The post Turning the Tide Against Hep B and HCC: Insights from New Zealand’s National Screening and Surveillance Program appeared first on Clinical Value of Diagnostics.
]]>Globally, 240 million people are affected by hepatitis B virus (HBV, Hep B), surpassing deaths from tuberculosis, HIV, and malaria in the WHO Western Pacific Region [1]. HBV is a major cause of hepatocellular carcinoma (HCC), with chronic infections accounting for over half of HCC cases [2]. In response, the United Nations aims to reduce HBV infections and deaths by 2030, with vaccinations from 1990 to 2020 preventing an estimated 310 million infections [3].
In New Zealand, HBV significantly impacts Maori (5.6%), Pacific peoples (7.3%), and Asians (6.2%), who represent over 50% of liver disease mortality, compared to 10% among European New Zealanders [1].
Despite a robust healthcare system, New Zealand faces hurdles in enhancing public awareness, fighting stigma, and increasing testing access, as emphasised by Prof. Ed Gane, Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital, and Professor of Medicine at the University of Auckland, New Zealand.
Nearly half of New Zealand’s chronic HBV infections remain undiagnosed [1], leading to late HCC detection.
Advanced-stage diagnoses leave limited treatment options, with life expectancy post-diagnosis ranging from 7 to 22 months [4]. This underscores the need for better HBV screening, diligent follow-up, and robust HCC surveillance to improve outcomes.
In response, the New Zealand National Hepatitis B Screening Program [5] emphasises early detection, public awareness, and healthcare access, serving as a global model for managing HBV and strengthening HCC surveillance protocols to enhance patient outcomes.
New Zealand faced a unique challenge. Despite successful neonatal vaccination drives, many adults were already living with HBV infection.
Chronic HBV often remains asymptomatic until serious complications – like liver fibrosis, cirrhosis, and HCC- arise. With only about 10% of those infected [3] being diagnosed in 1990, the Hepatitis Foundation of New Zealand [6] took action.
They launched the National Hep B Screening and Surveillance Program, which targeted undiagnosed chronic HBV in adults not covered by earlier neonatal vaccination efforts. Through Screening 177,292 people, 11,936 individuals were identified with chronic HBV [7] and provided with biannual monitoring and lifelong follow-up. The program is unique because it is fully funded by the government but executed by an experienced NGO, The Hepatitis Foundation of New Zealand. This partnership used cost-effective antiviral therapies and early liver cancer detection to improve outcomes significantly. Today, thanks to the work of the Hepatitis Foundation, 50-60% of people living with HBV in New Zealand have been diagnosed.
The program’s success is primarily due to government support, spurred by the foundation’s efforts to spotlight HBV’s toll on vulnerable groups like Māori and Pacific Islanders. Engaging these communities and gaining local leaders’ endorsement has been pivotal, transforming the initiative from mere healthcare provision to a proactive health solution by boosting awareness and tackling stigma at the grassroots.
The program has revolutionised care for chronic Hepatitis B, caring for over 16,000 individuals and dramatically increasing survival rates. With 80% of HBV-HCC cases detected early and receiving curative treatment, the program vastly outperformed the 7% curative treatment rate of cases found outside the program [4]. Survival rates have impressively increased, with 66% of those diagnosed within the program surviving over 10-years post-diagnosis, compared to just 9% outside the program. Moreover, the drastic reduction in palliative cases—from 68% to 26% since 1996 to 2021 [4]—and significant strides in preventing mother-to-child transmission underline the program’s impact on public health [6].
Treatment protocols include Nucleos(t)ide analogues (NUCs) like entecavir and tenofovir disoproxil, which suppress HBV DNA long-term in compliant patients, alongside alternatives such as lamivudine, adefovir, and telbivudine, and pegylated interferon for potential seroconversion after 48 weeks [6].
This national program is still ongoing till today and exemplifies a comprehensive approach to hepatitis B management through continuous surveillance efforts to maintain a robust defence against HBV and its complications.
Despite the success of the program, New Zealand still faces challenges in liver disease management that stretch its capacity and underscore the need for adaptation. [4] Late-stage detection is widespread, worsened by an increase in metabolic dysfunction-associated fatty liver disease (MAFLD) cases linked to obesity and diabetes [4,8]. This rise strains resources, as does the growing demand for six monthly alpha-feto protein (AFP) tests and ultrasounds for high-risk patients [4].
“We’re facing a supply and demand issue with ultrasound,” explains Prof. Ed Gane, noting the rise in chronic viral hepatitis and nonalcoholic steatohepatitis (NASH) diagnoses leading to increased ultrasound referrals, especially in ultrasound-scarce rural areas. He suggests exploring alternatives to ultrasound, emphasising the potential of new serum markers like PIVKA-II and GAAD.
Ultrasound is often inadequate for detecting small HCC in patients with advanced fatty liver and NASH, and the rise of HCC in NASH patients without cirrhosis complicates screening decisions [9]. FibroScan’s effectiveness decreases in patients with high BMI, and liver biopsy, the definitive NASH test, poses risks, costs, and potential for errors [9].
Care delivery still continues to face significant hurdles, especially in reaching populations in remote areas, with low GP engagement and high mistrust, particularly among the Māori, who are disproportionately affected by HCC. A strict ‘did-not-attend’ policy requires patients to secure new referrals if they miss an appointment. This creates a systematic barrier that disproportionately affects those who have difficulty navigating the healthcare system, leading to what is described as a “postcode lottery of care.”[4,9].
These challenges underscore the need for the program to adapt, using targeted strategies to address the evolving nature of liver disease effectively. To improve hepatitis B surveillance and early HCC detection, efforts need to be centred around collaboration, innovation, and inclusivity, including:
Listen to our podcast episode with Prof. Ed Gane to find out more about the campaign.
By harnessing innovative diagnostics, enhanced screening methods, and tailored strategies, the approach has shifted from merely managing to actively curing viral hepatitis and HCC, giving hope for a future with improved liver health.
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]]>The post Development and Clinical Validation of a Novel Algorithmic Score (GAAD) for the Detection of Early-stage Hepatocellular Carcinoma appeared first on Clinical Value of Diagnostics.
]]>The post Development and Clinical Validation of a Novel Algorithmic Score (GAAD) for the Detection of Early-stage Hepatocellular Carcinoma appeared first on Clinical Value of Diagnostics.
]]>The post HCC monitoring and surveillance update – the limbic appeared first on Clinical Value of Diagnostics.
]]>In these series of videos produced by the limbic, A/Prof. Simone Strasser and A/Prof. Jessica Howell discuss:
Click the buttons below to watch the videos directly on the limbic:
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]]>The post Patient-centric and ecosystem insights into hepatocellular carcinoma across Asia-Pacific – LEAP appeared first on Clinical Value of Diagnostics.
]]>Hepatocellular carcinoma (HCC) is largely preventable, with decades of time to intervene, yet millions still die from it. It is however not incomprehensible why this happens. The journey from liver disease to liver cancer is complex—a myriad of broken healthcare systems, patient behaviors, cultural influences, stigma, funding, and limited healthcare professional (HCP) capacity. At first glance, it seems overwhelming, leaving us with the question—where should we intervene?
Some cancers like breast cancer have high incidence but comparatively low mortality1. Liver cancer is the opposite; it often goes undetected until it reaches a late stage, resulting in dismal prognosis. Late presentation is a top issue in liver cancer. Without pain receptors, the liver has minimal symptoms until it is damaged beyond cure. People usually die within 6 – 22 months of a late-stage HCC diagnosis.2 HCC is known as the ‘silent killer’ and is typically diagnosed at a late stage, which has a <5% 5-year survival rate. If diagnosed early, the 5-year survival rate increases to 40 – 70%.3&4
Given the complexity, there is no single solution. Rather, it will take concerted action from multiple stakeholders in the system to bring about positive change. That said, there are logical places to start. First, we need to understand the ecosystem. An ecosystem represents factors required to deliver a service, in this case, liver care. It helps identify solution, scope, and strategy by providing a holistic view of actors, processes, flow, influence, and relationships.
Hepatitis B and C are the major causes of chronic liver disease and liver cancer in the world. An ongoing infection causes inflammation in the liver. This extended inflammation can cause scarring, called cirrhosis, and can ultimately lead to liver cancer. The Asia-Pacific region bears the highest overall burden of HBV, with 59% of those living with chronic HBV, 26% of new infections, and 79% of deaths.5 Given the shifting etiology with rising fatty liver disease, there is a pressing need to re-assess risk factors and stratify patients to ensure we are not failing to detect. Being able to optimize surveillance protocols based on patient risk will improve efficiency and ability to catch early HCC and drastically improve survival.
To further maximize the benefit of a surveillance program, or any other initiative, it is important to consider surrounding opportunities up- and down-stream. For example, surveillance programs will benefit from upstream awareness efforts to improve throughput, and down-stream availability of treatments. This paper provides an appreciation for the end-to-end patient journey and their needs along the way. Fundamentally, it advocates for the improvement of human life in the midst of receiving liver care, both clinically and experientially.
From the research, a central theme emerged – ultrasound used in HCC surveillance is a major bottleneck. It is the cause of delayed or even missed diagnosis, and stark inequities in care. Biomarkers such as PIVKA-II complementing AFP show promise in lessening this problem while also offering improved sensitivity and specificity for HCC detection.
This White Paper intends to facilitate concerted action among HCPs, patient advocacy groups, payers, and policy makers to reduce liver cancer incidence and mortality in APAC. It shares both holistic ecosystem and detailed human-centric insights as a starting point for change. Working with Key Opinion Leaders (KOLs) we provide tangible examples of active initiatives, and recommendations for taking the next steps.
Download or read the white paper below to find out more.
Stay tuned for interviews with select KOLs featured in the white paper, as they share about their insights and learning points on the initiatives piloted in their country.
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]]>The post Building modern hepatocellular carcinoma surveillance programmes: taking steps to address a leading cause of liver cancer death in Asia appeared first on Clinical Value of Diagnostics.
]]>HCC is a leading cause of cancer mortality in Asia. Causes of HCC include viral hepatitis B and C infections, with recent increases in metabolic disorders, such as NAFLD, also playing a factor.
Early HCC interventions are highly effective and can lead to improved patient outcomes and survival. Therefore, HCC surveillance programs are pivotal in detecting HCC early and making the appropriate interventions.
In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs in Asia, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program:
HCC surveillance programs should be fit into the national health strategy where appropriate, taking into account the local incidence and prevelance rates, and existing priorities and resources.
Long-term resourcing and financing is key to making HCC survaillance programs successful. The current health financign system in the area, and ability to pay should be assessed, while exploring various funding methods such as centralised healthcare coverage or private insurance.
The development of HCC surveillance program should be based on data, such as HCC epidemiology, patient outcomes, human and economic cost of HCC. These data should be collected and analysed.
Technology can help to improve access to HCC surveillance programs, as well as improve patient outcomes by detecting HCC early. Some examples include: including additional biomarkers such as PIVKA-II, using biomarker based digital algorithms and diagnostic models, using more advanced imaging techniques, and adapting IT systems to support surveillance programs.
Tapping on exisiting resources to expand capacity for HCC care and surveillance., For example increasing the range of HCPs who can diagnose and manage HCC like primary and community HCPs, expanding private healthcare capacity in HCC care.
Governmental decision-makers, physicians, patients and PAGs, payers and industry need to come together to drive implementation of a robust HCC surveillance programs that address needs of all stakeholders.
Raising the knowledge among the general population and HCPs on HCC and the importance of surveillance can improve uptake and compliance to surveillance programs.
The post Building modern hepatocellular carcinoma surveillance programmes: taking steps to address a leading cause of liver cancer death in Asia appeared first on Clinical Value of Diagnostics.
]]>The post Leading the Way for HCC Surveillance and Diagnosis: Prof. Henry LY Chan appeared first on Clinical Value of Diagnostics.
]]>Find out more about PIVKA-II in Hepatocellular Carcinoma (HCC) detection, or download our HCC Detection (HD) expert pack by filling in the form below:
Includes:
I am Professor Henry Chan, a honorary clinical professor of the Chinese University of Hong Kong and deputy chief hospital manager of Union Hospital Hong Kong.
Liver cancer is the 5th commonest cancer and 3rd commonest cancer mortality in Hong Kong. Most patients suffering from liver cancer are having underlying chronic liver disease such as viral hepatitis or fatty liver. As early liver cancer has no symptoms, regular surveillance is required to pick up small cancer, which are potentially curable by liver resection or loco-ablative therapy. On the other hand, systemic therapy for advanced liver cancer is not a very successful option. As patients with chronic liver disease are usually asymptomatic, one challenge on HCC surveillance is adherence of these patients to a regular program. Patient education and convenient testing will be pivotal to the success of HCC surveillance.
The standard tests for HCC surveillance is ultrasound of the liver and alfa-fetoprotein testing. The recommended interval of surveillance is 6 months to match the tumor doubling time of HCC. As there are limitations for both ultrasound and alfa-fetoprotein, these 2 investigations should be used together. For example, ultrasound may be difficult in patients with liver cirrhosis or obesity. On the other hand, alfa-fetoprotein may have limited sensitivity for small HCC. PIVKA II is a biomarker elevated in HCC with a completely different mechanism as AFP. There are ample data suggesting that testing AFP and PIVKA II together can improve the sensitivity for small HCC.
There are data from Japan and China suggesting that AFP is not as sensitive as PIVKA II to detect small HCC in patients with alcohol-related liver disease and non-alcoholic fatty liver disease. Although more studies may be needed to confirm this finding, PIVKA II may be a good biomarker for HCC in patients with liver cirrhosis secondary to these 2 conditions. Another group of patients are those known to have difficult ultrasound, including obese patients and patients with cirrhotic nodules. Adding PIVKA II to the HCC surveillance program may compensate the inadequacy of USG. Ultimately, if cost is not a concern, I think PIVKA II should be used together with AFP in all patients for HCC surveillance.
A digital algorithm composed of biomarkers and clinical parameters can generate a single score to inform the probability of HCC. It can facilitate a simple interpretation of the biomarker results in the context of the patients, and will be particularly useful for non-experts to carry out HCC surveillance. One challenge to implement digital algorithms is the education of clinical practitioners to interpret the meaning of the scores.
When I was working in the public hospital, I was annoyed by the long waiting time for an ultrasound, which may take up to 2 years. I think PIVKA II is a good alternative for this unmet need. Using PIVKA II together with AFP can improve the sensitivity to pick up early HCC during this window period without ultrasound. This is particularly important for patients with alcohol-related liver disease and non-alcoholic fatty liver when the sensitivity of AFP for early HCC is low.
The views and opinions expressed by Prof. Henry LY Chan are his own views and opinions. Roche disclaims all liability in relation to these views and opinions.
The post Leading the Way for HCC Surveillance and Diagnosis: Prof. Henry LY Chan appeared first on Clinical Value of Diagnostics.
]]>Singal AG, Zhang E, Narasimman M, Rich NE, Waljee AK, Hoshida Y, Yang JD, Reig M, Cabibbo G, Nahon P, Parikh ND, Marrero JA...
The post HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis appeared first on Clinical Value of Diagnostics.
]]>There is controversy regarding the overall value of hepatocellular carcinoma (HCC) surveillance in patients with cirrhosis given the lack of data from randomized-controlled trials. To address this issue, a systematic review and meta-analysis of cohort studies evaluating the benefits and harms of HCC surveillance in patients with cirrhosis was conducted.
A search of the Medline and EMBASE databases and national meeting abstracts were performed for studies reporting early-stage HCC detection, curative treatment receipt, or overall survival, stratified by HCC surveillance status, among patients with cirrhosis, from January 2014 through July 2020. Pooled risk ratios (RRs) and hazard ratios, according to HCC surveillance status, were calculated for each outcome using the DerSimonian and Laird method for random effects models.
The post HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis appeared first on Clinical Value of Diagnostics.
]]>The post Hepatocellular carcinoma surveillance and the emerging role of biomarker-based models appeared first on Clinical Value of Diagnostics.
]]>What are the greatest challenges in the early detection of Hepatocellular Carcinoma (HCC)?
So, what are the greatest challenges in the early detection of HCC? I would say, it’s firstly identifying the patients who are at risk for HCC; and in the large, that’s the patients with cirrhosis, and at the moment we’re not detecting those patients with cirrhosis, who are the greatest population at risk. So, what do we need to do about that? Well, we need to find them; and that means empowering the GPs, particularly, to have early detection of cirrhosis, so they can enroll patients in surveillance for HCC.
What is one thing you would do to improve HCC surveillance?
If I was to improve one thing in HCC surveillance, what would that be? Well again, I think it’s that first step in identifying the patients who need surveillance. But then once you’ve done that, how do you get most patients to surveillance? Well in the Australian context, that’s going to mean having a test that’s affordable, and that’s effective, and that is applicable to patients wherever they are in Australia. So it might be that one sort of test is available to somebody who lives very close to a major tertiary hospital, but for many many people in Australia, they’re not in that situation. They’re going to be living in rural or remote Australia, in regional towns, all over the country; because the risks of liver disease are diverse, and we’ve got to have a surveillance test that is applicable to all of them.
What are the challenges for patients in maintaining HCC surveillance? How can we overcome these?
So these are patients who we know they should be having surveillance. The patients know they should be having surveillance, and their doctors know they should be having surveillance, and there are challenges yet to getting those patients in regular surveillance. And by surveillance, we mean an assessment that’s conducted every 6 months, and currently that would be an ultrasound with or without an AFP level. So the challenges those patients have is firstly, they forget, their doctors forget, they drop out of follow up. The COVID pandemic had a huge impact in people being reluctant to access care and to go to diagnostic centers for imaging, for blood tests even. And then there are patients that move. There are patients that have to pay out of pocket to access testing, so the financial barrier is huge, and particularly the community of patients who live with liver disease are often the patients who can’t afford to access non-Medicare funded investigations. So having tests that are affordable, accessible, near them that they remember to have with regular reminders, are all ways that we can overcome those challenges.
What is the optimal model of care in HCC surveillance?
So what is an optimal model of care for an HCC surveillance program? Well it might be that there is not one model for everybody; and if people are coming regularly to a major center or have access to high quality ultrasound and blood testing, then a combination of ultrasound and blood testing might be what’s suitable for them. For other patients, another model of care might be more appropriate where they don’t have regular access to ultrasound, but where a blood test that had high sensitivity and high specificity may fill that gap. So it’s going to be varied, it’s going to be dependent on what the access to medical care is, what the access to imaging and blood testing care is, what the access to, perhaps, nursing care is; dependent on where that patient is, and where they live in the country.
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]]>The post PIVKA-II: Confidence in HCC surveillance and diagnosis: Prof. Ming-Lung Yu appeared first on Clinical Value of Diagnostics.
]]>Find out more about PIVKA-II in Hepatocellular Carcinoma (HCC) detection, or download our HCC Detection (HD) expert pack by filling in the form below:
Includes:
Hello everyone, I am Dr. Ming-Lung Yu. Currently I am a physician and Chair Professor of Hepatology at the Kaohsiung Medical University Hospital and Senior Vice President of National Sun Yat-sen University.
There are about 11,000 new liver cancer patients in Taiwan every year. Unfortunately, 60% of liver cancers are advanced stage at the time of first diagnosis, and usually, the effect of treatment is not satisfactory. Patients with early-stage tumors, that can be removed surgically or by ablation, have the best chance of long-term survival. Therefore, early detections of liver cancers are crucial to increase patient outcome.
Ultrasound sonography is the most important and reliable screening tool, but its sensitivity will be affected by the size and location of nodules, operation technique, fatty liver, etc. Therefore, it needs serum biomarkers as an assistant tool. AFP has been used commonly in liver cancer diagnosis now. And PIVKA-II has been used more and more in daily practice recently since it became the reimbursed item.
There is cumulating evidence supporting the application of PIVKA-II for HCC diagnosis. And PIVKA-II combined with AFP and ultrasound sonography can improve the sensitivity of HCC surveillance, especially in early stage of HCC.
We observed that PIVKA-II has good sensitivity & specificity in HCC patients, and it could be better when combined with AFP & ultrasound sonography.
For BCLC stage 0/A patients, we found PIVKA-II has the best sensitivity, compared to those of ultrasound sonography and AFP.
For example, some HCC patients have no liver nodules in ultrasound sonography and with normal AFP, but have increased levels of PIVKA-II and are further confirmed by CT/MRI. Obviously, PIVKA-II is very helpful for these patient population.
PIVKA-II can help us to have one more useful tool for improving the early diagnosis of liver cancers.
The views and opinions expressed by Prof. Ming-Lung Yu are his own views and opinions. Roche disclaims all liability in relation to these views and opinions.
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]]>The post Utility of Combining PIVKA-II and AFP in the Surveillance and Monitoring of Hepatocellular Carcinoma in the Asia-Pacific Region appeared first on Clinical Value of Diagnostics.
]]>A panel of 17 experts from the Asia-Pacific region reached a consensus on the clinical usefulness of protein-induced vitamin K absence II (PIVKA-II) for the surveillance and treatment monitoring of hepatocellular carcinoma (HCC). The experts agreed that PIVKA-II could be valuable in the detection of HCC in AFP-negative patients and for monitoring curative and intra-arterial locoregional treatments, outcomes, and recurrence. However, more evidence is required for the combined use of PIVKA-II with ultrasound and AFP for HCC surveillance, including small HCC. Implementing PIVKA-II in the region will also have challenges, such as standardizing cut-off values, cost-effectiveness, and improving awareness among healthcare providers.
The post Utility of Combining PIVKA-II and AFP in the Surveillance and Monitoring of Hepatocellular Carcinoma in the Asia-Pacific Region appeared first on Clinical Value of Diagnostics.
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