As the world continues to gain a better understanding of COVID-19 and ever present and new variants, Global Liver Institute wants to ensure that we are here to continue to guide, educate, and support the liver cancer community and other immunocompromised patients.
Liver cancer patients currently have the second highest risk of breakthrough infection compared with other cancers. Since advanced liver disease and liver transplant may increase the risk of severe COVID-19, it is important to know what therapies are available to you. It also remains important to avoid delays to care for any new liver diagnosis or to maintain your existing care path. Additionally, patients with underlying health conditions or people who already have a difficult time accessing care or maintaining distancing precautions given life circumstances may be more at risk for developing “long COVID” or post-COVID conditions.
As a patient, you may feel overwhelmed with updated guidelines, therapies, and treatments. Despite the uncertainty for high risk individuals, there are many options available to prevent infection or serious disease from COVID-19. Below, we have provided a guide on how you can take proactive steps to give yourself the best chance to stay COVID-free during this time.
As always, it is important to consult your doctor and care team to learn more about prevention or treatment decisions.
Monoclonal antibody treatments must be taken shortly after presenting symptoms and testing positive for COVID-19: baricitini (Olumiant), tolcilizumab (Actemra), Bebtelovimab
Please consult your doctor prior to making any prevention or treatment decisions. Also, recognize that not all physicians have access to all these interventions. *Paxlovid is not recommended for people with serious kidney or liver disease, or should be prescribed with caution in patients with liver conditions or liver enzyme abnormalities since ritonavir is capable of causing liver damage.
Prevention:
FDA Emergency Authorization Approved Therapies before COVID-19 Exposure
Evusheld is an antibody treatment that you can receive if you are someone who has a moderate to severe compromised immune system, and thus might not receive full protection from the COVID-19 vaccines. This treatment is also available to individuals who cannot receive the COVID-19 vaccination due to having severe adverse effects. You can receive this treatment from a medical provider as two intramuscular injections, given one after the other. Please contact your medical provider for more information on how to receive this treatment.
COVID-19 vaccines for immunocompromised patients: Patients who are taking immunosuppressants or who are immunocompromised might not have the same immune response after the COVID-19 vaccine as other patients. Because of this, per the CDC, immunocompromised individuals who are 12 years or older are recommended to receive 4 doses of the mRNA COVID-19 vaccine. For more information on vaccination protocol and schedule please consult your medical provider or local pharmacy. Check out the CDC guidelines here.
Consult with your providers prior to making any prevention decisions.
Treatment:
Available Therapies after COVID-19 Exposure or Diagnosis
The Biden-Harris Administration launched a new nationwide Test to Treat initiative to give people a faster and easier way to access COVID-19 treatment information. With this program, individuals can get tested – and if they test positive for COVID-19 – and find appropriate treatment options, receive a prescription from a health care provider, and get their prescription filled– all at one location. A locator for these “one-stop Test to Treat” can be found here.
Monoclonal antibodies can be taken shortly after presenting symptoms and testing positive for COVID-19 infection. These include Bebtelovimad, Olumiant, and Actemra.
Antiviral treatments are administered through pills or intravenous drugs used to treat mild to moderate COVID-19 infections. Paxlovid* and Lagevrio are pills that should be taken as soon as possible after diagnosis. Veklury is an IV antiviral treatment that is administered for high-risk, non-hospitalized individuals that have tested positive for mild to moderate COVID-19 infection.
*It is important to note that Paxlovid should be prescribed with caution in patients with liver conditions or liver enzyme abnormalities since ritonavir is capable of causing liver damage.
Individuals who previously tested positive for COVID-19 and have developed antibodies can donate their plasma to help immunocompromised patients fight against this infection. This COVID-19 convalescent plasma treatment is available in hospitals to help fight severe infection.
Consult with your providers prior to making any treatment decisions.
As always, it is important to stick to the basics to prevent COVID-19 infection:
Wash your hands. Clean your hands frequently, with soap and water for at least 20 seconds or use hand sanitizer with at least 60% alcohol.
Wear a mask when appropriate to protect yourself and others, especially when indoors. As mask-use guidelines change, it is critical that high risk individuals continue to wear a high-quality mask.
Avoid crowds and poorly ventilated areas. The more exposure you have to individuals, the higher the chance of infection.
Monitor your health daily.
Avoid close contact with people who are sick.
If you have traveled or been exposed, get a COVID-19 test 3-5 days after exposure or event.
From the Transplant Patient-in-Chief
Hello and welcome to Spring! The world is reopening, and we want to be a part of it.
As one of my favorite Peloton instructors says, “I make recommendations, you make decisions.” I am not even going that far, but am just telling you what actual decisions I have made – which you can take or leave. I have been part of the Johns Hopkins Vaccine Effectiveness Study, so I knew I had no antibody response to the 1st two shots. At this point, I have had 2 Pfizer vaccines and 3 Moderna vaccines with no worse side effects than feeling sleepy and having a sore arm for a day. I have kept all my regular doctor’s appointments and procedures. I have been out to dinner, a concert, several meetings, and 3 large events in the US and Europe. I wear a mask, carry hand sanitizer, and wash my hands (which, frankly, I did before COVID-19 as well!). I do intend to ask my transplant team to receive Evusheld. I also take a home antigen test before each event to protect others with whom I would interact. I am enjoying life following the best medical advice and common sense.
Donna R. Cryer, JD President & CEO Global Liver Institute
Global Liver Institute and partners bring together expert speaker panels, patient/provider materials in 16 languages and community screening events
(Washington, DC – May 9, 2022) – In exactly one month, Global Liver Institute will convene the fifth International NASH Day, held annually on the second Thursday in June! This year, partners from around the world will host events to raise awareness about nonalcoholic fatty liver disease (NAFLD) and its more advanced form nonalcoholic steatohepatitis (NASH) in their communities as we unite to Stop NASH Now. The theme is meant to emphasize all the actions each of us can take to combat this serious, progressive liver disease that affects 1 in 4 people.
Throughout #NASHday on June 9, local screening events, educational trainings, group walks, and more will be held worldwide. Additionally, GLI will also host four virtual panels as experts discuss the developments and challenges of key topics within NASH:
Pediatric NASH in Black Children
NASH Patients in Their Own Voices
NASH Diagnostics & Beyond
Leading Models for Care in NASH
Up to 444 million people and counting are estimated to already have NASH worldwide, per Mayo Clinic Proceedings. In light of this growing prevalence, it is critical that people be screened for NAFLD and NASH. Early detection allows people to be matched with the appropriate care pathway, whether clinical trials, lifestyle changes, or other treatment to prevent or reverse NAFLD.
It is important to stay informed! You can access several educational materials about NASH in 16 languages on the #NASHday website: Arabic, Chinese (Mandarin), Croatian, English, French, German, Greek, Hebrew, Hindi, Italian, Japanese, Macedonian, Portuguese, Russian, Spanish, Turkish. Two new patient resources – a guide to participating in clinical trials and an updated pocket card – will be released soon.
Get moving! Step up for liver health with GLI by taking a walk, hiking, or doing another activity. Share a photo of your walk with the hashtag #NASHday as we all practice a healthy liver lifestyle.
For additional information, visit the International NASH Day website.
To become an #NASHday sponsor, please submit an application here.
Support the #NASHday social media campaign using hashtags #NASHday #StopNASHNow. Please direct any additional questions to NASHDay@globalliver.org.
International NASH Day and its logo are registered trademarks of Global Liver Institute.
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About Global Liver Institute
Global Liver Institute (GLI) is a patient-driven 501(c)3 nonprofit organization headquartered in Washington, DC, with offices in the EU and UK, founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver disease and the importance of liver health to well-being. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to improve research, care, and policy. By bringing together more than 200 community-based, national, and international organizations across its Councils, Campaigns, and events, GLI equips advocates to identify and solve the problems that matter to liver patients. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube. GLI is the global host of International NASH Day.
(Washington, D.C., May 3, 2022) – Global Liver Institute (GLI), a premier patient-led liver health nonprofit operating globally, is deeply concerned by the draft opinion published by POLITICO indicating the Supreme Court of the United States may overturn Roe v. Wade. A decision of this magnitude would severely impact patients affected by liver disease in two critical ways.
First, Roe v. Wade is based on a long line of constitutional precedence against government interference with intensely personal decisions and health. At Global Liver Institute, we believe in women’s autonomy, and that a woman’s right to choose is fundamental to the sustainability of her and her family’s health. On top of this is the concerning reality that women in the U.S. are actually more likely to die as a result of pregnancy or childbirth complications than they were two decades ago, and Black women are nearly four times more likely to die than white women.1 These numbers are not improving, and among 11 developed countries, the United States has the highest maternal mortality rate.2
Second, liver health can directly impact a pregnancy whether it is because of a liver condition, surgeries and procedures, and/or medications. Each could impair a woman’s ability to conceive or safely carry a pregnancy to term. Many liver diseases affect infants, girls, adolescents, and women of child bearing age, particularly autoimmune diseases like primary biliary cholangitis (PBC). Pregnancy can also unexpectedly induce a variety of liver diseases that could threaten the life of the pregnant woman, including acute fatty liver of pregnancy (AFLP) and intrahepatic cholestasis of pregnancy (IHCP).3 Even more concerning, some liver diseases can flare up during pregnancy, such as autoimmune hepatitis (AIH) and Wilson’s disease, and diseases not related to the pregnancy, such as viral hepatitis, could also affect the pregnant woman at any time during gestation. 4
The leak of the draft Supreme Court decision may be yesterday’s triggering event, but the erosion of women’s autonomy and disdain for women’s health, especially at the state level, has been expanding perniciously for years. This expansion will continue unless we stop being distracted by tactics around viability, exceptions, and the ability of random neighbors to become bounty hunters. In a civil society it should not be the federal government’s, the state legislature’s, or another person’s decision as to whether and how an adult woman chooses to build a family. We need to collectively commit to putting the education and meaningful support for healthy women throughout the lifecycle and healthy families in place so that a choice can be freely and equitably exercised.
(Washington, D.C., April 29, 2022) – As leaders in the liver cancer community, Global Liver Institute and their Liver Cancers team expresses our gratitude and recognizes Dr. Ned Sharpless and his tremendous work as the Director of the National Cancer Institute (NCI), part of the National Institute of Health. Dr. Sharpless has held this position since 2017 and will serve through today.
GLI was honored to interview Dr. Sharpless, 15th director of the NCI, on October 1, 2021, during the GLI LIVE episode “The National Cancer Act at 50 and the Prospects for Ending Liver Cancer.” On liver cancer, he shared, “With a complicated shift in epidemiology and slow advances in research, we are seeing an increase in liver cancer incidence and mortality—making it a very challenging cancer to treat.” Additionally, in November 2021, NCI released information about a clinical trail that targets the cell surface protein GPC3 which provides a promising opportunity to treat hepatocellular carcinoma.
Dr. Sharpless has championed health equity and inclusion and developed fundamental programs in data science, and he will truly be missed.
GLI looks forward to developing its relationship with the NCI to continue to drive policy, education, and awareness of liver disease and liver cancers to increase screening, treatment, and prevention of the third deadliest cancer in the world.
Welcome to the very first edition of Pediatric & Rare Liver Diseases News! As we expand our offerings for and about this community, Global Liver Institute is also committed to keeping you informed about what is happening with pediatric and rare liver diseases. This edition is the first monthly community-specific newsletter within our new structure. Check out upcoming events in the pediatric and rare liver disease field, a patient’s perspective, exciting news, and more below. Not So Rare: The Paradox of Rare Diseases All too often, pediatric and rare liver diseases are thrown together as if they are just one issue, with one need and one solution–however, nothing could be further from the truth. The unmet needs in the pediatric and rare liver space are myriad, and the issues faced by patients, and their families, sit in a spectrum as long as it is wide. In Rare Liver Diseases Month this February, we brought to light and sought to address those challenges through our month-long campaign #RareAware. Having a rare disease is not rare. In fact, it is incredibly common: 25-30 million Americans live with a rare disease. It is as if every time you step onto a full elevator, one of your fellow riders has a rare disease. Despite the high numbers, little is generally known about rare liver diseases, such as the names of conditions or places of support or information. This was the driver in our #DiseaseoftheDay campaign, in which we used February to highlight 28 different rare liver conditions and places of knowledge or support. Living with a rare condition entails a powerful mix of emotional, psychosocial, and physical challenges; patients must learn to cope with each aspect in their own time. To this end, we incorporated two new elements in the #RareAware campaign to support patients on their journey. GLI Living sessions helped patients explore self-care and empowered them with tools and techniques to aid them on their journey. We also brought together pediatric patients and their young family members in weekly book talks to learn and share all about how being a rare disease patient makes them not abnormal, but rather extraordinary. In parallel with FDA, GLI convened the Primary Biliary Cholangitis (PBC) community for an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD). For almost six hours, patient and clinical experts from around the world shared their experiences to highlight unmet needs in current and future PBC treatments, clinical trials, and patient participation. Combined with recent data from PBC patient survey, we built compelling arguments to include more patient input into trials design, to include a more diverse patient group, to minimize the use of liver biopsy (e.g. in participation criteria), and to use real-world data as a synthetic control instead of “standard-of-care” placebo arms in disease progression trials. This has opened discussions with trial sponsors and regulators who intend to make the changes deemed most important by patients, bringing the focus to where it all begins: with a patient.
Donna R. Cryer, JD President & CEO Global Liver Institute
Upcoming Events
Pediatrics & Rare Council meeting, virtual Wednesday May 18.
“As rare as [PBC] is, we have people fighting for us daily and I’m forever grateful for that. I also realize that with my daily struggles, we have medicine that slows this progression down that allows me to live the best daily life I can. Don’t misunderstand me, it’s hard on a daily basis, real hard especially knowing this is now my life. But reaching out for support and education and advocating for myself with my doctors allows me to do and be the best I can in my control.”
We are delighted to bring to your attention the most recent edition of the Rare Revolution Magazine, focused on rare liver diseases. Not only does it feature much of GLI’s work during Rare Liver Disease Month, but also highlights the incredible work of a number of members of GLI’s Pediatric and Rare Liver Diseases Council.
Research & Development
So much research is being undertaken in rare liver disease currently that a comprehensive list would fill a full newsletter! However, a quick review on clinicaltrials.gov shows current trials in diseases from Autoimmune Hepatitis (AIH), Alagille Syndrome, Biliary Atresia, through PBC, PSC and PFIC, to Zellweger Spectrum Disorder and many more.
Why is this important? Great research conducted with patients can make the difference. October brought us a brand new treatment for pediatric liver disease: Livmarli–the first ever FDA-approved therapy in Alagille Syndrome–was approved to treat chronic itch (pruritus) in affected children. We congratulate our partners working in the incredibly difficult field to improve the lives of children and caregivers alike.
Finally, EASL will host their International Liver Congress (ILC) June 22-26, and GLI will be represented: in person, virtually, and in at least one abstract on the patient experience. We would love to see you there, so please say hello and let us know how we can work together.
If you’ve ever seen the movie Groundhog Day, that’s probably the best example I can give about my experience with PBC. I know each and every day what my day will be like. Waking up is tedious due to the joints just aching because of no movement during the night. Feeling totally “unrested” even with 6 to 7 hours of sleep. Slowly making my way down the steps each morning to start my day knowing that my day is going to be mind over matter getting through.
I’m a more upbeat person with the attitude I’m here to live, not just survive. I truly enjoy life and the people I have in it, so no matter how I feel, I’m going to enjoy my day and hopefully hide as much of the “exhaustion and pain” I have from the people I’m around. Although I still work, I’m fortunate to mostly do it from home. But I take the day on as though I will be out and about by shaving, showering, and getting dressed for work and go in my home office and get on the phone and computer to start my work day.
Usually late mornings I need to take a break and catch a bit of a nap in my lounge chair, although my work is not physical, it still seems to wear me down. It’s not uncommon for these naps during both day and late afternoon, the fatigue and pain throughout my body is a daily occurrence I just can’t seem to overcome. After work, we usually have a game to attend for one of the grandkids, which although really tough to motivate my body and mind to do, it’s the bright spot of my day watching them and having them know I’m there for them. Then off to home for dinner, a little TV, and off to bed by 10 p.m.
I need you to know one thing though, as bad as I think I have it, I’m blessed. I have a phenomenal support team: from my family, my Facebook support group, the PBC Foundation, and most recently the Global Liver Institute. As rare as this disease is, we have people fighting for us daily and I’m forever grateful for that. I also realize that with my daily struggles, we have medicine that slows this progression down that allows me to live the best daily life I can. Don’t misunderstand me, it’s hard on a daily basis, real hard especially knowing this is now my life. But reaching out for support and education and advocating for myself with my doctors allows me to do and be the best I can in my control.
Today, April 6, the members of the Liver Action Network (LAN) pledge our collective support for Living Donor Day to honor the donors, recipients, families and caregivers, and clinical teams that make the lifesaving gift of organ donation possible globally. In connection with this pledge, the U.S. members of the LAN are also proud to participate in today’s Advanced Advocacy Academy (A3) Spring Advocacy Day in an effort to simultaneously urge U.S. Members of Congress on Capitol Hill to support Living Donor Day and vital pieces of legislation like the Living Donor Protection Act (S. 511/H.R. 1255).
Organ donation and transplantation have become the best clinical treatment for end-stage organ failure.1 In 2020 a total of 129,681 organs were transplanted worldwide, but unfortunately thousands of people still die each year while on the transplant waiting list.1,2 There are many barriers that prevent thousands of individuals around the world from receiving a lifesaving organ donation, the predominant being long transplant waiting lists and donor organ shortages.1 Statistics confirm this gap between supply and demand, with 74.6% of candidates on the waiting list failing to receive a transplant in the U.S. in 2015 and 19.9% in the UK in 2018.1 These two factors unfortunately continue to lengthen the timeline for many end-stage organ failure patients to receive an organ donation, and many will die waiting for their chance.
A promising solution to this global crisis is to increase the number of living organ donations, in which an individual is able to donate a part of or an entire organ to someone waiting on the transplant list. Worldwide, kidney and liver transplants from living donors comprise the majority of living organ donations.1 This is why it is critical for the liver disease community to underscore the importance that living donation has in ensuring the gap between organ supply and demand does not continue to widen.
Collectively, GLI’s Liver Action Network, the undersigned organizations, are proud to support Living Donor Day, celebrated annually on April 6. As representatives of the liver disease community, we call upon local and national governments to enact policies that help to eliminate barriers for both living donors and recipients and to take steps to ensure living donors are protected. For many would-be donors, financial realities, including the potential loss of coverage or an increase in premiums, keep them from donating. On top of this, there is a risk that living donors might lose their employment during their recovery period. In the United States, the LAN supports legislation like the Living Donor Protection Act, which would address many of these issues. But, in the absence of passing that bill, it is critical that governments in the U.S. and abroad look to implement policies that protect individuals willing to save someone’s life by donating living tissue, like liver.
The Liver Action Network fully advocates for policies that make the process of living organ donation easier. Eliminating barriers will allow more individuals to become living organ donors and is the first step in addressing the global organ shortage crisis.
Liver Action Network Members: Global Liver Institute Community Liver Alliance Fatty Liver Alliance Fatty Liver Foundation Liver Coalition of San Diego Liver Health Foundation Midsouth Liver Alliance NASH kNOWledge Northeast Ohio Liver Alliance Texas Liver Foundation Empire Liver Foundation HepCURE
Transforming Global Consciousness of Liver Health through Education and Advocacy
(Washington, D.C., March 30, 2022) – Global Liver Institute (GLI), a patient-led liver health nonprofit operating globally, today announced the launch of its global Liver Health is Public Health (LHPH) initiative with a special feature in the 2022 Your Liver supplement in the Guardian. Liver conditions continue to be misunderstood, mischaracterized, and stigmatized, resulting in under-diagnosis, under-treatment, and unnecessarily poor outcomes. This multi-year program will look to address these ongoing challenges, and shift the conversation on liver health.
GLI’s president and CEO, Donna R. Cryer, JD, shared, “There are half a billion people in the world living with liver diseases, including me. Liver conditions are stigmatized, underdiagnosed, and often untreated in part because most people lack basic knowledge about their liver. It is imperative that people learn what steps they can take to prevent liver disease, and health systems need to organize themselves in a way to better diagnose and care for liver patients.”
It has long gone unrecognized that since everyone has a liver, everyone is at risk for or already has some degree of liver disease. With this in mind, over the past several decades, liver diseases have risen to become one of the leading causes of death and illness worldwide.
Globally:
2 million deaths per year
1 in 4 people are impacted by Nonalcoholic fatty liver disease (NAFLD). Of those, 1 in 5 people living with NAFLD will develop the more advanced liver condition, nonalcoholic steatohepatitis (NASH).
75 million people are at risk of alcohol-associated liver disease (ALD)
Liver transplantation is the second-most common solid organ transplantation, yet less than 10 percent of global transplantation needs are met at current rates.
Viral Hepatitis (hepatitis B (HBV) and C virus (HCV)) impacts more than 360 million people worldwide
In the United States:
Cirrhosis impacts 633,000 people
Liver cancer impacts 42,000
HBV impacts 2.2 million
HCV impacts 3.5 million
NAFLD impacts around 76 million
NASH impacts anywhere from 4.9 million to 19 million
Alcoholic liver disease (ALD) impacts 19 million people.
This initiative will urge the medical field globally to consider holistic liver health as an integral part of public health from nutrition, activity, prevention, early diagnosis and management of risk factors to education, support, optimized clinical pathways, and policy for children, adults, and seniors.
Through the development of workgroups specializing in the intersectional fields of public health, medicine, advocacy, and patient experience, LHPH will shift the conversation on liver health by:
Assessing the state of liver health globally
Developing educational resources for diverse audiences, and
Empowering a global cohort of liver health advocates.
GLI is working collaboratively with more than 200 global partners across GLI’s liver councils, and other global efforts, on the LHPH initiative. LHPH is endorsed in North America by the Community Liver Alliance, the Fatty Liver Alliance, the Fatty Liver Foundation, the Midsouth Liver Alliance, the Liver Wellness Foundation, NASH kNOWledge, the Liver Coalition of San Diego, the Texas Liver Foundation, the Northeast Ohio Liver Alliance, the Liver Health Foundation, HepCURE, and the Empire Liver Foundation. Globally, the program is endorsed by the Hepatology Society of the Philippines, the European Society for Organ Transplant, Liver Patients International, Turkish Association for the Study of the Liver, the European Reference Network on Metabolic Diseases and the World Hepatitis Alliance.
If you are interested in learning more about LHPH or in joining a workgroup to guide the creation of educational materials, please reach out to Giacomo Donnini at gdonnini@globalliver.org.
This initiative is made possible in the United States thanks to the support of Salix Pharmaceuticals and, globally, thanks to the support of Sanofi.
About Global Liver Institute
Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Twitter, Facebook, Instagram, LinkedIn, and YouTube.
New Season, New Format: Striving to meet the needs of the expanding liver health- interested community for timely information on must-know events and news specific to our Council communities in Liver Cancer, NASH, Pediatric and Rare Liver Diseases, Liver Health Policy, and the activities of Global Liver Institute in a format and frequency that respects your busy lives, we have reconfigured our newsletter schedule.
The Latest at GLI is the first of our quarterly updates dedicated to informing you about the latest happenings at Global Liver Institute and their impact, as well as sharing educational resources for patients, caregivers, and advocates. This issue This issue highlights key events of January, February, and March 2022.
With this new newsletter structure, you will still receive our monthly informational community-specific newsletters; editions dedicated to pediatric and rare liver diseases news, liver health policy news (LHPU news), NASH news, and liver cancer news will be shared twice a year, respectively.
We hope you enjoy! Please send feedback or news items to: info@globalliver.org
Donna R. Cryer, JD President & CEO Global Liver Institute
Pediatrics & Rare Liver Diseases
Throughout the month of February, Global Liver Institute led its second annual Rare Liver Diseases Month. Our month-long #RareAware campaign featured communication, education, and advocacy efforts throughout the month, focused solely on rare liver diseases. Below we highlight two key events that occurred.
Be sure to stay on the look-out for #RareAware’s report next month.
Primary Biliary Cholangitis (PBC) Externally-Led Patient-Focused Drug Development (EL-PFDD)
On 4th February 2022, GLI was joined by clinical and patient experts to discuss the current unmet needs in PBC: how PBC itself affects quality of life, how the current therapeutic landscape affects quality of life and how best to design PBC clinical trials of the future. The PBC EL-PFDD is a critical step in providing the liver community a greater understanding of PBC, directly from those affected by it, to inform and drive forward the next generation of clinical trials and treatment approvals.
The Burden of Pediatric Rare Liver Diseases
On February 25, 2022, GLI held a virtual briefing to hear directly from patients, patient advocacy organizations, and providers, about the challenges and opportunities surrounding rare liver diseases. This briefing was presented in partnership with the PFIC Network and NASPGHAN, featuring GLI Policy Director Andrew Scott; Dr. Rohit Kohli, MBBS, MS, FAASLD, Chief of Gastroenterology, Hepatology and Nutrition at the Children’s Hospital Los Angeles; Emily Ventura, PFIC Caregiver and Executive Director of the PFIC Network, and PSC/AIH patient; and GLI pediatric and rare program manager Nicole Wells, MA.
Policy & Advocacy
On February 16th, GLI applauded the confirmation of the new Food and Drug Administration (FDA) Commissioner Dr. Robert Califf. With a new FDA Commissioner, we look forward to continuing our strong partnership and advancing liver patient centric policies.
On March 16th, GLI’s Advanced Advocacy Academy (A3) held a webinar on Clinical Trials Application Navigation. GLI invited Rachel Coe, Manager of Science & Regulatory Affairs at Biotechnology Innovation Organization (BIO), to walk through some general tips and tricks for searching and applying to participate in clinical trials.
Updates from the Liver Action Network (LAN)
On March 3rd, GLI proudly announced the expansion of its LAN to include a partnership with Empire Liver Foundation. Based in New York City, this transformative organization provides clinical training to healthcare professionals on how to screen and treat patients with Hepatitis B & C in a variety of clinical settings. GLI looks forward to continued growth of the LAN in 2022 with goals of having representation in every state in the US as well as growing the network’s global footprint outside of the US.
On March 4th, GLI’s LAN released a global proclamation pledging collective support of World Obesity Day to acknowledge the strong connection between NASH and obesity. The need for action has never been greater, as the worldwide burden of obesity could affect upwards of 1 billion people by 2025, subsequently increasing the number of individuals at risk for developing NASH.
NASH
Global Liver Institute (GLI) launches the final NASH Externally-Led Patient Focused Drug Development Meeting Outcome Report. On November 4th 2021, Global Liver Institute led an Externally Led Patient-Focused Drug Development Meeting on NASH. This GLI led EL-PFDD meeting on NASH provided regulators, and drug developers the invaluable opportunity to hear from patients and caregivers directly about the challenges and burdens of this life-threatening condition.
Liver Central On January 6, 2022 Global Liver Institute, in partnership with TriSalus Life Sciences, launched Liver Central, a comprehensive site for all things liver cancer. Liver Central provides patients, clinicians, and researchers a unique hub to find information on ongoing clinical trials, treatment options and educational materials about the liver and liver cancers. Visit Liver Central, for more information.
International Workgroup At the end of 2021, GLI’s Liver Cancer Council established the first International Workgroup, chaired by Dr. Maria Reig. This workgroup will focus on facilitating international partnerships in the hopes of sharing best practices in liver advocacy, identifying gaps in international liver cancer initiatives, and creating an action plan to address barriers.
GLI Globally
Living with Rare Liver Diseases in Europe Webinar
On February 18 GLI organized and hosted its first webinar dedicated to pediatric and rare liver diseases in Europe to highlight the complexities within the field: diagnosis, treatment, care pathways, impacts upon the family, transition to adulthood.
The event was endorsed by: EASL (European Society for the Study of the Liver), MetabERN (European Reference Network for Hereditary Metabolic Diseases), LPI (Liver Patients International) and the PBC Foundation.
Interested in learning more? Check out what GLI’s President and CEO Donna Cryer, JD has to say on Season 3, Episode 12 of Surfing the NASH Tsunami here.
Nonalcoholic steatohepatitis (NASH) has a relatively short history as a recognized health condition. The terminology for NASH and its precursor nonalcoholic fatty liver disease (NAFLD) date back to only the 1980s1. As a young disease, the stakeholders from throughout the field have the opportunity to integrate a health equity perspective into research, diagnosis, and treatment from the start.
For Black people in the U.S., equity in NASH looks different than in many other diseases. Based on current data, Non-Hispanic Black Americans currently face the lowest rates of NAFLD compared to whites and Hispanic people (and, when included in studies, Asian Americans and other racial/ethnic groups).2 Blacks also have a lower risk of progression of cirrhosis from NAFLD to NASH than other groups.2 While these appear to be auspicious statistics, they obscure a more dire reality: Despite lower rates of diagnosis, Black patients with NASH face worse outcomes, more likely to die or face acute liver failure during a hospital stay3 and more likely to receive an unfavorable discharge4 compared with other races.
Why is this happening? There is not yet a comprehensive body of research to analyze this phenomenon, so we cannot draw a clear line from cause to effect. However, we can explore several established factors that do limit the liver health of Black people at all levels of the healthcare system.
Structural Factors:
Access and utilization: Despite the availability of noninvasive tests, the current requirement to prove a NASH diagnosis is biopsy, an invasive, unpleasant procedure. Recovery from biopsy can occur within a week, but side effects may last up to 8 weeks, depending on the patient. Limited local availability of biopsy services, in addition to limited insurance coverage and challenges finding the opportunity to schedule this procedure around work and other obligations, may mean that the appearance of lower rates of NASH among Black people simply reflects a difference in diagnosis, disguising comparable prevalence between populations.
Insurance coverage: Disparate insurance coverage between racial groups may also contribute to poor outcomes, whether through reduced quality of care, prohibitive out-of-pocket cost, or another factor.
Inclusion in clinical trials: After persistent exclusion from research studies and clinical trials, most data about treatment options does not take into consideration Black participants. If different groups have different responses to new treatment, it is unlikely that current studies have enough data to identify this variance.
Interpersonal Factors:
Inadequate hospital care: Black patients have been shown to have longer hospital stays than other races, and they face worse inpatient outcomes5. Implicit bias and historical, biologically inaccurate beliefs held about Black Americans are likely to play a role in subpar care.
Broken trust: A history of egregious treatment of Black Americans by the medical establishment has damaged trust, especially in experimental studies. This trust must be rebuilt before we reach full utilization of care and full participation in research.
Poor translation: The risks, benefits, and requirements of both treatment options and trial participation are often obscured by overly technical jargon. Liver health information must be presented at an appropriate level for patient understanding.
Organizations seeking to combat NASH must first invest meaningfully in local communities based on their own identified needs before inviting them to join in mutually beneficial initiatives for liver health, whether a screening campaign or a clinical trial. Researchers and evaluators must be sure to include a diverse population in all of their studies–enough to determine if certain groups respond differently to treatment. As we build trust and foster understanding at all levels amongst at-risk patients, increased trial participation and improved outcomes will follow.
Given the risks to Black people once NASH is diagnosed, it is time to focus efforts earlier in progression. Especially for Black people at risk of NASH and NAFLD, we must promote awareness, prevention, and control of risk factors to give people the chance to heal and strengthen their livers before it is too late. The NASH community has the opportunity to be on the right side of history as it matures. After all, as GLI’s president and CEO Donna Cryer, JD noted recently on the Surfing the NASH Tsunami podcast, “We are writing Black history now. This day will someday be a part of Black history, so let’s write it in a way that we can all be proud of.”
References:
1. Ayonrinde, O. T. (2021). Historical narrative from fatty liver in the nineteenth century to contemporary NAFLD – Reconciling the present with the past. JHEP Reports, 3(3), 100261. https://doi.org/https://doi.org/10.1016/j.jhepr.2021.100261
2. Samji, N.S., Snell, P.D., Singal, A.K. and Satapathy, S.K. (2020), Racial Disparities in Diagnosis and Prognosis of Nonalcoholic Fatty Liver Disease. Clinical Liver Disease, 16: 66-72. https://doi.org/10.1002/cld.948
4. Talens, M., Tumas, N., Lazarus, J. V., Benach, J., & Pericàs, J. M. (2021). What Do We Know about Inequalities in NAFLD Distribution and Outcomes? A Scoping Review. Journal of clinical medicine, 10(21), 5019.https://doi.org/10.3390/jcm10215019
5. Ghosh, A. K., Geisler, B. P., & Ibrahim, S. (2021). Racial/ethnic and socioeconomic variations in hospital length of stay: A state-based analysis. Medicine, 100(20), e25976. https://doi.org/10.1097/MD.0000000000025976
