HistoIndex's AI-based Digital Pathology Platform: A Validated Quantification Tool Recommended in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B in China

In the latest edition of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B [1], the digital pathology platform was recommended for use in providing an automated and quantitative analysis of the liver's morphological characteristics in unstained liver biopsies with high repeatability and accuracy.

Challenges in Treating CHB Patients

Hepatitis B has been known as a complex disease to treat, due to the challenge in distinguishing patients with an active infection. These patients require intervention as opposed to patients with an inactive infection who require only standard monitoring without treatment. For patients with an active CHB infection, the treatment decision is usually based on the increased level of alanine aminotransferase (ALT) indicating an inflammation of the liver, high HBV-DNA serum level and the presence of the Hepatitis B e-antigen. However, these levels do not determine the presence and level of fibrosis in the liver.

To prevent the progression of CHB to cirrhosis or Hepatocellular Carcinoma (HCC), it is important to identify patients whose livers are affected by advanced fibrosis prior to therapy, as the post treatment prognosis depends on the stage of fibrosis. This can only be achieved with a fibrosis assessment by performing a liver biopsy, the current gold standard in evaluating the degree of inflammation, necrosis, and fibrosis in all liver conditions.

Identifying Significant Morphological Features

Besides evaluating the severity of fibrosis and inflammation in biopsies via conventional observations, it is important to accurately assess dynamic changes in the extracellular matrix of the liver, especially the various degrees of fibrous enlargement in the liver. Having a very precise measurement of these features will help clinicians to understand the stage of fibrosis in a patient and carry out a suitable treatment management plan for their patients. Enabled by Second Harmonic Generation (SHG), HistoIndex's AI-based platform has been noted in multiple publications and studies for its ability to accurately and automatically quantify changes in liver fibrosis that are both observable and subtle, and critical for treatment evaluation and modification.

In a study in 2018, fibrosis changes were evaluated with the SHG platform CHB patients before and after 78 weeks' antiviral therapy, with results encouraging the use of this tool to assess the efficacy of new anti-fibrotic therapies in clinical trials [2]. An interesting observation from this study was the reduction in fibrous septa after treatment, which showed treatment efficacy and was analyzed with precision by the SHG platform (Figure 1). Therefore, this platform will be beneficial as an assistive tool for CHB-related diagnosis, as well as for monitoring the efficacy of antiviral therapies during CHB clinical trials. This is synonymous with the SHG platform's recommendation by China's guidelines for its value in providing an automated and quantitative analysis for the assessment of CHB.

Says Professor You Hong*, Chief Physician and Professor at the Beijing Friendship Hospital (affiliated with the Capital Medical University) and a co-author of the 2018 study, "As a clinician, we need to make practical and reasonable decisions for our patients. Including intelligent and reliable clinical tools such as the SHG platform in the guidelines will greatly enhance our diagnostic capability and personalize our treatment options in managing patients with CHB. Having utilized this platform in our studies has helped us to observe significant changes in the vital fibrosis parameters that are crucial in determining the severity of CHB and deciding the appropriate treatment route." Professor You is a Key Opinion Leader (KOL) in the Hepatology field, and her additional appointments include Deputy Director of the Chinese Society of Hepatology and Steering Committee Member of APASL.

Dr Dean Tai, Chief Scientific Officer of HistoIndex, adds, "We have substantial data from studies conducted with the involvement of KOLs that show the potential of our AI-based platform, in the area of CHB as well as Nonalcoholic Steatohepatitis (NASH). I am confident that our platform will contribute significantly if implemented in similar international clinical guidelines, as well as in consortiums and workgroups that have been set up globally for the management of CHB."

China: Bearing a Heavy Disease Burden

As one of the countries battling CHB infections, China has the highest burden in the world, with one third of the world's infected people living in China [3]. Most of them are unaware of their infection, making this disease a truly silent epidemic. With limited access to diagnosis and treatment, these people face a bleak future as their condition will eventually progress – without treatment – to cirrhosis and eventually, liver cancer. About 10 million people living with CHB will die by 2030 [4] [5], with most of these deaths being avoidable. As part of efforts to help the nation in this devastating disease, experts under the Chinese Medical Association's (CMA) Infectious Diseases and Liver Diseases Branch released the updated guidelines in 2019.