Congress grapples with budget and appropriations while the administration eliminates funding for health programs and terminates federal employees. – Liver Health Policy Update

Congress grapples with budget and appropriations while the administration eliminates funding for health programs and terminates federal employees. – Liver Health Policy Update

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Congress grapples with budget and appropriations while the administration eliminates funding for health programs and terminates federal employees.

The situation in Congress remains unclear as the House budget resolution calls for possible significant Medicaid cuts, while the Senate attempts to steer clear of policies reducing Medicaid and/or Medicare benefits.


Action Alert: Protect Medical Research Funding at the US Department of Defense

Each year as part of Congressionally Directed Medical Research Programs, the US Department of Defense supports medical research that will benefit Service members, their families, and the American public. These programs have funded innovative basic, applied, translational, and clinical research on several topics related to liver disease. The Peer Reviewed Cancer Research Program, for instance supports research into all cancers, including liver cancer.

We have recently learned that if Congress passes a long-term Continuing Resolution to fund Fiscal Year 2025, the DoD Secretary Hegseth plans to reallocate all of the money for these research programs into the Operations and Management account – leaving $0 for medical research funding for FY 2025.

We have prepared editable language for you to reach out to your legislators and include specific language in any upcoming legislation to protect this key resource for liver-related research funding.


Executive Order Creating MAHA Commission Highlights Fatty Liver Disease

The Executive Order (EO) that created the Make America Healthy Again Commission called for the production of a strategy, based on the findings of an assessment, to improve the health of America’s children. The EO stated, “18% of teens suffer from fatty liver disease, nearly 30% are prediabetic, and more than 40% are overweight or obese – these conditions were virtually unheard of in prior generations.” As part of the commission’s work, the EO calls for holding public hearings, meetings, roundtables, and similar events to receive expert input from leaders in public health. GLI looks forward to sharing recommendations with the Commission on strategies to prevent liver disease, the progression of liver disease to liver cancer, and complications of liver disease and liver cancer.


Congress Must Take Action to Keep Government Funded

The current Continuing Resolution (CR) keeping the government funded expires on March 15, raising concerns about a possible government shutdown. In light of federal employee terminations and funding freezes impacting NIH research and other programs, Democrats continue to push for language restricting the so-called Department of Government Efficiency (DOGE), as well as mandating that the Trump administration spend appropriated funds. The prospects for passing additional health priorities are dwindling. Nevertheless, advocates continue to push for pharmacy benefit manager (PBM) reforms and the Safe Step Act, a Pediatric Rare Disease Priority Review Voucher (PRV) Program extension, the Medicare Multi-Cancer Early Detection and Screening Act (MCED), Medicare Telehealth Flexibilities, and the ORPHAN Cures Act.


House Budget Resolution Passed, Medicaid Cuts May be on Agenda

The House adopted their budget resolution on a mostly party-line vote. It tasked the committee that oversees Medicaid and Medicare, the Energy and Commerce Committee, with cutting $880 billion, meaning Republicans will almost certainly have to find ways to curtail federal spending on those programs. One option supported by Republicans would be to require approximately 36 million Medicaid adults to prove they work or file paperwork for exemptions. On Feb. 26, the House Subcommittee on Health held a hearing during which bipartisan support for pharmacy benefit manager (PBM) reforms, especially related to formulary decisions and access to care, was clear. Democrats shared immense concerns surrounding potential cuts to Medicaid given the budget resolution. Republican members tried to assure Democrats that Medicaid, Medicare, and Social Security would not be targeted in budget cuts. It is not clear where the committee will otherwise find $880 billion in savings. The Senate has indicated bipartisan concerns with the House budget. GLI is urging Congress to protect Medicaid and Medicare. View more information here from our partners at Modern Medicaid Alliance.


      Tracking Trump 2.0 Administration Appointees

      President Donald Trump has selected Cabinet-level officials for his administration. GLI is monitoring the Senate’s confirmation process closely. Here are his picks in the healthcare arena:


      GLI Opposes Federal Program Funding Freeze

      GLI and other cancer advocates signed an open letter opposing recent executive actions to freeze funding for health care programs and research, highlighting the impact on progress in the fight against cancer today and for years to come. The letter stated, “Cuts to our nation’s health and research infrastructure funding and widespread layoffs at the National Institutes of Health, including the National Cancer Institute, the Centers for Disease Control and Prevention, and the Food and Drug Administration will have a devastating impact on the more than 2 million people who will be diagnosed with cancer this year alone.” View the letter here.


      GLI Joins Rare Disease Week!

      This multi-day event, hosted by the Rare Disease Legislative Advocates (a program of the EveryLife Foundation for Rare Diseases), brings together rare disease advocates from across the country to make their voices heard by their Members of Congress. Participants are educated on policy proposals impacting the rare disease community and provided opportunities to advocate for policy changes directly to their Members of Congress. GLI’s representatives emphasized the need for Congress to pass the ORPHAN Cures Act, bipartisan legislation that would maintain existing incentives and boost research into new treatments for the 30 million Americans currently suffering from one of more than 7,000 rare diseases. GLI also emphasized the need for Congressional action to reintroduce and pass the Medical Nutrition Equity Act, ensuring coverage of medical foods. GLI encouraged Congress not to cut essential health benefits provided to beneficiaries under Medicare and Medicaid as part of the budget reconciliation process being currently debated.


        GLI Joins Amicus Brief to Protect Coverage of Preventive Services

        GLI, along with 19 HIV and hepatitis organizations, filed an amicus brief with the U.S Supreme Court in support of the U.S. government’s position in Kennedy v. Braidwood Management, which challenges the ACA’s preventive services coverage requirement. The 20 non-profit organizations include national and state groups from around the country that promote access to and carry out HIV and hepatitis testing along with PrEP for the prevention of HIV. GLI was pleased to learn that the Trump administration is continuing to defend the law as we fight for coverage of preventive services in healthcare as recommended by the U.S. Preventive Services Task Force.


        Judge Blocks Trump Administration’s Mass Layoffs As Federal Workforce Cuts Advance

        A federal judge ruled that the Trump administration’s mass firing of probationary government workers was likely illegal, ordering the Office of Personnel Management (OPM) to rescind directives that led to the layoffs. The ruling comes as the Trump administration moves forward with its largest round of federal workforce reductions yet, following a February 13 executive order (EO) directing agencies to prepare for large-scale reductions in force (RIFs). GLI is very concerned about the impact of reduced staffing on federal health care programs and research.


        GLI Supports High Quality Access to Anti-Obesity Medications

        GLI strongly supports the CMS proposed rule to permit coverage of anti-obesity medications (AOMs) for weight loss when treating obesity. View GLI’s comments here. Additionally, GLI looks forward to the reintroduction of the Treat and Reduce Obesity Act (TROA) which would advance coverage of drugs treating obesity as well as improved access to intensive behavioral therapy.


        AASLD Joins GLI in Pushing Veteran Access to Care for MASH/NASH
        U.S. Veterans continue to be denied coverage for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), treatment without a biopsy. GLI has also expressed concerns that Veterans’ care is delayed due to the VA’s Criteria for Use to receive “comprehensive lifestyle intervention” for 6 months before being eligible for treatment. The VA’s decision is contrary to the label from the Food and Drug Administration and clinical guidelines. As part of GLI’s Beyond the Biopsy initiative, GLI and its partners sent a letter to the VA. Most recently, GLI and AASLD sent a follow-up letter to the VA calling for coverage consistent with clinical guidelines. We continue to encourage signatures here on a petition to all payers calling for coverage without biopsy!


        CMS Announces Public Engagement Events For Second Round Of IRA Negotiations

        Recently, the Centers for Medicare & Medicaid Services (CMS) announced a series of public engagement events as part of the Medicare Drug Price Negotiation Program, inviting patients, caregivers, clinicians, researchers, and other stakeholders to share input on the drugs selected for the second round of negotiation, including drugs to treat obesity as well as one to treat hepatic encephalopathy. From April 16 to April 29, CMS will hold 15 private, patient-focused roundtable discussions for each selected drug, open only to patients, patient advocacy organizations, and caregivers who register by March 12 and are selected to speak. Additionally, CMS will host a livestreamed town hall meeting on April 30, which will be open to the public and focused on clinical considerations for all selected drugs. For more details, visit CMS’ public engagement page.


         

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        Beyond the Diagnosis: Stories, Breakthroughs & Global Action – Fatty Liver Disease News

        Beyond the Diagnosis: Stories, Breakthroughs & Global Action – Fatty Liver Disease News

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        Beyond the Diagnosis: Stories, Breakthroughs & Global Action – Fatty Liver Disease News

        A Nurse, A Patient, A Journey

        At the recent Primary Care MASLD and MASH Summit, hosted by Fatty Liver Alliance, hepatology nurse and patient France Martineau shared her personal journey with fatty liver disease, highlighting the challenges, small victories, and the power of patient support. In conversation with Jeff McIntyre, GLI’s VP of Liver Health, this session reinforced the importance of lived experiences in liver health. MASLD MASH Summit.png


         

        Global Fatty Liver Day is on June 12!

        Mark your calendars for Global Fatty Liver Day on June 12, 2025! Join us in raising awareness and driving action to combat fatty liver disease and its more advanced forms,  worldwide. Partner with us to host events, share resources, and make a lasting impact on liver health.

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        Emerging Insights

        Metabolic dysfunction-associated fatty liver disease (MAFLD) is linked to sex-related and thyroid-related hormones in type 2 diabetes patients

        A recent study found the risk for MAFLD was higher for men than women, reportedly for women, there was no statistically significant association between the sex or thyroid hormones;however, when compared to the male hormone progesterone, there was a positive correlation and an increased risk for MAFLD.


         

        Fatty Liver Screening Gaps Emerge in HIV Care Survey

        A survey of primary care providers found barriers when screening their HIV patients for NAFLD. Although NAFLD is prevalent for people with HIV (PWH), providers are reportedly unclear of which test to order for their patients. The study results support the need for increased MAFLD education and clinical practice guidelines which will be beneficial to HIVpractitioners.


         

        Global burden of MAFLD, MAFLD-related cirrhosis and MASH-related liver cancer from 1990 to 2021

        MAFLD, MAFLD-related cirrhosis, and MASH-related liver cancer rates are increasing globally. Middle- and low-income regions of the world are especially facing increasing disparities because of the changing socioeconomic landscape. Public health strategies are needed to address prevention, treatment, access to care, and education.


         

        ⬇️ Education Resources Available ⬇️

        GLI is proud to offer a range of continuing education programs to support healthcare providers in expanding their knowledge and skills in MASLD and MASH. These programs provide valuable CE credits and are available until June 2025.


         

        Endocrinologists and PCPs: The Frontline Defense Against Cirrhosis in Patients with Type 2 Diabetes

        Through a partnership with the Global Learning Collaborative, GLI now offers this continuing education course on ReachMD. This series of bite-sized episodes will provide important information on MASLD and MASH in patients with type 2 diabetes. Drs. Naim Alkhouri, Robert Eckel, and physician assistant Tessa Janovsky discuss best practices for screening, diagnosis, treatment, and management of MASH/MASLD.

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        Build Your Own Case Study | Redefining MASLD/MASH Care: Personalized Strategies for Assessment, Diagnosis and Management

        In collaboration with the Medical Learning Institute, GLI presents an interactive course to Build Your Own Case Study. Healthcare providers in the endocrinology specialty setting are challenged to be knowledgeable of the pathophysiology of MASLD and MASH and its associated risk factors, as well as feel confident about how and when to order noninvasive diagnostic tests to prevent the emergence of more severe complications and stay on top of current guidelines and emerging treatment options.

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        Upcoming Events

          • March 7 – 8, 2025: Desert Liver Conference, Arizona, USA 

          • March 14 – 15, 2025: GLI’s Advanced Advocacy Academy, London, United Kingdom 

          • March 20 – 22, 2025Liver Connect, San Antonio, Texas, USA


           

          How to Stay Engaged Beyond Rare Liver Diseases Month – Pediatric and Rare Liver Diseases News

          How to Stay Engaged Beyond Rare Liver Diseases Month – Pediatric and Rare Liver Diseases News

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          How to Stay Engaged Beyond Rare Liver Diseases Month – Pediatric and Rare Liver Diseases News

          #RareAware Campaign: Our Impact on Rare and Rural Healthcare

          In February, we took action to bridge healthcare gaps for rare liver disease patients in rural communities—driving awareness, advocacy, and education where it’s needed most. Here are some highlights: 

          • Our February episode of Is Your Liver Healthy? podcast brought together Dr. Harsha Rajasimha of the US Indo Rare Disease Foundation, Dr. Cecilia Dueñas of the PBC Research Foundation, and Theresa Davidson of the MidSouth Liver Alliance to discuss the urgent need for equitable access to clinical trials for rural and rare patients around the globe.  
          • In the community, our pilot Rare Science Fairs program in Mississippi reached over 500 individuals, featuring seven research posters co-created with students and patient advocacy leaders to spark local engagement in rare disease research.
          • On Capitol Hill, we championed the ORPHAN Cures Act, a critical bipartisan bill that protects incentives for developing rare disease treatments by ensuring orphan drugs remain exempt from Medicare price negotiations if they are approved for more than one rare condition.

          But the work doesn’t stop here. There are still many ways to engage beyond Rare Liver Diseases Month. Here are some ways to engage:  

          • Direct patients and caregivers to our newly released rural healthcare resources, now available on our website.
          • Help us grow our Rare Science Fairs and bring them to more schools worldwide.
          • Urge your representatives to support policies that expand access to rare disease care. The ORPHAN Cures Act still needs backing—use this resource to make your voice heard.
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          Posters (Wilson And PSC) Presentations
          Kristin, Alyssa, And Senator Hyde Smith

          New Key Screening Questions for Early Diagnosis of Biliary Atresia 

          Early detection of biliary atresia is critical for timely intervention, yet diagnoses are often delayed. A new AAP guidance clinical report emphasizes three key questions for primary care providers: Is the infant jaundiced, do they have pale stool, was their direct bilirubin high at birth? If the answer to any of these is yes, a direct bilirubin level should be checked to assess for possible liver disease.

          Routine screening in primary care settings can significantly improve early diagnosis and outcomes for affected infants. Collaboration with pediatric hepatologists and awareness of patient advocacy resources can further support families navigating this condition.


           

          A Key Reason for Misdiagnosis of Alagille Syndrome in Low-Resource Settings

          A recent publication from South Africa highlights the challenge of diagnosing alagille syndrome (ALGS) in settings with limited access to genetic testing, where it is often misdiagnosed as biliary atresia. Without proper diagnostic tools, children may undergo unnecessary surgeries, as early liver biopsy findings can resemble biliary atresia. This publication underscores the urgent need for better diagnostic strategies, education, and resource allocation to prevent misdiagnoses, particularly in low-income regions.


           

          FDA Grants Chemomab Phase 3 Trial Approval for Nebokitug in PSC

          Progress is being made in the treatment of Primary Sclerosing Cholangitis (PSC) as the FDA has granted Chemomab approval to proceed with a Phase 3 trial for Nebokitug. PSC is a chronic liver disease that causes inflammation and scarring of the bile ducts, leading to serious complications like liver failure and cancer. With no approved treatments, patients rely on symptom management and, in severe cases, liver transplants. Nebokitug targets the underlying disease, aiming to slow progression and improve outcomes. Notably, this Phase 3 trial evaluates clinical outcomes without requiring liver biopsies—a meaningful shift from traditional PSC study designs.


           

          Highlighting the Fight for Life Club in Mexico 

          The National Institute of Pediatrics (INP) and the Fight For Life Club Foundation have achieved a significant milestone in pediatric transplantation, successfully performing two living donor liver transplants in a single week. With only 4.5 deceased organ donors per million people in Mexico, living donor transplants are a critical solution to reducing wait times and improving survival rates for children. This initiative is part of a broader effort to build a sustainable, world-class pediatric transplant program in Mexico.


           

          Expanded Newborn Screening in Victoria Enhances Early Detection of Rare Diseases

          Galactosemia, a rare metabolic disorder affecting approximately 1 in 50,000 newborns, can lead to life-threatening liver disease if left undiagnosed. Early detection through newborn screening is critical to preventing serious complications and enabling timely intervention. Victoria, Australia, has expanded its newborn screening program to include galactosemia, bringing the total number of screened conditions to 32.


           

          Recognizing Life-Saving Liver Transplants in Hyderabad, India

          Osmania General Hospital (OGH) has made a remarkable impact by successfully performing five liver transplants in a month, providing life-saving treatment to young patients from low-income backgrounds and treating patients with Tyrosinemia Type 1, Wilson’s disease, and Chronic Budd-Chiari syndrome. These complex procedures, typically costing 3 to 4 million rupees in private hospitals, were performed free of charge under the state’s Aarogyasri scheme, ensuring access to critical care for those who need it most. This achievement highlights OGH’s growing excellence in liver transplantation, particularly for rare liver diseases.


           

          Conditional Marking Approval for Seladelpar in Europe 

          Seladelpar has received conditional approval in Europe for the treatment of primary biliary cholangitis (PBC), either in combination with UDCA or as monotherapy for those unable to tolerate UDCA. This approval expands much-needed treatment options for PBC patients, a condition with limited therapeutic choices. While conditional approval allows early access, additional confirmatory trials are required to fully establish its clinical benefits.

          Upcoming Events


             

            For more information about the Pediatric and Rare Liver Diseases Council or to learn more about joining, please visit our webpage or email pedsrare@globalliver.org.

            Advances in Liver Cancer Treatment & Research – Liver Cancer News

            Advances in Liver Cancer Treatment & Research – Liver Cancer News

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            Advances in Liver Cancer Treatment & Research

            Liver cancer continues to be a growing public health concern, with new research and treatment innovations shaping the future of care. This newsletter brings you the latest advancements in the field, including promising therapies, diagnostic breakthroughs, and discussions on the rising impact of metabolic and alcohol-related liver diseases. Stay informed with expert insights and emerging strategies that could improve patient outcomes.


             

            HCC-LIVE Conference

            Sarah Manes, GLI’s Liver Cancers Program Director, had the honor of speaking on two panels at the HCC-Live Conference in Texas on February 22. She participated in the Patient Perspective Panel, moderated by Karim J. Halazun, MD, FACS, alongside Alan Wang from the Hepatitis B Foundation, with a patient story shared by Nick and Melissa Oprish.

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            Additionally, Sarah spoke at the Pipeline DiscussionMaking the Invisible Visible in Clinical Research, sponsored by Genentech. This panel was moderated by Anjana Pillai, MD, and featured panelist Mark Yarchoan, MD.

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            COR2ED HCC Podcast Series

            Cor2ed released the final episode of their four-part podcast series on hepatocellular carcinoma (HCC). In this episode, The Oncology Brothers, Dr. Rahul and Dr. Rohit Gosain, are joined by radiation oncologist Dr. Nina Sanford, interventional radiologist Dr. Edward Kim, and medical oncologist Dr. Mark Yaron to explore strategies for optimizing treatment in patients with intermediate-stage HCC. The discussion delves into the integration of new immunotherapies, the benefits of combining treatment modalities, and the critical role of multidisciplinary collaboration in developing individualized treatment plans.

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            New Treatment Called Histotripsy Kills Cancer Cells with Sound and Water

            Histotripsy, a new FDA-approved groundbreaking procedure, uses ultrasound waves to destroy malignant and benign liver tumors without the need for incisions. The advanced ultrasound technology creates high energy ultrasound waves that convert to sonic beams. These ultrasound waves then form bubble clouds that implode and collapse rapidly, effectively liquefying the tumor while sparing surrounding tissue. Histotripsy provides significant benefits by reducing the risk of complications such as infection and bleeding. It is particularly beneficial for patients who are not candidates for open surgery or whose tumors are considered inoperable.

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            Unique characteristics of a rare liver cancer identified as clinical trial of new treatment begins

            A recent study has uncovered important insights about fibrolamellar hepatocellular carcinoma (FLC), a rare type of liver cancer that most often affects children, teenagers, and young adults. Researchers found that FLC shows a unique pattern in how its genes work, setting it apart from other liver cancers. Researchers at Rockefeller University’s Laboratory of Cellular Biophysics have identified 301 genes that behave differently in FLC, and discovered that 35 of those genes are especially active only in FLC. This breakthrough could lead to better tests for early detection and more personalized treatment options. A clinical trial is now testing a new drug combination to fight FLC. These findings provide new information that can help refine the detection of the disease, change the course of treatment, and increase patient survival rates.


             

            New Model Estimates Hepatocellular Carcinoma Risk in Patients With Chronic Hepatitis B

            A new prognostic model, called Revised REACH-B (reREACH-B), shows potential in predicting and stratifying the risks for hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) patients without cirrhosis who aren’t on antiviral treatment. The reREACH-B model incorporates six variables: age, sex, platelet count, HBV DNA level, ALT, and hepatitis B e-antigen (HBeAg) – to assess risk, and found that patients with moderate HBV levels have the highest risk. This tool can guide timely decisions about enrolling patients in regular liver cancer monitoring programs.


             

            How the Hepatitis C Cure Affects Other Chronic Conditions 

            Hepatitis C infection is a chronic infection of the liver by the hepatitis C virus (HCV) that continues to affect millions of people across the globe. Left untreated, infection with hepatitis C leads to worsening liver damage and puts the body in distress, which can lead to brain fog, abdominal pain, and internal bleeding.  Since 2014, direct-acting antiviral (DAA) medications have proven to cure hepatitis C infection for over 95% of cases, improving overall well-being and reducing complications related to liver health. In a recent blog post, learn about how a U.S. study found that one year after treatment, nearly half of patients with diabetes saw improvements, with some also reporting better cholesterol and blood pressure. Given HCV’s impact on liver and heart health, the CDC recommends that all adults get screened at least once, with pregnant individuals screened during each pregnancy, making early detection and treatment essential for long-term health.

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            Upcoming Events:


               

              For more information about the Liver Cancers Council or to learn more about joining, please visit https://globalliver.org/liver-cancers-council/ or email cancer@globalliver.org

              How the Hepatitis C Cure Affects Other Chronic Conditions

              How the Hepatitis C Cure Affects Other Chronic Conditions

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              How the Hepatitis C Cure Affects Other Chronic Conditions

              Hepatitis C infection is a chronic infection of the liver by the hepatitis C virus (HCV) that continues to affect millions of people across the globe. Left untreated, infection with hepatitis C leads to worsening liver damage and puts the body in distress, which can lead to brain fog, abdominal pain, and internal bleeding. Many patients with hepatitis have co-occurring, ongoing conditions, including other infections and cardiometabolic diseases (those related to the heart, blood vessels, and metabolism).

              However, there is great news for these patients. A treatment called direct-acting antiviral (DAA) medication, often referred to as DAAs, has been available since 2014. These medications have proven to cure hepatitis C infection in more than 95% of cases not just in closely managed trials, but also in community clinics. Compared with earlier treatments for hepatitis C infection, DAAs have minimal side effects and have been shown in a study to improve overall well-being when successful.

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              Curing HCV infection can lead to improvements in the other, common conditions that someone might have. People infected with HCV become more likely to develop type 2 diabetes than those not infected, and patients with type 2 diabetes can face higher risks if infected with HCV. Similarly, HCV infection is a risk factor for high blood pressure (hypertension) and other heart disease. Although the exact biological reason for this is unclear, the liver is closely linked to both heart health and general metabolic/digestive health. This means that these parts of health are affected by HCV infection – and HCV cure.

              In a study of patients at several gastroenterology/hepatology practices in the U.S., one year after treatment, almost half of patients with diabetes saw the condition improve, and about a third of those reported improvements in cholesterol and blood pressure. This study included male and female participants from a variety of racial and ethnic backgrounds. The authors of the study suggest that because of the role of HCV in chronic inflammation and the importance of the liver, an improvement in liver health and function after curative treatment led to other improvements in health.

              Better managing both cholesterol and blood pressure is an important part of maintaining good health – especially in managing type 2 diabetes and reducing the risk of heart disease. The U.S. Centers for Disease Control and Prevention recommend that all adults 18 and older are screened at least once in their lifetime for hepatitis C – and that pregnant people are screened during each pregnancy. After screening, you should then verify with your insurance provider that the treatment will be covered.

              With the existence of a powerful, curative treatment option for HCV infection, this screening is a valuable step towards optimal health – both for the liver and for other systems in the body. To find a testing location in the U.S. near you, input your ZIP code into the CDC’s GetTested website.

              The statements and opinions presented in this blog post are solely the responsibility of the author(s) and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors, or the Methodology Committee.

              Congress grapples with budget and appropriations while the administration eliminates funding for health programs and terminates federal employees. – Liver Health Policy Update

              New Administration, New Congress, and Their Health Priorities Just Starting to Take Shape – Liver Health Policy Update

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              New Administration, New Congress, and Their Health Priorities Just Starting to Take Shape

              The new U.S. Congress is at work in Washington, DC. It is unclear if the healthcare legislation that came so close to passage last December will be included in a March appropriations package. The Senate must confirm political nominees, including the HHS Secretary and the CMS Administrator.


              Congress Must Take Action to Keep Government Funded

              In December, Congress struck a last-minute agreement to keep the government funded until mid-March, 2025. While a pared-back package was included to extend certain existing health programs, it did not include many of the health priorities supported by GLI and patients. Key provisions left out were the pharmacy benefit manager (PBM) reforms, a Pediatric Rare Disease Priority Review Voucher (PRV) Program extension, the Medicare Multi-Cancer Early Detection and Screening Act (MCED), and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. Some key reauthorizations were included, though only for a three-month window, including Medicare Telehealth Flexibilities, Medicaid Disproportionate Share Hospital (DSH) Cut Delay, Special Diabetes Program Funding, and Medicare’s Acute Hospital Care at Home Flexibilities. Provisions actively considered in December, but ultimately left out of the end-of-year package, could be reconsidered. GLI will continue to advocate that Congress include policies such as MCED, PRV, telehealth and PBM reforms in the final funding package anticipated in March 2025.


              Tracking Trump 2.0 Administration Appointees

              President Donald Trump has selected Cabinet-level officials for his administration. GLI is monitoring the Senate’s confirmation process closely. Here are his picks in the healthcare arena:

              • HHS: Robert F. Kennedy Jr. (Favorable vote in Finance Cmte, Senate hearing replays from January 29 and January 30)
              • CMS: Dr. Mehmet Oz (TBD)
              • CDC: Dr. Dave Weldon (TBD)
              • FDA: Dr. Martin Mackary (TBD)
              • NIH: Dr. Jay Bhattacharya (TBD)
              • Surgeon General: Dr. Janette Nesheiwat (TBD)
              • VA: Former Rep. Doug Collins (Confirmed)
              • Attorney General: Pam Bondi (Confirmed)

              New Committee Leadership Selected for 119th Congress

              • Cassidy To Lead Senate HELP Committee: Sen. Bill Cassidy (R-LA) will chair the Health, Education, Labor and Pensions (HELP) committee. Sen. Bernie Sanders is the Ranking Member. 
              • Crapo to Lead Senate Finance Committee: Sen. Mike Crapo (R-ID) will chair the Senate Finance Committee. Senator Ron Wyden (D-OR) is the Ranking Member.
              • Smith to Lead House Ways and Means Committee: Rep. Jason Smith (R-MO) will chair the House Ways and Means Committee. Rep. Richie Neal (D-MA) is the Ranking Member.
              • Guthrie to Lead House Energy and Commerce: Rep. Brett Guthrie (R-KY) will chair the House Energy and Commerce Committee. Rep. Frank Pallone (D-NJ) will be the Ranking Member.

                  GLI Supports CMS Proposal to Cover Obesity Medications Under Medicare

                  On November 26, CMS proposed to reinterpret an existing statute and permit coverage of anti-obesity medications (AOMs) for weight loss when treating obesity, and CMS would apply this reinterpretation across all Part D plans and Medicaid programs. GLI commented in response to the proposed rule that it strongly supports finalization. As often happens in a new administration, the Trump administration has chosen to “freeze” pending regulations to allow newly appointed officials to review and align rulemaking with the policy goals of the new administration. It is possible that the new administration may amend the final version of the rule. Therefore, it is unclear whether and how the rule will impact efforts to pass legislation that allows for more restrictive coverage of obesity medications. View GLI’s comments here.


                  Join GLI in Pushing for Patient Access to Care for MASH/NASH
                  Veterans continue to be denied coverage for metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), treatment without a biopsy or experience delayed care due to requirements to receive “comprehensive lifestyle intervention” for 6 months before being eligible for treatment. The VA’s decision is contrary to the label from the Food and Drug Administration and clinical guidelines. As part of GLI’s Beyond the Biopsy initiative, GLI and its partners sent a letter to the VA. We continue to encourage signatures here on a petition to all payers calling for coverage without biopsy!


                  Legislative Updates

                  • The Medicare Multi-Cancer Early Detection Screening Coverage Act has been reintroduced in the US Congress (H.R.842 / S.339). Learn more.
                  • The ORPHAN Cures Act has been reintroduced in the US Congress (H.R.946).

                    Patient Highlight

                    GLI Ambassador and passionate advocate Terri has shared her story, which underscores why it is imperative to advance the use of noninvasive diagnostics for fatty liver disease. Terri’s condition deteriorated rapidly after her biopsy, from being asymptomatic to experiencing ascites, compensated cirrhosis, hepatic encephalopathy, and brain fog. This experience has fueled her passion, and she shared “I will use my voice to advocate, giving doctors – and the patients and veterans that depend on them – an updated toolkit for a smoother journey to wellness.”


                     

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                    How to Stay Engaged Beyond Rare Liver Diseases Month – Pediatric and Rare Liver Diseases News

                    It’s Rare Liver Diseases Month! – Pediatric & Rare Liver Diseases News

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                    How to Stay Engaged Beyond Rare Liver Diseases Month – Pediatric and Rare Liver Diseases News

                    #RareAware Campaign: Our Impact on Rare and Rural Healthcare

                    In February, we took action to bridge healthcare gaps for rare liver disease patients in rural communities—driving awareness, advocacy, and education where it’s needed most. Here are some highlights: 

                    • Our February episode of Is Your Liver Healthy? podcast brought together Dr. Harsha Rajasimha of the US Indo Rare Disease Foundation, Dr. Cecilia Dueñas of the PBC Research Foundation, and Theresa Davidson of the MidSouth Liver Alliance to discuss the urgent need for equitable access to clinical trials for rural and rare patients around the globe.  
                    • In the community, our pilot Rare Science Fairs program in Mississippi reached over 500 individuals, featuring seven research posters co-created with students and patient advocacy leaders to spark local engagement in rare disease research.

                    On Capitol Hill, we championed the ORPHAN Cures Act, a critical bipartisan bill that protects incentives for developing rare disease treatments by ensuring orphan drugs remain exempt from Medicare price negotiations if they are approved for more than one rare condition.

                    But the work doesn’t stop here. There are still many ways to engage beyond Rare Liver Diseases Month. Here are some ways to engage:  

                    • Direct patients and caregivers to our newly released rural healthcare resources, now available on our website.
                    • Help us grow our Rare Science Fairs and bring them to more schools worldwide.
                    • Urge your representatives to support policies that expand access to rare disease care. The ORPHAN Cures Act still needs backing—use this resource to make your voice heard.
                    ICP Poster Presentation (Pine Grove)
                    Posters (Wilson And PSC) Presentations
                    Kristin, Alyssa, And Senator Hyde Smith

                    New Key Screening Questions for Early Diagnosis of Biliary Atresia 

                    Early detection of biliary atresia is critical for timely intervention, yet diagnoses are often delayed. A new AAP guidance clinical report emphasizes three key questions for primary care providers: Is the infant jaundiced, do they have pale stool, was their direct bilirubin high at birth? If the answer to any of these is yes, a direct bilirubin level should be checked to assess for possible liver disease.

                    Routine screening in primary care settings can significantly improve early diagnosis and outcomes for affected infants. Collaboration with pediatric hepatologists and awareness of patient advocacy resources can further support families navigating this condition.


                     

                    A Key Reason for Misdiagnosis of Alagille Syndrome in Low-Resource Settings

                    A recent publication from South Africa highlights the challenge of diagnosing alagille syndrome (ALGS) in settings with limited access to genetic testing, where it is often misdiagnosed as biliary atresia. Without proper diagnostic tools, children may undergo unnecessary surgeries, as early liver biopsy findings can resemble biliary atresia. This publication underscores the urgent need for better diagnostic strategies, education, and resource allocation to prevent misdiagnoses, particularly in low-income regions.


                     

                    FDA Grants Chemomab Phase 3 Trial Approval for Nebokitug in PSC

                    Progress is being made in the treatment of Primary Sclerosing Cholangitis (PSC) as the FDA has granted Chemomab approval to proceed with a Phase 3 trial for Nebokitug. PSC is a chronic liver disease that causes inflammation and scarring of the bile ducts, leading to serious complications like liver failure and cancer. With no approved treatments, patients rely on symptom management and, in severe cases, liver transplants. Nebokitug targets the underlying disease, aiming to slow progression and improve outcomes. Notably, this Phase 3 trial evaluates clinical outcomes without requiring liver biopsies—a meaningful shift from traditional PSC study designs. 


                     

                    Highlighting the Fight for Life Club in Mexico 

                    The National Institute of Pediatrics (INP) and the Fight For Life Club Foundation have achieved a significant milestone in pediatric transplantation, successfully performing two living donor liver transplants in a single week. With only 4.5 deceased organ donors per million people in Mexico, living donor transplants are a critical solution to reducing wait times and improving survival rates for children. This initiative is part of a broader effort to build a sustainable, world-class pediatric transplant program in Mexico.


                     

                    Expanded Newborn Screening in Victoria Enhances Early Detection of Rare Diseases

                    Galactosemia, a rare metabolic disorder affecting approximately 1 in 50,000 newborns, can lead to life-threatening liver disease if left undiagnosed. Early detection through newborn screening is critical to preventing serious complications and enabling timely intervention. Victoria, Australia, has expanded its newborn screening program to include galactosemia, bringing the total number of screened conditions to 32.


                     

                    Recognizing Life-Saving Liver Transplants in Hyderabad, India

                    Osmania General Hospital (OGH) has made a remarkable impact by successfully performing five liver transplants in a month, providing life-saving treatment to young patients from low-income backgrounds and treating patients with Tyrosinemia Type 1, Wilson’s disease, and Chronic Budd-Chiari syndrome. These complex procedures, typically costing 3 to 4 million rupees in private hospitals, were performed free of charge under the state’s Aarogyasri scheme, ensuring access to critical care for those who need it most. This achievement highlights OGH’s growing excellence in liver transplantation, particularly for rare liver diseases.


                     

                    Conditional Marking Approval for Seladelpar in Europe 

                    Seladelpar has received conditional approval in Europe for the treatment of primary biliary cholangitis (PBC), either in combination with UDCA or as monotherapy for those unable to tolerate UDCA. This approval expands much-needed treatment options for PBC patients, a condition with limited therapeutic choices. While conditional approval allows early access, additional confirmatory trials are required to fully establish its clinical benefits.


                     

                    Upcoming Events


                     

                    For more information about the Pediatric and Rare Liver Diseases Council or to learn more about joining, please visit our webpage or email pedsrare@globalliver.org.

                    Advances in Liver Cancer Treatment & Research – Liver Cancer News

                    Latest Developments in Treatments – Liver Cancer News

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                    Latest Developments in Treatments

                    In recent years, liver cancer has emerged as a significant global health concern, with increasing incidence rates and a pressing need for innovative treatment strategies. This newsletter highlights several articles that delve into the latest trends and advancements in liver cancer research and treatment. By exploring these developments, healthcare professionals and patients can stay informed about cutting-edge techniques that may improve health outcomes.


                     

                    Addressing liver health disparities in rural areas: A global conversation

                    In a recent roundtable hosted by Sarah Manes, Liver Cancers Program Director at Global Liver Institute (GLI), medical experts from the USA, Cameroon, and Mexico highlighted the significant disparities in liver health faced by rural populations. Dr. Andrew Moon, Dr. Mbinake Livancliff, and Dr. Jorge Emilio Lira Vera detailed the unique challenges in their regions, including limited access to healthcare, late-stage diagnoses, and the impact of social stigma. Key strategies discussed included expanding hepatitis screenings, leveraging telemedicine despite infrastructure gaps, conducting vaccination campaigns, and fostering community education. Innovative approaches such as training providers in cost-effective diagnostic techniques and engaging traditional healers to break cultural barriers are making progress. The panel emphasized that addressing liver diseases in rural communities will require global efforts to improve healthcare access and increase public awareness. These strategies pave the way for advancing health equity and improving outcomes for underserved communities worldwide.


                     

                    COR2ED HCC Podcast Series

                    COR2ED released episode 3 of their 4-part podcast series on hepatocellular carcinoma (HCC). The Oncology Brothers, Dr. Rahul and Dr. Rohit Gosain, are joined by hepatologist and GLI Liver Cancers Council Member Dr. Maria Reig, and interventional radiologist Dr. Emil Cohen to discuss treatment strategies for patients with intermediate-stage HCC. The experts offer essential insights into the various treatment options for this diverse patient population and examine how systemic treatments and multimodal strategies can contribute to achieving the best possible outcomes for patients.

                    Podcast Flyer, Intermediate HCC (1)

                     

                    New issue of touchREVIEWS in Oncology & Haematology eJournal 

                    TouchOncology has released its newest issue of touchREVIEWS in Oncology & Haematology. This edition highlights significant progress and ongoing challenges in oncology, presenting engaging articles on various topics such as breast, colorectal, gastrointestinal, lung, and prostate cancers. In this issue, TouchOncology aims to spark valuable discussions and provide readers with the latest evidence and expert insights.

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                    Alcohol and Cancer Risk 

                    The 2025 Alcohol and Cancer Risk Advisory from the U.S. Department of Health and Human Services, led by the Surgeon General, reveals the undeniable connection between alcohol consumption and increased cancer risk. The report shows how even moderate drinking can raise your chances of developing cancer, including breast cancer in women, colorectal cancer, esophageal cancer, laryngeal cancer, liver cancer, and cancers of the mouth and throat.

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                    Promising combination therapy could improve liver cancer outcomes

                    A recent study highlights a promising combination therapy that could significantly enhance outcomes for patients with liver cancer. Researchers explored the use of immune checkpoint inhibitors, which block proteins such as PD-1 or CTLA-4 that tumors use to evade immune attacks, thereby reactivating T cells to destroy cancer cells. Alongside this, they investigated a novel targeted therapy focusing on the chemokine receptor CXCR4, which plays a key role in tumor progression and immune regulation. CXCR4 inhibition helps disrupt the tumor microenvironment and enhances the effectiveness of immune checkpoint inhibitors by promoting better immune cell infiltration into tumors. The study revealed that this dual approach not only suppressed tumor growth but also extended survival in preclinical models. By leveraging both immunotherapy and targeted treatments, this innovative strategy aims to address the challenges of resistance and limited efficacy often seen with single therapies. These findings pave the way for further clinical research to assess the combination’s potential in improving liver cancer treatment outcomes.


                     

                    How diet and vaccinations can proactively prevent liver cancer

                    In a news segment on WBRZ, Mayo Clinic’s oncologist and GLI Liver Cancers Council Member, Dr. Lionel Kankeu Fonkoua, highlights proactive ways to reduce the risk of liver cancer through lifestyle choices and preventive measures. The discussion delves into the critical role of a healthy diet, emphasizing foods that support liver health, as well as the importance of vaccinations, like the hepatitis B vaccine, to lower the likelihood of liver cancer development. Dr. Fonkoua also discusses the impact of regular screenings and maintaining a healthy weight to prevent liver disease progression.

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                    The Case for Universal Access to Hepatitis C DAA Treatment for Your Patients

                    Direct-acting antiviral treatment for hepatitis C infection can cure the vast majority of cases, improve quality of life, and prevent further disease development– but many patients still lack access. In each health system or insurance policy, we must remove barriers to this lifesaving care, whether financial hurdles, prior authorization, demographic/behavioral restrictions, disease severity requirements, or something else. Let’s prevent liver cancer and disease progression in our communities by speaking up and demanding better!

                    PCORI R1G3

                     

                    Upcoming Events:


                       

                      For more information about the Liver Cancers Council or to learn more about joining, please visit https://globalliver.org/liver-cancers-council/ or email cancer@globalliver.org

                      Beyond the Diagnosis: Stories, Breakthroughs & Global Action – Fatty Liver Disease News

                      What’s New in 2025 – Fatty Liver Disease News

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                      What’s New in 2025

                      Dry January: A Wake-Up Call for Liver Health 

                      Stephen Silva-Brave, patient advocate and graduate of GLI’s Advanced Advocacy Academy (A3), shares how his wake-up call came after being diagnosed with fatty liver disease, which progressed to cirrhosis. In a Q&A with Dr. Robert Gish, they discuss how trends like Dry January can help people reassess their relationship with alcohol and why stronger education on the risks of alcohol-related liver disease is needed. While some hepatologists take a lenient approach to alcohol consumption, Dr. Gish emphasizes that those with fatty liver disease should avoid alcohol entirely and seek support if needed.

                      Dr. Gish Healio

                       

                      Global Fatty Liver Day is on June 12!

                      Mark your calendars for Global Fatty Liver Day on June 12, 2025! Join us in raising awareness and driving action to combat fatty liver disease and its more advanced forms,  worldwide. Partner with us to host events, share resources, and make a lasting impact on liver health.

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                      Emerging Insights

                      Liver-brain communication affects eating patterns and obesity

                      A study on mice shows that disrupting the liver’s circadian clock, either genetically or through a high-fat diet, alters eating patterns and contributes to weight gain by affecting liver-brain communication. These findings highlight the potential for therapies targeting this pathway to address metabolic disorders linked to irregular eating patterns.


                       

                      Moderate Alcohol Consumption Fuels Liver Disease Progression in People with MASLD

                      A recent study highlights that even moderate alcohol consumption significantly increases the risk of liver fibrosis in individuals with MASLD. Researchers emphasize that no amount of alcohol is safe for those with MASLD, as it exacerbates disease progression when combined with metabolic risk factors.


                       

                      MAFLD, NAFLD, and the Risk of Peripheral Artery Disease

                      A new study reveals that MAFLD and NAFLD are associated with an increased risk of peripheral artery disease (PAD). The findings highlight the connection between metabolic dysfunction liver disease and cardiovascular outcomes, underscoring the importance of early intervention.


                       

                      ⬇️ Education Resources Available ⬇️

                      GLI is proud to offer a range of continuing education programs to support healthcare providers in expanding their knowledge and skills in MASLD and MASH. These programs provide valuable CE credits and are available until June 2025.


                       

                      Endocrinologists and PCPs: The Frontline Defense Against Cirrhosis in Patients with Type 2 Diabetes

                      Through a partnership with the Global Learning Collaborative, GLI now offers this continuing education course on ReachMD. This series of bite-sized episodes will provide important information on MASLD and MASH in patients with type 2 diabetes. Drs. Naim Alkhouri, Robert Eckel, and physician assistant Tessa Janovsky discuss best practices for screening, diagnosis, treatment, and management of MASH/MASLD.

                      Nov Nordisk MASLD Flyer June 13 2024

                       

                      Build Your Own Case Study | Redefining MASLD/MASH Care: Personalized Strategies for Assessment, Diagnosis and Management

                      In collaboration with the Medical Learning Institute, GLI presents an interactive course to Build Your Own Case Study. Healthcare providers in the endocrinology specialty setting are challenged to be knowledgeable of the pathophysiology of MASLD and MASH and its associated risk factors, as well as feel confident about how and when to order noninvasive diagnostic tests to prevent the emergence of more severe complications and stay on top of current guidelines and emerging treatment options.

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                      Upcoming Events


                         

                        Rural Communities at Risk: Global Liver Institute Champions Awareness for Rare Liver Diseases

                        Rural Communities at Risk: Global Liver Institute Champions Awareness for Rare Liver Diseases

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                        Rural Communities at Risk: Global Liver Institute Champions Awareness for Rare Liver Diseases

                        (Washington, DC, February 1, 2025) As rural healthcare access shrinks across the United States and remains limited worldwide, Global Liver Institute (GLI) is shining a spotlight on the critical need for awareness and education about rare liver diseases during Rare Liver Diseases Month. Through its annual #RareAware campaign, the patient advocacy organization is calling for more open conversations about these conditions in rural areas, where patients often face life-threatening delays in diagnosis and treatment due to a shortage of healthcare resources, specialists, and education.

                        With over 190 rural hospitals closed in the US since 2005 and 700 more at risk, timely medical care is increasingly scarce. Studies from around the globe have shown that biliary atresia and other genetic conditions are not only more prevalent but are often diagnosed later in rural populations due to the lack of specialized care. GLI’s campaign seeks to tackle these disparities head-on by bringing rare liver diseases into the spotlight and encouraging conversations online and in communities that could lead to earlier diagnoses and, ultimately, save lives.

                        Larry R. Holden, CEO of GLI, emphasized the importance of awareness: “Normalizing conversations about rare liver diseases is key to breaking barriers to diagnosis, especially in rural areas where healthcare resources are scarce. By increasing awareness, we can bridge critical gaps in diagnosis and care, particularly in underserved rural areas, and empower individuals and communities to act early.”

                        Rare liver diseases are not always on the radar in rural communities, and often, the symptoms are overlooked or misdiagnosed. Since they are affiliated with major academic institutions, the NORD Rare Disease Centers of Excellence are concentrated in urban and suburban parts of the country. Studies indicate that rural healthcare providers are less equipped to manage these complex conditions due to inadequate access to specialists and insufficient training. With more than 90% of rural counties in the U.S. experiencing shortages of primary care physicians (let alone rare disease specialists), addressing these challenges has never been more urgent.

                        “My own experience as a patient in a rural area taught me how vital it is to share our stories and raise awareness. In rural and underserved areas, people listen to those who sound like them, live near them, or share similar experiences,” said Kristin Hatcher, GLI’s Program Director of Pediatric and Rare Liver Disease and rare liver disease patient advocate. “When rare liver diseases become part of everyday conversations, especially among friends, family, and neighbors, it creates a ripple effect. It can truly make the difference between life and death.”

                        To address this critical need, GLI will host in-person events throughout February, such as Rare and Rural Science Fairs and Clinical and Research Roundtables at rural medical schools to educate healthcare providers and the public about the unique challenges faced. GLI is also expanding its voice through its annual #RareAware campaign featuring patient and clinician stories and is partnering with groups alongside the EveryLife Foundation to advocate for policies that improve access to specialized care in underserved areas.

                        GLI urges everyone to join the conversation this month — whether through social media, local discussions, or educational resources. Everyone can be involved in the vital work of raising awareness for early recognition and bridging gaps in care, especially where specialists are scarce.

                        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. GLI holds Platinum Transparency with Candid/GuideStar, is a member of the National Health Council, and serves as a Healthy People 2030 Champion. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube or visit www.globalliver.org. GLI is the host of Global Fatty Liver Day.