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Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA
Published on: December 15, 2023
Treatment recommendations for chronic hepatitis B: an evaluation of current guidelines based on a natural history
Myron John Tong1, Carlos Hsien, Leeyen Hsu
1The Pfleger Liver Institute and the Division of Digestive Diseases, David Geffen School of Medicine at the University of California in Los Angeles, CA, USA. myrontong@hmri.org
Insights
Current chronic hepatitis B treatment guidelines miss many patients at high risk for liver cancer (hepatocellular carcinoma) and death. Adding albumin, platelet counts, and specific HBV mutations to guidelines could identify more at-risk patients for antiviral therapy.
Area of Science:
- Hepatology
- Virology
- Oncology
Background:
- Current guidelines for chronic hepatitis B (CHB) treatment rely on hepatitis B e antigen (HBeAg) status, HBV DNA levels, and ALT values.
- These guidelines are used in patients with chronic hepatitis or cirrhosis.
- The effectiveness of these guidelines in identifying patients who develop hepatocellular carcinoma (HCC) or die from non-HCC liver complications is unclear.
Purpose of the Study:
- To evaluate if current CHB treatment guidelines identify patients who develop HCC or die from non-HCC liver-related complications.
- To determine if adding other clinical and virological markers improves identification of at-risk patients.
Main Methods:
- A prospective study of 369 hepatitis B surface antigen (HBsAg)-positive patients was analyzed retrospectively.
- Treatment criteria from four published CHB guidelines were applied to the cohort.
- The study assessed the identification rates for antiviral therapy based on current guidelines and proposed additions.
Main Results:
- During 84 months of follow-up, 30 patients developed HCC and 37 died from non-HCC liver-related causes.
- Current guidelines identified only 20%-60% of HCC patients and 27%-70% of non-HCC death patients for antiviral therapy.
- Adding low albumin or platelet counts identified 89%-100% of non-HCC death patients and 96%-100% of HCC patients.
- Including basal core promoter and precore mutations identified 100% of HCC patients.
Conclusions:
- Current CHB treatment guidelines are insufficient for identifying patients at high risk of developing HCC or experiencing fatal liver complications.
- Incorporating serum albumin, platelet counts, and specific HBV mutations into treatment criteria significantly enhances the identification of at-risk individuals.
- Revised guidelines could improve patient outcomes by enabling earlier antiviral therapy initiation.
Unlabelled:
Current guidelines for treatment of chronic hepatitis B include hepatitis B e antigen (HBeAg) status, levels of hepatitis B virus (HBV) DNA, and serum alanine aminotransferase (ALT) values in the setting of either chronic hepatitis or cirrhosis. Based on findings from a prospective study of hepatitis B surface antigen (HBsAg)-positive patients, we determined whether these guidelines included patients who developed hepatocellular carcinoma (HCC) and who died of non-HCC liver-related complications. The criteria for treatment from four published guidelines were matched to a cohort of 369 HBsAg-positive patients enrolled in the study. During a mean follow-up of 84 months, 30 patients developed HCC and 37 died of non-HCC liver-related deaths. Using criteria for antiviral therapy as stated by the four guidelines, only 20%-60% of the patients who developed HCC, and 27%-70% of patients who died of non-HCC liver-related deaths would have been identified for antiviral therapy according to current treatment recommendations. If baseline serum albumin levels of 3.5 mg/dL or less or platelet counts of 130,000 mm(3) or less were added to criteria from the four treatment guidelines, then 89%-100% of patients who died of non-HCC liver-related complications, and 96%-100% of patients who developed HCC would have been identified for antiviral therapy. In addition, if basal core promoter T1762/A1764 mutants and precore A1896 mutants also were included, then 100% of patients who developed HCC would have been identified for treatment.
Conclusion:
This retrospective analysis showed that the current treatment guidelines for chronic hepatitis B excluded patients who developed serious liver-related complications.
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