Viral Liver Diseases

Biomarkers in viral liver diseases (hepatitis)

Although there are several diagnostic tools and measures of disease activity in viral liver diseases, some are invasive while others have limited predictive power. Predicting disease progression, especially in cirrhosis, has proven difficult.

Patients respond differently to viral infections, and predicting which patients will progress and when is currently impossible. There is a need for new treatments that can better control or cure viral liver disease. To achieve this, non-invasive tests (NITs) are needed to improve the screening process and the evaluation of treatment efficacy.

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The use of non-invasive biomarkers in viral liver diseases can accelerate the drug development process and enable personalized treatment options for the patients at risk of progression to cirrhosis, therefore, preventing end-stage liver disease death.

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Nordic ProteinFingerPrint Technology™ viral liver disease biomarkers

Viral liver diseases such as hepatitis are characterized by both inflammation and tissue fibrosis. The liver is rich in various collagens, proteoglycans, and matricellular proteins. These proteins are remodeled as part of liver homeostasis and regeneration. During remodeling, proteins are broken down and rebuilt as part of normal tissue repair and maintenance.

In viral liver diseases, the balance between tissue breakdown and rebuilding is disturbed, resulting in net tissue formation leading to fibrosis buildup. Nordic Bioscience’s extracellular matrix-based biomarkers for liver fibrosis can quantify this tissue turnover in the liver directly in serological samples. What we offer is an accurate liver fibrosis biomarker panel that gives insight into disease progression.

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Multimarker models for detection of fibrosis in chronic Hepatitis C patients

Nordic Bioscience biomarkers measured in serum differ in hepatitis C (HCV) and have been shown to help identify patients with high urgency of antiviral treatments (Metavir Fibrosis ≥3). Collagen formation (type III collagen; PRO-C3 (nordicPRO-C3™), type IV collagen; PRO-C4 or P4NP7S) and degradation (type I collagen; C1M, type III collagen; C3M, type IV collagen; C4M, type VI collagen; C6M) biomarkers are remodeled differently when comparing patients with early fibrosis (F0-F2), significant fibrosis (≥F2) and advanced fibrosis (≥F3).

The combination of two collagen biomarkers, PRO-C3 (nordicPRO-C3™), and C4M, together with clinical features (gender, age, BMI) in a multiple-ordered logistic regression model shows improved value for identifying patients with significant (AUC=0.80) and advanced fibrosis (AUC = 0.88), as shown on Figure 1.[1]

Figure 1. Collagen remodeling biomarkers detect fibrosis in chronic Hepatitis C[1]

Type III collagen formation associates with outcomes in Hepatitis C

Our biomarker PRO-C3 (nordicPRO-C3™) measured in serum allows us to quantify the formation of type III collagen in the liver and help predict outcomes in liver disease. In patients with hepatitis C, the levels of serum PRO-C3 (nordicPRO-C3™) are related to disease outcomes (Figure 2.) Patients with hepatitis C and higher serum levels of PRO-C3 (nordicPRO-C3™) are more likely to have a sooner outcome than patients with low PRO-C3 (nordicPRO-C3™).[2]

Figure 2. NordicPRO-C3™ is a predictor of clinical outcome[2]
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Biomarkers for pharmacodynamics and prediction of treatment response

Baseline levels of PRO-C3 (nordicPRO-C3™) serve as a predictive factor for alterations in fibrogenesis among hepatitis C patients following treatment. The percentage changes in PRO-C3 (nordicPRO-C3™), specifically, are contingent upon the initial PRO-C3 (nordicPRO-C3™) levels. This implies that patients with higher baseline PRO-C3 (nordicPRO-C3™) might exhibit varying degrees of response to treatment with farglitazar compared to those with lower baseline PRO-C3 (nordicPRO-C3™) levels. These findings highlight the importance of considering baseline PRO-C3 (nordicPRO-C3™) levels when assessing the efficacy of farglitazar treatment in individuals with hepatitis C.[3]

Baseline PRO-C3 (nordicPRO-C3™) levels are a reliable predictor of the changes observed in ISHAK score following farglitazar treatment among patients diagnosed with hepatitis C. The extent of alteration in ISHAK score during farglitazar treatment can be attributed to the initial levels of PRO-C3 (nordicPRO-C3™). Higher baseline PRO-C3 (nordicPRO-C3™) levels indicate a greater likelihood of significant modifications in ISHAK score following the administration of farglitazar for hepatitis C patients (Figure 3.)

Figure 3. NordicPRO-C3™ assesses fibrogenesis in liver fibrosis and response to treatment[3]
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About viral liver disease (hepatitis)

  • Viral liver disease is a generic term for liver damage caused by a viral infection. Hepatitis B and C are the most common viral infections that cause liver damage. Despite the different underlying viral infections, the pathogenesis of fibrosis can be divided into two phases. The acute inflammatory stage is followed by a chronic inflammatory stage with concurrent inflammatory, tissue destruction and repair processes.

  • The prevalence of Hepatitis B and Hepatitis C varies worldwide. In 2015, an estimated 2 billion people worldwide were infected with Hepatitis B, resulting in 650,000 deaths per year. An estimated 71 million people were infected with Hepatitis C in 2015.

  • Treatment of the underlying viral infection is best. Currently, several antiviral drugs (lamivudine, adefovir, entecavir, telbivudine, tenofovir, emtricitabine, standard and PEG-IFN) have shown to delay the progression of cirrhosis but rarely cure the viral infection. In most cases, therefore, lifelong treatment is required.

  • Diagnosis of hepatitis is based primarily on symptoms. Currently, diagnosis is based on the presence of a viral pathogen and blood tests to assess liver function. If blood tests indicate decreased liver function and advanced liver damage, further testing including imaging and liver biopsies may be required.

  • Biomarkers provide a non-invasive method to assess liver fibrosis and inflammation in patients with viral hepatitis. They enable early detection of disease progression, improve treatment monitoring, and support more efficient drug development.

  • Nordic Bioscience’s ECM-based biomarkers, such as PRO-C3 and C4M, can quantify liver collagen remodeling in hepatitis B and C. These biomarkers help identify patients with advanced fibrosis, monitor pharmacodynamic response, and predict clinical outcomes, optimizing trial design and patient selection.

  • Non-invasive biomarkers offer a safer, more scalable alternative to liver biopsies. They reduce patient burden, can be repeated over time, and provide consistent data for tracking liver fibrosis progression and therapeutic efficacy.

  • Yes, biomarkers like PRO-C3 can predict how patients with hepatitis C will respond to antifibrotic treatments. Baseline PRO-C3 levels are associated with changes in fibrosis scores, such as ISHAK, helping tailor treatment strategies for better outcomes.

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