Marlyn Mayo, MD, is a professor of internal medicine at UT Southwestern Medical Center.

Elafibranor (Iqirvo) maintained improvements in markers of disease activity in patients with primary biliary cholangitis (PBC) with either early or advanced stage disease for up to 4 years, according to data from the open-label extension (OLE) of the phase 3 ELATIVE trial presented at AASLD The Liver Meeting 2026.¹ Biochemical response rates were numerically lower among patients with advanced disease, but noninvasive tests (NITs) of fibrosis remained stable in both groups.¹

Marlyn Mayo, MD, of UT Southwestern Medical Center, presented the findings and discussed the data in an interview with 

. She noted patients with advanced disease are the ones clinicians most want to help, yet they remain the least represented in clinical trials, leaving long-term subgroup analyses as an important source of evidence.

Elafibranor in PBC: 4-Year ELATIVE Data Across Disease Stages

How Did Elafibranor Perform in Early vs Advanced Stage PBC?

The present analysis included patients who completed the ELATIVE double-blind period and continued elafibranor 80 mg into the OLE (continuous patients) or switched from placebo to elafibranor (crossover patients). Disease stage was categorized as early or advanced by liver stiffness measurement (LSM; ≤10 or >10 kPa) or, among patients with a biopsy, by Nakanuma fibrosis score (<2 or ≥2). Among continuous patients, 73 had early and 35 had advanced stage disease at baseline, compared with 31 and 14 among crossover patients.¹

Patients with advanced disease had greater mean baseline alkaline phosphatase (ALP) levels (continuous patients: 351.9 [SD, 109.1] U/L vs 306.6 [SD, 125.7] U/L).¹ At Week 156, biochemical response occurred in 73.1% of continuous patients with early stage disease vs 52.4% with advanced stage disease, while ALP normalization occurred in 28.9% versus 23.8%, respectively.¹

Among crossover patients, 60.0% with early stage and 37.5% with advanced stage disease achieved biochemical response at Week 104, and 24.0% versus 25.0% achieved ALP normalization. Through Week 208, continuous patients across disease stages had reductions in ALP and alanine aminotransferase, while total bilirubin and aspartate aminotransferase remained stable.¹

According to Mayo, patients with advanced disease showed a robust response worth pursuing, even if not quite as strong as in earlier stages. She emphasized durability as the central message, given evidence patients with PBC on ursodiol can maintain a biochemical response for years before breaking through, with breakthrough tied to worse outcomes.

“You can have good biochemical response for years, and then at some point you break through... So the durability is very important,” Mayo said.

Do Fibrosis Markers Change With Long-Term Elafibranor?

In a pooled analysis of continuous and crossover patients, mean enhanced liver fibrosis (ELF) scores, LSM, and PRO-C3 values remained stable in both early and advanced stage groups through 156 weeks of elafibranor exposure.¹ Elafibranor was well tolerated across disease stages, with safety findings reported through Week 208. The authors concluded elafibranor provided a consistent treatment effect regardless of disease stage, with stabilization or improvement in disease activity markers and NITs of fibrosis.¹

Mayo described the fibrosis findings as among the most notable aspects of the poster. Earlier analyses showed little change in fibrosis markers, and investigators had attributed this to short follow-up. At 4 years, she said, downward trends in liver stiffness and other fibrosis markers are beginning to emerge, particularly among patients with advanced fibrosis at baseline.

“The patients who have the most fibrosis to start with are the ones in which you can see the improvement in fibrosis best,” Mayo said.

Mayo cautioned key questions remain unanswered, including whether elafibranor will significantly improve liver stiffness and prevent decompensation events such as variceal bleeding, ascites, encephalopathy, or the need for transplant.

Elafibranor received accelerated approval from the US Food and Drug Administration in June 2024 for PBC in combination with ursodeoxycholic acid in adults with an inadequate response, or as monotherapy in those unable to tolerate it, based on the ELATIVE trial.²

Mayo M, Kowdley K, Bowlus C, et al. Elafibranor improves markers of disease activity in primary biliary cholangitis across disease stages in patients with up to 4 years of treatment. Presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO.

Kowdley KV, Bowlus CL, Levy C, et al. Efficacy and safety of elafibranor in primary biliary cholangitis. N Engl J Med. 2024;390(9):795-805. doi:10.1056/NEJMoa2306185

Videos

Marlyn Mayo, MD, discusses 4-year ELATIVE data on elafibranor sustaining biochemical response across PBC stages, with stable fibrosis markers.

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Elafibranor Sustains Biochemical Response Across PBC Stages Through 4 Years

Ivy Anne Sebastian, MD, DM, associate professor of neurology at Christian Medical College and Hospital

Ivy Sebastian, MD, DM, a neurologist at Christian Medical College and Hospital in Ludhiana, India, said recognizing 

 on vascular imaging can shift management away from standard carotid stenosis algorithms.

 in Seoul, Republic of Korea, Sebastian addressed when to escalate beyond first-line imaging and which lesions call for a different treatment strategy.¹ She also cautioned advanced imaging is revealing more biologically active carotid lesions, not all of which carry clinical significance.

“We do not need to do advanced vessel wall imaging in every patient,” said Sebastian. “The first step would be to just do a CT [angiography] in a patient with stroke.”

Recognizing Non-Atherosclerotic Carotid Disease, With Ivy Sebastian, MD

Tiered Vascular Imaging for Suspected Non-Atherosclerotic Carotid Disease

According to Sebastian, high-quality CT angiography (CTA) or magnetic resonance angiography (MRA) is often the appropriate first imaging step in patients with stroke, suspected stroke, or transient ischemic attack (TIA). In many settings, carotid Doppler ultrasound may be the only first-line modality available. Advanced techniques, including MRI vessel wall imaging, can supplement these initial studies but are not required for every patient.

Escalation is warranted when initial imaging reveals a clinically suspicious finding, such as a high-risk, vulnerable, or unstable plaque. Sebastian said the decision should also weigh the full clinical presentation and whether additional imaging would resolve an open diagnostic question. She described a tiered approach as especially important in resource-limited settings, including her own.

Pairing careful clinical phenotyping with high-quality initial vascular imaging allows clinicians to decide which lesions merit further workup. Sebastian said that without this discipline, clinicians risk overdiagnosing biologically interesting lesions lacking clinical relevance. The downstream consequence can be exposing patients to interventions they do not need.

Intraluminal Thrombus and Dissection: When Standard Carotid Algorithms Fall Short

A high-quality CTA or MRA is the recommended first step after stroke or TIA; advanced vessel wall imaging should be reserved for clinically suspicious lesions.

Intraluminal thrombus warrants initial anticoagulation, not early revascularization, per the 2023 ESVS guidelines.

Mural hematoma, intimal flap, or concentric luminal narrowing on CTA should prompt evaluation for dissection, vasculitis, or fibromuscular dysplasia.

Sebastian identified intraluminal thrombus as a key example where a standard stenosis pathway may be inappropriate. The lesion appears as an elongated thrombus attached to the carotid wall with a free-floating tip. It is uncommon but highly thrombogenic, particularly early in its course, and patients can present with recurrent strokes or TIA-like episodes.

For a stenotic atherosclerotic lesion, revascularization is often among the first options considered. In intraluminal thrombus, the same approach carries added risk.

“Jumping in with the revascularization process in an intraluminal thrombus would actually be more dangerous because here we are at the risk of manipulating the thrombus, and it could actually further cause more embolization,” Sebastian said.

She pointed to the 2023 European Society for Vascular Surgery (ESVS) guidelines, which added a dedicated section on free-floating thrombus.

 The recommended approach begins with anticoagulation to stabilize the thrombus, with revascularization reserved for patients who continue to have recurrent symptoms despite anticoagulation.

Imaging features can also flag dissection. Sebastian said a mural hematoma or intimal flap on CTA should prompt consideration of carotid dissection, which may follow mechanical trauma or relate to an underlying inflammatory process or fibromuscular dysplasia, and is more common in younger patients.

Concentric luminal narrowing is another signal. Eccentric narrowing is the typical pattern in atherosclerotic disease, and Sebastian said a concentric pattern should push clinicians to evaluate for vasculitis or fibromuscular dysplasia.

The 2023 ESVS guidelines explicitly exclude non-atherosclerotic conditions, including fibromuscular dysplasia, dissection, and arteritis, from their scope.

 For these patients, accurate etiologic classification at the imaging stage determines which management pathway applies.

Watch part 1 of our interview with Sebastian here: 

Carotid Disease Beyond Stenosis, With Ivy Anne Sebastian, MD

Editor’s note: Sebastian has no reported disclosures.

Naylor R, Rantner B, Ancetti S, et al. European Society for Vascular Surgery (ESVS) 2023 clinical practice guidelines on the management of atherosclerotic carotid and vertebral artery disease. 

Sebastain I. Carotid Disease Beyond Stenosis, With Ivy Anne Sebastian, MD. HCPLive. Published November 5, 2026. Accessed November 6, 2026. 

https://www.hcplive.com/view/carotid-disease-stenosis-ivy-sebastian

Sebastian outlines a tiered carotid imaging strategy and the CTA findings pointing to dissection, vasculitis, or intraluminal thrombus.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Abdallah Geara, MD, is an Associate Professor of Clinical Medicine at the University of Pennsylvania.

Dr. Wadhwani asks Dr. Cheung how each available drug class targets a different point in the multi-hit pathogenesis of IgAN, and how that thinking guides where each therapy belongs. Dr. Cheung begins with drugs that reduce production of pathogenic IgA and immune complexes. Targeted-release budesonide was the first approved. It is designed to release its maximum dose in the terminal ileum, where Peyer's patches prime the B cells that make pathogenic IgA. Much of it is metabolized in the liver, limiting systemic exposure.

IgAN Pathogenesis: How Each Drug Class Targets the Multi-Hit Pathway

Next come APRIL and BAFF inhibitors, which act on B-cell maturation and class switching to IgA-producing cells, as well as the plasma cells and plasmablasts that secrete antibody. Dr. Cheung notes lots of data on this class at Kidney Week. Agents still in development include anti-CD38 therapies that target plasma cells, along with approaches that aim to degrade galactose-deficient IgA1 and IgA itself.

Complement inhibitors act mainly on glomerular inflammation, although some data suggest effects on tubulointerstitial inflammation and fibrosis. They work at different levels of the cascade. More proximal agents, including an antisense oligonucleotide in a clinical trial, contrast with terminal pathway blockers. On the other side of the algorithm are kidney-protective drugs that manage the general response to nephron loss. These include familiar agents used across chronic kidney disease and newer options that may add anti-inflammatory effects.

Dr. Wadhwani calls this a good problem to have compared with six to ten years ago, when clinicians had mainly RAS inhibitors and corticosteroids. She notes that some regions still rely on lower-dose corticosteroids, while the new armamentarium offers greater efficacy and a better safety profile.

In "2025 KDIGO Guidelines in IgAN: Treatment Selection and Overcoming Inertia," the panel will turn to the 2025 KDIGO framework and how Dr. Geara and Dr. Cheung choose among six targeted therapies.

IgAN arises through a multi-hit process, and each therapeutic class acts at a different step. Dr. Cheung maps mucosal B-cell priming, plasma cells, complement, and kidney-protective therapies onto the pathway.

Dr. Wadhwani asks Dr. Geara whether optimized supportive care can be sufficient. Dr. Geara explains that earlier guidelines treated supportive care first and added IgA-directed therapy later, but current guidelines recommend addressing both at the same time. Supportive care remains important, and its umbrella keeps growing. Still, he stresses that IgAN is an inflammatory disease, so few patients should rely on supportive care alone. Only a patient with well-documented stability over several years might qualify.

IgAN Treatment Escalation: Beyond Supportive Care and Access Barriers

Dr. Cheung agrees that most patients benefit from added targeted therapy, with supportive care continued in the background, because these classes have shown better eGFR preservation. Dr. Cheung and Dr. Wadhwani highlight residual proteinuria as a concern for both renal and cardiovascular risk. Dr. Cheung says the KDIGO targets once seemed unrealistic but now look well within reach. The approach is to start effective therapy early, monitor frequently, and switch when response is insufficient. Dr. Wadhwani adds that data shown at Kidney Week suggest even the eGFR target is achievable.

On real-world challenges, Dr. Geara describes six approved therapies in the United States but uneven access, since most require insurance approval and are expensive. He adds that proteinuria and eGFR have shortcomings for assessing activity and response, and neither tells clinicians which drug to give or for how long. Dr. Wadhwani notes that no approved agent was compared head to head, populations differed, and baseline SGLT2 inhibitor use varied. Approval does not guarantee access.

Up next, in "IgAN Pathogenesis: How Each Drug Class Targets the Multi-Hit Pathway," Dr. Cheung maps each therapeutic class onto the points in the pathway where IgAN disease activity arises.

Guidelines now call for treating the immune driver of disease and providing supportive care at the same time. The panel considers how ambitious targets have become realistic, and why access still limits what clinicians can offer.

Abigail Brooks is a strategic content lead overseeing 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Switching to a once-daily trientine tetrahydrochloride formulation (QD TETA4) improved self-reported treatment convenience and medication adherence in adults with 

, according to findings from a phase 2 decentralized switch study presented at 

Emmanuel Tsochatzis, MD, PhD, of the Royal Free Hospital and University College London, presented 2 analyses from the trial, one focused on patient interviews and one on study feasibility and patient-reported outcomes (PROs).

Suboptimal adherence to lifelong maintenance therapy is increasingly recognized in Wilson disease, and all participants entered the study on chelator, zinc, or combination regimens prescribed at least twice daily.² No Wilson disease-specific treatment satisfaction PRO exists, and the investigators aimed to capture the patient experience directly through interviews and validated questionnaires.¹

How Did Once-Daily TETA4 Affect Convenience and Adherence?

The phase 2 study enrolled adults with Wilson disease (Leipzig score ≥4) on maintenance therapy prescribed at least twice daily. Participants switched from SoC to QD TETA4 for 28 days, followed by a return to SoC for 28 days. Chelator doses converted mg-for-mg, rounded to the nearest full tablet, while zinc-treated patients converted to 600 mg (2 tablets).²

A total of 10 participants (7 male; mean age, 35.3 years [range, 21-55]) enrolled, with hepatic (n = 2), neurologic (n = 3), mixed (n = 3), and asymptomatic (n = 2) phenotypes.² Baseline SoC included trientine (n = 4), zinc (n = 3), D-penicillamine (n = 2), and combination trientine and zinc (n = 1).

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) convenience score rose from a mean of 43.1 (90% CI, 26.3-59.9) at baseline to 85.0 (90% CI, 78.4-91.6) after 28 days of QD TETA4 (P = .008), then fell to 40.7 (90% CI, 26.9-54.4) after the return to SoC. Adherence followed the same pattern, with Morisky Medication Adherence Scale (MMAS-8) scores of 4.8 (90% CI, 3.7-5.8), 7.7 (90% CI, 7.4-8.0; P = .002), and 5.0 (90% CI, 4.0-5.9) at the same timepoints. Scores below 6 indicate poor adherence, and TSQM-9 effectiveness did not change, while satisfaction improved without reaching significance.

What Did Patients With Wilson Disease Say About Once-Daily Dosing?

In semi-structured online interviews conducted by PRO development experts, treatment satisfaction with QD TETA4 was high. A total of 5 participants rated their satisfaction as “very much” and 3 as “quite a bit.”¹

Of the 80% of participants preferring QD TETA4, the most cited benefits over SoC were dosing schedule (n = 5), reduced mental load (n = 3), fewer adaptations and less planning (n = 2), and side effects (n = 2).¹ Among participants asked, 78% (7/9) rated once-daily dosing as “much less challenging” for adherence and “much less disruptive” to daily life. No participant reported a worsening treatment experience.¹

Nine adverse events, 8 mild and 1 moderate, occurred in 7 participants, and all resolved.² The investigators concluded QD TETA4 meaningfully reduced treatment burden through dosing simplification, reduced mental load, and fewer planning demands.¹

Can Decentralized Trials Work in Rare Liver Disease?

The second analysis evaluated the decentralized design itself. Six UK centers of excellence referred participants from London, Birmingham, and Leeds to a virtual clinical trial center, with a single centralized ethics committee approval. Medications were dispensed and returned through a remote pharmacy, and blood draws, investigator visits, PRO questionnaires, and interviews took place in participants’ homes.²

Paper PRO questionnaires were mailed to participants and collected by courier on 5 fixed dates. The cohort represented more than 4 ethnic groups, and all PROs were fully completed. The authors concluded the findings confirm the feasibility of a decentralized trial in rare liver disease, with nationwide enrollment, diverse phenotypes, and successful home blood collection with central laboratory analysis.²

According to the investigators, decentralized designs may reduce participant burden and improve trial efficiency and access, which are important considerations for rare disease research.² The FDA also encourages inclusion of the patient voice in medical product development.¹

Tsochatzis E, Kamlin CO, Hurt C, et al. Understanding the drivers of treatment experience and adherence in Wilson disease: what do patient interviews and reported outcomes from a phase 2 study evaluating a new trientine tetrahydrochloride formulation tell us? Presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO.

Tsochatzis E, Ala A, Holt A, et al. De-centralized clinical trials in rare disease: incorporating the patient voice in the evaluation of tolerability, treatment satisfaction and adherence of a novel trientine tetrahydrochloride formulation for the treatment of Wilson disease. Presented at: The Liver Meeting 2026; November 5-9, 2026; Denver, CO.

Articles

In a phase 2 decentralized study, once-daily trientine tetrahydrochloride improved convenience and adherence in Wilson disease; 80% preferred it.

Once-Daily Trientine Tetrahydrochloride Aids Adherence in Wilson Disease

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Type 2 biologics reduced mucus plugs in asthma trials, and quantitative imaging may help detect this treatable phenotype, according to a GOLD 2026 session.

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In adults with late-onset PFIC, odevixibat improved pruritus within 3 months in a real-world study at presented at The Liver Meeting 2026.

Real-World Odevixibat Data Show Pruritus Relief in Late-Onset PFIC

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In ZIPS-2, 20 mg daily zinc reduced all-cause infection rates by 38% vs placebo in Ugandan children with sickle cell anemia aged <5 years.

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In patients with compensated MASH cirrhosis, Baveno VII and ANTICIPATE-NASH showed moderate agreement with HVPG and underestimated CSPH prevalence.

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Noninvasive Models Underestimate CSPH in MASH Cirrhosis vs HVPG

Carla Nester, MD, discusses sustained proteinuria reduction and kidney function findings through 76 weeks of pegcetacoplan treatment.

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Alex Hajduczok, MD, is an advanced heart failure and pulmonary hypertension specialist at Oklahoma Heart Institute. 

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Moving the Needle in Medicine: Mentorship, Teams, and Heart Failure Leadership, With Robert Mentz, MD

Àlvar Agustí, MD, PhD, is a prominent pulmonologist who serves as the chair of the GOLD Board of Directors (Global Initiative for Chronic Obstructive Lung Disease) and as professor of Medicine at the University of Barcelona.

At GOLD 2026, Alvar Agustí, MD, PhD, speaks on COPD underdiagnosis and misdiagnosis, barriers to spirometry in primary care, and managing pre-COPD.

Q&A: Why 70% of COPD Goes Undiagnosed, With Alvar Agustí, MD

In the phase 2b VISTAS trial, volixibat improved sleep vs placebo in PSC with cholestatic pruritus, and itch responders saw greater fatigue and sleep gains.

Latest News

Elafibranor Sustains Biochemical Response Across PBC Stages Through 4 Years

Recognizing Non-Atherosclerotic Carotid Disease, With Ivy Sebastian, MD

IgAN Pathogenesis: How Each Drug Class Targets the Multi-Hit Pathway

IgAN Treatment Escalation: Beyond Supportive Care and Access Barriers

Once-Daily Trientine Tetrahydrochloride Aids Adherence in Wilson Disease