“Delayed access to different diagnostic tests and its impact on accurate diagnosis of HBV-related liver diseases in Burkina Faso”

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Résumé

Background: Hepatitis B virus (HBV) diagnostic tests are essential for evaluating the risk of progression to fibrosis and informing the decision for treatment eligibility. However, determining eligibility requires multiple tests, and simultaneous access to these tests can be challenging in resource-limited settings. We aimed to describe delays in completing prescribed HBV tests for treatment eligibility, and we evaluated the impact of the delayed access on the diagnostic accuracy of the newly recommended 2024 WHO APRI cutoffs for staging fibrosis. As a secondary objective, we assessed the agreement level of the 2024 WHO treatment guidelines with existing criteria.
Material and Methods: We analysed medical records of all consecutive persons living with HBV (n=630) seen at Bogodogo University Hospital Centre from 2014 to 2022. Five diagnostic tests were prescribed to determine treatment eligibility: HBV DNA, FibroScan, HBeAg, transaminases (ALT & AST), and platelet count. Individuals less than 18 years old and those with HIV or HCV coinfections were excluded. We employed Kaplan Meier survival analysis to estimate the probability of test completion over time. We subsequently ran a logistic regression model with a binary outcome variable indicating discordance in fibrosis staging between APRI and FibroScan, and the sum of the intervals between FibroScan and each of the APRI tests: AST and platelet count as the explanatory variable. We then assessed the agreement level across existing treatment criteria using Cohen’s Kappa (κ). As references for the diagnostic accuracy analyses, we used FibroScan for fibrosis staging, and the 2017 European Association for the Study of the Liver (EASL) for treatment eligibility.
Results: A total of 609 individuals were used in the analysis after applying the exclusion criteria. A substantial proportion of these individuals were able to complete the three essential tests required for treatment eligibility: 95.1% for ALT, 87.5% for HBV DNA, and 85.9% for FibroScan. Among those with a first visit in Bogodogo hospital (n=162), the median test completion time was 1 day (IQR:0-24 days) for ALT, 22 days (IQR:4 - 659 days) for FibroScan and 40 days (IQR:7-352 days) HBV DNA. Test completion continued to increase between 1 year to 3 years of follow up, with an increase ranging from 4.8% to 22.2% for the different tests. A testing delay of 1-month to 1-year was associated with increased odds of fibrosis diagnostic misclassification using APRI compared to a 3 days interval: OR: 2.28 (95% CI: 1.06- 5.10) in the model adjusted for age, sex and family history of cirrhosis. Concordance with EASL 2017 was low for the 2024 WHO treatment guidelines (κ = 0.36), but was substantial for alternative treatment eligibility criteria based on accessible tests such as TREAT-B (κ = 0.66) and HEPSANET (κ = 0.67).
Conclusion: These findings highlight that the vast majority will eventually receive the required tests for treatment eligibility despite experiencing long delays. These diagnostic delays have a negative impact on the diagnostic accuracy of APRI to stage fibrosis. FibroScan and HBV DNA should continue to be prioritized as first-line tests for assessing treatment eligibility in urban settings. In settings where they are unavailable, treatment decisions can rely on criteria developed for resource-limited settings, TREAT B and HEPSANET that showed better concordance compared to the 2024 WHO guidelines.

Mots-clés

Hepatite B, Delais, scores de traitement, Burkina Faso