Hepatology

In a landmark decision, the FDA has granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic NASH with moderate to advanced fibrosis.

To acknowledge World Kidney Day, our latest episode of Crisis Point focuses on the stigma surrounding the use of HCV-positive donor kidneys amid the ongoing organ shortage crisis, with the perspective of a pair of experts and an HCV donor kidney recipient.

Saeed Mohammed, MD, MS, discusses maralixibat for pruritus in PFIC, describing how IBAT inhibitors have changed the way clinicians are able to treat cholestatic liver disease.

Treatment with DAA therapy at 3 years of age was associated with better health outcomes and cost savings versus deferring initiation to 6 years of age or older.

The phase 3 ENLIGHTEN program will consist of 2 phase 3 trials evaluating the safety and efficacy of pegozafermin in patients with MASH.

Curative DAA therapy did not completely normalize immune activation and inflammatory biomarkers in individuals with a history of injection drug use and HCV infection.

Although abstinence is the safest approach, patients with SLD at low risk for advanced fibrosis can safely consume < 7.4 g/day of alcohol, equivalent to half of a standard US drinking unit.

Seropositivity was associated with greater albuminuria but not peripheral artery disease in a cohort of patients ≥ 50 years of age with type 2 diabetes mellitus.

Our February 2024 month in review highlights some of our top hepatology content from the past few weeks, including pipeline updates, phase 2/3 trial data, and new research in liver diseases.

Results showed 95.8% of patients who were treated for HCV with DAA therapy and underwent renal transplantation did not experience HCV recurrence.

In the final part of our 3-part series, our panel of experts discuss what their fields and its leaders could do to make sure this lack of diversity in trials does not continue. These responses are highlighted in the following video and transcribed below.

In part 2 of our 3-part series on the impact of clinical trials lacking diversity, we are spotlighting responses to our second question, which addresses how the previously established lack of diversity in clinical trials has had a direct effect on the development and application of new therapies or devices in real-world settings.

In part 1 of our 3-part series on the impact of clinical trials lacking diversity, we are spotlighting responses to our first question, which sought to encapsulate the perspectives of our group of experts on how a historic lack of diversity in clinical trials has manifested itself in today’s care of patients from diverse backgrounds.

Results suggest a high prevalence of fatty liver in adults with chronic HCV, which was significantly associated with central obesity, elevated blood pressure, and metabolic syndrome.

Cross-sectional survey results suggest most providers are recommending HCV screening based on patient risk factors rather than universally for all patients 18-79 years of age.

Survodutide, a dual agonist from Boehringer Ingelheim and Zealand Pharma, was associated with MASH resolution without worsening fibrosis among 83% of participants in a phase 2 trial.

NAFLD, ALD, liver fibrosis and cirrhosis, and recently diagnosed viral hepatitis were all associated with a greater risk of cataract.

All patients who received an HCV+ organ achieved SVR12 and had lower rates of rejection and chronic lung allograft dysfunction compared to uninfected donor organ recipients.

Zhang discusses the consequences of stigmatizing language for substance use disorders and reasons gastroenterologists and hepatologists may be falling behind.

Results from the phase 3 trial showed seladelpar elicited biochemical response, normalized alkaline phosphatase, and reduced pruritus at a greater rate than placebo.

Retreatment with voxilaprevir/velpatasvir/sofosbuvir in patients with HCV and prior DAA failure is effective but may be impacted by hepatocellular carcinoma, cirrhosis, and genotype 3.

Stigmatizing language was found on 88% of transplant center websites and was most prevalent when discussing alcohol-associated hepatitis and cirrhosis.

The review explored the global epidemiology of HCV in patients on dialysis, providing novel estimations of its prevalence and case fatality rate in this patient population.

The investigational antisense oligonucleotide’s designation is based on data from the phase 2b trials B-Clear and B-Sure.

HealthFLD, a fully automated AI software for liver attenuation analysis from CT scans, has received FDA 510(k) clearance for use in the general population.

The analysis of several oral antidiabetic drugs revealed patients taking SGLT2 inhibitors had more NAFLD regression and fewer adverse liver-related outcomes.

Findings suggest the risk of hepatocellular carcinoma may persist in patients with HCV, even after achieving SVR with direct-acting antiviral therapy.

HCV seroprevalence and antigen positivity were both low, suggesting universal birth cohort screening may not be necessary or cost-effective.

Stephen Harrison, MD, provides insight into the use of resmetirom for NASH with fibrosis ahead of the thyroid hormone receptor-β selective agonist’s March 14 PDUFA date.

Stephen Harrison, MD, discusses results from the phase 3 MAESTRO-NASH trial, highlighting resmetirom’s safety and efficacy for NASH resolution and fibrosis improvement.