Hepatology Month in Review: June 2025

June brought notable momentum across the field of hepatology, with key regulatory approvals, emerging data from clinical trials, and new insights into modifiable liver disease risk factors.

The US Food and Drug Administration (FDA)’s label expansion for glecaprevir/pibrentasvir (Mavyret) marked the first approval of a direct-acting antiviral for acute hepatitis C virus (HCV) treatment in both adults and children, while phase 2b results for pemvidutide highlighted its dual potential in metabolic dysfunction-associated steatohepatitis (MASH) resolution and weight loss. Promising phase 1b findings for a novel hepatitis B virus (HBV) capsid assembly modulator added to the month’s pipeline activity.

Meanwhile, new population-based studies offered fresh perspective on the downstream risks of weight cycling, dietary salt intake, and the broader benefits of successful HCV therapy, reinforcing the importance of holistic risk management in liver health.

Check out this June 2025 hepatology month in review for a recap of HCPLive’s coverage of the top hepatic news and research from the past few weeks:

Regulatory, Pipeline Updates in Hepatology

FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV

On June 11, 2025, the FDA approved a label expansion for AbbVie’s glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With the decision, glecaprevir/pibrentasvir became approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.

The approval was supported by data from the phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults with acute HCV infection. Of note, the decision made glecaprevir/pibrentasvir the first and only DAA therapy approved to treat patients with acute HCV in 8 weeks with a 96% cure rate.

Pemvidutide Shows Significant MASH Effects, Weight Loss at 24 Weeks in Phase 2b IMPACT Trial

According to a June 26, 2025, announcement from Altimmune, the phase 2b IMPACT trial of pemvidutide in patients with MASH met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants and fibrosis improvement without worsening of MASH in up to 34.5% of participants in intent-to-treat analyses as well as weight loss of up to 6.2% at 24 weeks with no plateauing. Of note, the data make pemvidutide the first product candidate to demonstrate significant MASH effects and weight loss at 24 weeks.

Topline Phase 1b Data Support Once-Daily Oral ABI-4334’s Potential for Chronic HBV

On June 25, 2025, Assembly Biosciences announced positive topline efficacy, safety, and pharmacokinetic (PK) results from a phase 1b study evaluating ABI-4334, an investigational next-generation capsid assembly modulator (CAM), in patients with chronic HBV. A favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in the final 400 mg dose cohort, similar to that previously reported for the 150 mg dose cohort.

Understanding Liver Disease Risk Factors

Successful HCV Treatment with DAAs Linked to Lower Extrahepatic Manifestation Risk

Recent research suggests successful HCV treatment with direct-acting antivirals (DAAs) is associated with a reduced risk of several extrahepatic manifestations. Leveraging data from the BC Hepatitis Testers Cohort, the study found successful DAA treatment leading to sustained virologic response was linked to lower risks of chronic kidney disease, stroke, major adverse cardiac events, and neurocognitive disorders, but not type 2 diabetes, compared with no treatment.

Weight Cycling Increases Risk of MASLD, Other Cardiometabolic Diseases

Going through cycles of weight loss and subsequent regain, known as weight cycling, increases the risk of several cardiometabolic diseases compared with weight stability, according to findings from this study. Leveraging de-identified electronic health record data from > 80,000 adults treated at Vanderbilt University Medical Center, the study found that being a weight cycler significantly increased the risk of heart failure, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease (MASLD), and type 2 diabetes.

Frequently Adding Salt to Food May Increase Liver Disease Risk, Study Finds

Leveraging data for nearly 500,000 UK Biobank participants, a recent study found frequently adding salt to foods may incur a greater risk of incident MASLD, cirrhosis, and hepatocellular carcinoma. Those who self-reported more frequent use of salt were at an increased risk of developing these liver-related disorders than those who said they less frequently added salt to their food, suggesting that reducing salt/sodium intake could be a promising strategy for public health initiatives to promote liver health.