The Call for Advanced Therapy & Devices to Treat Hepatic Fibrosis

Screening tests and devices are needed to prevent this disease and more research needs to be done to find effective treatments and diagnostic tests for this disease.

Ajay Panwar, Sr. Quality Engineering Program Manager

April 25, 2022

6 Min Read
Image courtesy of magicmine / Alamy Stock Photo


Hepatic fibrosis is a chronic, progressive disease characterized by the deposition of excess extracellular matrix (ECM) proteins in the liver. This process leads to the formation of scar tissue, which can eventually lead to cirrhosis. Hepatic fibrosis is often caused by viral hepatitis, alcohol abuse, or fatty liver disease. The exact mechanism by which liver cells are damaged and the ECM is produced is not fully understood. However, it is believed that activated stellate cells, hepatic myofibroblasts, and other cell types play a part in the development of hepatic fibrosis.


Causes of hepatic fibrosis

Hepatic fibrosis is caused by a variety of different diseases and conditions. The most prevalent viral cause of hepatic fibrosis is hepatitis, which can be either acute or chronic. Other causes include alcohol abuse, fatty liver disease, biliary obstruction, and certain medications. In some cases, the exact cause of hepatic fibrosis is unknown.


Incidence and presentation of hepatic fibrosis

According to a recent study, 8.1% of the general population was considered more likely to develop advanced liver fibrosis without any prior illnesses (García-Compeán, 2020).

The disease presents with a plethora of symptoms that can differ depending on the severity of fibrosis. These symptoms can include fatigue, weight loss, jaundice, abdominal pain, and ascites. It progresses slowly and can eventually lead to cirrhosis, which is a life-threatening condition. There is no treatment for hepatic fibrosis, and the only way to prevent it from worsening is to find and treat the source of the problem.

Hepatic fibrosis is diagnosed by a variety of methods, including liver biopsy, imaging, and serologic tests. Serological tests are used to detect the presence of enzymes that are elevated in the blood in patients with liver fibrosis (García-Compeán, 2020). Computed tomography (CT) and magnetic resonance imaging (MRI) are examples of imaging tests that can be used to evaluate the severity of fibrosis. For diagnosing hepatic fibrosis, a liver biopsy is considered the best tool.


Medical therapies available to cope with hepatic fibrosis

Current medical therapies include interferon therapy, which is used to treat chronic hepatitis C, and oral antifibrotic agents, such as pirfenidone and bosentan. Pirfenidone has been shown to be effective in the treatment of idiopathic pulmonary fibrosis and is currently being studied for the treatment of hepatic fibrosis. Bosentan is an endothelin receptor antagonist that is used to treat pulmonary arterial hypertension. It has also been shown to be effective in the treatment of hepatic fibrosis.

Unmet clinical needs

However, there is no definitive cure for hepatic fibrosis, and the only way to prevent the progression of the disease is to stop the underlying cause. This can be difficult, as in many cases the cause is unknown. This disease progresses slowly over many years and often leads to cirrhosis, which can be fatal. But this disease also has the capacity for regression. According to studies, after long-term suppression of HBV replication, up to 88% of persons with hepatitis B virus-related liver fibrosis may be cured. Similarly, after viral clearance, the formation of fibrosis associated with hepatitis C infection (HCV) can be reversed. (Sun, 2020).

This underscores the fact that there is a pressing need for new therapies to slow the progression of hepatic fibrosis or reverse it altogether. To duplicate the liver's natural function, preclinical research must be done to clarify the cellular mechanism of fibrosis regression and preventative pharmaceuticals should be studied. The aforementioned standard of care is focused on managing the symptoms of the disease and preventing complications, but there are no approved therapies that can truly make a difference for patients suffering from this debilitating disease. As there are no approved therapies that can slow the progression of hepatic fibrosis or reverse it, as of yet.

As a result, from a clinical perspective, there are many limitations to current diagnostic techniques and therapeutic options for hepatic fibrosis. The unmet needs should be met to decrease the clinical burden of disease. New therapies and medical devices that can make a difference for patients suffering from this debilitating disease are urgently needed.

There are a few potential diagnostic tests for hepatic fibrosis. Liver biopsy is currently being used, which can assess the severity of liver damage. However, this method is invasive and uncomfortable. Additionally, it is not always accurate, as it can only provide a snapshot of the liver at the time of the biopsy. Research is being done on biopsy-based predictions by using artificial intelligence to quantify the reaction to particular therapies (Friedman, 2022).

Another potential diagnostic test for hepatic fibrosis is elastography. This is a non-invasive test that uses sound waves to assess liver stiffness. This can help determine the severity of fibrosis, but it is not always accurate (Vermehren, 2012).

Studies are being conducted on new potential treatments for hepatic fibrosis, but none of them are yet proven to be effective. One promising treatment is transarterial embolization, which is a procedure that involves blockage of the arteries that supply blood to the liver (Chen, 2020). This can help to shrink the liver and reduce fibrosis. However, this procedure is still in the early stages of research and has not been proven to be effective in all cases.

Another potential treatment for hepatic fibrosis is liver transplantation. This is often the only treatment option for those with advanced liver disease. However, this procedure is very expensive and is not always covered by insurance. Additionally, there is a shortage of donor organs, which means that not all patients who need a transplant will be able to get one.



The bottom line is that there is a great need for better treatment and diagnostic options for hepatic fibrosis. This disease is debilitating and often leads to death. Primary and secondary prevention should be prioritized as there are no FDA-approved treatments or diagnostic tests. Screening tests and devices are needed to prevent this disease and more research needs to be done to find effective treatments and diagnostic tests for this disease. Only then will we be able to make a difference for the millions of people affected by hepatic fibrosis.



About the Author(s)

Ajay Panwar

Sr. Quality Engineering Program Manager, Medtronic

Ajay Panwar is a senior quality engineering program manager at Medtronic. At Medtronic, Panwar is responsible for quality assurance, design improvements, risk benefits and field safety decisions, compliance by implementing complex global regulatory changes, and product development for unmet clinical needs. His experience in the medical device engineering field spans across vascular diseases, including neurovascular, cardiovascular, and peripheral vascular. He has contributed to various technical areas such as validation, risk management, advanced product quality planning, test method validation, and supplier quality. 

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