HCC – Clinical Value of Diagnostics https://clinicalvalue.com Thu, 12 Jun 2025 09:04:40 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://i0.wp.com/clinicalvalue.com/wp-content/uploads/2023/01/apple-touch-icon.png?fit=32%2C32&ssl=1 HCC – Clinical Value of Diagnostics https://clinicalvalue.com 32 32 225041835 End-to-end liver disease management at Zhuhai People’s Hospital: Project Pearl https://clinicalvalue.com/end-to-end-liver-disease-management-at-zhuhai-peoples-hospital-project-pearl/ Wed, 04 Dec 2024 07:47:45 +0000 https://clinicalvalue.com/?p=9362 ...

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Every year, liver cancer claims 740,000 lives worldwide, with 42% of these deaths occurring in China. In China, the 5-year survival for hepatocellular carcinoma (HCC) patients is just 14.4%, and over 80% of liver cancer patients diagnosed are those with Hepatitis B. Despite this alarming statistic, early screening and comprehensive, end-to-end disease management approaches remained limited in China. This created a critical gap in care, one that Zhuhai People’s Hospital in collaboration with Roche, aimed to address with the initiation of Project Pearl in 2022.

Project Pearl is a pioneering multi-stakeholder initiative designed to provide holistic care to patients with chronic liver disease by enabling end-to-end chronic disease management involving healthcare professionals, hospital administration, and payors. At its core, the project leverages on the Liver Integrated Solution, comprising of two key digital solutions:

  • Liver Disease Pathway (LDP), a digital platform streamlining HCC screening workflow and offering a patient portal for better care management
  • Oncology Hub (OH), a clinical workflow for multidisciplinary team meetings and decision support system

This integrated solution empowers clinicians with the right information at the right time, ensuring informed, precise decision-making throughout the patient’s journey.

Let’s explore how the patient’s journey has evolved under this new framework. Upon their first hospital visit, patients with chronic liver disease are registered on the digital solution, and are evaluated with abdominal ultrasound, AFP, PIVKA-II, and GAAD, aimed at early detection of HCC. The patients’ data and reports are synchronized for physicians to view in real time. Meanwhile, risk stratification scores provide physicians with a clearer understanding of each patient’s likelihood of developing liver cancer, allowing for more personalized, periodic surveillance plans. Physicians are able to easily arrange follow-ups with the patients and track their disease progression over time. Beyond the hospital, an interoperable mobile platform extends support with follow-up reminders, report interpretation, patient education, and 1 on 1 consultation. This empowers patients to better understand their condition and also ensures they receive continuous, standardized care, essential for early detection and intervention. For physicians, the new patient journey not only streamlines operations but also enhances clinical effectiveness by enabling early detection, offering curative treatment options, and improving patient outcomes.

The entire clinical and operational workflow from screening and diagnosis and follow-up is now automated, making it easier to manage every step of care delivery. Once patients are diagnosed with HCC, they are seamlessly transitioned into a comprehensive treatment management system. This integrated approach addresses the following challenges that are commonly observed in MDT care delivery. Lack of standardized MDT clinical protocol, absence of robust post-treatment follow-up system, and limited capabilities to analyse and gain insights from treatment data. Upon transition, a patient’s 360 report is automatically generated to show their entire patient history. This empowers them with data-driven insights to deliver clinical, operational and economic outcomes to manage HCC treatment more effectively and confidently.

Ultimately, Project Pearl enables a win for all stakeholders. For patients, early detection and personalized care plans lead to better outcomes. For physicians, streamlines, standardized workflows and digitally-enabled decision-making support clinical practice in a timely and effective manner. For the health system, the project accelerates the goals of “Healthy China 2030”, improving outcomes at reduced costs. By improving both patient outcomes and healthcare efficiency, we are taking significant steps toward a future where liver cancer can be detected early and treated effectively, creating hope for thousands of lives.

Since its launch, Project Pearl has seem promising results. Till date, 4,972 patients had been screened, and 40 cases of HCC had been diagnosed. Remarkably, 39 of those cases were detected at an early stage, offering significantly better chances for curative treatment. These outcomes demonstrate the project’s real-world impact in transforming liver cancer care and improving patient outcomes.

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9362 HCC Archives - Clinical Value of Diagnostics nonadult
Strategic Efficiencies: Evaluating Cost-Effectiveness of Biomarker-Based HCC Surveillance https://clinicalvalue.com/strategic-efficiencies-evaluating-cost-effectiveness-of-biomarker-based-hcc-surveillance/ Mon, 19 Aug 2024 06:23:20 +0000 https://clinicalvalue.com/?p=8823 ...

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Prof Pisit shares recent health economic data from Thailand, revealing that the GAAD score is cost-effective for HCC surveillance among Thai population

Interview transcript:

Introduction

Hello everyone. I am Dr. Pisit Tangkijvanich from the Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. Nice to meet all of you.

Could you provide an overview of the HECON study?

Hepatocellular Carcinoma, or HCC is one of the most common cancers in Thailand. From Global Cancer Statistic 2020, liver cancers, especially HCC, is the number 1 of cancer in Thailand with its highest incident in men and the fourth highest incidence in women. HCC is also a leading cause of cancer mortality in Thailand, like other countries in Southeast Asia. Together, these data highlight the importance of HCC as a major public health problem in our country.

The majority of HCC occurs in patients with chronic viral hepatitis, including hepatitis B and hepatitis C, fatty liver disease, and heavy alcohol consumption. It is generally accepted that the screening or regular surveillance for HCC should be performed in patients known to be at risk of this cancer, because the surveillance could identify HCC at an early stage and can improve the overall survival of the patients receiving curative treatment, such as surgical resection or liver transplantation.

Most professional society guidelines recommend using ultrasound and serum alpha fetoprotein, or AFP every 6 months for HCC detection in at-risk patients, such as those with cirrhosis. However, ultrasound (US) is operator dependent and its sensitivity is variable between centre to centre. Moreover, the US may have lower sensitivity in patients with obesity or fatty liver disease. As a result of US limitation, more accurate and accessible (surveillance) programs that could improve HCC early detection are required.

Currently, there are several emerging strategies for HCC detection. Among them, GAAD score which is derived from Gender, Age, and the combination of double tumour markers including AFP, and DCP (or PIVKA-II), is a promising tool for early detection of HCC. The available data show that GAAD score is superior to US for HCC diagnosis with a high sensitivity and specificity.

So the aim of our HECON study was to compare cost-effectiveness analysis between GAAD score with the standard-of-care using US plus AFP for HCC surveillance in Thai patients with compensated cirrhosis and chronic hepatitis B.

Could you walk us through the methodology employed in the HECON study and discuss key findings or results?

We selected cirrhotic patients in our study because these patients are at-risk of developing HCC as the incidence rate is more than 1.5% per year. For non-cirrhotic hepatitis B, we included this group of patients because the infection is highly prevalent in Thailand and also the subgroup of patients that at-risk of HCC, especially among males older than 40 years, and females older than 50 year, or those with family history of HCC.

So, we performed an economic model with Markov micro-simulation to simulate disease progression for individual patients, based on Thai population data. Literature review and interviews with Thai clinical experts were also used to identify model inputs that reflect current Thai clinical practice. Health states within the model were based on the patient’s underlying liver disease, such as cirrhosis or non-cirrhotic hepatitis B, HCC staging, such as early or late stage and treatment outcome according to the cancer stage.

Our results showed that GAAD score was cost-effective for Thai populations at the willingness to pay threshold of 160,000 THB (or approximately 4,400 USD). In fact, GAAD yielded lower cost and a better health outcome compared to US plus AFP. In addition, sensitivity analysis confirmed that routine surveillance using GAAD score had at least 55% probability of being cost-effective compared to no surveillance.

Together, our data indicate that GAAD score is suitable for use as a screening tool in Thailand.

In your opinion, what makes the HECON data important in the context of changing healthcare policies and decision-making in Thailand?

As the burden of liver cancer is high, HCC surveillance and control must be considered a public health priority. However, in Thailand, national efforts are focused on the control of viral hepatitis, which is primary prevention for HCC rather than the cancer surveillance.

So our data show that the new method using GAAD score is cost-effective, and importantly more feasible than US plus AFP testing, because GAAD score can be done the same day in the clinics. That will help in reducing several patient barriers such as transportation or logistical concerns.

Our data could play an important part in supporting the policymakers for making the best decision within limited resource in our country, to accelerate the reimbursement program for HCC surveillance in the future.

Are there any challenges or considerations that healthcare professional should be aware of when interpreting or applying the results of the HECON study in clinical practice?

Although our study provides promising results, there might be some concerns about the role of GAAD score as a screening tool for HCC detection. For example, in countries where there are inadequate facility for cancer therapy, the benefit of early detection might be reduced as limited number of patients could achieve curative treatment. In contrast, GAAD score is more suitable in community hospital or rural areas where access to US is limited, such as some areas in Thailand and many countries in the APAC region.

How do you foresee the results of the HECON study will help to inform clinicians’ HCC surveillance and clinical practice in the APAC region?

I think the results of HECON study can be used not only in Thailand but also can be applied to other country as well, which had a similar situation as Thailand, for example, the Philippines or Vietnam. Thank you.

The views and opinions expressed by Prof. Pisit Tankijvanich are his own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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8823 HCC Archives - Clinical Value of Diagnostics nonadult
A Bold Stride Forward for Liver Health: Thailand’s Nationwide HBV Screening and EZ Liver Clinic https://clinicalvalue.com/thailand-hbv-screening-and-ez-liver-clinic-leap/ Tue, 30 Jul 2024 03:52:57 +0000 https://clinicalvalue.com/?p=8699 ...

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Results of the Liver Ecosystem Advancement Project (LEAP) initiatives in Thailand

Listen to the podcast discussion with Dr. Passakorn Wanchaijiraboon on the EZ Liver Clinic

Introduction

Hepatitis B (HBV) and Hepatitis C (HCV) viruses significantly impact public health in Thailand, affecting about 5% (2-3 million people) and 0.4% (300,000 people) of the population, respectively. [1] Chronic HBV infections account for 49.8%  [2] of hepatocellular carcinoma (HCC) cases.

Despite a decline in viral hepatitis due to effective vaccinations and treatments, HCC related to metabolic dysfunction–associated steatotic liver disease (MASLD) is on the rise.[3]

Liver cancer remains the leading cause of cancer-related deaths in Thailand, accounting for over 10,000 deaths annually as of 2008, with a mortality rate of 87% and a survival rate of only 13% post-diagnosis. It is the most common cancer among men and the third most common among women.[1] Challenges in treatment include a lack of healthcare staff and resources, particularly in rural areas, and insufficient nationwide epidemiological data for tracking infected patients.[3] Managing these diseases in a diverse and uneven healthcare landscape requires innovative approaches.

Graphic of liver disease in Thailand. Hepatitis B prevalence is 5% of the population (estimated 2 to 3 million people). Hepatitis C prevalence is 0.4% of the population (estimated 300 thousand people). Icons show effective vaccines and treatments have reduced hepatitis rates, but MASL linked HCC is on the rise. There are 10,000 liver cancer deaths annually, 87% mortality rate of liver cancer.

In response, integrated health initiatives such as the Liver Ecosystem Advancement Program (LEAP)  were developed to bridge these gaps. They focus on improving the patient pathway, from screening and diagnosis to treatment and surveillance, using multi-disciplinary approaches and leveraging digital health platforms to enhance patient education and healthcare provider training. [1,3] 

The LEAP Program: Bridging Gaps in Hepatitis Management

LEAP represents a strategic initiative to address the comprehensive needs of hepatitis management in the APAC region. In Thailand, it is a collaborative effort involving healthcare professionals (HCPs), experts, and policymakers from the National Health Security Office. It combines functions into a cohesive system that enhances the management and surveillance of hepatitis and its progression to HCC.

1. Efficacy of the HBV Screening Pilot

“The patient pathway should include screening for viral hepatitis (HBV, HCV) in the general population. Infected persons will then be linked to antiviral treatment and care by general practitioners and/or medical specialists. Subsequently, high-risk groups will require further tests for HCC surveillance, or referrals for HCC treatment if indicated,” says  Prof. Pisit Tangkijvanich. [3]

One of the critical programs launched under LEAP was the nationwide HBV screening pilot. It evaluated people born before 1992, targeting a demographic that was largely unvaccinated and at higher risk for HBV. Approximately 100,000 Hepatitis B Rapid Test Kits (HBsAg strip tests) were distributed across 100 primary healthcare settings and district hospitals in more than 30 provinces across 5 regions. Under LEAP,10,000 fingertip blood tests for hepatitis B were provided at Sub-district Health Promoting Hospitals (SHPH) to benefit residents of other districts in Chanthaburi.[3]

The HBV screening pilot involved nearly 100,000 tests on a demographic of 40% males and 60% females, with average ages of 49.6 and 52.5, respectively. It found a 3.1% total HBV prevalence, down from 4.5% nationwide [4] in 2014, providing crucial data for governmental planning and resource allocation. [3]

Graphic describes the results of the national HBV screening pilot done in Thailand. Nearly 100,000 HBV tests were conducted, of which 60% were female with average age of 52.5, and 40% were male with average age of 49.6. The pilot revealed an HBV prevalence of 3.1%, a drop from 4.5% in 2014. This data can be used for governmental planning and resource allocation.

Amplifying the Impact of HBV Screening with Digital Health Platforms and Education Campaigns

“Digital health platforms have the potential to increase awareness and knowledge, as well as facilitate HBV care that leads to the prevention and early detection of HCC,” continues Prof. Pisit Tangkijvanich. [5]

To boost the efforts of the HBV screening pilot, HBV-infected patients and healthcare professionals were engaged through various digital interventions. These included a self-administered questionnaire and e-learning modules to help patients better understand the disease and empower them to take charge of their liver health. Additionally, an online training program was developed for healthcare professionals to enhance their capacity in managing HBV. 

Even in remote areas, significant public engagement was achieved through the World Hepatitis Day Campaign 2023, using videos, infographics, and texts across multiple digital platforms like Facebook, YouTube, and TikTok. This campaign alone garnered almost 9,000,000 views. [3]

2. The EZ Liver Clinic: A Comprehensive Care Model

The EZ Liver Clinic at the Phrapokklao Cancer Center of Excellence, the first in Thailand, represents a pioneering model in the integrated care for hepatitis and HCC, in the eastern provinces. Led by medical oncologist Dr. Passakorn Wanchaijiraboon, operator of the Chantaburi EZ liver network, this clinic was developed to address the region’s high prevalence of liver diseases by streamlining the process from screening to treatment.

It offered four key elements: proactive high-risk HCC group identification, digital health for HCC surveillance, new biomarkers for surveillance, and health information exchange. [1,5]

Graphic describes the EZ Liver Clinic Model that was developed as part of LEAP in Thailand. Components included in the clinic operation include: reactive and proactive screening, use of a cloud system for smoother referral, and an app for high risk patients to be able to access information on liver disease and schedule their appointments. The clinic focused on comprehensive liver function testing, ultrasound diagnostics within six weeks, and swift connection to treatment options such as microwave ablation or liver transplantation, if necessary. 

The program’s success was evident as it: 

  • Revealed an HBV prevalence of 5.5% over three years in the Chanthaburi province.
  • Reduced waiting time for treatment from 6 months to less than two months.
  • Ensured collaboration among GI physicians, radiologists, interventionists, hepatobiliary surgeons, and medical oncologists to streamline patient care.

Over the past two years, 30,000 at-risk individuals were screened, identifying new Hep B patients; 50% required no treatment due to normal liver inflammation levels, while the other 50% were referred to Siriraj Hospital for treatment.[1] 

Graphic describes the benefits of the EZ Liver Clinic as part of 300,000 at-risk individuals were screened. 50% were required no treatment (with normal liver inflammation levels), while 50% were hospitalised for treatment. Waiting time for treatment was reduced from 6 months to <2 months. The system model also ensured collaboration among healthcare professionals to streamline patient care.Early-stage liver cancer was detected in some, leading to referrals for potential curative surgeries or microwave ablation, supported by 2.5 million baht donations to purchase necessary equipment. 

After the clinic’s success, the Ministry of Public Health (MoPH) announced the “Cancer Warrior” project to prevent, screen and provide effective treatment for various cancers, including liver cancer. The goal is to screen 1,000,000 at-risk individuals above 35 years old for HBV. [1]

EZ Liver Clinic Supporting Initiatives

As Dr. Passakorn Wanchaijiraboon emphasises, “Resolving breaks in the ecosystem cannot always be tackled by more resources, but we can look towards technology to connect the resources we do have.” [5]

Digital platforms for education and screening have expanded access and engagement, proving essential for the widespread dissemination of health information. Examples include:

  • Health Link is a cloud platform under development intended to store and share patient health information digitally and connect community labs with referral hospitals to streamline the diagnostic and treatment processes.
  • SurviLiver is an app with educational materials, a patient diary, an appointment booking system, and features allowing physicians to monitor their patient’s health between visits. [1]

These solutions are still undergoing development to allow the full integration of appointment scheduling and teleconsultation with the hospital systems. [1]

To further these initiatives, the partnership between the Ministry of Public Health (MoPH) and the Ministry of Digital Economy and Society (MDES) is necessary. While MDES handles the development of the Health Link project, it is the medical personnel from MoPH who are in charge of direct care for HCC and HBV patients.[5]

Future Directions for Scaling Up: Shaping reimbursement policies, education and partnership

Updating national guidelines to include the latest diagnostic tools and treatments would ensure advanced care is available uniformly across all regions.[3]

In Thailand, AFP testing costs approximately USD 8, and PIVKA-II costs about USD 10.  Ultrasound is significantly more expensive at around USD 100 per session, with long waiting times. [5] 

To advocate for improved surveillance strategies – such as blood-based biomarkers, compared to traditional methods like ultrasound – the HECON study evaluated the cost-effectiveness of HCC surveillance in Thailand. 

The results showed that GAAD (Gender, Age, AFP, DCP/PIVKA-II) was cost-effective in Thailand at ICER <160,000 THB compared to no surveillance. GAAD also yielded lower costs and better health outcomes than US + AFP. [6] These data are invaluable in shaping local reimbursement policies to include blood-based biomarkers in HCC surveillance strategies. 

Additionally, broadening insurance coverage for critical diagnostics and treatments is recommended to address gaps in hepatitis management and enhance access and affordability. Investing in Health Information Exchanges, patient management apps, and provider training would also streamline monitoring and data management. 

As seen from the HBV Screening promotion efforts, educational campaigns can be effective in reaching even those in remote areas. Educational campaigns should be continued to boost hepatitis awareness and screening rates. [3]

Leveraging partnerships with the diagnostic and pharmaceutical industry can boost resource availability and technology transfer. This was exemplified by collaborations with Roche that catalysed efforts in the EZ Liver Clinic. [1] Collaboration and partnership are critical for these next steps, wherein HCPs, patients, government and industry partners will need to work closely with each other in order to effectively manage liver disease.

Conclusion

The LEAP program has enhanced patient pathways and healthcare access in Thailand through the synergy between the HBV Screening Pilot and the EZ Liver Clinic. By combining the strengths of both initiatives of wide-scale screening and education with an integrated care model, there has been a comprehensive enhancement in managing liver diseases from prevention to treatment.

Listen to our podcast episode with Dr Passakorn Wanchaijiraboon to find out more about the EZ Liver Clinic. 

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Urgent Global Need for PIVKA-II and AFP-L3 Measurements for Surveillance and Management of Hepatocellular Carcinoma https://clinicalvalue.com/urgent-global-need-for-pivka-ii-and-afp-l3-measurements-for-surveillance-and-management-of-hepatocellular-carcinoma/ Fri, 12 Apr 2024 02:47:09 +0000 https://clinicalvalue.com/?p=8271 ...

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Quick Summary

The incidence of AFP-negative HCC is increasing worldwide, particularly HCCs of nonviral etiology, such as MASLD/MASH. A high percentage of patients with MASLD/MASH-related HCC are positive for PIVKA-II, even those who are negative for AFP[1]. Higher levels of AFP-L3 have also been reported in cases of MASLD/MASH-related HCC [2]. Thus, the role of PIVKA-II and AFP-L3 measurements in HCC surveillance and diagnosis of AFP-negative HCCs has become more important.
This article by Prof Masatoshi Kudo details the importance of testing all 3 biomarkers, AFP, AFP-L3, and PIVKA-II, in HCC surveillance and management. He also discusses new algorithms, such as GALAD and GAAD, which incorporate these biomarkers have been useful in countries where access to imaging is limited.

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Turning the Tide Against Hep B and HCC: Insights from New Zealand’s National Screening and Surveillance Program https://clinicalvalue.com/turning-the-tide-against-hep-b-and-hcc-leap/ Mon, 08 Apr 2024 08:39:37 +0000 https://clinicalvalue.com/?p=8215 ...

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Liver Ecosystem Advancement Project (LEAP) highlights New Zealand’s successful National Hepatitis B Screening Program

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].

LEAP NZ article visual 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.

Roche_Visuals-02

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].

Roche_Visuals-03_op1

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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ESMO Asia 2023 Symposium – HCC illuminated: Exploring future frontiers with systemic immunotherapies https://clinicalvalue.com/event/esmo-asia-2023/ Fri, 22 Mar 2024 07:30:08 +0000 https://clinicalvalue.com/?post_type=event&p=8129 Missed the satellite symposium session from ESMO Asia 2023? Access the webcast recording here....

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Development and Clinical Validation of a Novel Algorithmic Score (GAAD) for the Detection of Early-stage Hepatocellular Carcinoma https://clinicalvalue.com/development-clinical-validation-and-implementation-of-a-novel-algorithmic-score/ Wed, 20 Mar 2024 03:33:04 +0000 https://clinicalvalue.com/?p=8100 This study aims to establish and train the algorithm coefficients, and clinically validate the performance of the GAAD algorithm in differentiating HCC and benign chronic liver disease (CLD), across different regions and aetiologies....

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Early-stage hepatocellular carcinoma screening in patients with chronic hepatitis B in China: a cost–effectiveness analysis https://clinicalvalue.com/gaad-hecon-china-early-liver-cancer/ Tue, 05 Mar 2024 05:03:08 +0000 https://clinicalvalue.com/?p=8092 ...

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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:

  1. US
  2. AFP
  3. PIVKA-II
  4. AFP+US
  5. AFP+PIVKA-II
  6. GAAD
  7. GAAD+US

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.

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The Pursuit for Better Patient Outcomes – Innovating HCC Management at Siriraj Hospital https://clinicalvalue.com/the-pursuit-for-better-patient-outcomes-innovating-hcc-management-at-siriraj-hospital/ https://clinicalvalue.com/the-pursuit-for-better-patient-outcomes-innovating-hcc-management-at-siriraj-hospital/#comments Tue, 13 Feb 2024 03:48:29 +0000 https://clinicalvalue.com/?p=8030 ...

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Prof Tawesak Tanwandee and Asst Prof Sansnee Senawong demonstrates how digital algorithms are used in Siriraj Hospital for the early detection of HCC

Interview transcript:

TT: Prof. Tawesak Tanwandee

SS: Asst. Prof. Sansnee Senawong

Introduction

TT: My name is Tawesak Tanwandee, Professor of Medicine, Head of Division of Gastroenterology, Faculty of Medicine, Siriraj Hospital.

SS: Hello, I am the Assistant Professor of Medicine, Sansanee Senawong, Chief of the Immunology Department, Faculty of Medicine, Siriraj Hospital, Mahidol University.

TT: Siriraj Hospital is the largest and the oldest hospital in Thailand. As it is a large and highly advanced hospital, a large number of patients come to Siriraj Hospital annually.

SS: The laboratory of the Department of Immunology was certified by the international standard ISO 15189 since May 2006. It has passed the continuous evaluation and inspection for the ISO 15189:2012 standards to date.

TT: As we are a large hospital, we receive patients from other hospitals. The patients who are referred to our hospital are mostly terminally ill. They are already in the terminal stage of cancer.

What is the unmet need in HCC surveillance and diagnosis in Siriraj Hospital?

SS: In Thailand, liver cancer is one of the most common and leading causes of death in cancer patients in the country. We find that over 70% of patients who die of liver cancer are not admitted to the surveillance program, resulting in delayed diagnosis at the terminal stage and they pass away soon after.

TT: For patients at risk of liver cancer, we don’t always have the chance to screen them sufficiently at an early stage. Moreover, an early stage of liver cancer has no visible symptoms. Therefore, the patient does not realize they need to be tested.

SS: In terms of liver cancer, there are still challenges regarding the effectiveness of liver cancer surveillance.

TT: The standard practice for liver cancer surveillance today is composed of ultrasound scans and blood (biomarker) tests to check alpha fetoprotein (AFP) levels every 6 months.

SS: However, we find that the sensitivity rate is as low as 63%.

TT: Due to ultrasound capacity limitations, patients may have to wait for months or even a year for a scan. Ultrasound also relies heavily on the doctor conducting the scan and how meticulous they are. Patients who are obese or have been diagnosed with liver cirrhosis, may be difficult to detect liver cancer by ultrasound.

SS: As a laboratory, when choosing a test or a platform for our services, we must take into account the challenge of reporting laboratory results quickly and efficiently to keep up with the increasing laboratory workloads. Also, it has to minimize human errors as much as possible. We need to find an appropriate system that can support various biomarker testing and is reliable.

What is your clinical experience with PIVKA-II? How has it brought value to HCC diagnosis?

TT: The data from studies show that PIVKA-II was quicker to detect early stages of liver cancer in patients. Checking the levels of AFP and PIVKA-II at the same time is much more convenient to doctors. Therefore, a single blood test from the patient allows both tests to be run. When testing both, we see for some patients, that the level of AFP is normal but the PIVKA-II level is abnormal. This helps to alert the doctor to abnormalities in the patient.

SS: Providing PIVKA-II to use in our laboratory will help improve the efficiency of early liver cancer surveillance in the future.

What is your experience using digital algorithms? How does the digital algorithm bring value to enable early HCC diagnosis?

TT: There are about 50-60 patients who have used the digital algorithm. And it has been very beneficial to some patients.

SS: But due to the limitations of ultrasound access combined with the sensitivity performance of AFP, considering to add new biomarkers such as PIVKA-II and  the digital algorithm will play a very important role.

TT: When applying the digital algorithm, in practice, we have to add two other factors, age and gender. Sometimes, abnormalities in the AFP level or PIVKA-II level is detected. But the digital algorithm shows it as normal. The algorithm makes surveillance more accurate.

SS: According to many studies and the reports from the doctors who directly treat the patients, it was found that using PIVKA-II and the digital algorithm, compared to the results of AFP and ultrasound, which is considered standard/conventional practice, helps detect liver cancer at an early stage more efficiently.

What does your workflow using the digital algorithm look like?

TT: The digital algorithm has simplified the workflow. Every time a patient has a health check, it’s standard practice to run a blood test to check the liver health. With the blood sample, we can run the digital algorithm at the same time. This means the patient only needs to give one blood sample. Everything is done in one visit.

SS: After collecting the samples, the laboratory performs AFP, PIVKA-II, and digital algorithm tests. After the AFP and PIVKA-II test results are reported, the laboratory results will be combined with gender and age to automatically calculate the score. The result will be sent to the LIS or HIS system of the hospital, allowing the doctors to see the test results quickly. This makes the laboratory workflow more convenient and reporting of results faster.

TT: It’s very easy to interpret the result because there is only ‘positive’ or ‘negative’ (score). The doctors don’t need to interpret complicated numbers. When an abnormality in the digital algorithm is found, the doctor should conduct further (confirmatory) testing, especially using medical imaging techniques such as X-ray, CT or MRI scans.

What’s your expectation for the digital algorithm in the future?

TT: If we use the digital algorithm or PIVKA-II in addition to AFP, the liver cancer surveillance will likely be more accurate because this test already shares the same platform as their regular blood tests. And this will help us to decide if the patient is at risk of cancer, or need further surveillance tests. We might be able to detect the liver cancer at an earlier stage in more patients and provide successful treatment.

What is Siriraj  Hospital’s vision for the liver disease and HCC management?

TT: In patients who have been screened and found to have liver cancer, over 90% of them live longer than 5 years. In this case, it changes the patient’s life. If we can use other surveillance methods such as PIVKA-II or the digital algorithm, it might help to improve surveillance effectiveness.

SS: The department is very pleased to have been a part of an important step in using digital diagnostic tools which are helping liver cancer patients have a better quality of life and increase the survival rate.

TT: At Siriraj Hospital, we provide knowledge and raise awareness for everyone, which includes both patients and healthcare workers. So, the patients who are at risk of liver cancer, can receive surveillance regularly. We hope that in the future, every patient who is at risk of liver cancer, everyone in Siriraj Hospital, will receive the surveillance process regularly.

The views and opinions expressed by Prof. Tawesak Tanwandee and Asst. Prof. Sansnee Senawong are their own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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HCC monitoring and surveillance update – the limbic https://clinicalvalue.com/hcc-monitoring-and-surveillance-update-the-limbic/ Wed, 01 Nov 2023 08:57:26 +0000 https://clinicalvalue.com/?p=7535 ...

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The limbic HCC monitoring and surveillance update with A/Prof. Simone Strasser and A/Prof. Jessica Howell

In these series of videos produced by the limbic, A/Prof. Simone Strasser and A/Prof. Jessica Howell discuss:

  • how changes in the epidemiology of advanced liver disease – both in Australia and globally – present challenges to the surveillance and monitoring of hepatocellular carcinoma
  • discuss ways that specialists can ensure at-risk patients are undergoing surveillance for HCC
  • current and future approaches to HCC surveillance and monitoring

Click the buttons below to watch the videos directly on the limbic:

The changing epidemiology of advanced liver disease and HCC

HCC surveillance in at-risk patients

Limitations of current HCC surveillance strategies and future solutions

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