Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

September was a busy month for pulmonology, with the 

 accepting a wide range of treatments and the European Respiratory Society 2026 Congress highlighting a series of major trial readouts. As we close in on the end of the year, catch up on any major headlines you may have missed with the 

FDA Updates Sotatercept Label with HYPERION Data in Early PAH


On September 22, the FDA approved a label update for sotatercept-csrk for 

. The new label includes efficacy and safety data from the phase 3 HYPERION trial, which demonstrated sotatercept’s efficacy in reducing the risk of clinical worsening events compared to placebo. While the activin signaling inhibitor already carries approval for adults with PAH to improve exercise capacity and reduce clinical worsening events, the HYPERION trial specifically targeted patients earlier in their disease course, leading to the label update.


FDA Grants Priority Review for Insmed's ARIKAYCE sNDA for MAC Lung Disease


On September 21, 2026, the FDA officially granted priority review to the supplemental New Drug Application for amikacin liposome inhalation suspension to treat mycobacterium avium complex lung disease. Announced by parent company Insmed, the decision comes in response to positive data from the ENCORE trial, which demonstrated earlier, greater, and more durable culture conversion with amikacin liposome inhalation suspension versus placebo. The FDA has issued an expected PDUFA date of January 28, 2027.


FDA Accepts Nebulized Treprostinil sNDA for Idiopathic Pulmonary Fibrosis


On September 3, 2026, the FDA accepted a supplemental New Drug Application for nebulized Treprostinil Inhalation Solution to treat idiopathic pulmonary fibrosis (IPF). The submission was based on positive data from the phase 3 TETON-1 and TETON-2 trials, which demonstrated the drug’s efficacy in improving absolute forced vital capacity. The FDA’s review is expected to be complete in late April 2027.


Semaglutide Cuts Asthma Attacks by up to 40% in Real-World Study


A real-world analysis of UK electronic health records has indicated semaglutide’s association with a ≤40% reduction in 

chronic obstructive pulmonary disease (COPD)

 flare-ups compared to sulfonylureas. While prior research has indicated that GLP-1s have possible anti-inflammatory effects that may improve lung-related outcomes, the present analysis more directly addresses semaglutide’s efficacy in reducing airway exacerbations.


Tozorakimab Cuts COPD Exacerbations Across Eosinophil Levels: Frank Sciurba, MD


Full phase 3 results from the replicate OBERON and TITANIA trials have demonstrated tozorakimab’s efficacy in reducing COPD exacerbations irrespective of blood eosinophil count or smoking status. The anti-interleukin-33 monoclonal antibody, dosed every 4 weeks, successfully reduced moderate and severe exacerbations by 29% in OBERON and 34% in TITANIA among former smokers, leading the FDA to accept tozorakimab’s Biologics License Application. A PDUFA date is anticipated in the first quarter of 2027.


Verekitug's TSLP Mechanism and VALIANT Trial Results, With Michael Wechsler, MD


Upstream Bio’s investigational monoclonal antibody verekitug, developed to target the thymic stromal lymphopoietin (TSLP) receptor, met its primary endpoint of reducing annualized asthma exacerbation rates in the phase 2 VALIANT trial. In a Q&A with the 

 editorial team, Michael Wechsler, MD, MMSc, professor of medicine and director of the Cohen Family Asthma Institute at National Jewish Health, discusses the drug’s mechanism and the trial’s key safety and efficacy findings.


Oral STAT6 Degraders Fill Niche in Asthma Care, With Michael Wechsler, MD


In a presentation at the European Respiratory Society Congress 2026, Michael Wechsler, MD, MMSc, discussed the potential of oral STAT6 degraders as unique, distinct additions to the asthma pipeline. In particular, Wechsler highlighted KT-621, Kymera Therapeutics’ investigational STAT6 degrader, and its effects in patients with comorbid asthma in the phase 1b BroADen trial.


What 2 Seasons of Arexvy Data Reveal About RSV-Related Risk Reduction

Real-world data from 2 respiratory syncytial virus (RSV) seasons have indicated that adjuvanted RSVPreF3 vaccination (Arexvy) effectively reduces the risk of RSV-related cardiovascular events, severe COPD exacerbations, and severe asthma exacerbations in adults ≥60 years. Presented at the European Respiratory Society Congress 2026 by Ann Falsey, MD, professor of medicine at the University of Rochester School of Medicine, these data may help inform recommendations for revaccination timing in the future.

Articles

Regulatory momentum in pulmonology included an FDA label update for sotatercept in PAH incorporating phase 3 HYPERION data in earlier-stage disease, plus FDA actions on amikacin liposome inhalation suspension for MAC lung disease and nebulized treprostinil for IPF. Clinically, real-world evidence linked semaglutide to fewer asthma attacks and COPD flare-ups. Phase 3 data supported tozorakimab for COPD exacerbation reduction independent of eosinophils and smoking status, while phase 2 results advanced verekitug targeting TSLP signaling in asthma. ERS 2026 highlighted emerging oral STAT6 degraders and Arexvy effectiveness across two RSV seasons.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 30 days.

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FDA News

8 Pulmonology Headlines You Missed in September 2026

There have been no approved therapies for 

 in more than 80 years, and only about 50% to 55% of patients adequately respond to antimalarials, the foundation of current systemic therapy. Litifilimab is a subcutaneous monoclonal antibody binding blood dendritic cell antigen 2 on plasmacytoid dendritic cells, reducing type I interferon and other proinflammatory cytokines implicated in CLE. The earlier phase 2 LILAC Part B trial met its primary endpoint, showing a significant dose response in CLASI activity at week 16.¹

AMETHYST Part A, a phase 2 portion of an operationally seamless phase 2/3 study, randomized 93 participants with active CLE refractory or intolerant to antimalarials to subcutaneous litifilimab or placebo every 4 weeks. Fifty-nine participants received litifilimab and 34 received placebo, with baseline CLASI-A scores well balanced between groups. The primary endpoint was CLA-IGA-R erythema score of 0 to 1, or clear to almost clear, at week 16.²

Among participants who started litifilimab during the double-blind period, response rates continued improving from week 24 through week 52: CLA-IGA-R erythema 0-1 rose from 19.0% to 27.2%, CLASI-70 from 21.7% to 28.8%, and CLASI-50 from 40.8% to 46.0%. Participants who switched from placebo to litifilimab at week 24 began responding within about 4 weeks, reaching week 52 response rates of 33.7% for CLA-IGA-R erythema 0-1 and 48.5% for CLASI-50.

Adverse events in the extended treatment period were similar between groups, at 76.8% for participants who started litifilimab early and 78.1% for later starters, with all but 2 events mild or moderate. Serious adverse events occurred in 3.6% and 3.1% of these groups, respectively, and no serious viral infections were observed through week 52.

Victoria Werth, MD, professor of dermatology and medicine at the University of Pennsylvania and a co-author on the AMETHYST Part A abstract, spoke with 

European Academy of Dermatology and Venereology

 (EADV) 2026 Congress held in Vienna from September 30-October 3. In the following interview, Werth discusses what the 52-week data add to the case for litifilimab in refractory CLE.

: Where does therapy stand today for patients who do not respond to antimalarials, and what gap was AMETHYST built to address?

This is an amazingly exciting time. There have been no approved therapies for over 80 years in cutaneous lupus, and we're really on the cusp of changing the way we practice. Antimalarials are the foundation of systemic therapy, but patients only respond maybe 50 to 55 percent of the time, and some patients are intolerant of them or experience side effects. There is unresolved disease activity that often persists, especially with discoid lupus, along with dyspigmentation and scarring that can be very disfiguring for patients. In LILAC Part B, which was published in the New England Journal of Medicine in 2022, the trial met its primary endpoint, showing a significant dose response and percent change in CLASI activity from baseline to week 16. CLASI is an outcome measure that's been validated and is now accepted as a primary outcome for cutaneous lupus, and that really allowed this trial to go forward. We were very excited about the results of the phase 2 trial.

HCPLive: What did the 24-week AMETHYST Part A data show, and what does the 52-week readout add?

These results were reported at the American Academy of Dermatology meeting in 2026. The primary endpoint was CLA-IGA-R erythema score of 0 to 1, meaning clear or almost clear, at week 16. At that time point, about 14.7% of patients who got litifilimab had a statistically significant improvement versus only 2.9% with placebo. The CLASI-50 response separated from placebo as early as week 4, at 19.3% versus 5.5%, which was exciting to see this early, since it suggests a therapy that can respond quickly. At week 24, CLASI-50 was 40.8% versus 21% with placebo, CLASI-70 was 21.7% versus 5.8% with placebo, and CLASI 0 to 3, or minimal residual activity, was 16.3% versus 0% with placebo.

HCPLive: Why does durability specifically matter for patients with refractory cutaneous lupus, beyond the drug itself?

In Part A, the patients enrolled were refractory or intolerant to antimalarial therapy. That's a population with very few remaining systemic options, other than immunosuppressives or other medicines that can have potential side effects, and there's ongoing risk of dyspigmentation and scarring while you're trying to find a therapy that controls the unresolved disease activity.

HCPLive: After week 24, every participant is on active drug. How should clinicians interpret continued improvement through week 52?

 The point of this type of open-label long-term extension is really to see whether the drug maintains efficacy and to evaluate safety better. Placebo-assigned participants crossed over to open-label litifilimab starting at week 24, and from that point, week 52 comparisons are largely within-group, the change from week 24 for the people who only started the drug at that point, rather than placebo-controlled. This design lets investigators assess durability and continued improvement in the original litifilimab arm, and separately, whether the late-starting patients begin to catch up.

HCPLive: In your own practice, how would a validated CLASI threshold change how you counsel patients on treatment response?

CLASI activity is increasingly used as a trial outcome measure in CLE. A defined minimal clinically important difference gives clinicians and patients a shared benchmark beyond raw score changes.

HCPLive: What did the additional 28 weeks of safety exposure show, and does it support chronic use?

 Adverse events (AEs) were carefully recorded through week 24. 74.6% of patients on litifilimab had some kind of AE, not necessarily attributed to the drug, versus 64.7% with placebo, so there wasn't really a difference between placebo and drug, and most of these were mild to moderate in severity. Serious AEs were seen in 6.8% with litifilimab and 2.9% with placebo. The sponsor characterized the overall safety profile through the 24-week readout as generally well tolerated and consistent with prior studies.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Werth’s disclosures include

Xoma, RPS, Janssen/Centocor, Biogen-Idec, Sanofi-Aventis, UVC, Novartis, Idera, Pfizer, Lupus Foundation of America, Medimmune, Rigel, Merck, Genentech, GSK Stiefel and Celgene.

Werth VP, Furie RA, Romero-Diaz J, et al. Trial of anti-BDCA2 antibody litifilimab for cutaneous lupus erythematosus. N Engl J Med. 2022;387(4):321-331. doi:10.1056/NEJMoa2118024

Merola JF, Werth V, Chong B, et al. Efficacy and safety of litifilimab in cutaneous lupus erythematosus (CLE): 52-week results of the Phase 2 study, AMETHYST Part A. Presented at: EADV Congress 2026; September 30-October 3, 2026; Vienna, Austria. Abstract AS-1846.

Litifilimab, an anti-BDCA2 subcutaneous monoclonal antibody targeting plasmacytoid dendritic cells to downregulate type I interferon signaling, is being advanced to address major unmet need in CLE refractory or intolerant to antimalarials. In AMETHYST Part A (n=93), early efficacy separated from placebo by week 4 on CLASI-50 and met the week-16 CLA-IGA-R erythema 0–1 endpoint. Open-label extension data through week 52 suggest continued response maturation and acceptable longer-term tolerability without serious viral infections.

Werth discusses what the 52-week AMETHYST Part A data add to the case for litifilimab in antimalarial-refractory cutaneous lupus erythematosus.

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AMETHYST: Litifilimab Sustains CLE Gains at 52 Weeks, With Victoria Werth, MD

The third quarter of 2026 was a busy one for cardiology, with several monumental approvals from the 

 and a handful of major conferences. Key trial readouts on everything from 

 were presented at the European Society of Cardiology in Germany and the American Society for Preventive Cardiology in Arizona, while the FDA provided for great strides in the management of 

With so much major news announced over the last 3 months, the 

 team has collected some of the most impactful headlines to help you catch up on anything you may have missed. As we enter the fourth and final quarter of this eventful year, stay up to date with our Q3 recap:


FDA Approves Enlicitide for LDL-C Lowering in Adults With Hypercholesterolemia


On July 16, the FDA approved enlicitide, a once-daily oral PCSK9 inhibitor, for the reduction of LDL-C in patients with hypercholesterolemia. The decision was based on 2 major phase 3 trials, CORALreef Lipids and CORALreef HeFH, which demonstrated enlicitide’s superiority to placebo in cholesterol reduction in both hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH). However, enlicitide’s cardiovascular outcomes are still uncertain – ongoing trials, namely CORALreef Outcomes, will determine its effects on morbidity and mortality.


Tirzepatide Gets FDA Approval to Cut Cardiovascular Risk in Type 2 Diabetes


On August 28, the FDA approved tirzepatide for cardiovascular disease risk in patients with type 2 diabetes, based on the SURPASS-CVOT trial. Parent company Eli Lilly positioned this trial as a higher evidentiary bar, comparing tirzepatide to dulaglutide, which holds an established cardiovascular indication. Tirzepatide ultimately displayed noninferiority for a composite of cardiovascular death, heart attack, or stroke, allowing the FDA to provide clinicians with a new option for managing these events in this population with increased risk.


FDA Approves Mavacamten for Pediatric Patients With Obstructive HCM


On September 30, just before the end of the quarter, the FDA approved mavacamten’s updated label to include pediatric patients with obstructive HCM. The decision, based on positive data from the phase 3 SCOUT-HCM trial, positions the cardiac myosin inhibitor as the first direct therapy for this underserved patient population, which represents a substantial unmet need.


SHASTA-3/4: What an 80% Triglyceride Cut Means, With Christie Ballantyne, MD


Presented at ESC 2026, the SHASTA-3 and -4 trials demonstrated plozasiran’s capacity for triglyceride reductions in patients with severe hypertriglyceridemia. Christie Ballantyne, MD, of the Baylor College of Medicine, discussed the implications of these data in an interview with 

, highlighting the average 80% triglyceride reduction in the SHASTA program and the promising number needed to treat findings.


Aficamten Safe, Efficacious in nHCM, Improves Symptoms and Exercise Capacity


Another presentation from EASD 2026, this one by Ahmad Masri, MD, MS, cardiomyopathy section head at Oregon Health & Science University and director of the OHSU hypertrophic cardiomyopathy center, the ACACIA-HCM trial demonstrated aficamten’s efficacy in improving symptom burden and exercise capacity in patients with non-obstructive HCM. Additionally, investigators saw improvements in New York Heart Association functional class and NT-proBNP.


VESALIUS-CV: Evolocumab Prevents Cardiovascular Disease in High-Risk Diabetes


Presented at the American Society for Preventive Cardiology (ASPC) 2026 Congress by Marc Bonaca, MD, MPH, executive director at CPC Clinical Research and a cardiologist with Brigham and Women’s Hospital, the VESALIUS-CV trial ultimately confirmed the efficacy of evolocumab in preventing cardiovascular disease in patients with type 2 diabetes. After roughly 4.6 years of follow-up, patients ultimately saw significant reductions in coronary heart disease, ischemic stroke, myocardial infarction, or ischemia-driven arterial revascularization.


Q&A: Cutlip on the SELUTION SLR DEB’s FDA Approval for Coronary In-Stent Restenosis


On September 21, the FDA approved the SELUTION Sustained Limus Release (SLR) Drug-Eluting Balloon (DEB) for coronary in-stent restenosis. The 

 team spoke with Donald Cutlip, MD, to discuss the process by which the balloon achieved its approval and the gaps in care that it will fill for patients with in-stent restenosis.


Moving the Needle in Medicine: Innovation, Leadership, and the Future of Heart Failure, With Philip Adamson, MD, MSc


In this episode of Moving the Needle in Medicine, host Alex Hajduczok, MD, sits down with Philip Adamson, MD, MSc, chief medical officer of CVRx, to explore the mentors, experiences, and decisions that shaped his cardiovascular career. Adamson discusses his perspective on the transformation of HF care over the past 40 years, turning the spotlight on advancements in treatment and prediction of the disease.


Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

, Ann Marie Navar, MD, PhD, associate professor of medicine in the Division of Cardiology at UT Southwestern Medical Center, discussed the FDA’s groundbreaking approval of enlicitide for LDL-C lowering in hypercholesterolemia. She discussed the results of CORALreef Lipids and CORALreef HeFH, how clinicians can circumvent similar barriers to those that injectable PCSK9 inhibitors encountered on their first rollout, and the ongoing CORALreef Outcomes trial investigating the cardiovascular impact of enlicitide.

Q3 2026 featured multiple FDA actions and late-breaking cardiology data spanning dyslipidemia, diabetes-related risk reduction, and hypertrophic cardiomyopathy. Enlicitide, a once-daily oral PCSK9 inhibitor, gained approval for LDL-C lowering with outcomes data pending from CORALreef Outcomes. Tirzepatide received a cardiovascular risk indication in type 2 diabetes after demonstrating noninferiority versus dulaglutide in SURPASS-CVOT. Mavacamten expanded into pediatric obstructive HCM. Trial updates highlighted profound triglyceride lowering with plozasiran, efficacy of aficamten in non-obstructive HCM, and evolocumab benefit in high-risk diabetes.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.

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9 Cardiology Headlines You Missed in Q3 2026

Mike Hess, MPH, RRT, RPFT, senior director of advocacy and regulatory affairs at the COPD Foundation.

 on October 2, 2026, Mike Hess, MPH, RRT, RPFT, senior director of advocacy and regulatory affairs at the COPD Foundation, told 

pulmonologists can help close persistent gaps in supplemental oxygen therapy access, education, and stigma.¹

The COPD Foundation observes World Oxygen Day each year on October 2, or “O-2 Day,” as part of its Oxygen 360 initiative, which Hess leads.¹ Supplemental oxygen is among the most commonly prescribed therapies in pulmonology, yet patients continue to report problems with equipment, delivery, and training.² Hess, a registered respiratory therapist and former chronic disease coordinator at WMed Health in Kalamazoo, Michigan, framed the observance as a way to bring these barriers to the attention of clinicians, patients, and the public.

"There's still a lot of misconceptions about it,” he said. “There's a lot of misunderstanding about it, both in the patient community and in the general public, about how best to use it and what it means. World Oxygen Day is intended to try and cut through some of that.”

Why Oxygen Stigma Persists, With Mike Hess, MPH

Oxygen Therapy Stigma and Patient Phenotypes in Pulmonology

Hess said patients frequently interpret a new oxygen prescription as a sign of approaching end of life or as a mandate to stay home and conserve energy. He said pulmonologists may underestimate how widespread this belief is among their patients, creating an education gap at the point of prescribing.

"It's very important to encourage people to continue to live their best life, as we say," said Hess. "Stay as active as possible, as engaged as possible."

Hess also cautioned against a 1-size-fits-all approach to oxygen delivery. Patients with pulmonary fibrosis often have different oxygenation needs than patients with COPD, and patients with pulmonary hypertension tend to be younger and more often female, with some managing oxygen therapy alongside raising families.

SOAR Act and Medicare Barriers to Supplemental Oxygen Access

The Supplemental Oxygen Access Reform (SOAR) Act, reintroduced in April 2025 as H.R. 2902 and S. 1406, has the backing of roughly 3 dozen patient and professional advocacy organizations, according to Hess.³ Hess said 30 to 40 years of Medicare reimbursement cuts have made liquid oxygen virtually inaccessible for patients outside the Veterans Affairs system.

Training represents a second gap. In an American Thoracic Society Nursing Assembly survey of 1926 supplemental oxygen users, most respondents received instruction on their equipment from an oxygen delivery person rather than a health care professional.²

"It's not fair to pulmonologists who really want to help their patients adhere to their therapy [and] stay active," said Hess.

The bill would establish separate, inflation-indexed Medicare payments for liquid and nonliquid oxygen, remove oxygen from the competitive bidding program, and add a payment for respiratory therapist services such as home assessments and education.³ It would also require a standardized electronic ordering template to guard against fraud and abuse.

"Ultimately it aims to make medical oxygen therapy more patient centric, rather than just getting whatever is available,” Hess said.

Oxygen 360 Resources for Clinicians and Patients


World Oxygen Day is an annual observance led by the COPD Foundation on October 2 to raise awareness of supplemental oxygen therapy, reduce stigma, and highlight barriers to access.

What would the SOAR Act change for patients on supplemental oxygen?


The bill would set separate Medicare payments for liquid and nonliquid oxygen, remove oxygen from competitive bidding, add reimbursement for respiratory therapist services, and create a standardized electronic ordering template.

How can pulmonologists address oxygen therapy stigma?


Hess recommends framing oxygen as a tool to help patients stay active and engaged and recognizing many patients view a new prescription as a sign of end-stage disease.

Oxygen 360 serves as the umbrella for the foundation's oxygen initiatives, including World Oxygen Day and 2 monthly discussion groups.¹ One group convenes innovators and stakeholders across medical oxygen globally, building on the Lancet Global Health Commission on Medical Oxygen Security, whose February 2025 report highlighted World Oxygen Day as a platform for unified advocacy.⁴ The second, Oxy Talk, gives patients and caregivers new to oxygen therapy a forum to ask clinicians and experienced users about stigma, tubing management, cooking, and showering.

The foundation has also studied "noncentrators," devices sold online without a prescription and marketed with claims Hess described as “fantastical.” He said these products appeal to patients without access to standard equipment who may not recognize the difference between an over-the-counter device and true medical equipment.

Hess said the COPD Foundation continues to seek organizational partners in medical oxygen, with webinars and social media campaigns planned for observance of World Oxygen Day.

World Oxygen Day. COPD Foundation. Accessed October 2, 2026. 

https://www.copdfoundation.org/Take-Action/Get-Involved/World-Oxygen-Day.aspx

Jacobs SS, Lindell KO, Collins EG, et al. Patient perceptions of the adequacy of supplemental oxygen therapy: results of the American Thoracic Society Nursing Assembly Oxygen Working Group Survey. 

SOAR Act of 2025, HR 2902, 119th Cong (2025). Accessed October 2, 2026. 

https://www.congress.gov/119/bills/hr2902/BILLS-119hr2902ih.pdf

Graham HR, King C, Rahman AE, et al. Reducing global inequities in medical oxygen access: the Lancet Global Health Commission on medical oxygen security. 

On World Oxygen Day, the COPD Foundation's Mike Hess outlines the stigma, training gaps, and Medicare barriers affecting patients on supplemental oxygen.

Mandana Khalili, MD, is Chief of Clinical Hepatology and Director of Clinical and Translational Research in Hepatology at San Francisco General Hospital, and directs the UCSF T32 Hepatology Training Program.

Stevan Gonzalez, MD, MS, is the Director of Liver Transplantation at Baylor Scott and White All Saints Medical Center in Fort Worth, Texas. 

Brian Lee, MD, is a hepatologist and liver transplant specialist with Keck School of Medicine of USC.

Frances Lee, MD, is an assistant professor of medicine in the division of liver diseases at Mount Sinai.

US drinking is falling for the first time since the COVID-19 pandemic, but heavy drinking is still rising among adults aged 50 to 64.¹ Hepatologists say 

 may be slow to follow the decline, particularly for that age group, women, and other populations already at higher risk.

"The patient in front of you is more likely to be a woman or someone in their 50s than a decade ago, more likely to have metabolic comorbidity, and more likely to present with cirrhosis rather than steatosis as the first diagnosis," Brian P. Lee, MD, MAS, a hepatologist and liver transplant specialist with Keck Medicine of USC, told HCPLive.

, and hit women, young adults, and American Indian and Alaska Native people hardest. Even with the recent dip, both drinking and alcohol-related cirrhosis deaths remain above 2018 levels.¹˒²

For Liver Awareness Month, HCPLive asked 4 liver disease experts where ALD is headed and what clinicians can do now, from asking every patient about alcohol to catching liver disease before cirrhosis and treating 

Will Alcohol-Associated Liver Disease Continue to Rise?

"I'd expect it to keep climbing," Brian Lee said when asked whether the burden of ALD will peak within the next 5 years. "Three things point that way. The lag between drinking and cirrhosis means the pandemic-era increase hasn't finished working through the population. The group still drinking more is the group in the window for disease. And metabolic risk is rising in the same patients, which raises the harm per drink even where drinking is flat."

Frances Lee, MD, assistant professor of medicine (liver diseases) at the Icahn School of Medicine at Mount Sinai and director of the Alcohol-Associated Liver Disease Program, described the combination of metabolic factors and alcohol as acting "like adding fuel to the fire."

Modeling supports the lag. A 2022 study projected that a single year of increased drinking during the pandemic would lead to 8,000 additional ALD-related deaths from 2020 to 2040, with only about 100 of them expected by 2023.³

Brian Lee said he is particularly concerned about adults aged 50 to 64, whose 

heavy drinking rose >36% from 2018 to 2024

"This is the group in which the combination of exposure and timing is most concerning," he said. "Fibrosis accumulates over decades, so a 55-year-old who increased their drinking in 2020 is often adding to damage that's already there rather than starting from a healthy liver. This is also the decade when cirrhosis and hepatocellular carcinoma most often declare themselves, and there's less physiologic reserve to absorb an insult."

"Cirrhosis and liver cancer in adults over 50 I'd expect to rise through the end of the decade," Brian Lee said. He was more cautious about younger adults.

"If younger adults' drinking stays below 2018 levels, I'd expect those acute presentations to ease sooner than the cirrhosis burden in older patients," he said. "That's a hypothesis rather than something this study can show, and doesn't account for co-factors of alcohol-associated liver disease that are changing in prevalence independent of alcohol consumption."

"Whether the overall burden peaks in five years or ten depends mostly on whether the 50 to 64 trend reverses, and there is no indication of that yet in the data," he said.

Some of the observed rise may also reflect better detection. Asked whether the increase among younger adults and women reflects more disease or better recognition, Frances Lee said it is likely both.

"I believe that both can be true. The rise in ALD is likely multifactorial: increased alcohol use in our society, metabolic features/syndrome in younger and more patients, and increased detection of ALD," she told HCPLive. "More evidence is needed to inform providers in their counseling to patients."

Why Alcohol-Associated Liver Disease Is Often Diagnosed Late

Part of the challenge is that liver damage rarely announces itself.

"The liver is actually a very resilient organ that will continue doing that work every single day, without any complaints, without any symptoms," Stevan Gonzalez, MD, MS, director of liver transplantation at Baylor Scott & White All Saints Medical Center in Fort Worth, Texas, said in an 

A 2024 study at one US academic primary care network found that more than half of patients with cirrhosis or hepatocellular carcinoma had a missed or delayed chronic liver disease diagnosis, and ALD was the most common cause among them.⁴

Gonzalez said catching these patients will take more than specialists.

"What we're recognizing is that chronic liver disease in the U.S. is vastly underestimated, and it's beyond what... just a specialist can do in terms of the general population, and that's where our primary care providers and our community-based health organizations are going to play a very important role in increasing awareness, education, and screening," he said.

He added that finding liver disease earlier matters because the damage is not always permanent.

"Even if a person does have evidence of advancing or progressive liver disease, it's reversible," Gonzalez said. "So you can actually avoid cirrhosis, and the liver can actually return to an improved function."

How Clinicians Can Screen for Alcohol Use and Liver Fibrosis

"What clinicians can do is to stop relying on patients to bring alcohol use up in conversation," Brian Lee said. "Alcohol use should be asked about at every visit, like smoking, with a validated screen like the AUDIT-C, and for patients where the history is uncertain there's now a biomarker, phosphatidylethanol, that gives an objective measure of intake over the prior 4 weeks."

The 2024 American College of Gastroenterology guideline on ALD recommends brief screening tools such as the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), and identifies the Fibrosis-4 score and transient elastography as the best noninvasive tests for fibrosis.⁵

 is a common blind spot. In CDC data, most adults reported being asked about alcohol at a checkup, but only about 38% were asked about binge-level drinking.⁶

"Current definitions of metALD and ALD account for chronic consistent alcohol intake, but binge alcohol intake has also been known to be associated with worsened liver outcomes," said Frances Lee, whose research presented at Digestive Disease Week 2026 linked binge drinking frequency to advanced fibrosis. "Binge alcohol intake may increase the risk of fibrosis progression in 

"The thresholds for heavy drinking are lower than most patients and a fair number of physicians assume, so being knowledgeable about those thresholds (≥15 drinks per week or ≥5 drinks on any given day for men and ≥8 drinks per week or ≥4 drinks on any given day for women) is important," Brian Lee said. "For women, it means using the sex-specific thresholds explicitly, since a patient told '14 or fewer drinks a week' is being given the wrong number."

Frances Lee noted that much about ALD in women remains unknown. "There is still so much to learn, though, as far as other features of sex differences, such as hormone levels, menopausal status, on the progression of ALD," she said.

Federal guidance no longer offers a number. The 

2025–2030 Dietary Guidelines for Americans

 replaced the previous daily limits with advice to "consume less alcohol for better overall health."⁷

Brian Lee said physician messaging also matters.

"Many patients, and some physicians, still believe a glass of wine a day is good for the heart," he said. "That idea came from observational studies that compared drinkers with abstainers who had often quit because they were already sick, and when that bias is accounted for, the protective effect largely disappears. The current evidence is that cancer and liver risk can begin even at low alcohol levels and rise with dose, and the message coming from physicians should reflect that. A patient who hears 'moderate drinking is fine' from their doctor has no reason to cut back."

The evidence on low-level drinking remains debated. A 2023 meta-analysis found no mortality benefit for low-volume drinkers,⁸ while a 2024 National Academies review concluded that moderate drinking was associated with lower all-cause mortality but higher breast cancer risk.⁹

"Most prevention messaging is built for young people, and the data suggest young people are already responding," Brian Lee said. "The group that needs it is 50 to 64, and they're largely invisible to it. Tailored prevention for this group looks like alcohol screening built into the visits they're already having, which are for blood pressure, diabetes, and cancer screening, with a fibrosis assessment attached when drinking is at or near threshold."

Integrating Alcohol Treatment Into Hepatology Care

Screening is only the first step. A randomized trial published in 

 in June 2026 tested a telehealth stepped alcohol treatment model in 157 patients with chronic liver disease and unhealthy alcohol use at safety-net and Veterans Affairs hepatology clinics. Patients received motivational interviewing by telehealth, and those still drinking at 3 months were referred to addiction medicine.¹⁰ The trial missed its primary endpoint, but stepped care led to significantly greater reductions in drinks per week.

"One of the most important findings was that the participants receiving the step care treatment had a significantly higher reduction in the amount of average alcohol intake," Mandana Khalili, MD, professor of medicine at the University of California, San Francisco, and chief of clinical hepatology at Zuckerberg San Francisco General Hospital, said in an 

. "Even reducing alcohol consumption short of complete abstinence is meaningful clinically in this population with chronic liver disease and is also consistent with a model of harm reduction."

"Rather than thinking of alcohol treatment as something that happens only in specialty addiction services, hepatology clinics themselves can play an active role in engaging patients in this type of evidence-based care," she said.

With follow-up near 90% in a population facing medical, socioeconomic, and access barriers, Khalili said patients were willing to engage. "This lets us know that chronic liver disease patients are receptive to discussing alcohol use and engaging in treatment if it's offered in patient-centered and accessible ways," she said.

She said motivational interviewing works best when clinicians tie cutting back to what patients care about, such as sleep, mood, family, or finances. "I think helping patients connect alcohol reduction with the goals that are personally meaningful to them increases their motivation, and it's much more effective in sustaining behavioral change," she said.

AUD Medications Remain Underused in Alcohol-Associated Liver Disease

When patients do meet criteria for AUD, "we have effective medications that are prescribed far less often than they should be," Brian Lee said.

In 2024, only 2.4% of US adults with past-year AUD received medication for it.¹¹ Patients with liver disease fared worse: in one claims study, AUD medication was prescribed to 14.5% of patients without ALD but only 2.3% of those with ALD cirrhosis.¹² In a survey of liver disease providers, 71% said they had never prescribed AUD pharmacotherapy, most often citing low comfort.¹³

That gap matters. In a cohort of 9635 patients with AUD, medication for AUD was associated with lower odds of developing ALD and, among those with cirrhosis, lower odds of decompensation.¹⁴

Turning Alcohol Screening Into Earlier ALD Intervention

For now, the tools clinicians already have may matter most. A prepandemic model projected that a strong intervention to reduce high-risk drinking could prevent about 299,100 ALD deaths from 2019 to 2040.¹⁸

"It means treating a heavy drinking history the way we treat a family history of colon cancer, as an indication for evaluation rather than counseling alone," Brian Lee said.

Khalili added that a clinician's role does not end with identifying the problem. Motivation, she said, "really is something that clinicians can actively help strengthen."

Editor's note: Frances Lee does not report any relevant disclosures. Gonzalez reports relevant disclosures with Mallinckrodt Pharmaceuticals, Salix, AbbVie, Gilead, and others. Brian Lee reports consulting for Gilead Sciences, Novo Nordisk, GlaxoSmithKline, Altimmune, Bausch Health, and others. 

Khalili reports relevant disclosures with Gilead, GSK, Resolution, and Intercept.

US alcohol consumption has begun declining post-pandemic, yet heavy drinking continues rising in adults aged 50–64, positioning ALD burden to keep increasing due to exposure–disease lag and worsening metabolic comorbidity. Clinicians are encountering more women, more metabolic risk, and later-stage presentations (cirrhosis rather than steatosis). Missed or delayed diagnosis remains common in primary care, underscoring the need for routine alcohol screening and early fibrosis assessment. Integrating AUD treatment—including harm-reduction approaches, telehealth stepped care, and pharmacotherapy—remains a major unmet opportunity.

Drinking fell for the first time since COVID-19, but not for adults 50 to 64. Hepatologists explain what clinicians can do to close the gap.

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