Our Summary

This research paper discusses the developments and challenges in the field of metabolic dysfunction-associated steatohepatitis (MASH), a type of liver disease. The paper highlights that liver fibrosis, or the scarring of the liver, is a key indicator of serious liver conditions.

One of the main obstacles in developing drugs for MASH is the use of liver histology, which involves studying the microscopic structure of tissues. This process is invasive, costly, and can vary greatly depending on who is conducting the analysis. To overcome these challenges, the paper suggests that there should be more consistency in the way that these tests are read and interpreted.

The paper also suggests a new approach where non-invasive biomarkers (substances in the body that can indicate disease) could be used as a quicker way to get drugs approved for use. The authors provide an overview of how the process of using liver biopsies in MASH drug trials has changed over the years and discuss the biggest challenges associated with this method.

The paper concludes with recommendations for best practices in using liver biopsies in the development of drugs for MASH.

FAQs

  1. What challenges are associated with liver biopsy in MASH drug development?
  2. How has the liver biopsy reading process evolved within the MASH trial landscape over recent decades?
  3. What are the best practices for liver biopsy evaluation in MASH drug development?

Doctor’s Tip

A helpful tip a doctor might give a patient about liver biopsy is to follow all pre-procedure instructions carefully, including fasting before the procedure and informing the healthcare provider of any medications or supplements being taken. It is also important to discuss any concerns or questions about the procedure with the healthcare provider beforehand. After the biopsy, it is important to follow post-procedure instructions, such as avoiding heavy lifting or strenuous activities for a period of time, to ensure proper healing.

Suitable For

Patients with suspected liver diseases such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), autoimmune liver diseases, viral hepatitis, and liver fibrosis are typically recommended to undergo a liver biopsy. Liver biopsy is considered the gold standard for diagnosing and staging liver diseases, as it allows for direct visualization of liver tissue and assessment of inflammation, fibrosis, and other pathological changes. Patients with abnormal liver function tests, unexplained hepatomegaly or splenomegaly, or suspected liver tumors may also be recommended for a liver biopsy to help determine the underlying cause of their symptoms. Additionally, patients with known risk factors for liver disease, such as obesity, diabetes, and alcohol abuse, may also be candidates for a liver biopsy to assess the extent of liver damage and guide treatment decisions.

Timeline

Before liver biopsy:

  1. Patient is referred for liver biopsy by their healthcare provider after abnormal liver function tests or imaging studies.
  2. Patient may undergo blood tests and imaging studies to assess liver function and the need for the biopsy.
  3. Patient may be instructed to fast before the procedure and to stop taking certain medications.
  4. Patient may receive sedation or local anesthesia before the biopsy.
  5. Patient is positioned on their back or side, and the skin over the liver is cleaned and numbed.
  6. A needle is inserted through the skin and into the liver to collect a small tissue sample.
  7. After the biopsy, pressure is applied to the site to stop any bleeding.

After liver biopsy:

  1. Patient is monitored for a few hours after the procedure for any complications, such as bleeding or infection.
  2. Patient may experience some pain or discomfort at the biopsy site for a few days.
  3. Patient is advised to avoid heavy lifting or strenuous activity for a few days.
  4. Patient may be instructed to avoid certain medications, such as blood thinners, for a period of time.
  5. Patient will follow up with their healthcare provider to discuss the biopsy results and any further treatment or monitoring needed.

What to Ask Your Doctor

  1. What are the risks and potential complications associated with a liver biopsy procedure?
  2. How will the results of the liver biopsy impact my treatment plan for MASH?
  3. How experienced is the pathologist who will be interpreting the liver biopsy sample?
  4. Are there alternative diagnostic tests or imaging techniques that could provide similar information without the need for a liver biopsy?
  5. How long will it take to receive the results of the liver biopsy?
  6. What specific information will the liver biopsy provide about the stage of my liver disease and potential prognosis?
  7. Will I need to make any special preparations before the liver biopsy procedure?
  8. How many samples will be taken during the liver biopsy, and from which area of the liver?
  9. Will I need to stay in the hospital overnight after the liver biopsy, or can I go home the same day?
  10. Are there any restrictions on activities or medications following the liver biopsy procedure?

Reference

Authors: Harrison SA, Dubourg J. Journal: J Hepatol. 2024 Nov;81(5):886-894. doi: 10.1016/j.jhep.2024.06.008. Epub 2024 Jun 13. PMID: 38879176