Liver Health - Q1 2022 by Mediaplanet UK&IE

Q1 2022 | A promotional supplement distributed on behalf of Mediaplanet, which takes sole responsibility for its content

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Global Liver Institute launches a new global public health initiative in liver health Despite affecting more than half a billion people, liver conditions continue to be misunderstood and stigmatised, resulting in under-diagnosis, undertreatment and poor outcomes.

new initiative to raise the profile of liver disease as a major public health issue is being launched globally. Donna Cryer, CEO of Global Liver Institute (GLI), the non-profit organisation representing patients with liver disease, says: “Everyone is at risk of liver disease and should be concerned about their liver health. “There are over half a billion people living with some form of liver disease, most of whom do not know. That is why we feel it should be positioned in the pantheon of public health issues.” A public health issue The Liver Health is Public Health (LHPH) Initiative, launched this March by Global Liver Institute, will be a multiyear initiative that aims to see liver health given the same status among the general public, researchers, doctors and policymakers as heart, brain and other major health issues. GLI looks forward to working collaboratively with the more than 200 global partners across GLI’s liver councils on the LHPH initiative. The LHPH Initiative is endorsed by the Hepatology Society of the Philippines, the European Society for Organ Transplant, Liver Patients International, European Reference Network on Metabolic Diseases, Turkish Association for the Study of the Liver and GLI’s Liver Action Network, including 12 global liver patient advocacy organisations. Founded in 2014 and based in Washington DC with offices in Rome and Edinburgh, Global Liver Institute works with partner organisations and societies in numerous countries and covers all aspects of liver health from cancer, fatty liver diseases, paediatric and rare liver diseases. Through LHPH it also wants to alert people of the influence they can have on their liver health by what they eat and the exercise they take. Cryer, who had a liver transplant 27 years ago after developing a rare autoimmune liver disease, says: “I was blessed to receive the gift of life but I hope that I can prevent people from ever needing a liver transplant. But if they do, they need to get all the innovation and care that would help them lead a healthy life.” Reducing stigma Although there are more than 100 different types of liver disease, the condition has been stigmatised because of a perception that it is caused primarily by alcohol. But as Cryer points out, many cases affect children, viral hepatitis is a cause of liver cancer and one of the main conditions is NAFLD (nonalcoholic fatty liver disease). “Most people do not know there are so many potential causes of liver disease, whether they are environmental, nutritional, genetic or autoimmune disease,” she says. She also points out that COVID-19 has affected liver patients harshly and also created more liver patients, as some forms of COVID have caused liver damage. INTERVIEW WITH Donna R. Cryer, JD President & CEO, Global Liver Institute

Paid for by Global Liver Institute Find out more at globalliver.org

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WRITTEN BY Mark Nicholls

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How to stop Greater awareness the NAFLD is needed of NAFLD domino effect Samantha shares her experiences of her mother suffering with non-alcohol related fatty liver disease (NAFLD). Greater awareness of condition could help earlier diagnosis and save lives.

WRITTEN BY British Liver Trust Samantha’s story who lost her Mum (picture above) to NAFLD due to late diagnosis

y mum was diagnosed with NAFLD on 19th April 2018 and sadly passed away just four days later. At her inquest, the coroner cited missed opportunities for diagnosis and treatment.

Living a healthy lifestyle When my mum was younger, she was very active, running cross country for our local county and a marathon for charity. She also maintained a healthy diet. However, her mobility was destroyed by osteoarthritis and spondylitis, which led to her weight gain and subsequent knee replacement surgery. My mum knew she had problems with her liver having had multiple liver function tests (LFTs) from 2004, which all had abnormal results. Despite this, she was not referred for any further testing as doctors did not believe she was at risk. My mum didn’t drink alcohol and avoided taking pain medication, but she was overweight which we now know to be a risk factor for NAFLD. Noticing behaviour changes Just over a year before her death, we started to notice changes in her behaviour. She didn’t want to eat and her mood changed, she seemed very low and worried a lot. Following the knee replacement surgery, my mum started to experience brain fog and muscle spasms. Both brain fog and muscle spasms are common symptoms of liver disease, but we thought these were side effects of her surgery.

Liver disease is often diagnosed late because the symptoms are either vague or non-existent in the early stages. Rapid deterioration After a week of antibiotics, I visited her at home, it was the first time she had left her bed in days. As soon as she walked into the living room I was shocked at her appearance. I had seen jaundice before and knew something was wrong. We got her an emergency appointment with her GP who agreed she needed to go into hospital. She underwent a number of scans and tests over the next four weeks, all the while deteriorating rapidly. By the time they diagnosed NAFLD it was already too late. She had developed encephalopathy and days later suffered a stroke. My mum passed away surrounded by her family in hospital. Delays in diagnosis Liver disease is often diagnosed late because the symptoms are either vague or non-existent in the early stages but also little is known about the disease by both the public and healthcare professionals. I think, if there had been greater awareness, as the coroner suggested, my mum could have been diagnosed earlier and may still be here today. 04

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In recent years, non-alcoholic fatty liver disease (NAFLD) has become the most common cause of chronic liver disease.

ased on the official studies, NAFLD affects one in four adults and one in 10 children/ adolescents in Europe. The prevalence and incidence of the condition are expected to increase worldwide as the global obesity epidemic spreads and the trend in developing countries toward the Western lifestyle continues. NAFLD can cause what is called the ‘domino effect’ and together with co-morbidities such as obesity, hypertension and hypertriglyceridemia can be the cause of cirrhosis and hepatocellular carcinoma. COVID-19 pandemic measures may have played an essential role in the global increase of the NAFLD ‘domino effect’ as most individuals needed to change how they live, work, study and socialise.

specific action steps to EU and stop the ‘domino effect’ of the disease. A specific working group has been created within ELPA members to work precisely in that direction. Recently, the working group, together with the ELPA Scientific committee coordinator, Dr Teresa Casanovas, has organised a survey which in the first phase aimed to:

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Find out the knowledge level of the disease among the general population. Uncover the unmet needs of people living with this disease. The survey was translated into seven different languages, and the final results will be announced in September 2022.

International NASH day Another critical step ELPA is taking in It is also clear how fighting the ‘domino Pandemic changes effect’ is gathering health care systems in lifestyle all stakeholders, and must be improved to In combination discussing important, with the isolation framing issues fight inequalities across measures, these related to NAFLD Europe and not leave sudden changes patients on June 9, influenced emotional some people behind. 2022 - international and psychosocial NASH day. wellbeing, as well as food habits. The These two actions are essential pandemic has affected our lives and because citizens need health literacy contributed to increasing the time and updated scientific information. we spend in front of a screen, maybe Politicians should introduce changes eating while watching, paying less in legislation related to food and attention to the size of the portion, or alcohol labels. It is also clear how the quality of food. In addition, this health care systems must be improved means greater exposure to advertising to fight inequalities across Europe and of unhealthy products and decreased not leave some people behind. physical activity. In addition, an We are aware that liver diseases have increase in harmful alcohol use has a significant public health component been reported. and many liver diseases might be preventable; NASH is one of them. New working group needed The European Liver Patients Association (ELPA) strongly believes that 2022 is crucial to frame a set of

WRITTEN BY Yiannoula Koulla Leader of NAFLD/ NASH Working Group, European Liver Patients’ Association (ELPA)

WRITTEN BY Dr Teresa Casanovas M.D. Scientific Committee Leader, European Liver Patients’ Association (ELPA)

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Regenerative Nanotherapy to Treat NAFLD Non-alcoholic fatty liver disease (NAFLD) is a major chronic liver disease affecting over 24% of the world’s adult population.

hile NAFLD/steatosis is benign and can be reversed with lifestyle and diet modifications, over 30% of the NAFLD population can progress to a more advanced stage known as non-alcoholic steatohepatitis (NASH), characterised by inflammation, fibrosis and cirrhosis.

WRITTEN BY Tuhin Bhowmick Co-Founder and CEO, Pandorum Technologies

Addressing unmet need NASH in effect is a pandemic of unmet clinical needs. The complications related to NASH are associated with three major components- metabolic, fibrotic and inflammatory. Further, an additional reason for failure of drugs in advanced stages of clinical trials is the lack of suitable experimental models which can reliably translate to humans. Pandorum is a tissue-engineering and regenerative medicine company specialized in developing stem cell-derived therapeutics known as exosomes, enriched with factors to treat liver diseases involving inflammation and fibrosis. These exosomes are not only capable of reversing the disease pathology, but can also promote healthy regeneration, restoring the liver to a healthier state.

Paid for by Pandorum

Screening therapeutic agents At Pandorum, we address the issue of drug failure by developing 3D human liver micro-tissue (organoids) of NASH and using them as an advanced screening platform for our exosome-based therapeutics. Our disease model successfully recapitulates the transition from NAFLD to NASH and serves as a human relevant model that can predict the efficacy of drugs with high reliability. We use multi-parameter molecular readouts to capture disease reversal state when treated with exosomes and relevant pharmacological agents in the market.

Find out more at pandorum.com

Liver disease: getting more from your blood test Rates of liver disease are increasing across the United Kingdom. It is a rapidly rising cause of death in those under the age of 65.

ince 1970, there has been between a 400-500% increase in the mortality rates for liver disease. This is in a stark contrast to most other diseases where the mortality rates have stayed stable or fallen in the same time period.

WRITTEN BY Professor John Dillon Consultant Hepatologist, Professor of Hepatology and Gastroenterology, University of Dundee Vice-President for Hepatology, British Society of Gastroenterology

Late-stage diagnosis Liver disease is in many ways a sneaky killer, people are unaware that they have the disease until it’s too late. Most people are often first aware that they have the problem when they present to hospital, with a severe complication such as internal bleeding or the development of massive fluid in the abdomen. The most common causes of liver disease in the UK – which are also preventable - are related to excess alcohol consumption, chronic viral hepatitis or obesity related fatty liver disease. All three cause chronic low-grade damage to the liver where it is progressively replaced with fibrosis leading to cirrhosis. Importance of liver function tests This development of liver disease is even more surprising given that one of the common blood tests performed on people are liver function tests. Most adults in the UK have had them at least once. The blood test is very simple and commonly taken within general practice. However, the interpretation of these blood tests is complex as liver disease will often only cause minor abnormalities,

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despite leading to serious complications. These abnormalities are difficult to detect but there are techniques which combine liver function tests with a mathematical formula to identify those at high risk of progressive scarring of the liver. These mathematical calculations are not commonly available nor are they well understood by the average primary medical care provider. Greater awareness and education needed The British Society of Gastroenterology has highlighted members who have developed services that make these calculations routinely available to GPs to allow early detection of liver disease. For example, in South Wales, there is the “Gwent Liver Pathway” and in Scotland “intelligent Liver Function Testing (iLFT) where if GPs queried liver disease or requested liver blood tests they automatically have the additional calculations performed. The information is then provided back to GPs. There are plans afoot to make this commonplace across the United Kingdom. We are hopefully entering a time in which liver disease is routinely and automatically detected early. This gives people an opportunity to avoid the dire consequences of liver disease, by changing lifestyle at an early stage.

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Progress is being made in new treatments for liver cancer Treatment of cancer has recognised a true revolution in the past two decades. Those who treat liver tumours could not hope for a better time to shake up clinical practice.

or way too long and despite incessant efforts from clinicians, patients, universities, charities and industry - liver tumours have remained neglected orphans from the transformative changes that chemotherapy has lent to a wide variety of cancers including breast, lung and ovary.

WRITTEN BY Lorenza Rimassa Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy, International Liver Cancer Association

Demonstrating the value of therapies Hepatocellular cancer, the most common form of liver cancer, is tough to treat as it arises most frequently in a scarred liver. Demonstrating that drug therapy was worth pursuing in this highly untreatable cancer type took years and for over a decade we only had one drug to treat it. At medical conferences and in the clinic, more and more we hear a word being pronounced. One that we desperately needed: choice. After years of failure, there are now an increasing number of drugs that are available to patients and a disease that would prove fatal in 3-6 months can be successfully managed for up to two years in patients who respond to treatment. We have learnt over the years that hepatocellular cancer is often invisible to our own immune system and we have developed immunotherapy to remove the “invisibility cloak” that protects cancer from our own natural defences. The same approach is proving useful in bile duct cancers,

a rarer form of liver cancer from which we have learnt that combining chemotherapy and immunotherapy may be the way forward. Offering treatment to those in need As novel choices for treatment arise it becomes crucial that, as a society, we are able to offer these treatments to everyone who needs them and understand who has the best chance of responding to each type of therapy. New drugs can be expensive and may not benefit all, so a lot of work remains to be done to make anti-cancer therapy affordable, universal and truly personalised. We are at a turning point for the treatment of this disease, we have new drugs and we will have more in the near future. By working all together with the ultimate goal of improving not only the prognosis but also the quality of life of our patients, we will finally be able to offer true hope for patients affected by liver cancer.

WRITTEN BY Dr David James Pinato MD, MRCP (UK), MRes, PhD Clinical Senior Lecturer and Consultant Medical Oncologist, International Liver Cancer Association

This year, the 16th edition of the ILCA Annual Conference will take place in Madrid, Spain on 1-4 September 2022 and we invite everyone in the liver cancer community to join. Find out more: ilca2022.org

Liver cancer is an all-out battle Over the past 20 years, there has been a 70% increase in liver cancer-related mortality in Europe.1 From 1997 to 2016, incidence and deaths from hepatocellular carcinoma (HCC) have tripled in England.2

nfortunately, liver cancer is usually asymptomatic. When discovered, it could be too late. At an advanced stage, options are limited and connected to high costs. Every year €4 billion is spent in Europe on liver cancer.

WRITTEN BY Marko Korenjak President, European Liver Patients’ Association (ELPA)

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Lowering liver cancer incidence The European Liver Patients’ Association - ELPA has been working in the field of advocacy for liver patients for more than 17 years. What is striking us the most is that many liver diseases could lead to liver cancer and, if treated or avoided, can lower its incidence. Almost 50% of cases are preventable, 35% of deaths could be avoided through preventive measures and lifestyle choices. Hepatitis B and C are responsible for up to 76% of liver cancer worldwide. It means that working on hepatitis reduction and elimination is also a way to fight cancer. Fatty liver, smoking and alcohol are among the scientifically recognised liver cancer risk factors and they can be tackled by adopting a healthy lifestyle and promoting health literacy. Therefore, we are in front of three driving forces: prevention, early screening and early detection. These are crucial because they can ensure several options for treatment. However, ELPA can testify how advocating this at EU level is not easy.

Lack of focus on early diagnosis When Europe’s Beating Cancer Plan was first announced, we wanted to engage with it and flag up the lack of focus on risk-stratified screening and early diagnosis in liver cancer. However, our submission to the consultation focused on communicable diseases (Hepatitis B and C) and the Plan was officially about a non-communicable condition. We reached out to our fellow patient advocates in Digestive Cancers Europe - DiCE, and other organisations. Liver cancer is now mentioned in the plan at least on the prevention front in the chapter dedicated to infectious diseases. We regret that there is currently no mention of screening. Still, we continued to work and together with DiCE, we also drew up a White Paper Liver Cancer: No Patient Left Behind in October 2021. We call upon all stakeholders across Europe to work together to ensure that best practices are implemented at every stage of the patient pathway in each country, giving every patient the best possible opportunity for a positive outcome.

WRITTEN BY Dr Teresa Casanovas M.D Scientific Committee Leader, Euroepan Liver Patients’ Association (ELPA)

We believe we can achieve more and faster if we work together. References 1. Data from the Lancet Commission on Liver Diseases Dec 2022. 2. Data from the National Cancer Research Institute (NCRI). 3. Data from the Lancet Commission on Liver Diseases Dec 2022.

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Stepping up care standards for patients with a rare liver disease Treatment for patients with a rare and chronic liver condition could be significantly improved following a nationwide audit of NHS centres.

INTERVIEW WITH Dr George Mells Consultant Hepatologist WRITTEN BY Mark Nicholls

rimary biliary cholangitis (PBC) is a rare liver disease that occurs in fewer than one in 2,000 people. It is a leading indication for liver transplantation in the UK. Hepatologists from almost all NHS liver centres in the UK have recently completed an audit of management of PBC. It has raised important questions about the provision of health care for rare liver diseases in the NHS. Slow progression PBC is an autoimmune liver disease, resulting from a person’s immune system damaging the small bile ducts in the liver. “There is a slow progression over time and in a substantial proportion of patients, PBC eventually leads to cirrhosis. Some patients develop chronic liver failure and require a liver transplant,” says Dr Mells from Addenbrooke’s Hospital in Cambridge. It is an important cause of liver disease. First-line treatment The first-line treatment for PBC is ursodeoxycholic acid, which is effective in most but not all patients. Second-line treatments are available in the UK for patients whose PBC is not controlled by ursodeoxycholic acid alone. Prescription of second-line treatment for PBC is monitored by the NHS. This has shown that the number of prescriptions issued for second-line treatments is “substantially fewer” than the number of patients predicted to need it. “That was the real prompt to do the audit,” adds Dr Mells. “It needed to be national because we wanted to be able to compare the management of PBC in specialist centres to district general hospitals and across different regions of the UK.” Dr Mells explains there were also growing concerns that PBC was not being managed in accordance with the care quality standards outlined in guidelines from the British Society of Gastroenterology (BSG). While data from the audit are still being analysed, Dr Mells says one of the key findings is that only half of the patients eligible for second-line treatment are receiving it. “That means that patients are missing out on the treatments they need. That puts them at risk of progressive liver disease and future complications of cirrhosis,” he says.

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Lack of familiarity Not unexpectedly, the audit also shows that prescribing rates are higher for patients managed in specialist centres compared to smaller hospitals. The reason for this disparity is unclear. One possibility, however, is that due to its rarity, treatment pathways for PBC might be less well-rehearsed in smaller centres than in the UK’s major liver hubs.

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PBC patients may also have no symptoms, so the observations that should trigger a referral for second-line treatment might be overlooked. Expanding on how this might lead to patients with PBC being overlooked, Dr Mells says that specialist centres frequently have clinics focussed on the condition. Conversely, in smaller centres, rare patients with PBC are interspersed amongst those with more prevalent liver conditions. PBC patients may also have no symptoms, so the observations that should trigger a referral for secondline treatment might be overlooked. If effective treatment is delivered earlier, however, it can prevent patients from developing complications from liver disease. “Effective treatment needs to start as early as possible to prevent progression of the disease and avoid the future need for a liver transplant,” he says. Audit data The audit covered all aspects of PBC management and was co-led by the Addenbrooke’s team, which found that most UK centres willingly contributed data for a national report. Project manager, Steven Flack, explains: “Each centre is going to receive their data back to identify gaps within their own centre to put procedures in place to improve treatment.” Dr Mells adds: “The broad aim is to improve care for PBC and make sure that patients eligible for second-line treatment are identified and referred to the local multi-disciplinary team.” While this audit has identified issues that must be addressed, there is hope that it will lead to measurable improvement in care for patients with this rare liver disease in the UK. This article has been sponsored by Intercept Pharma UK & Ireland Limited (“Intercept”). Intercept has recommended the potential authors for this article, however, with the exception of a factual accuracy check, Intercept has had no editorial control over the content of this article. UK-PB-MED-00090 Date of Prep: March 22

Find out more at pbcfoundation.org.uk britishlivertrust.org.uk

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The most common causes of liver disease in the UK – which are also preventable - are related to excess alcohol consumption, chronic viral hepatitis or obesity related fatty liver disease. ~Professor John Dillon, Consultant Hepatologist, Professor of Hepatology and Gastroenterology, University of Dundee, Vice-President for Hepatology, British Society of Gastroenterology

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