Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand

Study Overview
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Brief Summary
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International and national guideline for chronic hepatitis B (HBV) infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. In Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital. Recently, many of simplified scoring system (TREAT-B score, WHO (World Health Organization)-simplified score and REACH-B score) were developed for assessment of antiviral initiation. This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.

Detailed Description
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According to WHO Global health sector strategy on viral hepatitis 2016- 2021, WHO aim to global eliminate HBV infection within 2030. Main strategies for achievement are effective prevention and treatment. International and national guideline for HBV infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. Thus, HBV viral load and liver elastography are required for indication assessment. In low-to-middle income country such as Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital. Recently, many of simplified scoring system (TREAT-B score, WHO-simplified score and REACH-B score) were developed for assessment of antiviral initiation. This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.

Official Title
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Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Diagnostic Test: TREAT-B score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021 Age > 18 years Exclusion Criteria: Treatment experience chronic hepatitis B infection patients HIV co-infection HCV (hepatitis C) co-infection concomitant HCC (hepatocellular carcinoma) Pregnancy Incomplete data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with chronic hepatitis B infection<br>Patient with chronic hepatitis B infection visited at liver and internal medicine clinic, Siriraj hospital between January 2015-2020 | Diagnostic Test: TREAT-B score<br>* TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis<br>* Other names: REACH-B score;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of TREAT-B score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to EASL (European Association for the Study of the Liver) criteria Description: performance was define by sensitivity(%), specificity(%), PPV(positive predictive value)(%), NPV (negative predictive value)(%), positive LR(likelihood ratio), negative LR | at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus) | 
| Performance of WHO simplified score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR | at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) | 
| Performance of REACH-B score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR | at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of TREAT-B score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR | at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) | 
| Performance of WHO simplified score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR | at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) | 
| Performance of REACH-B score for eligible antiviral treatment | Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR | at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis B, TREAT-B, REACH-B, WHO criteria