908 episodes

Driving the Discussion in Fatty Liver Disease. Join hepatology researcher and Key Opinion Leader Jörn Schattenberg, Liver Wellness Advocate Louise Campbell, and Forecasting and Pricing Guru Roger Green and a global group of Key Opinion Leaders and patient advocates as they discuss key issues in Fatty Liver disease, including epidemiology, drug development, clinical pathways, non-invasive testing, health economics and regulatory issues, from their own unique perspectives on the Surfing the MASH Tsunami podcast. #MASH #MAFLD #FattyLiver #livertwitter #AASLD #GlobalLiver #NoNASH #EASL

Surfing the MASH Tsunami SurfingNASH.com

    • Health & Fitness
    • 3.8 • 21 Ratings

Driving the Discussion in Fatty Liver Disease. Join hepatology researcher and Key Opinion Leader Jörn Schattenberg, Liver Wellness Advocate Louise Campbell, and Forecasting and Pricing Guru Roger Green and a global group of Key Opinion Leaders and patient advocates as they discuss key issues in Fatty Liver disease, including epidemiology, drug development, clinical pathways, non-invasive testing, health economics and regulatory issues, from their own unique perspectives on the Surfing the MASH Tsunami podcast. #MASH #MAFLD #FattyLiver #livertwitter #AASLD #GlobalLiver #NoNASH #EASL

    S5 - E6.3 - Staging and screening patients for Rezdiffra using NITs

    S5 - E6.3 - Staging and screening patients for Rezdiffra using NITs

    This conversation focuses on the necessity of using NITs to screen and identify Rezdiffra patients, while at the same time acknowledging the shortcomings of current tests. Panelists suggest some different NIT testing strategies while commenting on upsides and potential challenges for each MASH NIT.

    Laurent Castera joins the conversation at the beginning, which is helpful given his extensive research and knowledge of the surrounding communities. Laurent points out that distinguishing F3 patients from F4 will be a difficult challenge to solve, in part because we used categorical scores for fibrosis instead of recognizing that it is, in fact, a continuum where, in Laurent's words, "you are not 1.2 or 1.5. You're F1, 2, 3 or 4." Having a drug will facilitate a shift from the old-school categorical view to a more linear one.  

    Laurent goes on to comment that it is not clear exactly how we will use NITs, but that liver stiffness will certainly be one key metric, one he describes as "a prediction scale." He also comments on the problems caused by relatively low arbitrary cutoffs here, 12.25) and the need for (a) repeat measures and (b) use of at least two tests. He mentions platelet counts as one important example.  

    Jörn Schattenberg discusses the importance of clinical observation and judgment. Zobair Younossi takes that point further to stress the importance of conservative judgment in assessing for cirrhosis. Laurent suggests that a second, "more specialized test" that is "not related" to VCTE will tremendously improve accuracy. 

    I comment that one important issue is that individual prescribers will now start treating with Rezdiffra and will derive opinions about the drug based on their experiences with the first few patients for whom they prescribe. I suggest that similar patterns may be true for NITs and ask how panelists anticipate providers will receive education on NITs. 

    Louise Campbell talks about the roadmap that Madrigal showed of what they're going to have their reps and MSL trained doctors on and believes that will be exceptionally helpful. She also feels it is vital that practitioners early in the patient visit change also be well-educated on this topic. She notes that many of the people focusing on this topic, including former panelist Suneil Hosmane, now at Madrigal, are first-rate. 

    Jeff McIntyre closes the conversation by suggesting there will be a "huge patient role," because patients are people who can demand, or at least ask questions of doctors that will lead the doctor to do things they might not otherwise and to get more informed on related issues. Jeff notes that we have not come up with an adequately specific answer to the question, "What's the best NIT?" which mandates that we keep educating and speaking out.

    • 15 min
    S5 - E6.2 - How Approval Of Rezdiffra,The First MASH Drug, Might Improve Patient Adherence To Lifestyle Recommendations

    S5 - E6.2 - How Approval Of Rezdiffra,The First MASH Drug, Might Improve Patient Adherence To Lifestyle Recommendations

    This conversation focuses on what panelists see as a key (and somewhat unusual) benefit of Rezdiffra: that having a prescription drug for MASH creates a better environment for discussing lifestyle intervention and improving overall patient adherence with diet and exercise.
     
     This conversation focuses on the impact of having a drug on getting patients to comply with lifestyle interventions. Zobair Younossi starts by noting that, historically, it has been "very difficult" to institute successful lifestyle interventions because patients "are not used to thinking about lifestyle as a prescription." Now, providers can counsel patients to adhere to a regimen that includes medication and lifestyle changes.
     
    Jörn Schattenberg notes that Rezdiffra is indicated in the label as an adjunct to diet and exercise, which is common wording for most metabolic drugs. Zobair agrees but notes that this is still difficult to achieve in practice. One example: in the US, not everyone can comply with the idealized Mediterranean diet. As he notes, diet recommendations must be geographically and culturally relevant.

    I note that in my 25 years of marketing research, one thing I learned was that physicians feel they "have nothing" when all they can offer patients is lifestyle modification. With a drug in the discussion, the provider can "flip the script" to make lifestyle intervention adjunctive to the drug.  Jeff McIntyre points out specifically that having Rezdiffra to prescribe will help reduce stigma by "medicalizing" the recommendation to lose weight and add exercise. In effect, Jeff says, this takes the onus off the patient to feel responsible for their own disease. Zobair discusses a recent publication from the Global MASH Council on the impact of stigma.  

    At this point, Laurent Castera joins the conversation.  He adds the thought that having a drug to prescribe will increase interest among primary care providers. He also notes the importance of the label coming without a biopsy requirement, "a very important message to convey."  The conversation ends with Ian Rowe sharing his concern that it will be "quite difficult" to differentiate patients living with advanced fibrosis patients from those living with cirrhosis.

    • 11 min
    S5 - E6.1 - Rezdiffra Is Approved! How Key Opinion Leaders Processed The News About The First MASH Drug

    S5 - E6.1 - Rezdiffra Is Approved! How Key Opinion Leaders Processed The News About The First MASH Drug

    FDA approval of the first MASH drug, Rezdiffra, on March 14 marked what co-host and Key Opinion Leader Jörn Schattenberg describes as a "watershed moment" for hepatology. This opening discussion covers how panelists heard the news of Rezdiffra's approval, how they reacted, and their initial thoughts about appropriate patient targets.

    As the conversation starts, the various panelists describe their moves throughout the day on March 14th and their reactions when word of the FDA's approval came. They all describe having felt various degrees of trepidation as the day progressed. Jeff McIntyre describes him and his friends as "constantly refreshing our screens" throughout the day. Zobair Younossi probably felt less anxiety than others, while some of the Europeans described feeling more.

    This was replaced by excitement and joy at the final announcement. Jörn Schattenberg describes the day as a "watershed moment," that, in Zobair's words, "energiz[ed] for the entire field."

    Panelists go on to describe the patients they expect to prescribe Rezdiffra for at launch (now for the US, whatever comes available on the EMR). Jörn intends to prescribe initially for F3 patients but realizes he might not know exactly how to distinguish them from early-stage cirrhosis. Zobair points to prescribing for F2 and F3 patients as indicated in the label. 

    • 11 min
    S5 - E6 - Rezdiffra Is Here! Key Opinion Leaders React To The First MASH Drug Approval

    S5 - E6 - Rezdiffra Is Here! Key Opinion Leaders React To The First MASH Drug Approval

    Last Thursday, March 14, Rezdiffra (resmetirom) became the first MASH drug approved in the US. A global panel of Key Opinion Leaders convenes to discuss their excitement about this approval, the opportunities it will create and some of the (largely manageable) challenges it might present.

    00:00:00 - Surf's Up: Season 5 Episode 6
    Opening introduction from an excited, enthusiastic panel, including brief quotes taken directly from the episode discussion.

    00:05:02 - Groundbreakers
    Each panelist shares one piece of good news from the previous week.

    00:08:15 - Waiting for news and initial reactions
    Panelists  describe their moods throughout the day on March 14 and reactions when word of the approval came from FDA. They describe feeling varying degrees of trepidation as the day progressed without word from the agency, replaced by excitement and joy at the final announcement.

    00:14:30 - Specific patients to target or avoid
    Panelists describe the patients they expect to prescribe Rezdiffra for first (now for the US, when it becomes available for EMA).  The group aligns on the benefits for F3 and F2 patients (the two groups listed on the label) but shares concerns about accurate identification of F3 vs. compensated cirrhosis.

    00:17:07 - Impact on explaining lifestyle interventions
    Zobair Younossi notes the historical difficulty of getting patients to view lifestyle modification as a specific prescription to be followed. He, Roger and Jeff all makes points to suggest  that  the combination of drug + lifestyle modification will be easier to explain to patients.

    00:26:32 - Staging and screening patients using NITs
    Laurent Castera joins the conversation as the topic switches to proper use of NITs.  Previously, Jörn Schattenberg and Ian Rowe touched on challenges in deciding which patients have F3 fibrosis vs. early stage cirrhosis. Now the group explores the relative value of different strategies for qualifying patients. One key: while FIB-4 is an efficient screening test in largely negative populations, it produced a high level of false positives in specialty practices.

    00:33:50 - How to educate providers
    Roger points out that individual providers will conduct individual "clinical trials" in their own practices. This makes provider education on proper use critical to launch success. Louise Campbell commends Madrigal for the education pathway they laid out during the webcast. Jeff discusses the important role patients must play.

    00:39:06 - Finding the initial patients
    Apropos of education, Zobair points out that most early patients will be found in GI practices. Jeff points out that these patients are already in the system and can be easily identified.

    00:43:12 - Why Rezdiffra's strong safety profile matters so much
    Panelists agree that Rezdiffra's safety profile alleviates some concern that a well-meaning provider might prescribe for a patient with compensated cirrhosis due to inadequacy of current tests.

    00:48:39 - Suggested takeaways for industry
    Panelists suggest that industry learn from the large sample sizes and thoughtful use of NITs found in the Rezdiffra trial protocols.

    00:52:20 - FDA and NITs
    Louise asks how important FDA's two-day NIT workshop last year was in the agency not requiring biopsy prior to prescribing. Zobair says agency officials are moving slowly down a path toward greater acceptance.

    00:53:53 - Closing Thoughts
    Each panelist shares a closing thought. The topics vary widely.

    01:01:06 - Question of the Week
    The question is what impact Rezdiffra's approval will have on individuals' day-to-day work.

    01:01:47 - Business report
    News on audience metrics, future episodes and why there will be no Vault conversation this week

    • 1 hr 4 min
    S5 - E5.6 - From The Vault: Tsunami's First Look At MASEF, A Major New NIT

    S5 - E5.6 - From The Vault: Tsunami's First Look At MASEF, A Major New NIT

    This conversation comes from our first look at MASEF, last September, when lead author Mazen Noureddin joined the Surfers to discuss his recent breakthrough paper on this new NIT.  The original conversation had a robust write-up:

    Mazen Noureddin joins co-hosts Jörn Schattenberg, Louise Campbell and Roger Green to discuss serum identification of at-risk MASH and the Metabolomics-Advanced Steatohepatitis Fibrosis Score (MASEF). In late July, Mazen co-authored a paper on the subject which was published in Hepatology.
    This conversation begins with Louise’s initial response around the setting of application for MASEF. She poses a question that leads the group to explore possible pros and cons of different approaches and the potential impact each might have in terms of cost effectiveness. For example, Jörn wonders how feasible it will be for non-experts to administer. Mazen suggests that its application will be relatively easy before explaining how to navigate the caveat of a gray zone similar to that of VCTE. After a few more comments on sequential pairing with FIB-4, Mazen next teases the possibility of demonstrating therapeutic efficacy in the drug development space. 
    Louise returns to a question around cohorts and asks whether variables like age or sex has an impact on the test’s capabilities. She then asks whether this sort of work has the potential to inform retrospective cardiac studies. After Mazen and Louise go back and forth with a few ideas in response, Roger makes the comment that he is struck by the wide breadth of application and describes the platform as “elegant.” As the conversation winds down, the group discusses a few comparisons between different blood-based markers. 
    If you have questions or comments around MASEF, metabolomics or any other ideas considered in this episode, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com. The Surfing the NASH Tsunami will be back next week with more original content.

    • 13 min
    S5 - E5.5 - More on GLP-1s and a Broader MASH Wrap-up

    S5 - E5.5 - More on GLP-1s and a Broader MASH Wrap-up

    After some final discussion about GLP-1s, this conversation entails Roger Green summarizing what he has heard in the episode so far and testing for confirmation or correction. It goes fast and covers significant ground. 

    Naim Alkhouri starts this conversation by discussing patients for whom he would prescribe resmetirom vs. GLP-1s. Lean MASH patients are likely to receive resmetirom. Earlier fibrosis patients are more likely to receive semaglutide. A multimorbid F3 patient might receive both. 

    Roger asks how things might change with tirzepatide, since it is a dual agonist with strong MASH-lowering effects. Naim expresses doubt that tirzepatide will be antifibrotic, since neither GLP-1 nor GIP have direct liver effects. He has more faith in the glucagon dual- and triple-incretin agonists. 

    The rest of the conversation involves Roger stating themes he has heard earlier and asking for confirmation or amendment. It moves pretty fast, covers a lot of territory, and receives some agreement and some correction.

    • 11 min

Customer Reviews

3.8 out of 5
21 Ratings

21 Ratings

Absolutely fav bible app! ,

Insightful and diverse perspectives

I find this podcast easy to listen to and insightful, covering interesting topics and diverse perspectives in NASH!

Healthy live-r ,

At long last!

We have sorely needed a podcast that allows clinicians and academics to focus on major issues in NASH and NAFLD. Their recent coverage of ILC was timely and incisive. I find myself discussing the episodes with colleagues and Twitter buddies.

Ptquirks ,

Finally!

A podcast for the NASH community! So many relevant topics. There are guest speakers almost every week who contribute a new energy to each episode. Keep the good work coming

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