The accurate diagnosis of significant liver fibrosis in patients suffering from chronic hepatitis B (CHB) is pivotal for the initiation of antiviral treatment (AVT). A recent meta-analysis has evaluated the diagnostic capabilities of transient elastography (TE) for detecting significant liver fibrosis in AVT-naïve CHB patients, particularly those whose serum alanine transaminase (ALT) levels are within five times the upper limit of normal (ULN). This analysis holds potential implications for improving market access to non-invasive diagnostic tools in liver disease management.
Study Methodology and Data Sources
To conduct this comprehensive study, researchers scoured databases including Ovid-Medline, EMBASE, Cochrane, and KoreaMed to find studies that juxtaposed the effectiveness of TE against liver biopsy, the gold standard, in diagnosing significant liver fibrosis (≥ F2) in AVT-naïve CHB patients. The analysis utilized a hierarchical summary receiver operating characteristic curve (HSROC) and a bivariate model to evaluate the diagnostic performance of TE.
Key Findings and Diagnostic Performance
The meta-analysis incorporated data from eight studies encompassing a total of 2,003 patients. The summary sensitivity and specificity of TE in diagnosing significant liver fibrosis were 0.78 (95% confidence interval [CI], 0.66-0.86) and 0.72 (95% CI, 0.60-0.82), respectively. The HSROC for diagnosing significant liver fibrosis stood at 0.81 (95% CI, 0.72-0.86). Additionally, the optimal TE cut-off value for diagnosing significant liver fibrosis was found to be 7.7 kPa, with a sensitivity of 0.64 (95% CI, 0.50-0.76) and specificity of 0.83 (95% CI, 0.72-0.90).
The results underscore TE’s viability as a non-invasive diagnostic tool, thus potentially enhancing market access by providing a cost-effective and less intrusive alternative to liver biopsy. This could be especially beneficial in regions where healthcare resources are limited and the demand for less invasive diagnostic methods is high.
Inferences and Implications
Key Takeaways
- TE shows a strong diagnostic performance, making it a viable alternative to liver biopsy.
- The non-invasive nature of TE could enhance patient compliance and reduce healthcare costs.
- Improved diagnostic tools like TE can facilitate early detection and timely initiation of AVT in CHB patients.
- Market access for TE could be particularly transformative in regions with limited healthcare infrastructure.
The study concludes that TE demonstrates acceptable diagnostic performance for significant liver fibrosis in AVT-naïve CHB patients with ALT levels within five times the ULN. These findings could reshape the landscape of liver disease diagnostics, offering a promising non-invasive alternative that could be more accessible to a broader population.
Original Article:
Clin Mol Hepatol. 2024 Jul 23. doi: 10.3350/cmh.2024.0371. Online ahead of print.
ABSTRACT
BACKGROUND AND AIMS: Accurate diagnosis of significant liver fibrosis in patients with chronic hepatitis B (CHB) is crucial when determining whether to initiate antiviral treatment (AVT). We conduct a meta-analysis to assess the diagnostic performance of transient elastography (TE) for significant liver fibrosis in AVT-naïve CHB patients with serum alanine transaminase (ALT) levels within 5-fold the upper limit of normal (ULN).
METHODS: The Ovid-Medline, EMBASE, Cochrane, and KoreaMed databases were searched to identify studies that compared the performance of TE and liver biopsy (reference standard) when diagnosing significant liver fibrosis (≥ F2) in AVT-naïve CHB patients with ALT within 5-fold the ULN. A hierarchical summary receiver operating characteristic curve (HSROC) and bivariate model were performed to evaluate the diagnostic performance of TE in the meta-analysis.
RESULTS: Eight studies (2,003 patients) were included. The summary sensitivity and specificity for diagnosis of significant liver fibrosis were 0.78 [95% confidence interval (CI), 0.66-0.86] and 0.72 (95% CI, 0.60-0.82), respectively. The HSROC for the diagnosis of significant liver fibrosis was 0.81 (95% CI, 0.72-0.86). The optimal cut-off value of TE for diagnosis of significant liver fibrosis was 7.7 kPa with a sensitivity of 0.64 (95% CI, 0.50-0.76) and specificity of 0.83 (95% CI, 0.72-0.90).
CONCLUSIONS: Our study demonstrated that TE has an acceptable diagnostic performance for significant liver fibrosis in AVT-naïve CHB patients with ALT within 5-fold the ULN.
PMID:39043361 | DOI:10.3350/cmh.2024.0371
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