COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.

Introduction: Obeticholic acid (OCA) treatment for primary biliary cholangitis (PBC) was conditionally approved in the phase 3 POISE trial. The COBALT confirmatory trial assessed whether clinical outcomes in patients with PBC improve with OCA therapy.

Methods: Patients randomized to OCA (5-10 mg) were compared with placebo (randomized controlled trial [RCT]) or external control (EC).

A randomized multicenter trial of a chronic disease management intervention for decompensated cirrhosis. The A ustra l ian L iver F a i lur e (ALFIE) trial.

Background And Aims: Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes.

Hepatitis C Virus Antiviral Drug Resistance and Salvage Therapy Outcomes Across Australia.

Background: Hepatitis C virus (HCV) infection can now be cured with well-tolerated direct-acting antiviral (DAA) therapy. However, a potential barrier to HCV elimination is the emergence of resistance-associated substitutions (RASs) that reduce the efficacy of antiviral drugs, but real-world studies assessing the clinical impact of RASs are limited. Here, an analysis of the impact of RASs on retreatment outcomes for different salvage regimens in patients nationally who failed first-line DAA therapy is reported.

Integrating smart phone applications in the management of cirrhotic patients: A scoping review.

Background And Aim: Chronic liver disease and cirrhosis is a significant cause of healthcare utilization and patient morbidity and mortality worldwide. Smartphone applications have high uptake in most communities and therefore have great potential to provide remote support solutions to this patient population. The aim of this scoping review was therefore to provide a comprehensive overview using narrative synthesis on the use of smartphone-application-based digital interventions in cirrhotic populations.

Acute on chronic liver failure: A South Australian experience.

Background And Aim: Acute on chronic liver failure (ACLF) is a clinical syndrome described in patients with acute decompensation (AD) of cirrhosis, characterized by organ failures and high mortality. Intensive management, including liver transplantation (LT), has been shown to improve survival. To address the limited Australian data on ACLF, we describe the prevalence, clinical profile, and outcome of ACLF in an Australian cohort of hospitalized patients.

Monitoring quality of care in hepatocellular carcinoma: A modified Delphi consensus.

Although there are several established international guidelines on the management of hepatocellular carcinoma (HCC), there is limited information detailing specific indicators of good quality care. The aim of this study was to develop a core set of quality indicators (QIs) to underpin the management of HCC. We undertook a modified, two-round, Delphi consensus study comprising a working group and experts involved in the management of HCC as well as consumer representatives.

High rates of treatment stage migration for early hepatocellular carcinoma and association with adverse outcomes: An Australian multicenter study.

Background And Aim: The rate of contraindications to percutaneous ablation (PA) for inoperable early hepatocellular carcinoma (HCC) and subsequent outcomes is not well described. We investigated the prevalence and outcomes of inoperable early HCC patients with contraindications to PA, resulting in treatment stage migration (TSM).

Methods: Barcelona Clinic Liver Cancer (BCLC) 0/A patients diagnosed between September 2013 and September 2019 across five hospitals were identified.

Impact of cardiac dysfunction on morbidity and mortality in liver transplant candidates.

The prognostic role of cardiac dysfunction in cirrhotic patients is increasingly recognized. We studied its impact on morbidity and mortality before and after liver transplantation (LT) including development of post-transplant cardiovascular disease (CVD). In this retrospective study, cirrhotic patients who underwent LT assessment from January 2010 to December 2020 were reviewed.

Circulating cell-specific extracellular vesicles as biomarkers for the diagnosis and monitoring of chronic liver diseases.

Chronic liver diseases represent a burgeoning health problem affecting billions of people worldwide. The insufficient performance of current minimally invasive tools is recognised as a significant barrier to the clinical management of these conditions. Extracellular vesicles (EVs) have emerged as a rich source of circulating biomarkers closely linked to pathological processes in originating tissues.

Association of physiological reserve measures with adverse outcomes following liver transplantation.

Background And Aim: The comparative utility of physiological reserve measures in predicting important clinical outcomes following liver transplantation (LT) requires further study. The aim of this work was therefore to compare the utility of physiological reserve measures in predicting early adverse clinical outcomes post-LT.

Methods: A single-center, retrospective cohort study of LT patients consecutively recruited between 1 January 2015, and 31 August 2020.

Treating chronic hepatitis C in general practice.

Background: Hepatitis C virus (HCV) infection continues to result in significant morbidity and mortality in Australia. Eradication of HCV remains a challenge, with many patients unaware of their infection. With the new era of direct-acting antivirals (DAAs), higher viral eradication rates are attainable, and access to treatment can be expanded by treating most patients with HCV in general practice, moving away from the traditional model of treatment by a gastroenterologist, hepatologist or infectious diseases physician.

Management, outcomes and survival of an Australian IgG4-SC cohort: The MOSAIC study.

Background And Aims: IgG4 sclerosing cholangitis (IgG4-SC) is the biliary component of the multisystem IgG4-related disease. We aimed to investigate the clinical features, demographics, treatment response and outcomes of IgG4-SC in a large Australian cohort.

Methods: We conducted nationwide retrospective cohort via the Australian Liver Association Clinical Trials Network (ALA-CRN).

Nurse Led Clinics; a Novel Model of Care for Compensated Liver Cirrhosis: A Qualitative Analysis.

A nurse-led cirrhosis clinic model for management of stable, compensated cirrhotic patients is practised in our unit since 2013, wherein these patients are reviewed every six months by specialist nurses in community clinics under remote supervision of hepatologists. We evaluated the experiences of patients and healthcare providers involved in the model to understand the acceptability, strengths, and limitations of the model and obtain suggestions to improve. A qualitative design using in-depth interviews was employed, followed by thematic analysis of eight patients, one attending physician both nurse and hospital clinics, four hepatologists, and three experienced specialist nurses running the nurse-led cirrhosis clinic.

Measuring quality of hepatitis B care in a remote Australian Aboriginal community: opportunities for improvement.

Background: Chronic hepatitis B (CHB) infection remains a significant public health issue for Indigenous Australians, in particular for remote communities.

Aim: To evaluate the spectrum of hepatitis B virus (HBV) care provided to a remote Aboriginal community. Measures studied included screening, seroprevalence, vaccination rates and efficacy, and HCC risk and surveillance adherence.

Outcomes of transjugular intrahepatic portosystemic shunt procedures: a 10-year experience.

Introduction: Transjugular intrahepatic portosystemic shunt (TIPSS) is an effective modality in reducing portal pressure, and its current main indications are for the management of recurrent ascites and variceal bleeding. The demand and indications for TIPSS are growing. However, it is a complicated and technically demanding procedure with poorer outcomes associated with low volume centres.

Outcomes of community-based hepatitis C treatment by general practitioners and nurses in Australia through remote specialist consultation.

Background: A unique model of care was adopted in Australia following introduction of universal subsidised direct-acting antiviral (DAA) access in 2016 in order to encourage rapid scale-up of treatment. Community-based medical practitioners and integrated hepatitis nurses initiated DAA treatment with remote hepatitis specialist approval of the planned treatment without physical review.

Aims: To evaluate outcomes of community-based treatment of hepatitis C virus (HCV) through this remote consultation process in the first 12 months of this model of care.

Psychometric validation of the Partners in Health scale as a self-management tool in patients with liver cirrhosis.

Background And Aim: Liver cirrhosis is a chronic disease complicated by recurrent hospital admissions. Self-management skills could facilitate optimal disease management. At present there is no validated instrument for measuring self-management in these patients.

Cost effectiveness of treatment models of care for hepatitis C: the South Australian state-wide experience.

Aim: The objective was to study the long-term (lifetime) cost effectiveness of four different hepatitis C virus (HCV) treatment models of care (MOC) with directly acting antiviral drugs.

Methods: A cohort Markov model-based probabilistic cost-effectiveness analysis (CEA) was undertaken extrapolating to up to 30 years from cost and outcome data collected from a primary study involving a real-life Australian cohort. In this study, noncirrhotic patients treated for HCV from 1 March 2016 to 28 February 2017 at four major public hospitals and liaising sites in South Australia were studied retrospectively.

Validation of Knowledge Questionnaire for Patients With Liver Cirrhosis.

Background & Aims: There is no validated questionnaire to assess disease knowledge and self-management in patients with liver cirrhosis. We developed and validated a Cirrhosis Knowledge Questionnaire (CKQ).

Methods: We created a preliminary CKQ comprising 10 questions relevant to self-management of cirrhosis, based on publications and clinical experiences.

High rates of indeterminate interferon-gamma release assays for the diagnosis of latent tuberculosis infection in liver transplantation candidates.

Background And Aims: Screening for latent tuberculosis infection (LTBI) is recommended prior to solid organ transplantation. Interferon-gamma release assays (IGRAs) are the most widely used test for LTBI screening; however, assessment of IGRA performance in patients with end-stage liver disease is limited. The purpose of this study was to evaluate the prevalence and predictors of indeterminate (INDT) IGRA results in liver transplantation candidates.

Hepatitis C virus infection in Australian psychiatric inpatients: A multicenter study of seroprevalence, risk factors and treatment experience.

Screening and treatment for hepatitis C virus (HCV) infection were not prioritised in psychiatric patients due to adverse neuropsychiatric effects of interferon therapy despite reports of high prevalence. However, with the safe new antiviral drugs, HCV eradication has become a reality in these patients. The aim of this study was to report HCV seroprevalence, risk factors and treatment model in an Australian cohort.