Background To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care, compared with hospital-based specialist care. Methods We randomized PWID with HCV attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care [SOC]). The primary outcome was to determine whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. Results We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7–100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P < .001; relative risk [RR] 2.48, 95% CI 1.54–3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P = .043; RR 1.63, 95% CI 1.0–2.65). Conclusions Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. Clinical Trials Registration NCT02555475.
Hepatocellular carcinoma (HCC) incidence is rising rapidly in many developed countries. Primary epidemiological data have invariably been derived from cancer registries that are heterogeneous in data quality and registration methodology; many registries have not adopted current clinical diagnostic criteria for HCC and still rely on histology for classification. We performed the first population-based study in Australia using current diagnostic criteria, hypothesizing that HCC incidence may be higher than reported. Incident cases of HCC (defined by American Association for the Study of Liver Diseases diagnostic criteria or histology) were prospectively identified over a 12-month period (2012)(2013)) from the population of Melbourne, Australia. Cases were captured from multiple sources: admissions to any of Melbourne's seven tertiary hospitals; attendances at outpatients; and radiology, pathology, and pharmacy services. Our cohort was compared to the Victorian Cancer Registry (VCR) cohort (mandatory notified cases) for the same population and period, and incidence rates were compared for both cohorts. There were 272 incident cases (79% male; median age: 65 years) identified. Cirrhosis was present in 83% of patients, with hepatitis C virus infection (41%), alcohol (39%), and hepatitis B virus infection (22%) the commonest etiologies present. Agestandardized HCC incidence (per 100,000, Australian Standard Population) was 10.3 (95% confidence interval [CI]: 9.0-11.7) for males and 2.3 (95% CI: 1.8 to 3.0) for females. The VCR reported significantly lower rates of HCC: 5.3 (95% CI: 4.4 to 6.4) and 1.0 (95% CI: 0.7 to 1.5) per 100,000 males and females respectively (P < 0.0001). Conclusions: HCC incidence in Melbourne is 2-fold higher than reported by cancer registry data owing to under-reporting of clinical diagnoses. Adoption of current diagnostic criteria and additional capture sources will improve registry completeness. Chronic viral hepatitis and alcohol remain leading causes of cirrhosis and HCC. (HEPATOLOGY 2016;63:1205-1212 SEE EDITORIAL ON PAGE 1078 P rimary liver cancer (PLC) has become the second leading cause of cancer mortality worldwide and is also the fifth-most common cancer. (1) Hepatocellular carcinoma (HCC), the predominant type of primary liver cancer, mostly arises in the setting of cirrhosis, with the most common etiologies being chronic viral hepatitis B and C, alcohol, and nonalcoholic fatty liver disease.
Background and Aims: As the merits of screening at-risk populations for hepatocellular carcinoma (HCC) remain unclear, we compared the clinico-pathologic features and survival of patients with cirrhosis and HCC detected by screening (Group A) to that in non-screened cases (Group B). Methods: We studied cirrhotics who developed HCC between 1994 and 2002. During this period, cirrhotics managed by the Gastroenterology Unit were regularly screened at 6-12 monthly intervals while those managed by other hospital units were not. Demographic data, tumor details, treatment received and survival were recorded and compared according to screening status. Results: There were 96 cases identified; 41 by screening (group A) and 55 by non-screening methods (Group B). HCC in Group A were smaller (P < 0.01), more likely unilobar (P < 0.01), at an early stage (P < 0.0005) and before vascular invasion (P < 0.005) than Group B cases. The frequency of hepatic surgery and/or local ablation was higher in Group A than Group B (P = 0.001). Overall median survival of Group A was 882 days versus 99 days in Group B (P < 0.0001). One-and 3-year probabilities of survival in Group A were 89% and 38%, versus 33% and 19% in Group B (P < 0.001). Independent predictors of survival included screening, Child-Pugh score, creatinine, tumor stage and absence of alcohol as the etiology. Conclusions: Screening for HCC in cirrhosis identifies tumors at an earlier stage, results in a higher chance of receiving curative treatment and possibly improves patient survival. The absence of alcoholic liver disease impacts favorably on survival.
his consensus statement was developed by the Gastroenterological Society of Australia (GESA), the peak body in gastrointestinal and liver health and diseases, to provide a list of contemporary recommendations for health professionals involved in the care of patients living with hepatitis B infection. The endorsing institutions are listed in the online Supporting Information. This statement is applicable to all clinicians involved in the management of people with hepatitis B, including specialist and general physicians, general practitioners, nurses, health coordinators, hospital administrators and policymakers. It covers six main topics that include epidemiology, natural history, diagnosis and monitoring, treatment and complications, and specific subgroups, such as people with viral coinfection, immunosuppressed individuals, those with renal impairment and pregnant women, especially with regard to preventing vertical transmission.One of the primary objectives is to provide a consensus statement to inform clinical decisions and to set a standard of care, with particular reference to the Australian health care setting, thus providing a local context for management recommendations. The expected benefits of this consensus statement include a standardised approach to the management of hepatitis B across varied health care settings in Australia. At a community level, the benefits of producing locally relevant guidance are ultimately to improve the health care, experience and outcomes of people living with hepatitis B.These recommendations summarise the complete consensus statement found at https://www.gesa.org.au/educa tion/clini calinfor matio n/hbv-conse nsus-state ment. MethodsThis consensus statement was developed applying the principles outlined by the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. 1 Consensus was determined using the modified Delphi approach, comprising three online questionnaires and a hybrid (combined face-to-face and online) meeting on 14 May 2021. 2 Sixty-eight experts in hepatitis B virus (HBV) infection management as well as consumer representatives, including those with lived experience, were invited to participate in the modified Delphi process, with online completion rates of 97% (66/68), 100% (66/66) and 98.5% (65/66) in rounds 1, 2 and 3 respectively. Each recommendation has been graded according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. For each recommendation, the quality of the evidence has been classified as one of four levels -high (A), moderate (B), low (C) or very low (D) -and the strength of recommendation as either strong (1) or weak (2) (Box 1). Recommendations Prevalence, transmission and priority populations (R1-R2)In 2020 an estimated 222 559 people in Australia were living with chronic hepatitis B, representing 0.9% of the population. 3 Since the introduction of immunisation in the 1980s and universal vaccination in 2000, the incidence and prevalence of HBV infection in younger Australians has fa...
The combination of LSM ≤25 kPa and Pl ≥100 can be used in clinical practice to exclude the presence of high-risk GOV in patients with Child-Pugh A cirrhosis.
BackgroundHigh quality, contemporary data regarding patterns of chronic disease is essential for planning by health services, policy makers and local governments, but surprisingly scarce, including in rural Australia. This dearth of data occurs despite the recognition that rural Australians live with high rates of ill health, poor health behaviours and restricted access to health services. Crossroads-II is set in the Goulburn Valley, a rural region of Victoria, Australia 100–300 km north of metropolitan Melbourne. It is primarily an irrigated agricultural area.The aim of the study is to identify changes in the prevalence of key chronic health conditions including the extent of undiagnosed and undermanaged disease, and association with access to care, over a 15 year period.Methods/designThis study is a 15 year follow up from the 2000–2003 Crossroads-I study (2376 households participated). Crossroads-II includes a similar face to face household survey of 3600 randomly selected households across four towns of sizes 6300 to 49,800 (50% sampled in the larger town with the remainder sampled equally from the three smaller towns). Self-reported health, health behaviour and health service usage information is verified and supplemented in a nested sub-study of 900 randomly selected adult participants in ‘clinics’ involving a range of additional questionnaires and biophysical measurements. The study is expected to run from October 2016 to December 2018.DiscussionBesides providing epidemiological and health service utilisation information relating to different diseases and their risk factors in towns of different sizes, the results will be used to develop a composite measure of health service access. The importance of access to health services will be investigated by assessing the correlation of this measure with rates of undiagnosed and undermanaged disease at the mesh block level. Results will be shared with partner organisations to inform service planning and interventions to improve health outcomes for local people.
Based on the current published literature, this systematic review has identified that the reported association between PPI use and dementia is limited by methodological issues and conflicting results. Further longitudinal studies with robust bias limitation are required to explore the use of PPIs and dementia or acute cognitive impairment, and to ascertain the existence of any causal relationships.
Objectives: To determine the factors associated with survival of patients with hepatocellular carcinoma (HCC) and the effect of HCC surveillance on survival. Design, setting and participants: Prospective population‐based cohort study of patients newly diagnosed with HCC in seven tertiary hospitals in Melbourne, 1 July 2012 – 30 June 2013. Main outcome measures: Overall survival (maximum follow‐up, 24 months); factors associated with HCC surveillance participation and survival. Results: 272 people were diagnosed with incident HCC during the study period; the most common risk factors were hepatitis C virus infection (41%), alcohol‐related liver disease (39%), and hepatitis B virus infection (22%). Only 40% of patients participated in HCC surveillance at the time of diagnosis; participation was significantly higher among patients with smaller median tumour size (participants, 2.8 cm; non‐participants, 6.0 cm; P < 0.001) and earlier Barcelona Clinic Liver Cancer (BCLC) stage disease (A/B, 59%; C/D, 25%; P < 0.001). Participation was higher among patients with compensated cirrhosis or hepatitis C infections; it was lower among those with alcohol‐related liver disease or decompensated liver disease. Median overall survival time was 20.8 months; mean survival time was 18.1 months (95% CI, 16.6–19.6 months). Participation in HCC surveillance was associated with significantly lower mortality (adjusted hazard ratio [aHR], 0.60; 95% CI, 0.38–0.93; P = 0.021), as were curative therapies (aHR, 0.33; 95% CI, 0.19–0.58). Conversely, higher Child–Pugh class, alpha‐fetoprotein levels over 400 kU/L, and later BCLC disease stages were each associated with higher mortality. Conclusions: Survival for patients with HCC is poor, but may be improved by surveillance, associated with the identification of earlier stage tumours, enabling curative therapies to be initiated.
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