5 Hepatology Headlines You Missed in April 2026

April brought a series of important developments in hepatology, with advances in chronic viral hepatitis, rare cholestatic liver diseases, and precision medicine continuing to shape the field. From regulatory momentum in chronic hepatitis B to emerging therapies for hepatitis D and evolving conversations around genetic testing and women’s liver health, the month underscored the growing complexity and personalization of modern hepatology care.

Among the most notable updates was the US Food and Drug Administration (FDA) granting Priority Review and Breakthrough Therapy designation to bepirovirsen for chronic hepatitis B, signaling potential progress toward achieving functional cure in a disease area with significant unmet need. Promising clinical trial data also emerged for brelovitug in chronic hepatitis D, with results from the phase 2b AZURE-1 study demonstrating robust antiviral activity across dose groups.

At the same time, the treatment landscape for rare cholestatic liver diseases continued to evolve with growing interest in ileal bile acid transporter (IBAT) inhibitors and their potential to improve symptoms and long-term outcomes. Broader discussions in hepatology also focused on the expanding role of genetic testing in cholestatic disease and the need for greater awareness of sex-specific differences in liver disease risk, progression, and care.

Here’s a look at 5 key hepatology headlines from April 2026 you may have missed:

FDA Grants Bepirovirsen Breakthrough Therapy Designation, Priority Review for Chronic Hepatitis B

On April 28, 2026, the FDA accepted for Priority Review the New Drug Application (NDA) for bepirovirsen, an investigational antisense oligonucleotide (ASO) developed by GSK in partnership with Ionis Pharmaceuticals, for the treatment of adults with chronic hepatitis B. The Agency simultaneously granted bepirovirsen Breakthrough Therapy designation and established a PDUFA target action date of October 26, 2026.

If approved, bepirovirsen would represent the first therapy to achieve clinically meaningful functional cure rates in this population, addressing a significant gap in the current treatment landscape.

AZURE-1: Brelovitug Meets Key Endpoints in Hepatitis D, With Tatyana Kushner, MD

On April 27, 2026, Mirum Pharmaceuticals announced that the primary endpoint was met in the phase 2b portion of the AZURE-1 study evaluating brelovitug, an investigational monoclonal antibody designed to bind hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus.

At week 24, treatment with brelovitug demonstrated robust antiviral activity across both dose groups. 100% of patients in the 300 mg once weekly (QW) arm and 75% of patients in the 900 mg once every 4 weeks arm achieved virologic response (≥2 log10 reduction in HDV RNA from baseline or undetectable HDV RNA [<LLOQ, TND]), as compared to 0% in the delayed treatment arm.

Optimizing Cholestatic Disease Care With IBAT Inhibitors, With Mercedes Martinez, MD

As the treatment landscape for rare cholestatic liver diseases evolves, focus is shifting beyond biochemical control to the broader burden of disease. With the emergence of IBAT inhibitors, clinicians are beginning to rethink traditional treatment approaches and their potential to improve both symptoms and long-term outcomes.

Maralixibat, an IBAT inhibitor currently approved for Alagille syndrome and progressive familial intrahepatic cholestasis, is now being explored for the treatment of cholestatic pruritus in patients aged 6 months or older with rare cholestatic liver diseases, including biliary atresia, in the phase 3 EXPAND trial.

Liver Lineup: Navigating Genetic Testing in Cholestatic Liver Disease

In this episode of Liver Lineup, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by Saul Karpen, MD, PhD, inaugural chief scientific officer for the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University and president of AASLD, and Robert Gish, MD, medical director of the Hepatitis B Foundation and the American Pacific Health Foundation, to unpack the evolving role of genetic testing in cholestatic disorders and provide practical guidance for integrating these tools into routine care.

Liver Lineup: Closing the Gap in Women’s Liver Health

In this episode of Liver Lineup, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by Meena Bansal, MD, to examine how liver disease uniquely affects women across the lifespan. While conditions like metabolic dysfunction-associated steatotic liver disease (MASLD) are often discussed in broad terms, the trio highlights how risk, progression, and outcomes can differ significantly based on sex and hormonal status.