Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
- Conditions
- Chronic Hepatitis B
- Interventions
- Diagnostic Test: TREAT-B score
- Registration Number
- NCT05295914
- Lead Sponsor
- Mahidol University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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
- Treatment experience chronic hepatitis B infection patients
- HIV co-infection
- HCV (hepatitis C) co-infection
- concomitant HCC (hepatocellular carcinoma)
- Pregnancy
- Incomplete data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with chronic hepatitis B infection TREAT-B score Patient with chronic hepatitis B infection visited at liver and internal medicine clinic, Siriraj hospital between January 2015-2020
- Primary Outcome Measures
Name Time Method Performance of REACH-B score for eligible antiviral treatment at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Performance of TREAT-B score for eligible antiviral treatment at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus) 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
Performance of WHO simplified score for eligible antiviral treatment at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
- Secondary Outcome Measures
Name Time Method Performance of TREAT-B score for eligible antiviral treatment at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Performance of WHO simplified score for eligible antiviral treatment at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Performance of REACH-B score for eligible antiviral treatment at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus) Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Trial Locations
- Locations (1)
Siriraj Hospital
🇹ðŸ‡Bangkok, Thailand