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In a phase 3 randomized trial, 199 patients with type 1 hepatorenal syndrome were assigned to receive the vasoconstrictor terlipressin plus albumin and 101 to receive placebo plus albumin. Renal function was better with terlipressin than with placebo; however, mortality was not lower, and terlipressin was associated with adverse events, including respiratory failure.

The prevalence of Hepatitis C Virus (HCV) infection is significantly higher in patients with end-stage renal disease compared to the general population and poses important clinical challenges in patients who undergo kidney transplantation. Historically, interferon-based treatment options have been limited by low rates of efficacy and significant side effects, including risk of precipitating rejection. Limited data exist on the use of all-oral, interferon-free direct-acting antiviral (DAA) therapies in kidney transplant recipients. In this study, we performed a retrospective chart review with prospective clinical follow-up of post-kidney transplant patients treated with DAA therapies at three major hospitals in Boston, MA. A total of 24 kidney recipients with HCV infection received all-oral DAA therapy post-transplant. Patients were predominantly male (79%) with a median age of 60 years (range 34-70 years), median creatinine of 1.2 mg/dL (0.66-1.76), and 42% had advanced fibrosis or cirrhosis. The majority had HCV genotype 1a infection (58%). All patients received full-dose sofosbuvir; it was paired with simeprevir (9 patients without and 3 patients with ribavirin), ledipasvir (7 patients without and 1 patient with ribavirin) or ribavirin alone (4 patients). The overall sustained virologic response (SVR12) was 91% (21 out of 23 patients). One patient achieved SVR4 but demised prior to SVR12 check point due to treatment unrelated cause. Two treatment failures were successfully retreated with alternative DAA regimens and achieved SVR. Both initials failures occurred in patients with advanced fibrosis or cirrhosis, with genotype 1a infection, and prior HCV treatment failure. Adverse events were reported in 11 patients (46%) and were managed clinically without discontinuation of therapy. Calcineurin inhibitor trough levels did not significantly change during therapy. In this multi-center series of patients, all-oral DAA therapy appears to be safe and effective in post-kidney transplant patients with chronic HCV infection.

Background Accurate assessment of viable HCC on pre-transplant cross sectional imaging is important for correct organ allocation and overall patient outcome following liver transplantation. Purpose Determine accuracy of LI-RADS TRA compared to explant pathology in patients treated with thermal ablation, using contrast enhanced multiphase CT and MRI. Materials and methods Imaging studies for 119 consecutive adult HCC patients treated with thermal ablation and liver transplantation from March 2001 to September 2019 at a single tertiary care hospital were retrospectively studied by three Board-certified radiologists. LI-RADS TRA categories for each tumor were compared with explant pathology. Cohens Kappa test and inter-reader agreement by Fleiss κ test, with 95% confidence intervals obtained with bootstrap technique were used. Results Of the 119 patients (median age 59 years, 95 [80%] male) with 165 HCCs treated with percutaneous thermal ablation, 68% were completely necrotic and 32% were viable on pathologic analysis. Tumors viable on explant were larger on pre-treatment imaging (median 2.4 vs. 2.1 cm; p  = 0.02) with no difference in pre-transplant ablation cavity sizes between groups (4.0 vs. 3.9 cm, respectively; p  = 0.58). NPV of LI-RADS TRA for viable tumor was 71% (68–74); PPV of 62.5% (39–81) ( p  = 0.01) with a sensitivity of 19% (9.4–32), specificity of 95% (89–98), and accuracy of 70% (63–77). On explant, 55 incidental treatment naïve viable tumors, not visible on pre-transplant imaging, were found in 33 patients. Conclusion The “non-viable” category of LI-RADS TRA even when applied to a relatively uniform percutaneous ablation cohort, demonstrated low sensitivity in predicting absence of viable tumor. MRI had more accuracy than CT in predicting tumor viability when compared to explant pathology.

Background and Aims. Nonalcoholic fatty liver disease is the leading cause of chronic liver disease globally and can progress to cirrhosis, liver failure, and liver cancer. Current AASLD, AGA, and ADA guidelines recommend assessment for liver fibrosis in all patients with NAFLD. Serum biomarkers for fibrosis, while widely available, have notable limitations. Imaging-based noninvasive testing for liver fibrosis/cirrhosis is more accurate and is becoming more widespread. Methods. We evaluated the feasibility of a novel shear wave absolute vibroelastography (S-WAVE) modality called Velacur® for assessing liver stiffness measurement (LSM) for fibrosis and attenuation coefficient estimation (ACE) in differentiating patients with chronic liver disease from normal healthy controls. Results. Fifty-four healthy controls and 89 patients with NAFLD or cured HCV with a prior known LSM of >8 kPa were enrolled, and all subjects were evaluated with FibroScan® and Velacur®. Velacur® was able to discriminate patients with increased liver stiffness as determined by a FibroScan® score of >8 kPa from healthy controls with an AUC of 0.938 (0.88-0.96). For assessment of steatosis in NAFLD patients only, Velacur® could identify patients with steatosis from healthy controls with an AUC of 0.831 (0.777-0.880). The Velacur® scan quality assessment was superior in healthy controls, as compared to patients, and the scan quality, as assessed by the quality factor (QF) and interquartile range (IQR)/median, was affected by BMI. Velacur® was safe and well tolerated by patients, and there were no adverse events. Conclusion. Velacur® assessment of liver stiffness measurement and liver attenuation is comparable to results obtained by FibroScan® and is an alternative technology for monitoring liver fibrosis progression in patients with chronic liver disease. This trial is registered with NCT03957070.

In this phase 3 study involving patients with HCV genotype 1, 2, 3, 4, or 6 and decompensated cirrhosis, sofosbuvir–velpatasvir with or without ribavirin for 12 weeks or sofosbuvir–velpatasvir for 24 weeks resulted in high rates of sustained virologic response. The number of patients with decompensated cirrhosis caused by chronic infection with the hepatitis C virus (HCV) is projected to rise in the coming decade. 1 For many years, the only treatment option for such patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis and that successful treatment is associated with early improvement in liver function. 2 – 11 The possible long-term benefits of treatment on existing liver disease remain unknown. The only regimen that is currently approved for the . . .

In two trials involving patients with hepatitis C in whom previous treatment with direct-acting antiviral agents failed, treatment for 12 weeks with sofosbuvir, velpatasvir, and voxilaprevir achieved high rates of sustained virologic response. The majority of patients who are chronically infected with hepatitis C virus (HCV) can now be successfully treated with drugs that directly target viral replication. 1 , 2 Combination regimens of direct-acting antiviral agents (DAAs) provide rates of sustained virologic response exceeding 90%, regardless of HCV genotype, disease stage, or treatment history. 3 The proportion of patients who do not have a sustained virologic response to treatment with approved regimens is small, but given the size of the infected population — estimates range up to 150 million people worldwide 4 — the absolute number of such patients is substantial and will increase as more . . .

Cirrhosis, a rising cause of death in the United States, has an extended preclinical phase characterized by progressive liver fibrosis. Despite the developments in noninvasive fibrosis measurement, there is no recommended screening, in part due to an incomplete understanding of the disease epidemiology on a national scale. Herein, we aim to define the prevalence of liver fibrosis and compare strategies to identify the at‐risk population. We analyzed 4,510 US adults with complete liver stiffness measurement (LSM) by vibration‐controlled transient elastography (VCTE) in the 2017‐2018 National Health and Nutrition Examination Survey to estimate the disease burden of increased liver stiffness. An estimated 11.6 million (95% confidence interval [C.I.], 8.1‐15.0 million) US adults had LSM ≥9.5 kPa, indicating advanced fibrosis and representing 1 in every 18 adults. Among them, 7.1 million (95% CI, 5.0‐9.1 million) had LSM ≥12.5 kPa, which is concerning for cirrhosis. LSM ≥9.5 kPa is associated with male sex (S), history of other liver diseases (O), diabetes (D), advanced age (A), and an elevated BMI (B). A simple SODA‐2B score had a sensitivity of 96.4% in identifying individuals at risk for advanced cirrhosis (LSM ≥9.5 kPa) and a negative predictive value of 99.3% in stratifying more than half of the adult population. When the liver function test (LFT) is available, the inclusion of abnormal LFT and elevated fibrosis‐4 index can further increase screening efficiency. Conclusion: Elevated liver stiffness is prevalent among US adults. A SODA‐2B score can risk stratify adults for VCTE‐based fibrosis screening.

Real‐world data are limited on tenofovir alafenamide (TAF). We aimed to study TAF real‐world outcomes with other first‐line regimens for chronic hepatitis B (CHB). We enrolled patients with CHB from 10 centers retrospectively and followed them for 36 months prospectively. We analyzed switching patterns of antiviral therapy and treatment outcomes of TAF, tenofovir disoproxil fumarate (TDF), and entecavir therapy. For efficacy and safety, we analyzed a subset of patients with complete data at 24 months after switching to TAF or remaining on TDF or entecavir. Among 1037 enrollees, 889 patients were analyzed. The mean age was 52%, and 72% were hepatitis B e antigen–negative. After enrollment, shifts in therapies were mostly in reduced use of TDF from 63% to 30% due to switching to TAF. Clinical parameters were compared at enrollment or initiation to measures at 24 months for patients remaining on TAF (187), TDF (229), or entecavir (181). At 24 months, a significantly higher portion of patients on TAF achieved hepatitis B virus (HBV) DNA ≤ 20 IU/ml (93% vs. 86%; p = 0.012) and normalized alanine aminotransferase (ALT) (66% vs. 56%; p = 0.031) with stable estimated glomerular filtration rates (eGFRs). However, a higher percentage of the patient with eGFR < 60 ml/mi/1.7 m2 was observed in the TDF‐treated group (9% vs. 4%; p = 0.010). In patients who remained on entecavir or TDF for 24 months, ALT and HBV‐DNA results did not differ significantly from baseline. Treatment of CHB in the United States has significantly shifted from TDF to TAF. Our data suggest that switching from TDF or entecavir to TAF may result in increased frequency of ALT normalization and potential clearance of viremia at the 24‐month time point. Treatment of CHB in the US has significantly shifted from TDF to TAF. Our data suggest that switching from TDF or entecavir to TAF increased the frequency of ALT normalization and clearance of viremia.

Cirrhosis is a common condition that complicates the management of patients who require critical care. There is interest in identifying scoring systems that may be used to predict outcome because of the poor odds for recovery despite high-intensity care. We sought to evaluate how Model for End-Stage Liver Disease (MELD), an organ-specific scoring system, compares with other severity of illness scoring systems in predicting short- and long-term mortality for critically ill cirrhotic patients. This was a retrospective cohort study involving seven intensive care units (ICUs) in a tertiary care, academic medical center. Adult patients with cirrhosis who were admitted to an ICU between 2001 and 2008 were evaluated. Severity of illness scores (MELD and Sequential Organ Failure Assessment [SOFA]) were calculated on admission and at 24 and 48 hours. The primary end points were 28-day and 1-year all-cause mortality. Of 19742 ICU hospitalizations, 848 had cirrhosis. Relevant data were available for 521 patients (73%). Of these cases, 353 patients (69.5%) were admitted to medical ICU (MICU), and the other 155 (30.5%), to surgical unit. Alcohol abuse and hepatitis C were the most common reasons for cirrhosis. Patients who died within 28 days were more likely to receive mechanical ventilation, pressors, and renal replacement therapy. Among 353 medical admissions, both MELD and SOFA were found to be significantly associated with both 28-day and 1-year mortality. Among the 155 surgical admissions, both scores were found to be not significant for 28-day mortality but were significant for 1 year. Our results demonstrate that the prognostic ability of a variety of scoring systems strongly depends on the patient population. In the MICU population, each model (MELD + SOFA, MELD, and SOFA) demonstrates excellent discrimination for 28-day and 1-year mortality. However, these scoring systems did not predict 28-day mortality in the surgical ICU group but were significant for 1-year mortality. This suggests that patients admitted to a surgical ICU will behave similarly to their MICU cohort if they survive the perioperative period.