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Catch up on the latest in hepatology, from bulevirtide’s FDA approval for hepatitis delta to expert perspectives on new and emerging therapies in PBC, PSC, and MASLD.
June was another eventful month in hepatology, with new insights into viral hepatitis, cholestatic liver diseases, and metabolic dysfunction-associated steatotic liver disease (MASLD) continuing to reshape clinical practice. From expert discussions on newly approved therapies to emerging data on disease progression and cardiometabolic risk, the month's developments highlighted the increasingly personalized approach to liver disease management.
Among the notable updates were continued conversations surrounding the historic approval of bulevirtide for chronic hepatitis delta virus infection and the evolving treatment pipeline for HDV. Regulatory momentum also continued in primary biliary cholangitis (PBC), with expert analysis of the Priority Review application for saroglitazar, while new data for the investigational ileal bile acid transporter inhibitor volixibat reinforced its potential to improve symptom burden in primary sclerosing cholangitis (PSC).
Meanwhile, MASLD remained a major focus, with new evidence supporting more comprehensive approaches to disease management. Experts highlighted evolving pharmacologic strategies, emerging biomarkers to identify patients at risk of advanced liver disease, and additional analyses suggesting resmetirom may provide cardiovascular benefits alongside its effects on MASH.
In this hepatology month in review, the editorial team of HCPLive Hepatology highlights the key clinical updates, expert perspectives, and research findings that shaped June.
In the latest episode of Liver Lineup, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by guest Tatyana Kushner, MD, to discuss HDV testing gaps, bulevirtide’s historic FDA approval, and the emerging delta hepatitis pipeline.
Following the FDA Priority Review of the new drug application (NDA) for saroglitazar in PBC, with a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026, Raj Vuppalanchi, MD, discusses the therapy’s mechanism of action and the Phase 2b/3 EPICS-III data supporting the application.
Volixibat, an investigational ileal bile acid transporter (IBAT) inhibitor, may eventually offer the first FDA-approved therapy specifically targeting cholestatic pruritus in PSC. Full results from the phase 2b VISTAS study evaluating volixibat in patients with PSC were presented at the European Association for the Study of the Liver (EASL) meeting and will eventually support a 2026 NDA.
In an interview with HCPLive, Gideon Hirschfield, FRCP, PhD, discussed the data and its implications for patient-centered care in PSC, particularly around symptom burden related to itch and fatigue.
While lifestyle intervention remains the foundation of care in MASLD, it is increasingly being recognized that the delivery may be more effective if given as a structured, prescription-like intervention, outsourcing appropriate clinical support. Zobair Younossi, MD, MPH, reviews expanding pharmacologic options for MASLD/MASH and phase 4 EXCEL trial data supporting a multidimensional approach to MASLD treatment outcomes.
The triglyceride-glucose (TYG) index, a traditional marker of insulin resistance, may be a useful tool for predicting incident end-stage liver disease in patients with MASLD without diabetes, according to data presented at the Endocrine Society (ENDO) Annual Meeting 2026 in Chicago, Illinois, by Michal Meron, MD, an endocrine fellow at the Albert Einstein College of Medicine, who discussed the findings with HCPLive.
New data from a secondary analysis of phase 3 MAESTRO-NASH trial suggest resmetirom (Rezdiffra) may reduce cardiovascular risk in patients with MASH by significantly improving multiple atherogenic lipids and lipoproteins, including LDL-C, ApoB, and Lp(a), regardless of baseline statin use. Meena Bansal, MD, breaks down the findings and explains resmetirom's potential to target liver disease and cardiometabolic risk in MASH.