may be a useful component of future HCC prognostic models.
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http://dx.doi.org/10.1007/s10620-021-07001-6DOI Listing
May 2021

A Panel of Glycopeptides as Candidate Biomarkers for Early Diagnosis of NASH Hepatocellular Carcinoma Using a Stepped HCD Method and PRM Evaluation.

J Proteome Res 2021 Apr 30. Epub 2021 Apr 30.

Department of Surgery, University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States.

Changes in N-glycosylation on specific peptide sites of serum proteins have been investigated as potential markers for diagnosis of nonalcoholic steatohepatitis (NASH)-related HCC. To accomplish this work, a novel workflow involving broad-scale marker discovery in serum followed by targeted marker evaluation of these glycopeptides were combined. The workflow involved an LC-Stepped HCD-DDA-MS/MS method coupled with offline peptide fractionation for large-scale identification of -glycopeptides directly from pooled serum samples (each = 10) as well as differential determination of N-glycosylation changes between disease states. We then evaluated several potentially diagnostic N-glycopeptides among 78 individual patient samples (40 cirrhosis, 28 early stage NASH HCC, and 10 late-stage NASH HCC) by LC-Stepped HCD-PRM-MS/MS to quantitatively analyze 65 targeted glycopeptides from 7 glycoproteins. Of these targets, we found site-specific -glycopeptides nGSLFAFR_HexNAc(4)Hex(5)NeuAc(2) and nISDGFDGIPDNVDAALALPAHSYSGR_HexNAc(5)Hex(6)Fuc(1)NeuAc(3) from VTNC were significantly increased comparing samples from patients with NASH cirrhosis and NASH HCC ( < 0.05). When combining results of these 2 glycopeptides with AFP, the ROC curve analysis demonstrated the AUC value increased to 0.834 (95% CI, 0.748-0.921) and 0.847 (95% CI, 0.766-0.932), respectively, as compared to that of AFP alone (AUC = 0.791, 95% CI, 0.690-0.892). These 2 glycopeptides may serve as potential biomarkers for early HCC diagnosis in patients with NASH related cirrhosis.
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http://dx.doi.org/10.1021/acs.jproteome.1c00175DOI Listing
April 2021

Expanding COVID-19 Vaccine Availability: Role for Combined Orthogonal Serology Testing (COST).

Vaccines (Basel) 2021 Apr 13;9(4). Epub 2021 Apr 13.

Department of Pathology, University of Texas Southwestern Medical Center, Dallas, TX 75390, USA.

Background: The persisting Coronavirus disease 2019 (COVID-19) pandemic and limited vaccine supply has led to a shift in global health priorities to expand vaccine coverage. Relying on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular testing alone cannot reveal the infection proportion, which could play a critical role in vaccination prioritization. We evaluated the utility of a combination orthogonal serological testing (COST) algorithm alongside RT-PCR to quantify prevalence with the aim of identifying candidate patient clusters to receive single and/or delayed vaccination.

Methods: We utilized 108,505 patients with suspected COVID-19 in a retrospective analysis of SARS-CoV-2 RT-PCR vs. IgG-nucleocapsid (IgG) antibody testing coverage in routine practice for the estimation of prevalence. Prospectively, an independent cohort of 21,388 subjects was simultaneously tested by SARS-CoV-2 RT-PCR and IgG to determine the prevalence. We used 614 prospective study subjects to assess the utility of COST (IgG, IgM-spike (IgM), and IgG-spike (IgG)) in establishing the infection proportion to identify a single-dose vaccination cohort.

Results: Retrospectively, we observed a 6.3% (6871/108,505) positivity for SARS-CoV-2 RT-PCR, and only 2.3% (2533/108,505) of cases had paired IgG serology performed. Prospectively, IgG serology identified twice the number of COVID-positive cases in relation to RT-PCR alone. COST further increased the number of detected positive cases: IgG+ or IgM+ (18.0%); IgG+ or IgG+ (23.5%); IgM+ or IgG+ (23.8%); and IgG+ or IgM+ or IgG+ (141/584 = 24.1%).

Conclusion: COST may be an effective tool for the evaluation of infection proportion and thus could define a cohort for a single dose and/or delayed vaccination.
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http://dx.doi.org/10.3390/vaccines9040376DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8069830PMC
April 2021

Doylestown Plus and GALAD Demonstrate High Sensitivity for HCC Detection in Patients with Cirrhosis.

Clin Gastroenterol Hepatol 2021 Apr 14. Epub 2021 Apr 14.

Department of Internal Medicine, University of Michigan, Ann Arbor MI.

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http://dx.doi.org/10.1016/j.cgh.2021.04.018DOI Listing
April 2021

Transarterial radioembolization versus systemic treatment for hepatocellular carcinoma with macrovascular invasion: Analysis of the US National Cancer Database.

J Nucl Med 2021 Apr 9. Epub 2021 Apr 9.

Cedars-Sinai Medical Center, United States.

Systemic therapy remains the recommended first-line treatment for hepatocellular carcinoma (HCC) with macrovascular invasion (MVI). Transarterial radioembolization (TARE) is a promising alternative treatment given superior quality of life. The aims of this study were to 1) characterize trends and correlates for TARE as first-line treatment of HCC patients with MVI in the US and 2) compare survival after TARE versus systemic therapy. We used the US National Cancer Database to identify patients with T3BN0M0 HCC during 2010-2017. We performed multivariable logistic regression to identify factors associated with use of TARE vs. systemic therapy and Cox proportional hazards regression to identify factors associated with overall survival. Of 11,259 patients with T3BN0M0 HCC, 1454 (12.9%) and 3915 (34.7%) patients were treated with TARE and systemic therapy, respectively. The proportion of patients who received TARE increased from 13.0% in 2010 to 37.0% in 2017. Older age, White race, and receiving care at an academic cancer program were associated with receipt of TARE, while lack of insurance, higher MELD score, Charlson comorbidity Index ≥3, and Northeast region were associated with receipt of systemic therapy. TARE was associated with reduced mortality compared to systemic therapy (adjusted hazard ratio: 0.74, 95%CI: 0.68-0.80), with consistent results observed in propensity weighted analysis and across all examined subgroups. Use of TARE as first-line therapy for HCC with MVI has increased in the US. Patient characteristics, region, and medical center type affected the use of TARE. TARE was associated with reduced mortality compared to systemic therapy for HCC patients with MVI.
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http://dx.doi.org/10.2967/jnumed.121.261954DOI Listing
April 2021

Real-world effectiveness of lenvatinib monotherapy among unresectable hepatocellular carcinoma patients in the USA.

Future Oncol 2021 Apr 9. Epub 2021 Apr 9.

Global Real World Evidence & US HEOR, Eisai, Inc., Woodcliff Lake, NJ 07677, USA.

This study evaluated the effectiveness of lenvatinib monotherapy for first-line treatment of unresectable hepatocellular carcinoma (uHCC) in a real-world setting. This retrospective cohort study included patients who initiated lenvatinib monotherapy as first-line treatment for uHCC (n = 233). Clinical outcomes included provider-reported best response, progression-free survival (PFS) and overall survival (OS). PFS and OS were estimated using Kaplan-Meier methods. Most patients (67.8%) were male. A total of 44.6% had Child-Pugh A and 39.1% had Child-Pugh B. Dose reductions were reported in 9%. Median PFS and OS were not reached. At 6 and 12 months, landmark PFS were 85.1 and 64.9%, respectively; landmark OS were 91.8 and 72.6%, respectively. These results affirm the clinical effectiveness of first-line lenvatinib monotherapy in uHCC.
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http://dx.doi.org/10.2217/fon-2021-0242DOI Listing
April 2021

Racial and Sex Disparities in Hepatocellular Carcinoma in the USA.

Curr Hepatol Rep 2020 Dec 12;19(4):462-469. Epub 2020 Nov 12.

Division of Digestive and Liver Diseases, Department of Internal Medicine.

Purpose Of Review: In this review, we aim to provide a summary of the current literature on race and gender disparities in hepatocellular carcinoma (HCC) incidence, stage at diagnosis, treatment and prognosis in the United States.

Recent Findings: HCC incidence rates are rising in the U.S. in all racial/ethnic groups except for Asian/Pacific Islanders, with disproportionate rises and the highest rates among Hispanics compared to Blacks and non-Hispanic whites. There are striking sex disparities in HCC incidence and mortality; however, with the shifting epidemiology of HCC risk factors in the U.S, there is recent evidence that HCC is trending towards less male predominance, particularly among younger birth cohorts. Despite significant advances in HCC treatment over the past decade, disparities in HCC surveillance and treatment receipt persist among racial and ethnic minorities and the socioeconomically disadvantaged. Black patients continue to experience worse survival outcomes than non-Black patients with HCC.

Summary: There are significant racial and gender disparities in HCC incidence, treatment, and mortality in the U.S. Though these disparities are well-documented, data are still limited on the specific determinants driving disparities in HCC. To achieve health equity for all patients with HCC, we must advance beyond simply reporting on disparities and begin implementing targeted interventions to eliminate disparities.
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http://dx.doi.org/10.1007/s11901-020-00554-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8020839PMC
December 2020

Clinical evaluation of the Abbott Alinity SARS-CoV-2 spike-specific quantitative IgG and IgM assays among infected, recovered, and vaccinated groups.

J Clin Microbiol 2021 Apr 7. Epub 2021 Apr 7.

Department of Pathology, University of Texas Southwestern Medical Center, Dallas, Texas

The COVID-19 pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remains important, laboratories must now pivot and consider an assessment of SARS-CoV-2 immunity in the setting of the recent availability of multiple COVID-19 vaccines. Here we have utilized the latest Abbott Alinity semi-quantitative IgM and quantitative IgG spike protein (SP) serology assays (IgM and IgG) in combination with Abbott Alinity IgG nucleocapsid (NC) antibody test (IgG) to assess antibody responses in a cohort of 1236 unique participants comprised of naïve, SARS-CoV-2 infected, and vaccinated (including both naïve and recovered) individuals. The IgM and IgG assays were highly specific (100%) with no cross-reactivity to archived samples collected prior to the emergence of SARS-CoV-2, including those from individuals with seasonal coronavirus infections. Clinical sensitivity was 96% after 15 days for both IgM and IgG assays individually. When considered together, the sensitivity was 100%. A combination of NC- and SP-specific serologic assays clearly differentiated naïve, SARS-CoV-2-infected, and vaccine-related immune responses. Vaccination resulted in a significant increase in IgG and IgM values, with a major rise in IgG following the booster (second) dose in the naïve group. In contrast, SARS-CoV-2 recovered individuals had several fold higher IgG responses than naïve following the primary dose, with a comparatively dampened response following the booster. This work illustrates the strong clinical performance of these new serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination.
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http://dx.doi.org/10.1128/JCM.00388-21DOI Listing
April 2021

Failure in all steps of hepatocellular carcinoma surveillance process is frequent in daily practice.

Ann Hepatol 2021 Apr 2;25:100344. Epub 2021 Apr 2.

Hospital de Clínicas José de San Martín (UBA), CABA, Argentina.

Introduction And Objectives: Failures at any step in the hepatocellular carcinoma (HCC) surveillance process can result in HCC diagnostic delays and associated worse prognosis. We aimed to estimate the prevalence of surveillance failure and its associated risk factors in patients with HCC in Argentina, considering three steps: 1) recognition of at-risk patients, 2) implementation of HCC surveillance, 3) success of HCC surveillance.

Methods: We performed a multi-center cross-sectional study of patients at-risk for HCC in Argentina seen between10.01.2018 and 10.30.2019. Multivariable logistic regression analysis was used to identify correlates of surveillance failure.

Results: Of 301 included patients, the majority were male (74.8%) with a mean age of 64 years old. At the time of HCC diagnosis, 75 (25%) patients were unaware of their diagnosis of chronic liver disease, and only 130 (43%) patients were under HCC surveillance. Receipt of HCC surveillance was significantly associated with follow-up by a hepatologist. Of 119 patients with complete surveillance, surveillance failure occurred in 30 (25%) patients. Surveillance failure was significantly associated with alpha fetoprotein ≥20 ng/mL (OR 4.0, CI 95% 1.43-11.55).

Conclusions: HCC surveillance failure was frequent in all the evaluated steps. These data should help guide strategies to improve the implementation and results of HCC surveillance in our country.
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http://dx.doi.org/10.1016/j.aohep.2021.100344DOI Listing
April 2021

Role of Multidisciplinary Care in the Management of Hepatocellular Carcinoma.

Semin Liver Dis 2021 Jan 14;41(1):1-8. Epub 2021 Jan 14.

Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas.

Despite advances in treatment options for hepatocellular carcinoma (HCC), 5-year survival for HCC remains below 20%. This poor survival is multifactorial but is partly related to underuse of curative treatment in clinical practice. In light of growing treatment options, delivered by different types of providers, optimal management requires input from multiple specialties. A multidisciplinary approach has been evolving over the past couple of decades, bringing different specialists together to develop a therapeutic plan to treat and manage HCC, which significantly increases timely guideline-concordant treatment and improves overall survival. The present review attempts to highlight the need for such a multimodal approach by providing insights on its potential structure and impact on the various aspects of HCC management.
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http://dx.doi.org/10.1055/s-0040-1719178DOI Listing
January 2021

LI-RADS treatment response algorithm after first-line DEB-TACE: reproducibility and prognostic value at initial post-treatment CT/MRI.

Abdom Radiol (NY) 2021 Mar 23. Epub 2021 Mar 23.

Radiology, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Purpose: To evaluate the inter-reader reproducibility and prognostic accuracy of the Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (LR-TR) at the time of initial post-treatment evaluation following drug-eluting beads transarterial chemoembolization (DEB-TACE) for hepatocellular carcinoma (HCC).

Methods: This retrospective study included patients with HCC who underwent first-line DEB-TACE between January 2011 and December 2015. Six readers (three fellowship-trained radiologists and three radiology trainees) independently assessed lesion-level response in up to two treated lesions per LR-TR and modified Response Evaluation Criteria in Solid Tumors (mRECIST)-target criteria, as well as patient-level response per mRECIST-overall criteria, on the initial post-treatment CT/MRI. Inter-reader agreement was calculated by Fleiss' multi-reader κ. We tested whether LR-TR, mRECIST-target, and mRECIST-overall response were associated with overall survival using Kaplan-Meier and Cox proportional hazard model analyses.

Results: A total of 82 patients with 113 treated target lesions were included. Inter-reader agreement was moderate for LR-TR and mRECIST-overall (κ range 0.42-0.57), and substantial for mRECIST-target (κ range 0.62-0.66), among all three reader-groups: all readers, experienced readers, and less-experienced readers. LR-TR and mRECIST-target response were not significantly associated with overall survival regardless of reader experience (P > 0.05). In contrast, mRECIST-overall response was significantly associated with overall survival when assessed by all readers (P = 0.02) and experienced readers (P = 0.03), but not by the less-experienced readers (P = 0.35).

Conclusion: Although LR-TR algorithm has moderate inter-reader reproducibility, it alone may not predict overall survival on the initial post-treatment CT/MRI after first-line DEB-TACE for HCC.
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http://dx.doi.org/10.1007/s00261-021-03043-6DOI Listing
March 2021

Hepatocellular carcinoma recurrence after direct-acting antiviral therapy: an individual patient data meta-analysis.

Gut 2021 Mar 19. Epub 2021 Mar 19.

Liver and Transplant Unit, Policlinico Tor Vergata, Rome, Italy.

Objective: The benefit of direct-acting antivirals (DAAs) against HCV following successful treatment of hepatocellular carcinoma (HCC) remains controversial. This meta-analysis of individual patient data assessed HCC recurrence risk following DAA administration.

Design: We pooled the data of 977 consecutive patients from 21 studies of HCV-related cirrhosis and HCC, who achieved complete radiological response after surgical/locoregional treatments and received DAAs (DAA group). Recurrence or death risk was expressed as HCC recurrence or death per 100 person-years (100PY). Propensity score-matched patients from the ITA.LI.CA. cohort (n=328) served as DAA-unexposed controls (no-DAA group). Risk factors for HCC recurrence were identified using random-effects Poisson.

Results: Recurrence rate and death risk per 100PY in DAA-treated patients were 20 (95% CI 13.9 to 29.8, I=74.6%) and 5.7 (2.5 to 15.3, I=54.3), respectively. Predictive factors for recurrence were alpha-fetoprotein logarithm (relative risk (RR)=1.11, 95% CI 1.03 to 1.19; p=0.01, per 1 log of ng/mL), HCC recurrence history pre-DAA initiation (RR=1.11, 95% CI 1.07 to 1.16; p<0.001), performance status (2 vs 0, RR=4.35, 95% CI 1.54 to 11.11; 2 vs 1, RR=3.7, 95% CI 1.3 to 11.11; p=0.01) and tumour burden pre-HCC treatment (multifocal vs solitary nodule, RR=1.75, 95% CI 1.25 to 2.43; p<0.001). No significant difference was observed in RR between the DAA-exposed and DAA-unexposed groups in propensity score-matched patients (RR=0.64, 95% CI 0.37 to 1.1; p=0.1).

Conclusion: Effects of DAA exposure on HCC recurrence risk remain inconclusive. Active clinical and radiological follow-up of patients with HCC after HCV eradication with DAA is justified.
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http://dx.doi.org/10.1136/gutjnl-2020-323663DOI Listing
March 2021

State-Level Hepatocellular Carcinoma Incidence and Association with Obesity and Physical Activity in the United States.

Hepatology 2021 Mar 17. Epub 2021 Mar 17.

Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.

Background & Aims: Hepatocellular carcinoma (HCC) remains a leading cause of cancer-related mortality, with a disproportionate impact on racial/ethnic minority groups. However, state-level variation in racial/ethnic disparities and temporal trends of HCC incidence remain unknown. Therefore, we aimed to characterize: 1) state-level racial/ethnic disparity in HCC incidence, 2) state-level temporal changes in HCC incidence, and 3) the ecological correlation between HCC incidence and obesity/physical activity levels in the US.

Approach And Results: Trends in HCC incidence between 2001-2017 were calculated using data from Center for Disease Control (CDC) and Prevention's National Program of Cancer Registries and the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER), and annual percent change (APC) in rates were calculated. State-level percent of obesity and level of physical activity were obtained from the CDC, and the correlation between obesity, physical activity, and state-specific average APC (AAPC) was tested by Pearson correlation coefficient. There were striking state-level racial/ethnic disparities in HCC incidence; incidence rate ratios ranged between 6.3 and 0.9 in Blacks, 6.1 and 1.7 in Asians/Pacific Islanders, 3.8 and 0.9 in Hispanics, and 6.0 and 0.9 in American Indians/Alaska Natives (compared to Whites as reference). Despite overall decreasing HCC incidence rates after 2015, HCC incidence continued increasing in 26 states over recent years. HCC incidence trends had a moderate correlation with state-level obesity (r=0.45, P<0.001) and a moderate inverse correlation with state-level physical activity (r=-0.40, P=0.004).

Conclusions: There is wide state-level variation in racial/ethnic disparity of HCC incidence. There are also disparate incidence trends across states, with HCC incidence continuing to increase in over half of states. Regional obesity and lack of physical activity have moderate correlations with HCC incidence trends, suggesting interventions targeting these factors may help curb HCC incidence.
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http://dx.doi.org/10.1002/hep.31811DOI Listing
March 2021

A Blood-Based Prognostic Liver Secretome Signature Predicts Long-Term Risk of Hepatic Decompensation in Cirrhosis.

Clin Gastroenterol Hepatol 2021 Mar 13. Epub 2021 Mar 13.

Division of Digestive and Liver Diseases, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address:

Cirrhosis is the terminal stage of progressive liver fibrosis, affecting 1%-2% of the global population and accounting for 1.3 million deaths annually. Median survival for persons with compensated cirrhosis is approximately 12 years, compared with only 2 years for those with hepatic decompensation. Accurate prediction of hepatic decompensation is an unmet need to enable identification of patients with cirrhosis who could benefit from close monitoring and timely medical interventions. Besides, risk stratification of patients with cirrhosis could help inform patient selection for trials evaluating therapies to prevent hepatic decompensation. Although various clinical scores, such as the albumin-bilirubin (ALBI) and fibrosis-4 (FIB-4) indices (ALBI-FIB4 score) have been proposed to predict long-term risk of hepatic decompensation, external validation has often shown suboptimal prognostic capability and revealed room for improvement..
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http://dx.doi.org/10.1016/j.cgh.2021.03.019DOI Listing
March 2021

International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma.

Gastroenterology 2021 Mar 9. Epub 2021 Mar 9.

Division of Liver Diseases and Hematology/Medical Oncology, Liver Cancer Program, Tisch Cancer Institute, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address:

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http://dx.doi.org/10.1053/j.gastro.2021.01.233DOI Listing
March 2021

A Real-World Observational Cohort of Patients with Hepatocellular Carcinoma: Design and Rationale for TARGET-HCC.

Hepatol Commun 2021 Mar 21;5(3):538-547. Epub 2020 Dec 21.

Division of Gastroenterology and Hepatology St. Louis University St. Louis MO USA.

This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.
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http://dx.doi.org/10.1002/hep4.1652DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7917285PMC
March 2021

Evaluation and Management of Hepatocellular Adenomas.

Clin Liver Dis (Hoboken) 2021 Feb 28;17(2):57-60. Epub 2021 Feb 28.

Division of Digestive and Liver Diseases UT Southwestern Medical Center Dallas TX.

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http://dx.doi.org/10.1002/cld.949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7916436PMC
February 2021

Novel Application of Predictive Modeling: A Tailored Approach to Promoting HCC Surveillance in Patients With Cirrhosis.

Clin Gastroenterol Hepatol 2021 Mar 2. Epub 2021 Mar 2.

Department of Population Sciences, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas; Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center and Parkland Health & Hospital, Dallas, Texas.

Objective: There has been increased interest in interventions to promote hepatocellular carcinoma (HCC) surveillance given low utilization and high proportions of late stage detection. Accurate prediction of patients likely versus unlikely to respond to interventions could allow a cost-effective approach to outreach and facilitate targeting more intensive interventions to likely non-responders.

Design: We conducted a secondary analysis of a randomized clinical trial evaluating a mailed outreach strategy to promote HCC surveillance among 1200 cirrhosis patients at a safety-net health system between December 2014 and March 2017. We developed regularized logistic regression (RLR) and gradient boosting machine (GBM) algorithm models to predict surveillance completion during each of the 3 screening rounds in a training set (n = 960). Model performance was assessed using multiple performance metrics in an independent test set (n = 240).

Results: Among 1200 patients, surveillance was completed in 41-47% of patients over the three rounds. The RLR and GBM models demonstrated good discriminatory accuracy, with area under receiver operating characteristic (AUROC) curves of 0.67 and 0.66 respectively in the first surveillance round and improved to 0.77 by the third surveillance round after incorporating prior screening behavior as a feature. Additional performance characteristics including the Brier score, Hosmer-Lemeshow test and reliability diagrams were also evaluated. The most important variables for the predictive model were prior screening completion status and past primary care contact.

Conclusions: Predictive models can help stratify patients' likelihood to respond to surveillance outreach invitations, facilitating tailored strategies to maximize effectiveness and cost-effectiveness of HCC surveillance population health programs.
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http://dx.doi.org/10.1016/j.cgh.2021.02.038DOI Listing
March 2021

Patient Preferences for Hepatocellular Carcinoma Surveillance Parameters.

Clin Gastroenterol Hepatol 2021 Feb 19. Epub 2021 Feb 19.

North American Liver Cancer Consortium; Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan. Electronic address:

Background And Aims: Professional societies recommend abdominal ultrasound (US) with or without alpha fetoprotein (AFP) for hepatocellular cancer (HCC) surveillance; however, there are several emerging surveillance modalities, including abbreviated MRI and blood-based biomarker panels. Most studies have focused on provider perspectives for surveillance logistics, but few have assessed patient preferences. We aimed to measure preferences among patients with cirrhosis regarding HCC surveillance modalities.

Methods: We conducted a choice-based conjoint survey to patients with cirrhosis at four institutions. Participants were provided 15 scenarios in which they were asked to choose surveillance modalities based on five test attributes: benefits, i.e. sensitivity for early HCC (range: 35-95%), physical harm, i.e. false positives requiring additional testing (range: 10-40%), financial harm, i.e. out-of-pocket costs (range: $10-100), test logistics and convenience, i.e. duration of testing (range: 10-60 min). Hierarchical Bayes discrete choice conjoint analysis was used to derive attribute importance, and preference shares were determined by simulation.

Results: In total 91% (182/199) of approached patients consented to participate in the study and 98% (n=179) successfully completed the survey. Surveillance benefits (importance: 51.3%, 95%CI: 49.0-53.4%) were valued more than risk of physical harm (importance: 7.6%, 95%CI 7.0-8.2%), financial harm (importance: 15.2%, 95%CI 14.0-16.3%), convenience (importance: 9.3%, 95%CI 8.5-10.1%) and test logistics (importance: 16.7%, 95%CI 15.4-18.1%). Based on simulations including all possible tests, patients preferred abbreviated MRI (29.0%), MRI (23.3%), or novel blood-based biomarkers (20.9%) to ultrasound alone (3.4%) or with AFP (8.8%).

Conclusions: Patients with cirrhosis prioritize early HCC detection over potential surveillance-related harms or inconvenience.
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http://dx.doi.org/10.1016/j.cgh.2021.02.024DOI Listing
February 2021

HCC Surveillance in Cirrhosis Patients: Room for Improvement.

Hepatology 2021 Feb 22. Epub 2021 Feb 22.

Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX, USA.

In our recent systematic review and meta-analysis, we found that HCC surveillance continues to be underused in clinical practice, with a pooled surveillance of 24.0%. In subgroup analyses, the highest surveillance receipt was reported in studies that enrolled patients from Gastroenterology subspecialty clinics and lowest in studies including population-based cohorts, in which many patients were followed in primary care clinics. The letter from Drs. Huang and Nguyen regarding our study raises some points that warrant further discussion..
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http://dx.doi.org/10.1002/hep.31762DOI Listing
February 2021

Characterization of Prevalent, Post-Endoscopy, and Incident Esophageal Cancer in the United States: A Large Retrospective Cohort Study.

Clin Gastroenterol Hepatol 2021 Feb 5. Epub 2021 Feb 5.

Division of Gastroenterology and Hepatology, University of Colorado Anschutz Medical Campus, Aurora, Colorado. Electronic address:

Background & Aims: Efforts to assess and improve the effectiveness of Barrett's esophagus (BE) screening and surveillance are ongoing in the United States. Currently, there are limited population-based data in the United States to guide these efforts.

Methods: We performed a retrospective cohort study using data from large commercial and Medicare Advantage health plans in the United States from 2004 - 2019. We identified individuals with BE and analyzed the proportion who developed EAC. EACs were classified as prevalent EAC (diagnosed within 30 days of index endoscopy), post-endoscopy esophageal adenocarcinoma (PEEC, diagnosed 30 - 365 days after index endoscopy), and incident EAC (diagnosed 365 days or more after index endoscopy). Using this cohort, we performed a nested case-control study to identify factors associated with prevalent EAC at BE diagnosis and study healthcare utilization prior to BE diagnosis.

Results: We identified 50,817 individuals with incident BE. Of the 366 who developed EAC, 67.2%, 13.7%, and 19.1% were diagnosed with prevalent EAC, PEEC, and incident EAC respectively. Factors positively associated with prevalent EAC versus BE without prevalent EAC included male sex, dysphagia, weight loss, and Charlson-Deyo comorbidity score. In those with prevalent EAC, most patients with dysphagia or weight loss had their symptoms first recorded within three months of EAC diagnosis. Healthcare utilization rates were similar between those with and without prevalent EAC.

Conclusions: Two-thirds of EACs among individuals with BE are diagnosed at the time of BE diagnosis. Additionally, PEEC accounts for 14% of these EACs. These results may guide future research studies that investigate novel BE diagnostic strategies that reduce the morbidity and mortality of EAC.
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http://dx.doi.org/10.1016/j.cgh.2021.02.005DOI Listing
February 2021

Hepatocellular carcinoma.

Nat Rev Dis Primers 2021 01 21;7(1). Epub 2021 Jan 21.

Department of Oncology, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Liver cancer remains a global health challenge, with an estimated incidence of >1 million cases by 2025. Hepatocellular carcinoma (HCC) is the most common form of liver cancer and accounts for ~90% of cases. Infection by hepatitis B virus and hepatitis C virus are the main risk factors for HCC development, although non-alcoholic steatohepatitis associated with metabolic syndrome or diabetes mellitus is becoming a more frequent risk factor in the West. Moreover, non-alcoholic steatohepatitis-associated HCC has a unique molecular pathogenesis. Approximately 25% of all HCCs present with potentially actionable mutations, which are yet to be translated into the clinical practice. Diagnosis based upon non-invasive criteria is currently challenged by the need for molecular information that requires tissue or liquid biopsies. The current major advancements have impacted the management of patients with advanced HCC. Six systemic therapies have been approved based on phase III trials (atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib and ramucirumab) and three additional therapies have obtained accelerated FDA approval owing to evidence of efficacy. New trials are exploring combination therapies, including checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies, or even combinations of two immunotherapy regimens. The outcomes of these trials are expected to change the landscape of HCC management at all evolutionary stages.
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http://dx.doi.org/10.1038/s41572-020-00240-3DOI Listing
January 2021

Racial and Ethnic Disparities in Survival Among Patients With Hepatocellular Carcinoma in the United States: A Systematic Review and Meta-Analysis.

Clin Gastroenterol Hepatol 2020 Dec 30. Epub 2020 Dec 30.

Division of Digestive and Liver Diseases, Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas.

Background And Aims: Hepatocellular carcinoma (HCC) is the fastest rising cause of cancer-related death in the United States; however, HCC incidence and mortality are not equally distributed among racial-ethnic groups. Our aim was to characterize the direction and magnitude of racial-ethnic disparities in overall survival and early tumor detection among patients with HCC.

Methods: We searched MEDLINE, EMBASE and Cochrane databases from inception through August 2020 for studies reporting HCC outcomes (early stage presentation and overall survival) by race and ethnicity. We calculated pooled hazard ratios (HRs) and odds ratios (ORs) for each racial-ethnic group (White, Black, Hispanic, Asian) using the DerSimonian and Laird method for a random-effects model.

Results: We identified 35 articles comprising 563,097 patients (53.0% White, 17.3% Black, 18.4% Hispanic, 5.0% Asian). Compared with White patients, Black patients had worse survival (pooled HR 1.08; 95% CI, 1.05 - 1.12), whereas Hispanic (pooled HR 0.92; 95% CI, 0.87 - 0.97) and Asian (pooled HR 0.81; 95% CI, 0.73 - 0.88) patients had better survival. Among articles reporting tumor stage (n = 20), Black patients had lower odds of early stage HCC compared with White patients (OR, 0.66; 95% CI, 0.54 - 0.78). Conversely, there was no difference in odds of early HCC detection for Asian (OR, 1.01; 95% CI, 0.97 - 1.05) or Hispanic patients (OR, 0.87; 95% CI, 0.74 - 1.01) compared with White patients. The most common limitation of studies was risk of residual confounding from socioeconomic status and liver dysfunction.

Conclusions: There are significant racial and ethnic disparities in HCC prognosis in the United States, with Black patients having worse overall survival and Hispanic and Asian patients having better overall survival compared with White patients. Interventions are needed to reduce disparities in early HCC detection to improve HCC prognosis.
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http://dx.doi.org/10.1016/j.cgh.2020.12.029DOI Listing
December 2020

Racial and Ethnic Disparities in Germline Genetic Testing of Patients With Young-Onset Colorectal Cancer.

Clin Gastroenterol Hepatol 2020 Dec 24. Epub 2020 Dec 24.

Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas; Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas; Department of Population & Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas. Electronic address:

Background & Aims: Up to 20% of younger patients (age <50 years) diagnosed with colorectal cancer (CRC) have germline mutations in cancer susceptibility genes. Germline genetic testing may guide clinical management and facilitate earlier intervention in affected relatives. Few studies have characterized differences in genetic testing by race/ethnicity.

Methods: We identified young adults (age 18-49 years) diagnosed with CRC between 2009 and 2017 in 2 health systems in Dallas, TX. We evaluated referral to genetic counseling, attendance at genetic counseling appointments, and receipt of germline genetic testing by race/ethnicity.

Results: Of 385 patients with young-onset CRC (median age at diagnosis 44.4 years), 176 (45.7%) were Hispanic, 98 (25.4%) non-Hispanic Black, and 111 (28.8%) non-Hispanic White. Most patients (76.9%) received immunohistochemistry (IHC) for mismatch repair proteins, and there was no difference in receipt of IHC by race/ethnicity. However, a lower proportion of Black patients were referred to genetic counseling (50.0% vs. White patients 54.1% vs. Hispanic patients 65.9%, p = .02) and attended genetic counseling appointments (61.2% vs. 81.7% White patients vs. 86.2% Hispanic patients, p < .01). Of 141 patients receiving genetic testing, 38 (27.0%) had a pathogenic or likely pathogenic variant in a cancer susceptibility gene. An additional 33 patients (23.4%) had variants of uncertain significance, of which 84.8% occurred in racial/ethnic minorities.

Conclusions: In a diverse population of patients diagnosed with young-onset CRC, we observed racial/ethnic differences in referral to and receipt of germline genetic testing. Our findings underscore the importance of universal genetic testing to address racial/ethnic disparities in young-onset CRC.
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http://dx.doi.org/10.1016/j.cgh.2020.12.025DOI Listing
December 2020

Randomized Clinical Trial of Inreach With or Without Mailed Outreach to Promote Hepatitis C Screening in a Difficult-to-Reach Patient Population.

Am J Gastroenterol 2021 05;116(5):976-983

Department of Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.

Introduction: Hepatitis C virus (HCV) treatment can significantly reduce the risk of liver-related mortality; however, many patients remain unaware of their infection in clinical practice. The aim of this study is to compare the effectiveness of inreach, with and without mailed outreach, to increase HCV screening and follow-up in a large, difficult-to-reach patient population.

Methods: We conducted a pragmatic randomized clinical trial from August 2018 to May 2019 in a large safety-net health system. Patients born between 1945 and 1965 were randomly assigned (1:1) to inreach with an electronic health record reminder to providers (n = 6,195) or inreach plus mailed HCV screening outreach (n = 6,191) to complete HCV antibody screening. Outreach also included processes to promote HCV RNA testing among those with a positive HCV antibody and linkage to care among those with positive HCV RNA. The primary outcome was completion of HCV antibody testing within 3 months of randomization (ClinicalTrials.gov NCT03706742).

Results: We included 12,386 eligible patients (median age 60 years; 46.5% Hispanic, 33.0% Black, and 16.0% White). In intent-to-treat analyses, HCV screening completion was significantly higher among inreach-plus-outreach patients than inreach-alone patients at 3 months (14.6% vs 7.4%, P < 0.001) and 6 months (17.4% vs 9.8%, P < 0.001) after randomization. Among those who completed HCV screening within 6 months, a higher proportion of inreach-plus-outreach patients with positive antibody results completed RNA testing within 3 months than inreach-alone patients (81.1% vs 57.1%, respectively, P = 0.02); however, linkage to care within 3 months of HCV infection confirmation did not significantly differ between the 2 groups (48.1% vs 75.0%, respectively, P = 0.24).

Discussion: Among difficult-to-reach patients, a combination of inreach and mailed outreach significantly increased HCV screening compared with inreach alone. However, HCV screening completion in both arms remained low, highlighting a need for more intensive interventions.
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http://dx.doi.org/10.14309/ajg.0000000000001085DOI Listing
May 2021

Outcome of Hepatocellular Carcinoma Detected During Surveillance: Comparing USA and Japan.

Clin Gastroenterol Hepatol 2020 Oct 22. Epub 2020 Oct 22.

Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, Texas.

Background & Aims: Differences in outcomes of hepatocellular carcinoma (HCC) between countries have been largely attributed to variation in the conduct of surveillance and subsequent HCC treatment eligibility. However, differences in outcomes among those detected under surveillance have not been well described. We compared characteristics and prognosis between patients with surveillance-detected HCC from the United States (US) and Japan.

Methods: Patients in whom initial HCC was detected under surveillance between January 2006 and December 2015 from two centers in the US and two from Japan were included. Survival was compared between patients from the US and Japan using multivariable Cox regression analysis and propensity-score matched analysis. We performed subgroup analyses by liver disease etiology, tumor stage, and type of HCC treatment.

Results: Of 3788 HCC patients, 1797 (47.4%) were diagnosed under surveillance, 715 from the US and 1082 from Japan. Patients from the US diagnosed under surveillance had worse liver dysfunction and larger tumor burden than those from Japan. In multivariate analysis, US patients with surveillance-detected HCC had significantly worse survival than those from Japan (HR 1.17, 95% CI 1.00-1.35), which was also observed in propensity-score matched analysis. However, this difference was no longer significant after adjusting for treatment type (HR 1.07, 95% CI 0.92-1.25). When stratified by treatment type, survival was comparable between the two countries except lower survival among patients who underwent resection in the US versus Japan.

Conclusions: Prognosis of patients with surveillance-detected HCC is poorer in the US than Japan, primarily driven by differences in treatment delivery. Studies are necessary to elucidate reasons for these differences.
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http://dx.doi.org/10.1016/j.cgh.2020.10.033DOI Listing
October 2020

Harms of hepatocellular carcinoma surveillance.

Curr Hepatol Rep 2019 Dec 15;18(4):383-389. Epub 2019 Oct 15.

Division of Digestive and Liver Diseases, Department of Internal Medicine, UT Southwestern Medical Center, Dallas TX.

Purpose Of Review: Hepatocellular carcinoma (HCC) surveillance in patients with cirrhosis is associated with decreased mortality by enabling early tumor detection. However, the benefits of any cancer screening program must be considered in light of potential physical, financial, and psychological harms, as well as the risk of overdiagnosis. Herein, we summarize the potential harms of HCC surveillance.

Recent Findings: To date, two retrospective studies have addressed physical harms of HCC surveillance. Based on these data, 15% to 28% of patients undergoing HCC surveillance experience physical harm including additional cross-sectional imaging or liver biopsy. Although psychological and financial harms have been reported for other cancers, there are currently limited data specific to HCC. An ongoing multi-center prospective study assessing all four types of harms should provide data in near future.

Summary: HCC screening may prevent death by diagnosing tumors at an early stage, but limited sensitivity and specificity of screening tests can result in unintended harms. There is a need for further quality data evaluating both the benefits and harms of HCC surveillance.
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http://dx.doi.org/10.1007/s11901-019-00488-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7673298PMC
December 2019

Reply: Wang et al, "Should growth pattern of hepatocellular carcinoma be constant and homogenous?"

Hepatology 2020 Nov 18. Epub 2020 Nov 18.

Division of Digestive and Liver Diseases, Department of Internal Medicine, UT Southwestern Medical Center, Dallas TX, USA, Dallas.

We appreciate the letter from Wang et al regarding our recent publication. We agree that the study of tumor growth patterns is challenging, and the ideal model for determining tumor growth remains debated. We used the Schwartz equation for our analyses, which remains the most widely used model across cancer types. This model assumes that tumors grow at a consistent (exponential, rather than linear) rate and HCCs are relatively homogeneous. Exponential growth models assume that tumor cells continue to divide without constraint, and therefore are good models of early tumor growth.
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http://dx.doi.org/10.1002/hep.31638DOI Listing
November 2020

Utilizing public health data to geotarget hepatitis C virus elimination approaches in urban and rural Michigan.

J Viral Hepat 2021 Feb 27;28(2):440-444. Epub 2020 Nov 27.

Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA.

Using Michigan public health data, we assessed geographical access to specialist providers for hepatitis C virus (HCV) treatment in urban and rural areas in Michigan and explored correlates of HCV in these areas to help inform HCV elimination planning and resource allocations. We found higher HCV incidence in urban areas, lower treatment specialist access in rural areas, but few correlates of HCV across adult populations in both areas. State and local HCV elimination planning should include population-based screening among all adults and address geographical barriers to care.
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http://dx.doi.org/10.1111/jvh.13438DOI Listing
February 2021