Notable research presented at the European Association for the Study of the Liver (EASL) annual meeting included studies that showed a sustained response to bulevirtide among patients with difficult-to-treat chronic hepatitis delta virus, the association between liver cirrhosis and higher risk of stroke, and an increase in lifestyle improvements after early liver disease detection. Below are a few more highlights from this year’s EASL meeting.
Bepirovirsen Promising for Hepatitis B
Bepirovirsen, an investigational antisense oligonucleotide, led to sustained virologic response and a sustained decrease in hepatitis B virus (HBV) DNA, without the need for rescue medication, in patients with chronic HBV, according to interim results of the randomized phase IIb B-Clear study.
Among 457 patients, 28% of those taking nucleoside analogues and 29% of those not taking nucleoside analogues who received bepirovirsen 300 mg achieved undetectable levels of hepatitis B surface antigen (HBsAg) and HBV DNA levels at 24 weeks, reported Man-Fung Yuen, MD, PhD, of the University of Hong Kong.
“The reduction in hepatitis B surface antigen and HBV DNA to below the lower limit of quantification has the potential to be clinically meaningful and lead to functional cure,” Yuen said.
By the end of treatment, 68% of those on nucleoside analogues and 65% of those not on nucleoside analogues had HBsAg levels <100 IU/mL. Better virologic response occurred in those with low baseline HBsAg.
Serious treatment-related adverse events occurred in <1% of patients on nucleoside analogues and 1% of those not on nucleoside analogues.
Resmetirom Safe in NAFLD/NASH
Resmetirom, a selective thyroid hormone receptor-beta agonist, was safe and well tolerated among patients with nonalcoholic fatty liver disease (NAFLD) and presumed nonalcoholic steatohepatitis (NASH), the phase III randomized MAESTRO-NAFLD-1 trial found.
At 52 weeks, only mild to moderate adverse events had occurred in over 1,100 patients receiving resmetirom 80 or 100 mg once daily, reported Stephen Harrison, MD, of Pinnacle Clinical Research in San Antonio, Texas.
In a modified intent-to-treat analysis of 943 patients, both doses of resmetirom led to significant reductions in all key secondary outcomes — liver fat assessed by MRI-proton density fat fraction, controlled attenuation parameter, and atherogenic lipids (LDL-cholesterol, apolipoprotein B, and triglycerides).
In this study, 1,143 patients were randomized to receive either resmetirom 80 mg, resmetirom 100 mg, or placebo, while 171 patients received 100 mg of open-label resmetirom, across over 80 sites.
Rates of serious treatment-emergent adverse events were similar across the treatment groups: 6.1% with 80-mg resmetirom, 7.4% with 100 mg, and 6.3% with placebo.
“As the first phase III study in NASH that does not rely on liver biopsy to identify patients and measure treatment response, MAESTRO-NAFLD-1 will help accelerate the role of non-invasive imaging and biomarkers in NASH drug development,” Harrison noted.
Low-Carb, High-Fat Diet Shows Benefits in NAFLD and Type 2 Diabetes
The low-carbohydrate, high-fat (LCHF) diet improved glycemic control and reduced disease progression among NAFLD patients with type 2 diabetes, according to the open-label randomized REDUCTION trial.
Those who followed the LCHF diet compared with a low-fat diet had a significantly greater reduction in HbA1c levels (-9.5 vs -3.4 mmol/mol) and an improvement in the NAFLD activity score (NAS) at 6 months (70% vs 49%, P=0.028), reported Camilla Dalby Hansen, a PhD fellow at Odense University Hospital in Denmark.
In this single-center trial, 165 patients (mean age 56 years, 58% women) were randomized 2:1 to a calorie-unrestricted LCHF diet or a low-fat diet. “We told participants, ‘please do not lose any weight, eat until you’re full,'” Hansen said.
Patients on the LCHF diet also experienced more unintended weight loss (-5.8% vs -1.8%) and a non-significant change in NAS by at least 2 points (22% vs 17%, P=0.587).
Disclosures
Funding for the B-Clear study was provided by GSK.
Yuen reported relationships with Assembly Biosciences, Bristol Myers Squibb, Arrowhead Pharmaceuticals, Gilead, Merck Sharp and Dohme, Fujirebio Incorporation, Sysmex Corporation and Roche, Spring Bank Pharmaceuticals, Arbutus Biopharma, Immunocore, AbbVie, Antios Therapeutics, Dicerna, Clear B Therapeutics, Janssen, Finch Therapeutics, ALIGOS, Silverback, Fishawack Health, and Vir Biotechnology.
Co-authors reported multiple relationships with industry.
Harrison and co-authors reported no conflicts of interest.
Hansen and co-authors reported relationships with Novo Nordisk Fonden, the Danish Diabetes Academy, A.P. Moller Fonden, University of Southern Denmark, Flash, and the region of Southern Denmark.
Source: MedicalNewsToday.com
