Hepatology

Big news in the field of Hepatology

In 1980, Jurgen Ludwig and his colleagues at Mayo Clinic, identified a severe type of fatty liver disease in people who did not drink signficant amounts of alcohol. The disease was more common in women, most patients were obese and suffered… pic.twitter.com/aAq2vneIov

— TheLiverDoc (@theliverdr) June 25, 2023

Phase 2 RCT | FGF21 analogue Pegozafermin treatment leads to improvement in NASH fibrosis

30 Jun, 2023 | 14:58h | UTC

Summary: In a phase 2b, multicenter, double-blind, randomized, placebo-controlled trial, the fibroblast growth factor 21 (FGF21) analogue pegozafermin was examined for its efficacy and safety in treating patients with biopsy-confirmed noncirrhotic nonalcoholic steatohepatitis (NASH). A total of 222 patients with moderate or severe fibrosis (stage F2 or F3) were assigned to receive either subcutaneous pegozafermin at varying doses or a placebo. The primary endpoints were an improvement in fibrosis and resolution of NASH without worsening of fibrosis at 24 weeks.

The results showed that a larger percentage of patients receiving pegozafermin met the criteria for fibrosis improvement and NASH resolution compared to those receiving placebo. The most significant improvements were observed in the 44-mg pegozafermin group, with 27% showing fibrosis improvement and 26% meeting NASH resolution criteria, compared to 7% and 2% in the placebo group, respectively. Adverse events were mainly gastrointestinal and included nausea and diarrhea. These findings support the progression of pegozafermin into phase 3 development.

Article: Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary on Twitter

Late breaking at #EASLCongress: In this phase 2b, placebo-controlled trial involving patients with nonalcoholic steatohepatitis, pegozafermin, a long-acting glycopegylated FGF21 analogue, reduced fibrosis at 24 weeks. Full results by @drloomba et al.: https://t.co/mfRRrV2yX2

— NEJM (@NEJM) June 24, 2023

Liver Transplantation 2023 | Status report, current and future challenges

29 Jun, 2023 | 13:50h | UTC

Liver Transplantation 2023: Status Report, Current and Future Challenges – Clinical Gastroenterology and Hepatology

RCT | Bulevirtide reduces HDV RNA and ALT levels in chronic hepatitis D patients

28 Jun, 2023 | 13:20h | UTC

Summary: This randomized phase 3 trial evaluated the efficacy of bulevirtide, an inhibitor of HDV entry into hepatocytes, in patients with chronic hepatitis D. Patients were randomized to receive either 2 mg or 10 mg of bulevirtide daily for 144 weeks, or no treatment for 48 weeks followed by 10 mg bulevirtide daily for 96 weeks. The study involved 150 patients, 49 in the 2-mg group, 50 in the 10-mg group, and 51 in the control group.

After 48 weeks of treatment, 45% and 48% of patients in the 2-mg and 10-mg groups respectively achieved the primary end point of undetectable HDV RNA level or a decrease of at least 2 log10 IU per milliliter from baseline, and normalization of ALT level. Only 2% in the control group reached the primary endpoint. ALT levels normalized in 51% and 56% of patients in the 2-mg and 10-mg groups respectively, a significant difference from the 12% normalization in the control group. Notably, loss of HBsAg did not occur by week 48 in the bulevirtide groups. No serious adverse events related to the treatment were reported, though side effects including headache, pruritus, and fatigue were more common in the bulevirtide groups.

These results demonstrate the effectiveness of bulevirtide in reducing HDV RNA and ALT levels in patients with chronic hepatitis D. However, the absence of HBsAg loss in bulevirtide groups raises questions about its long-term implications.

Article: A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary on Twitter

Presented today at #EASLCongress: In a randomized trial, 48 weeks of treatment with bulevirtide, which inhibits hepatitis D virus entry into hepatocytes, reduced HDV RNA and alanine aminotransferase levels in patients with chronic hepatitis D. https://t.co/Q8RNZFbQlQ

— NEJM (@NEJM) June 22, 2023

EASL Clinical Practice Guidelines on acute-on-chronic liver failure

27 Jun, 2023 | 14:00h | UTC

EASL Clinical Practice Guidelines on acute-on-chronic liver failure – Journal of Hepatology

Commentary on Twitter

📢NEW@EASLnews Clinical Practice Guidelines on acute-on-chronic liver failure

Available here: https://t.co/GCNg1AIX9X pic.twitter.com/aKd0DUJBkL

— Journal of Hepatology (@JHepatology) June 24, 2023

News Release: Alcohol consumption increases the risks of over 60 diseases – University of Oxford

M-A | Comparing non-invasive tests, histology for predicting non-alcoholic fatty liver outcomes

15 Jun, 2023 | 14:50h | UTC

Performance of non-invasive tests and histology for the prediction of clinical outcomes in patients with non-alcoholic fatty liver disease: an individual participant data meta-analysis – The Lancet Gastroenterology & Hepatology

M-A | Significant non-alcoholic fatty liver disease prevalence in South Asia, many non-obese affected

6 Jun, 2023 | 14:00h | UTC

Prevalence and associated factors for non-alcoholic fatty liver disease among adults in the South Asian Region: a meta-analysis – The Lancet Regional Health – Southeast Asia

AASLD-IDSA Guideline | Updated 2023 recommendations for the testing, management, and treatment of Hepatitis C virus infection

1 Jun, 2023 | 12:21h | UTC

Hepatitis C Guidance 2023 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection – Clinical Infectious Diseases

Perspective | Clinicians debate the usefulness of NAFLD name change

M-A | Percutaneous catheter drainage superior to needle aspiration for liver abscess treatment success

Clinical Trial Update | Long-term Givosiran treatment shows sustained acute hepatic porphyria symptom improvement

Review | Diagnosis and management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome

Review | Non-alcoholic fatty liver disease: pathophysiological concepts and treatment options

RCT | Bictegravir regimen noninferior to dolutegravir regimen in HIV-1, HBV co-infection treatment

Systematic Review | Dual therapy of Rifaximin and lactulose potentially reduces risk in hepatic encephalopathy

M-A | Hepatic, extra-hepatic outcomes and causes of mortality in NAFLD

RCT | Midodrine show promise as an alternative to albumin for the prevention of circulatory disturbance in paracentesis between 3 and 5 L

AHA Statement | Indications, evaluation, and outcomes for dual heart-kidney and heart-liver transplantation

EASL Guidelines on the management of liver diseases in pregnancy

AASLD Guidance | Use of TIPS, variceal embolization, and retrograde transvenous obliteration in variceal hemorrhage

Guideline | Acute liver failure

Review | Acute-on-chronic liver failure

From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

Phase 2 RCT | FGF21 analogue Pegozafermin treatment leads to improvement in NASH fibrosis

Liver Transplantation 2023 | Status report, current and future challenges

RCT | Bulevirtide reduces HDV RNA and ALT levels in chronic hepatitis D patients

EASL Clinical Practice Guidelines on acute-on-chronic liver failure

Review | Update in the treatment of the complications of cirrhosis

Podcast | Inpatient cirrhosis management

Cohort Study | Alcohol consumption and risks of more than 200 diseases in Chinese men

M-A | Comparing non-invasive tests, histology for predicting non-alcoholic fatty liver outcomes

M-A | Significant non-alcoholic fatty liver disease prevalence in South Asia, many non-obese affected

AASLD-IDSA Guideline | Updated 2023 recommendations for the testing, management, and treatment of Hepatitis C virus infection

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