Surfing the MASH Tsunami

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In a follow-up preview, Jörn Schattenberg, Louise Campbell, Mazen Noureddin, Ian Rowe and patient advocate Jeff McIntyre join Roger Green to discuss key presentations and posters of interest at the 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). On November 4th-8th in Washington DC, as many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care.

This conversation focuses on a presentation by Laurent Castera from Parallel Session 33 on Monday afternoon. The abstract looks to validate and compare head-to-head the FASTTM, MAST, and MEFIB scores as well as FIB-4 and NAFLD fibrosis score in a large cohort of T2D patients with NAFLD. Mazen points out that while the paper compares the various tests, the key is to ask which test is best for each specific purpose. In general, these results show that MAST and FAST perform better than the other three tests in terms of area under curve. Results also indicate that MAST has an indeterminate range of around 20%, as compared to 44% for FAST and MEFIB. The latter result suggests to Mazen that the researcher will need fewer biopsies to classify patients using MAST and MAST should score better on true classifications. Roger refers to last week’s discussion around which test to use at different points in the patient screening process. Mazen notes that while he has concerns with FIB-4, it remains as one of the best primary test options today. He repeats Stephen Harrison’s question from last week on whether we should start primary screening with FibroScan instead of FIB-4.

As the session ends, Jörn suggests that the discussion on best clinical use will continue. He notes that the goal of this paper is to contribute to discussion around the value of each test, ‘the true task of academia.’

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In a follow-up preview, Jörn Schattenberg, Louise Campbell, Mazen Noureddin, Ian Rowe and patient advocate Jeff McIntyre join Roger Green to discuss key presentations and posters of interest at the 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). On November 4th-8th in Washington DC, as many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care.

Mazen begins by highlighting a presentation by Laurent Castera which covers an abstract the two collaborated on. The paper looks to validate and compare head-to-head the FASTTM, MAST, and MEFIB scores as well as FIB-4 and NAFLD fibrosis score in a large cohort of T2D patients with NAFLD. Roger notes last week’s discussion on use of FIB-4 as a primary screening tool, commending its performance in NPV but not PPV. He suggests this study offers a way forward for an enriched population who would benefit from a test offering high PPV and a narrow indeterminate zone. Jörn and Louise respond with their thoughts on FIB-4 as a cheap, accessible tool for primary care. Their analysis aligns with a conclusion from last week’s preview: FIB-4 is not a tool for the specialist’s office but, instead for primary care practices conducting first-line screening.

Ian suggests some of the preceding conversation anchors performance of these tests to biopsy. Interested in moving beyond biopsy, he points out presentations which compare outcomes of patients according to either biopsy or associated noninvasive tests. The first paper investigates whether screening for advanced fibrosis in the community can identify the subgroup of people with NAFLD at higher risk for development of liver-related complications. The study aimed to determine the prognostic value of baseline noninvasive fibrosis tests for predicting liver-related outcomes and mortality in patients with NAFLD from T2D clinics or primary care. Ian then looks at a presentation by Samer Gawrieh which provides data on progression. Mazen agrees with the idea that as data accumulates around NITs, we can better understand how longitudinal changes impact outcomes.

Jörn highlights his anticipation for Parallel 12: NASH therapeutics and OMICs. He specifically points to a presentation by Jonathan Stine on answering an unmet need to develop effective lifestyle intervention programs. This randomized proof of concept trial evaluates the feasibility, acceptability and safety of a novel commercially available mobile health app. This topic immediately resonates with Jeff, who is encouraged by two elements: the development of remote personalized technologies and the resulting patient empowerment. Roger raises questions around the commercial model buttressing this study: who is paying and for how long can they maintain motivation? He envisions a more viable approach will be supported by commercial payers, who in return are investing in health care data. Given this may take some time to play out, Roger casts a third suggestion: FDA-approved digital therapeutic apps. He predicts this to be fertile grounds for patient empowerment over the next few years. After some back and forth with Jeff, Roger shifts focus to his interest in posters on primary care screening and the metabolic-NAFLD link. Mazen shares his enthusiasm for the potential of machine learning to ensure accuracy in the use of NITs.

As time winds down, the panelists provide closing comments touching on a number of topics. It’s noted that this data-rich, insight-laden conference will host a dynamic inclusion of presentations on therapeutics, drug development and solutions deployed to market. Stay tuned for the upcoming live recorded coverage from Washington DC.

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When AASLD announced that the 2021 event would be held as a purely virtual meeting, attendees and observers feared a loss of focus and the kind of amplifying energy that comes from being with colleagues. As this episode suggests, the breadth, quality and novelty of the meeting’s presentations generated exceptional positive energy even though colleagues could not meet in person throughout the event. In particular, this group noted the many ways in which the conference format and presentation implicitly challenges some older beliefs and perspectives about NAFLD, NASH and the people who live with these diseases.

Surf on for a conversation focused largely on determining key takeaways from the 2021 meeting and predictions as to what would be the big stories in 2022. 

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The 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) takes place on November 4th-8th in Washington DC. As many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care. Key Opinion Leaders Stephen Harrison, Jörn Schattenberg and patient advocate Jeff McIntyre join Roger Green to preview key presentations and posters of interest.

This conversation continues from the theme that NAFLD is not a disease of affluence. Roger notes data from Zobair Younossi which reveals extremely high rates of NAFLD in the Middle East and North Africa region - a region recognized for the wealth of its residents. Jeff connects this prevalence to growth in easy-to-access, overprocessed, low nutrition foods. “If anything, it is not a question of ease of access, but which foods are easy to access.” He is enthusiastic that with the possibility of earlier diagnosis in identifying F2 patients, earlier intervention can follow.

Jörn suggests another issue that might help: NAFLD is a precursor to hepatic cell carcinoma (HCC). For many patients, HCC comes before progression to cirrhosis. Roger expands this observation, noting NAFLD to be a predictor of a range of non-liver cancers in addition. Stephen expresses the need to draw attention to treating Fatty Liver, which is the “canary in the metabolic dysregulation coal mine.” He says that if all we do is raise awareness of the need to treat, we have accomplished quite a lot.

Roger briefly references posters that take innovative looks at how to create inexpensive, widely available screening through tests and/or analysis of medical records. At the end, he invites everyone back next week to discuss more of the presentations and this data-rich, insight-laden conference. The closing question explores one important thought about the meeting each panelist wants to raise before the next preview discussion. 

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The 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) takes place on November 4th-8th in Washington DC. As many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care. Key Opinion Leaders Stephen Harrison, Jörn Schattenberg and patient advocate Jeff McIntyre join Roger Green to preview key presentations and posters of interest.

This conversation starts with Stephen’s comments on the presentation covering fibrosis progression rates for diabetic vs. non-diabetic patients with biopsy-proven NAFLD. Stephen says it highlights important elements of the diabetes population, who are known to have significantly higher rates of NASH and fibrosis. This study demonstrates faster progression rates for this population. He makes two notes of interest: First, this is a relatively young population. Second, while the mean BMI is clearly obese at 34, it is lower than many patients seen by hepatologists in clinic. He suggests that older patients with progressed obesity might demonstrate more dramatic results. In closing, he wonders whether duration or severity of diabetes impacts the speed of fibrosis progression.

Focus shifts to papers and presentations identified by Jeff McIntyre. He notes two items, the first of which is Donna Cryer’s Patient Keynote address titled, Liver Health Equity: Overcoming Stigma, Access and Policy Barriers. Jeff comments that stigma, access and policy barriers are themes that actually run through the entire agenda. He cites a range of issues that reflect on challenges facing health equity, but also overall patient care and support. For example, he mentions the broadened use of NITs. He also points specifically to a session called Liver and Queer, an introduction to the AASLD LGBTQ task force.

With Louise Campbell absent, Roger looks to Jörn for a response to challenges facing health equity. Jörn states, “NAFLD has inequality written all over it,” citing far reaching factors including food distribution, access to care and green spaces where people feel safe while exercising. He looks forward to Donna discussing how to overcome these issues from a patient advocacy perspective. 

Finally, Jeff and Jörn agree on two public perceptions that need to be addressed: NAFLD as a disease of affluence and food issues standing somewhat independent of health.

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The 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) takes place on November 4th-8th in Washington DC. As many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care. Key Opinion Leaders Stephen Harrison, Jörn Schattenberg and patient advocate Jeff McIntyre join Roger Green to preview key presentations and posters of interest.

The preceding conversation finished with Jörn discussing the proper use for FIB-4 (in referral pathways) and the improper use (in specialty practices and clinics). This conversation picks up with Jörn listing tests he prefers in his clinic: MRE and FAST. Stephen notes that many guidelines recommend FIB-4 followed by FAST. He asks, why not start with both and improve our ability to identify patients who need therapy? Roger responds by mentioning a poster from Mayo Clinic (#2309, Performance of AGA Clinical Care Pathway for the Risk Stratification of Patients with NAFLD in the US population). The poster suggests defining the AGA guidelines so that only patients with Type 2 diabetes and FIB-4 >1.3 would reduce the number of scans by almost 10 million, or 70% of demand. This would not significantly affect how many patients are missed. The group agrees this is a good approach in specialty practices, but probably not easy to implement or cost-effective in primary care.

Jörn shifts focus to Daniel Huang’s presentation at Sunday’s Presidential Plenary session. The presentation compares fibrosis progression rates for diabetic vs. non-diabetic patients with biopsy-proven NAFLD. He notes two key findings of interest: First, while it has always been assumed that fibrosis progresses one level in seven years, the number for patients with diabetes may be closer to one level every six years. Second, the cumulative progression over the entire populations in a 12-year period was 93% for patients with diabetes and 76% for patients without diabetes. Jörn notes this to be a significant difference in patient numbers, highlighting an urgent need for treatment in the diabetic population.

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The 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) takes place on November 4th-8th in Washington DC. As many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care. Key Opinion Leaders Stephen Harrison, Jörn Schattenberg and patient advocate Jeff McIntyre join Roger Green to preview key presentations and posters of interest.

This conversation focuses on a presentation by Rohit Loomba that will review results from MAESTRO-NASH, a 2,000-patient Phase 3 trial. Stephen highlights that this analysis demonstrated FIB-4 with a cutoff of 1.3 failed to identify 57% of F2 patients, 40% of F3 and 26% of F4. To Stephen, this implies that if we rely solely on FIB-4, “we’re probably leaving behind a lot of patients that should be treated.”  He suggests adding VCTE to FIB-4 to improve precision in screening these patients. As the session ends, Jörn shares his impressions and agrees with Stephen that FIB-4 is inappropriate for specialty clinics. He notes that the primary anticipated use is to screen patients in referral pathways where the number of patients with clinical fibrosis is far lower.

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The 73rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) takes place on November 4th-8th in Washington DC. As many as 10,000 attendees will convene in an effort to advance and disseminate the science and practice of hepatology, and to promote liver health and quality patient care. In this preview, Key Opinion Leaders Stephen Harrison, Jörn Schattenberg and patient advocate Jeff McIntyre join Roger Green to discuss key presentations and posters of interest.

Earlier this month, Stephen and Jörn joined Roger, Louise Campbell and Mazen Noureddin to review a string of recent press releases on NASH drug development. Many of these are AASLD late-breakers. Today's podcast covers presentations and posters not discussed previously.

Stephen begins by mentioning an analysis Rohit Loomba will present from MAESTRO-NASH results, a 2,000-patient Phase 3 trial. This analysis demonstrated that FIB-4 with a cutoff of 1.3 failed to identify 57% of F2 patients, 40% of F3 and 26% of F4. To Stephen, this says if we rely solely on FIB-4, “we’re probably leaving behind a lot of patients that should be treated.”  He suggests adding VCTE to FIB-4 to improve precision in screening these patients.

Jörn and Roger have a common reaction: FIB-4 is not a tool for the specialist's office but, instead for primary care practices conducting first-line screening. Jörn states that the guideline referrals for FIB-4 use apply specifically to primary care and that in his clinic, he would never evaluate a patient solely based on FIB-4. Roger comments about a large number of papers at the conference seeking to improve efficiency and reduce cost of front-line screening, not to add literally millions of VCTE tests per year to primary care schedules and budgets. Jörn closes the discussion by saying that the common message to the field today is that FIB-4 is an important primary care tool, but it is far from perfect and we should seek better options over time. 

Jörn focuses on Dr. Daniel Huang’s presentation at Sunday’s Presidential Plenary session comparing fibrosis progression rates for diabetic vs. non-diabetic patients with biopsy-proven NAFLD. He notes that while conventional wisdom is that NASH progresses by one stage of fibrosis every seven years, the rate for diabetic patients in this study is reported to be one stage every six years. This leads to a broader discussion about screening and treatment for patients with diabetes, where the emerging consensus is to assume NAFLD and screen for NASH and fibrosis.

Jeff McIntyre focuses on patient issues by discussing Donna Cryer’s “Health Equity” talk on Saturday morning. Jeff suggests while we all think of health equity in context of stigma, access and policy barriers, these are broader than simple equity issues.  “Access,” he notes, can refer to how adoption of NITs in clinical trial programs will make trials practical for a larger number of patients. “Stigma” refers not only to the stigma of liver disease, but also to whether stigmatized groups such as the obese or people living with HIV get care sensitive to their needs. To that end, he points specifically to a session at 10:30a Saturday morning called “Liver and Queer,” an introduction to the AASLD LGBTQ task force. This bridges into discussions about obesity and its global implications, one of which is that Fatty Liver leads to HCC and other cancers… and from there to ways to draw attention to the need to treat Fatty Liver, which Stephen describes as the “canary in the metabolic dysregulation coal mine.”

As time winds down, Roger briefly references a couple of posters that take innovative looks at how to create inexpensive, widely available screening through tests and/or analysis of medical records. He invites everyone back next week to discuss some more of the presentations and this data-rich, insight-laden conference.

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One of the most intriguing presentations at the inaugural Innovations in NAFLD Care 2022 conference (INCBCN) came from physician, author and entrepreneur Dr. Marcus Ranney. In this conversation, Roger Green interviews Marcus on his experiences unique vision and the future of #biohacking.

In this conversation From the Vault, Marcus discusses his own “journey of figuring out…how to augment [his] own health.” He describes his personal history and career, how he came to write the best-selling book “At the Human Edge,” to begin his Human Edge consultancy and to begin developing the #biohacking app Mito. Along the way, we learn about his long-standing passion for mitochondria and the ways experiencing long-haul COVID-19 has affected his health and perspective. From a market perspective, he discusses the rapid growth of technologies designed to collect and share information about the individual’s metabolism.

From the platform of understanding Human Edge and Mito, the dialogue veers into broader social issues. Roger discusses how the conference presented and amplified four very different views of power and control in managing individuals’ health. Marcus shares his view that if we are to address social developmental needs and goals necessary to advance health, data — at all levels — will be key to formulating, evaluating and improving strategies and programs. These ideas do not sound radical in their one-sentence summaries, but the discussion is richer, farther-reaching and more powerful than the summaries themselves suggest.

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One critical success factor for putting a dent in Fatty Liver disease – one we do not discuss very often on the podcast – is patient empowerment. In this conversation, Roger Green and Louise Campbell are joined by patient advocates Michael Betel, Wayne Eskridge and Robert Mitchell-Thain to discuss the use of FIB-4 as a front-line tool for primary care triage.

Roger starts by noting FIB-4 as cheap and relies on a small number of widely-used tests. At different levels, FIB-4 is prognostic not only for major adverse liver outcomes and mortality but also at its indeterminate level for cardiovascular and overall mortality. He connects the most recent Rising Tide episode, where it’s mentioned that the US may be the only country to include AST so widely in standard testing. It's asked in that episode whether this is an issue advocates can adopt and use to advance disease awareness and screening. Wayne endorses the idea and Robert expresses some concern about FIB-4. Robert does acknowledge that Fatty Liver Alliance’s new charity status positions it as an excellent organization to make the major change. 

The final question asks each advocate what change they can make in their country in the next 12 months that might extend beyond the country’s borders. Surf on to hear their answers.