Clinical trial NCT05295914: Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
Official title: Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B, TREAT-B, REACH-B, WHO criteria
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance of TREAT-B score for eligible antiviral treatment
timeFrame: at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)
measure: Performance of WHO simplified score for eligible antiviral treatment
timeFrame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
measure: Performance of REACH-B score for eligible antiviral treatment
timeFrame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Secondary outcomes:
measure: Performance of TREAT-B score for eligible antiviral treatment
timeFrame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
measure: Performance of WHO simplified score for eligible antiviral treatment
timeFrame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
measure: Performance of REACH-B score for eligible antiviral treatment
timeFrame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Watcharasak Chotiyaputta, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References: