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.
]]>Listen to the podcast interview with Prof. Ed Gane on New Zealand’s National Hep B Screening and Surveillance Program
The Challenge of Viral Hepatitis and HCC in New Zealand: A Closer Look
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.
From Vision to Victory: The Journey of New Zealand’s Hepatitis Screening Program
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.
The Road Ahead: Strategic Insights for Advancing Hepatitis Care
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:
- Leveraging partnerships with pharmaceutical companies, as demonstrated through Prof. Ed Gane’s work in hepatitis C initiatives, has broadened testing and care access, showcasing the impact of joint efforts.
- Integrating serum biomarkers like PIVKA-II and GAAD with AFP into the Standard of Care (SOC) has sharpened HCC detection, particularly for early-stage tumours, by facilitating blood tests in local clinics for efficient patient triaging and reducing the demand for imaging services. [9].
- Customising healthcare access for Māori, Asians, and Pacific Islanders through increased awareness and free screening has improved program engagement.
- Adopting strategies from the “Stick it to Hep C” campaign, such as finger prick point-of-care (POC) testing in pharmacies and clinics, has simplified testing access, enhancing early diagnosis.
Listen to our podcast episode with Prof. Ed Gane to find out more about the campaign.
Conclusion
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 ESMO Asia 2023 Symposium – HCC illuminated: Exploring future frontiers with systemic immunotherapies appeared first on Clinical Value of Diagnostics.
]]>The post Early-stage hepatocellular carcinoma screening in patients with chronic hepatitis B in China: a cost–effectiveness analysis appeared first on Clinical Value of Diagnostics.
]]>Quick Summary
The recently published Chinese standards for the diagnosis and treatment of primary liver cancer [1] mention various screening strategies, including abdominal ultrasonography (US), serological tests such as alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist-II (PIVKA-II).
However, combined screening strategies may be associated with increased costs. The Chinese guidelines [2] highlight that there is a lack of health economic evaluations and evidence on the cost–effectiveness of different liver cancer screening strategies.
This study aims to compare the cost-effectiveness of seven screening strategies:
This was done by developing a health economic model from the Chinese healthcare system perspective to identify the most cost-effective strategy for early detection of liver cancer in patients with chronic hepatitis B in China.
The post Early-stage hepatocellular carcinoma screening in patients with chronic hepatitis B in China: a cost–effectiveness analysis 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.
]]>Prof Henry LY Chan discusses liver cancer tumor markers for early HCC detection
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:
Get the latest updates in the liver space with our HCC detection (HD) expert pack.
Includes:
- Highlights and a PDF copy of the latest APAC regional consensus for PIVKA-II and AFP in HCC
- APASL 2023 Congress Report
- Updates on future studies and patient cases
Interview transcript:
Introduction
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.
What is the unmet need in HCC surveillance and diagnosis?
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.
What is your current HCC surveillance practice and how is PIVKA-II implemented?
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.
What clinical situations do you think are the most appropriate to use PIVKA-II for HCC surveillance?
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.
What are your expectations for digital algorithms that aid in diagnosis of HCC, and how can they add value to overall clinical decisions in addition to biomarkers?
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.
What advice would you give to your fellow colleagues?
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.
]]>Fang YS, Wu Q, Zhao HC, Zhou Y, Ye L, Liu SS, Li XX, Du WD...
The post Do combined assays of serum AFP, AFP-L3, DCP, GP73, and DKK-1 efficiently improve the clinical values of biomarkers in decision-making for hepatocellular carcinoma? A meta-analysis appeared first on Clinical Value of Diagnostics.
]]>Quick Summary
Serum biomarkers are valuable for clinical decision-making for patients with hepatocellular carcinoma (HCC), among which the most promising are AFP, AFP-L3, DCP, DKK-1, and GP73; however, the efficacy of using combined biomarkers remains controversial. This meta-analysis provides insights regarding this topic.
PubMed, Embase, and Cochrane Library were systematically surveyed, and 28 qualified articles published since January 2015 were identified. A random-effects model was used to assess pooled sensitivity, specificity, positive and negative likelihood ratios (PLRs and NLPs), and diagnostic odds ratio (DOR).
The post Do combined assays of serum AFP, AFP-L3, DCP, GP73, and DKK-1 efficiently improve the clinical values of biomarkers in decision-making for hepatocellular carcinoma? A meta-analysis appeared first on Clinical Value of Diagnostics.
]]>Li B, Liu A, Wen Y, Yang G, Zhao J, Li X, Mao Y, Li B...
The post The prognostic values of serum markers in hepatocellular carcinoma after invasive therapies based on real-world data appeared first on Clinical Value of Diagnostics.
]]>Quick Summary
Hepatocellular carcinoma (HCC) is one of the most common malignancies with poor prognosis, and the mortality rate remains high. More than 70% of HCC patients have recurrence within 5 years after treatment. The purpose of this study is to evaluate the prognostic values of serum markers with retrospective data.
Real‐world data (RWD) was applied to analyze the prognostic values of six serum markers for HCC patients after treatment, including α‐fetoprotein (AFP), α‐fetoprotein‐L3 (AFP‐L3), Golgi protein73 (GP73), alanine aminotransferase (ALT), albumin (ALB), and total bilirubin (TBil). A total of 268 cases were enrolled to analyze recurrence‐free survival (RFS), and 104 cases were used to analyze overall survival (OS).
The post The prognostic values of serum markers in hepatocellular carcinoma after invasive therapies based on real-world data appeared first on Clinical Value of Diagnostics.
]]>Xu F, Zhang L, He W, Song D, Ji X, Shao J...
The post The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients appeared first on Clinical Value of Diagnostics.
]]>Quick Summary
At present, the diagnostic accuracy of alpha-fetoprotein (AFP) for hepatocellular carcinoma (HCC) surveillance is insufficient. It remains controversial whether prothrombin induced by vitamin K absence II (PIVKA-II) has a better diagnostic value than AFP for HCC patients.This study aims to investigate the diagnostic role of PIVKA-II alone or in combination with AFP in Chinese HCC patients.
Serum AFP and PIVKA-II levels were detected and analyzed in 308 HCC afflicted patients and 120 unafflicted controls. The receiver operator curve (ROC) and area under the curve (AUC) were conducted to evaluate the clinical value of AFP and PIVKA-II for diagnosing HCC and early HCC.
The post The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients 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.
]]>Quick Summary
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.
]]>Huan L...
The post Efficacy analysis of combined detection of 5 serological tumor markers including MIF and PIVKA-II for early diagnosis of primary hepatic cancer appeared first on Clinical Value of Diagnostics.
]]>Quick Summary
The aim of this study was to investigate the efficacy of combined detection of 5 serological tumor markers including macrophage migration inhibitory factor (MIF) and abnormal prothrombin (PIVKA-II) in the early diagnosis of primary liver cancer.
A total of 90 patients with suspected primary liver cancer admitted from January 2016 to May 2017 were selected as the research subjects. All patients were examined by imaging and histopathology. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum MIF, GP73 and PIVKA-II. Automatic electrochemiluminescence immunoassay system was used to detect serum AFP and AFP-L3. The diagnostic value of single and combined detection of five serological tumor markers for primary liver cancer was compared and analyzed.
The post Efficacy analysis of combined detection of 5 serological tumor markers including MIF and PIVKA-II for early diagnosis of primary hepatic cancer appeared first on Clinical Value of Diagnostics.
]]>The post APASL 2023 Taiwan Congress Report appeared first on Clinical Value of Diagnostics.
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