5 Hepatology Headlines You Missed in August 2026

Hepatology news this month centered on regulatory developments in cholestatic and viral liver disease, along with new data on diet-driven liver fat reduction and alcohol use disorder treatment in patients with chronic liver disease.

On August 5, 2026, the US Food and Drug Administration (FDA) granted volixibat Breakthrough Therapy and Orphan Drug designations for cholestatic pruritus due to primary sclerosing cholangitis (PSC), based on phase 2b VISTAS trial results, although the agency has since recommended an additional phase 3 study before Mirum Pharmaceuticals submits a new drug application (NDA). Separately, the FDA accepted an NDA for lonafarnib in chronic hepatitis D (CHD) on August 11, 2026, backed primarily by phase 3 D-LIVR trial data, positioning the oral agent as a potential first-in-class option for a condition with no currently approved oral therapy in the United States.

On the diet and metabolic front, a randomized trial published August 27, 2026, in Cell Metabolism found that a ketogenic diet reduced liver fat and improved glycemic control more than Mediterranean or plant-forward diets, even after matched weight loss.

In an interview with HCPLive, Mandana Khalili, MD, of UCSF and Zuckerberg San Francisco General Hospital, discussed findings from a randomized trial showing that patients' baseline motivation and confidence predicted their success in reducing alcohol use as part of a telehealth-delivered stepped alcohol treatment model for chronic liver disease.

Regulatory Updates

FDA Grants Volixibat Breakthrough Therapy, Orphan Designations for PSC

The FDA granted volixibat, an investigational ileal bile acid transporter inhibitor, Breakthrough Therapy and Orphan Drug designations on August 5, 2026, for cholestatic pruritus due to PSC, an area without any disease-specific symptomatic therapies. The designations were based on topline results from the phase 2b VISTAS trial, in which volixibat produced a statistically significant, placebo-adjusted improvement in itch severity along with reduced serum bile acids. At a subsequent pre-NDA meeting, the FDA recommended that Mirum Pharmaceuticals conduct an additional phase 3 study before submission, pushing a potential NDA filing to the first half of 2027.

Lonafarnib NDA Enters FDA Review for Chronic Hepatitis D

The FDA accepted EIT Pharma's NDA for lonafarnib as a treatment for chronic hepatitis D on August 11, 2026, supported primarily by the phase 3 D-LIVR trial, which enrolled more than 400 patients across 21 countries. Lonafarnib, an oral agent designed to interfere with the hepatitis D virus life cycle, previously received FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations. No FDA action date, advisory committee plans, or proposed regimen have been disclosed.

Trial Data

Ketogenic Diet Offers Liver Benefits Beyond Weight Loss Alone

A randomized trial published August 27, 2026, in Cell Metabolism compared ketogenic, Mediterranean, and very-low-fat plant-forward diets in 55 adults with obesity, prediabetes, and hepatic steatosis. After matched weight loss of roughly 10% across all three groups, the ketogenic diet produced a 67% reduction in intrahepatic triglyceride content, compared with 45% in the other two groups, along with greater improvements in hepatic insulin sensitivity and glycemic measures. Half of participants in the ketogenic group had remission of prediabetes, versus 29% in the Mediterranean group and 7% in the plant-forward group.

Expert Perspective

Baseline Motivation Predicts Alcohol Reduction in Chronic Liver Disease

Mandana Khalili, MD, of UCSF and Zuckerberg San Francisco General Hospital, discussed findings from a randomized controlled trial of a telehealth-delivered stepped alcohol treatment (SAT) model in patients with chronic liver disease and unhealthy alcohol use. Higher baseline confidence predicted a 43% increase in the odds of achieving less-than-moderate alcohol use, while higher baseline importance predicted a 40% increase in the odds of 30-day abstinence at 6 months. Khalili noted that motivational interviewing can be taught to hepatologists, making the model potentially replicable even in clinics without dedicated behavioral health staff.