Characterization of social determinants of health of a liver transplant referral population.

Disparities exist in referral and access to the liver transplant (LT) waitlist, and social determinants of health (SDOH) are increasingly recognized as important factors driving health inequities, including in LT. The SDOH of potential transplant candidates is therefore important to characterize when designing targeted interventions to promote equity in access to LT. Yet, it is uncertain how a transplant center should approach this issue, characterize SDOH, identify disparities, and use these data to inform interventions. We performed a retrospective study of referrals for first-time, single-organ LT to our center from 2016 to 2020. Addresses were geoprocessed and mapped to the corresponding county, census tract, and census block group to assess their geospatial distribution, identify potential disparities in referrals, and characterize their communities across multiple domains of SDOH to identify potential barriers to evaluation and selection. We identified variability in referral patterns and areas with disproportionately low referrals, including counties in the highest quartile of liver disease mortality (9%) and neighborhoods in the highest quintile of socioeconomic deprivation (17%) and quartile of poverty (21%). Black individuals were also under-represented compared with expected state demographics (12% vs. 18%). Among the referral population, several potential barriers to evaluation and selection for LT were identified, including poverty, educational attainment, access to healthy food, and access to technology. This approach to the characterization of a transplant center's referral population by geographic location and associated SDOH demonstrates a model for identifying disparities in a referral population and potential barriers to evaluation that can be used to inform targeted interventions for disparities in LT access.

Racial and Socioeconomic Disparities in Utilization of Telehealth in Patients with Liver Disease During COVID-19.

BACKGROUND AND AIMS: The coronavirus disease 2019 (COVID-19) pandemic resulted in a rapid expansion of telehealth services in hepatology. However, known racial and socioeconomic disparities in internet access potentially translate into barriers for the use of telehealth, particularly video technology. The specific aim of this study was to determine if disparities in race or socioeconomic status exist among patients utilizing telehealth visits during COVID-19. METHODS: We performed a retrospective cohort study of all adult patients evaluated in hepatology clinics at Duke University Health System. Visit attempts from a pre-COVID baseline period (January 1, 2020 through February 29, 2020; n = 3328) were compared to COVID period (April 1, 2020 through May 30, 2020; n = 3771). RESULTS: On multinomial regression modeling, increasing age was associated with higher odds of a phone or incomplete visit (canceled, no-show, or rescheduled after May 30,2020), and non-Hispanic Black race was associated with nearly twice the odds of completing a phone visit instead of video visit, compared to non-Hispanic White patients. Compared to private insurance, Medicaid and Medicare were associated with increased odds of completing a telephone visit, and Medicaid was associated with increased odds of incomplete visits. Being single or previously married (separated, divorced, widowed) was associated with increased odds of completing a phone compared to video visit compared to being married. CONCLUSIONS: Though liver telehealth has expanded during the COVID-19 pandemic, disparities in overall use and suboptimal use (phone versus video) remain for vulnerable populations including those that are older, non-Hispanic Black, or have Medicare/Medicaid health insurance.

Impact of Malnutrition on Outcomes in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Insertion.

BACKGROUND: Malnutrition is common in patients with cirrhosis and is associated with poor outcomes after hepatic resection and liver transplantation. Transjugular intrahepatic portosystemic shunt (TIPS) is performed for complications of cirrhosis. AIM: To assess the impact of malnutrition on TIPS outcomes. METHODS: A retrospective analysis was performed using the Healthcare Cost and Utilization Project: National Inpatient Sample database for TIPS procedures from 2005 to 2014. The primary end point was in-hospital mortality. The association of specific malnutrition diagnostic codes and race-ethnicity on mortality was evaluated with survey-weighted logistic regression adjusted for age, gender, admission type, insurance payer, hospital region, comorbidities, and length of stay (LOS). RESULTS: From 2005 to 2014, an estimated 53,207 (95% CI 49,330-57,085) admissions with TIPS occurred. A diagnosis of malnutrition was present in 11%. In-hospital death post-TIPS occurred in 15.0% versus 10.7% (p value < 0.001) of patients with and without malnutrition, respectively. Patients with malnutrition had longer post-procedural LOS (median 6.7 vs. 2.9 days, p value < 0.001) and greater total hospital charges (median $144,752 vs. $79,781, p value < 0.001) and were more likely to be discharged to a skilled nursing facility (21.6% vs. 9.7%) than patients without malnutrition. Patients with malnutrition had increased odds of mortality (OR 1.31, 95% CI 1.07, 1.59) compared to patients with no malnutrition. CONCLUSION: Malnutrition was associated with worse outcomes after TIPS. Further research is needed to understand the mechanism of malnutrition in post-procedure outcomes and the ability of interventions for nutritional optimization to improve outcomes.

Addressing Hepatitis C in the American Incarcerated Population: Strategies for Nationwide Elimination.

PURPOSE OF REVIEW: The prevalence of Hepatitis C virus (HCV) in the US incarcerated population is disproportionately high, and when inmates with infection are released back into the general population, they play a substantial role in the spread of disease. This review provides support for targeting the jail/prison population to eliminate HCV in the general population. It will also summarize various screening/treatment models to curtail the burden of disease behind and beyond bars. RECENT FINDINGS: Transitioning from risk-based testing to opt-out testing in prisons/jails would be cost-effective through greater identification of cases and treatment to prevent complications from cirrhosis. Other innovative strategies, such as the nominal pricing mechanism or the "Netflix" DAA subscription model, have the potential to be cost-effective and to increase access to treatment. Addressing HCV in the incarcerated population is a strategy to bring the US closer to successfully eradicating the epidemic. Such findings should incentivize policymakers to implement care models that target this population.

The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial.

INTRODUCTION: Among patients with hepatitis C virus (HCV) infection, alcohol synergistically increases the risk of cirrhosis, hepatocellular carcinoma, and death. Randomized controlled trials of integrated models of HCV-alcohol treatment have been recommended but only performed in patients with severe alcohol use disorders. OBJECTIVES: This pragmatic randomized controlled trial seeks to compare clinical effectiveness and cost-effectiveness of integrated alcohol treatment compared to enhanced treatment as usual (TAU) on alcohol consumption and economic outcomes among patients ever infected with HCV. METHODS: Patients recruited from three liver centers who had current or prior chronic HCV and qualifying alcohol screener scores were randomly assigned to enhanced TAU or the Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention. All patients received enhanced TAU, consisting of a patient-administered alcohol screener and care from medical providers who were trained in Screening, Brief Intervention and Referral to Treatment (SBIRT), including brief motivational interviewing counseling. The Hep ART intervention combined enhanced TAU with up to six months of integrated co-located individual and/or group therapy that provided motivational, cognitive, and behavioral strategies to reduce alcohol consumption. The Timeline Followback (TLFB) Method was used to evaluate alcohol use at baseline, 3, 6, and 12 months. Primary outcomes are alcohol abstinence and fewer heavy drinking days, and for the cost-effectiveness analysis, measures included grams of alcohol consumed. DISCUSSION: This study will determine whether Hep ART, a six-month integrated alcohol treatment, compared to enhanced TAU, is both clinically effective and cost-effective in patients with a history of comorbid HCV and alcohol use.

Significant Morbidity and Mortality Among Hospitalized End-Stage Liver Disease Patients in Medicare.

CONTEXT: For end-stage liver disease (ESLD) patients, care focuses on managing the life-threatening complications of portal hypertension, causing high resource utilization. OBJECTIVES: To describe the end-of-life trajectory of hospitalized ESLD patients in Medicare. METHODS: Using a 5% random sample of Medicare fee-for-service beneficiaries, we performed a retrospective cohort study, identifying hospitalized ESLD and heart failure (HF) patients (2007-2011). Index hospitalization end points included mortality, discharge to hospice, and length of stay. Postdischarge end points included all-cause mortality, rehospitalization, hospice enrollment, and days alive and out of hospital (DAOH). Follow-up was at one and three years after index hospitalization discharge. A reference cohort of decompensated HF patients was used for baseline comparison. RESULTS: At one year, the ESLD cohort (n = 22,311) had 209 DAOH; decompensated HF (n = 85,397) had 252 DAOH. Among ESLD patients, inpatient mortality was 13.5%; all-cause mortality was 64.9%. For these outcomes, rates were higher in those with ESLD than HF. In the ESLD group, rehospitalization rate was 59.1% (slightly lower than the HF group), hospice enrollment rate was 36.1%, and there were higher than expected cancer rates. For hospice-enrolled patients, the median length of time spent in hospice was nine days. The HF cohort had lower hospice enrollment, but more days enrolled. CONCLUSION: The results of this study show that morbidity and mortality rates associated with end of life in ESLD are substantial. There is an acute need for alternative approaches to manage the care of ESLD patients.

Role of patient factors, preferences, and distrust in health care and access to liver transplantation and organ donation.

Despite major improvements in access to liver transplantation (LT), disparities remain. Little is known about how distrust in medical care, patient preferences, and the origins shaping those preferences contribute to differences surrounding access. We performed a single-center, cross-sectional survey of adults with end-stage liver disease and compared responses between LT listed and nonlisted patients as well as by race. Questionnaires were administered to 109 patients (72 nonlisted; 37 listed) to assess demographics, health care system distrust (HCSD), religiosity, and factors influencing LT and organ donation (OD). We found that neither HCSD nor religiosity explained differences in access to LT in our population. Listed patients attained higher education levels and were more likely to be insured privately. This was also the case for white versus black patients. All patients reported wanting LT if recommended. However, nonlisted patients were significantly less likely to have discussed LT with their physician or to be referred to a transplant center. They were also much less likely to understand the process of LT. Fewer blacks were referred (44.4% versus 69.7%; P = 0.03) or went to the transplant center if referred (44.4% versus 71.1%; P = 0.02). Fewer black patients felt that minorities had as equal access to LT as whites (29.6% versus 57.3%; P < 0.001). For OD, there were more significant differences in preferences by race than listing status. More whites indicated OD status on their driver's license, and more blacks were likely to become an organ donor if approached by someone of the same cultural or ethnic background (P < 0.01). In conclusion, our analysis demonstrates persistent barriers to LT and OD. With improved patient and provider education and communication, many of these disparities could be successfully overcome. Liver Transplantation 22 895-905 2016 AASLD.

Hepatitis C Virus Treatment: Is It Possible To Cure All Hepatitis C Virus Patients?

The recent advances in hepatitis C virus (HCV) therapeutics have brought combinations of direct acting antiviral medications that offer interferon-free, well-tolerated regimens with sustained virologic response rates greater than 90% in clinical trials for many patient groups. The successes have prompted discussions regarding cure for all patients. These regimens have already demonstrated the ability to cure previously challenging patient groups, including human immunodeficiency virus-HCV coinfection, decompensated cirrhosis, and post-liver transplantation. Limitations exist in the current portfolio of agents, with suboptimal outcomes for genotype 3 and limited data in genotypes 5 and 6. More data are urgently needed in patients with chronic kidney disease and in children. With ongoing developments, highly effective regimens for all these patient groups are within reach. To deliver HCV treatment throughout the world and particularly in low- and middle-income countries, regimens need to be affordable but also pan-genotypic, well-tolerated, and delivered once daily for 4-8 weeks. With such a regimen, cure for all patients would then hinge on the ability to identify patients with HCV infection and deliver treatment within their communities. This review will discuss the strategies that will be necessary to realize this opportunity to cure all persons with HCV infection.

Economic evaluation of direct-acting antiviral therapy in chronic hepatitis C.

In 2011, the protease inhibitors boceprevir and telaprevir were approved in the United States and European Union for the treatment of hepatitis C infection. While remarkably effective, the newly approved therapies are also accompanied by additional side effects and considerable costs. Understanding the balance between costs and effectiveness is critical to making decisions about the optimal use of these new agents, especially for health care systems constrained by rising costs. Our goal for this review is to facilitate an understanding of the importance of cost-effectiveness analyses in guiding policy decisions about the use of newly approved drugs as well as future therapies for hepatitis C.

Cost-effectiveness of truncated therapy for hepatitis C based on rapid virologic response.

BACKGROUND: Shortened courses of treatment with pegylated interferon alfa and ribavirin for patients with hepatitis C virus infection who experience rapid virologic response can be effective in appropriately selected patients. The cost-effectiveness of truncated therapy is not known. OBJECTIVE: To assess the cost-effectiveness of response-guided therapy versus standard-duration therapy on the basis of best available evidence. METHODS: We developed a decision model for chronic hepatitis C virus infection representing two treatment strategies: 1) standard-duration therapy with pegylated interferon alfa and ribavirin for 48 weeks in patients with genotype 1 or 4 and for 24 weeks in patients with genotype 2 or 3 and 2) truncated therapy (i.e., 50% decrease in treatment duration) in patients with rapid virologic response. Patients for whom truncated therapy failed began standard-duration therapy guided by genotype. We used a Markov model to estimate lifetime costs and quality-adjusted life-years. RESULTS: In the base-case analysis, mean lifetime costs were $46,623 ± $2,483 with standard-duration therapy and $42,354 ± $2,489 with truncated therapy. Mean lifetime quality-adjusted life-years were similar between the groups (17.1 ± 0.7 with standard therapy; 17.2 ± 0.7 with truncated therapy). Across model simulations, the probability of truncated therapy being economically dominant (i.e., both cost saving and more effective) was 78.6%. The results were consistent when we stratified the data by genotype. In one-way sensitivity analyses, the results were sensitive only to changes in treatment efficacy. CONCLUSION: Truncated therapy based on rapid virologic response is likely to be cost saving for treatment-naive patients with chronic hepatitis C virus infection. Cost-effectiveness varied with small changes in relative treatment efficacy.

Disparities in liver transplantation before and after introduction of the MELD score.

CONTEXT: In February 2002, the allocation system for liver transplantation became based on the Model for End-Stage Liver Disease (MELD) score. Before MELD, black patients were more likely to die or become too sick to undergo liver transplantation compared with white patients. Little information exists regarding sex and access to liver transplantation. OBJECTIVE: To determine the association between race, sex, and liver transplantation following introduction of the MELD system. DESIGN, SETTING, AND PATIENTS: A retrospective cohort of black and white patients (> or = 18 years) registered on the United Network for Organ Sharing liver transplantation waiting list between January 1, 1996, and December 31, 2000 (pre-MELD cohort, n = 21 895) and between February 28, 2002, and March 31, 2006 (post-MELD cohort, n = 23 793). MAIN OUTCOME MEASURES: Association between race, sex, and receipt of a liver transplant. Separate multivariable analyses evaluated cohorts within each period to identify predictors of time to death and the odds of dying or receiving liver transplantation within 3 years of listing. Patients with hepatocellular carcinoma were analyzed separately. RESULTS: Black patients were younger (mean [SD], 49.2 [10.7] vs 52.4 [9.2] years; P < .001) and sicker (MELD score at listing: median [interquartile range], 16 [12-22] vs 14 [11-19]; P < .001) than white patients on the waiting list for both periods. In the pre-MELD cohort, black patients were more likely to die or become too sick for liver transplantation than white patients (27.0% vs 21.7%) within 3 years of registering on the waiting list (odds ratio [OR], 1.51; 95% confidence interval (CI), 1.15-1.98; P = .003). In the post-MELD cohort, black race was no longer associated with increased likelihood of death or becoming too sick for liver transplantation (26.5% vs 22.0%, respectively; OR, 0.96; 95% CI, 0.74-1.26; P = .76). Black patients were also less likely to receive a liver transplant than white patients within 3 years of registering on the waiting list pre-MELD (61.6% vs 66.9%; OR, 0.75; 95% CI, 0.59-0.97; P = .03), whereas post-MELD, race was no longer significantly associated with receipt of a liver transplant (47.5% vs 45.5%, respectively; OR, 1.04; 95% CI, 0.84-1.28; P = .75). Women were more likely than men to die or become too sick for liver transplantation post-MELD (23.7% vs 21.4%; OR, 1.30; 95% CI, 1.08-1.47; P = .003) vs pre-MELD (22.4% vs 21.9%; OR, 1.08; 95% CI, 0.91-1.26; P = .37). Similarly, women were less likely than men to receive a liver transplant within 3 years both pre-MELD (64.8% vs 67.6%; OR, 0.80; 95% CI, 0.70-0.92; P = .002) and post-MELD (39.9% vs 48.7%; OR, 0.70; 95% CI, 0.62-0.79; P < .001). CONCLUSION: Following introduction of the MELD score to the liver transplantation allocation system, race was no longer associated with receipt of a liver transplant or death on the waiting list, but disparities based on sex remain.

An examination of factors predicting prioritization for liver transplantation.

With the recent transition of the liver transplant allocation system to the Model for End-Stage Liver Disease, a major change is its reliance entirely on objective criteria. In previous reports, potential donor families and members of the transplant community have questioned the fairness of the subjective nature of previous systems. Therefore, we examined the United Network for Organ Sharing database to determine if the previous allocation system benefited a particular group in prioritization for transplant. We included adult patients with chronic liver disease listed for transplant in the year 2000. Patients who had ever been listed as status 2A or 2B were analyzed. A multivariable analysis examined the patient characteristics that predicted being uplisted to status 2A. Of the 9244 patients, 2376 (25.7%) had received a liver transplant as a status 2A or had been listed as status 2A. In the multivariate analysis, the strongest patient characteristics that predicted status 2A were listing in the western United States and shorter duration of registration. Other predictors include blood type O, college education, unemployment, and coverage with private insurance or a health maintenance organization/preferred provider organization. In addition, patients with Laennec's cirrhosis were less likely to be uplisted to status 2A. Age, gender, and race were not predictors of uplisting to status 2A. In conclusion, these data show the wide range of practice patterns with the use of status 2A, and these findings suggest that certain patient groups might have received preference in the previous liver transplant allocation system.