Comparison of non-invasive assessment to diagnose liver fibrosis in chronic hepatitis B and C patients

Stibbe, Krista J. M.; Verveer, Claudia; Francke, Jan; Hansen, Bettina E.; Zondervan, Pieter E.; Kuipers, Ernst J.; Knegt, Robert J. de; Vuuren, Anneke J. van

doi:10.3109/00365521.2011.574725

Cited by 51 publications

(37 citation statements)

References 41 publications

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“…Studies that were judged as low risk of bias or unknown in the three most important QUADAS domains, namely patient selection, index test and reference standard, were still a modest fraction of the total number of studies (29 out of 152; 19%). 72,73,79,80,86,91,92,106,110,133,135,143,148,165,167,173,[197][198][199]201,203,[206][207][208]211,214,215,221,222 We explored potential sources of heterogeneity as outlined in the methods section. As all but five studies were of low methodological quality, 86,127,143,186,222 this potential source of heterogeneity could not be assessed.…”

Section: Results: Hepatitis C Virusmentioning

confidence: 99%

Cost-effectiveness of non-invasive methods for assessment and monitoring of liver fibrosis and cirrhosis in patients with chronic liver disease: systematic review and economic evaluation

Crossan

Tsochatzis

Longworth

et al. 2015

Health Technology Assessment

147

190

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BackgroundLiver biopsy is the reference standard for diagnosing the extent of fibrosis in chronic liver disease; however, it is invasive, with the potential for serious complications. Alternatives to biopsy include non-invasive liver tests (NILTs); however, the cost-effectiveness of these needs to be established.ObjectiveTo assess the diagnostic accuracy and cost-effectiveness of NILTs in patients with chronic liver disease.Data sourcesWe searched various databases from 1998 to April 2012, recent conference proceedings and reference lists.MethodsWe included studies that assessed the diagnostic accuracy of NILTs using liver biopsy as the reference standard. Diagnostic studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Meta-analysis was conducted using the bivariate random-effects model with correlation between sensitivity and specificity (whenever possible). Decision models were used to evaluate the cost-effectiveness of the NILTs. Expected costs were estimated using a NHS perspective and health outcomes were measured as quality-adjusted life-years (QALYs). Markov models were developed to estimate long-term costs and QALYs following testing, and antiviral treatment where indicated, for chronic hepatitis B (HBV) and chronic hepatitis C (HCV). NILTs were compared with each other, sequential testing strategies, biopsy and strategies including no testing. For alcoholic liver disease (ALD), we assessed the cost-effectiveness of NILTs in the context of potentially increasing abstinence from alcohol. Owing to a lack of data and treatments specifically for fibrosis in patients with non-alcoholic fatty liver disease (NAFLD), the analysis was limited to an incremental cost per correct diagnosis. An analysis of NILTs to identify patients with cirrhosis for increased monitoring was also conducted.ResultsGiven a cost-effectiveness threshold of £20,000 per QALY, treating everyone with HCV without prior testing was cost-effective with an incremental cost-effectiveness ratio (ICER) of £9204. This was robust in most sensitivity analyses but sensitive to the extent of treatment benefit for patients with mild fibrosis. For HBV [hepatitis B e antigen (HBeAg)-negative)] this strategy had an ICER of £28,137, which was cost-effective only if the upper bound of the standard UK cost-effectiveness threshold range (£30,000) is acceptable. For HBeAg-positive disease, two NILTs applied sequentially (hyaluronic acid and magnetic resonance elastography) were cost-effective at a £20,000 threshold (ICER: £19,612); however, the results were highly uncertain, with several test strategies having similar expected outcomes and costs. For patients with ALD, liver biopsy was the cost-effective strategy, with an ICER of £822.LimitationsA substantial number of tests had only one study from which diagnostic accuracy was derived; therefore, there is a high risk of bias. Most NILTs did not have validated cut-offs for diagnosis of specific fibrosis stages. The findings of the ALD model were dependent on assuptions about abstinence rates assumptions and the modelling approach for NAFLD was hindered by the lack of evidence on clinically effective treatments.ConclusionsTreating everyone without NILTs is cost-effective for patients with HCV, but only for HBeAg-negative if the higher cost-effectiveness threshold is appropriate. For HBeAg-positive, two NILTs applied sequentially were cost-effective but highly uncertain. Further evidence for treatment effectiveness is required for ALD and NAFLD.Study registrationThis study is registered as PROSPERO CRD42011001561.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Results: Hepatitis C Virusmentioning

confidence: 99%

Cost-effectiveness of non-invasive methods for assessment and monitoring of liver fibrosis and cirrhosis in patients with chronic liver disease: systematic review and economic evaluation

Crossan

Tsochatzis

Longworth

et al. 2015

Health Technology Assessment

147

190

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“…A number of studies have explored the feasibility of using non-invasive tests to predict cirrhosis. These include the Fibroscan and FibroTest-ActiTest, galactose and methacetin breath tests, TE, fibrotest, cirrhosis discriminant score, AST/ALT ratio, APRI, FIB-4 and AP index (24)(25)(26)(27)(28)(29). However, certain tests are impractical to use in a clinical setting since they require expensive instrumentation or may use less common biochemical markers, including α2-macroglobulin, haptoglobin and apolipoprotein A1, or the use of specialized software for computations.…”

Section: Discussionmentioning

confidence: 99%

Serum HBsAg and HBeAg levels are associated with liver pathological stages in the immune clearance phase of hepatitis B virus chronic infection

Zeng

Liu

Dong

et al. 2015

Molecular Medicine Reports

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Abstract.The association between hepatitis B surface antigen (HBsAg) and hepatitis B 'e' antigen (HBeAg) levels and liver inflammation and fibrosis in patients with chronic hepatitis B (CHB) in the immune clearance (IC) remains elusive. The aim of the present study was to investigate whether HBsAg and HBeAg levels were associated with liver inflammation and fibrosis in CHB patients during the IC phase. Kendall's rank correlation analysis and receiver operating characteristic curves were used to determine the correlation between HBsAg, HBeAg and liver pathological stages. Multivariate analysis by forward logistic regression was used to analyze significant predictors of cirrhosis. A liver pathology-predicting model (IC model), which used routinely assessed markers in combination with HBsAg and HBeAg levels, was constructed. There were significantly positive correlations between the HBsAg and HBeAg levels (γ= 0.317, P<0.001), and between the HBsAg and HBV-DNA levels (γ=0.489, P<0.001). However, there was no correlation between the HBsAg and alanine aminotransferase levels. HBsAg and HBeAg levels differed significantly at various liver pathological stages and declined progressively in advanced liver pathological stages. Multivariate logistic regression analysis showed that age, HBsAg and HBeAg levels as well as the international normalized ratio (INR) were independent predictors of liver fibrosis during the IC phase. The IC model had a specificity and sensitivity of 88.64 and 78.24%, respectively, a positive predictive value of 48.15% and negative predictive value of 96.79%. In conclusion, HBsAg and HBeAg levels were negatively and indirectly correlated with liver inflammation and fibrosis in CHB patients in the IC phase. The IC model reliably predicted the probability of liver cirrhosis.

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“…It was initially validated primarily in Caucasian populations with CHC and the results showed a good correlation with liver fibrosis stage [18], [19], [20]. However, in contrast to TE, only a few studies have been reported to date in patients with CHB [21], [22], [23], [24], [25]. In particular, the investigation focusing Asian population with CHB has been extremely scarce.…”

Section: Introductionmentioning

confidence: 99%

Prospective Validation of FibroTest in Comparison with Liver Stiffness for Predicting Liver Fibrosis in Asian Subjects with Chronic Hepatitis B

Kim

Park

et al. 2012

PLoS ONE

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Background and AimsDiagnostic values of FibroTest (FT) for hepatic fibrosis have rarely been assessed in Asian chronic hepatitis B (CHB) patients. We aimed to validate its diagnostic performances in comparison with liver stiffness (LS).MethodsFrom 2008 to 2010, 194 CHB patients who underwent liver biopsies along with FT and transient elastography were prospectively enrolled. Fibrosis stage was assessed according to the Batts and Ludwig system.ResultsTo predict significant fibrosis (F≥2), advanced fibrosis (F≥3), and cirrhosis (F = 4), areas under receiver operating characteristic curves (AUROCs) of FT were 0.903, 0.907, and 0.866, comparable to those of LS (0.873, 0.897, and 0.910, respectively). Optimized cutoffs of FT to maximize sum of sensitivity and specificity were 0.32, 0.52, and 0.68 for F≥2, F≥3, and F = 4, while those of LS were 8.8, 10.2, and 14.1 kPa, respectively. According to FT and LS cutoffs, 123 (63.4%) and 124 (63.9%) patients were correctly classified consistent with histological fibrosis (F1, F2, F3, and F4), respectively. Overall concordance between each fibrosis stage estimated by FT and LS was observed in 111 patients, where 88 were correctly classified with histological results. A combination formula adding LS to FT (LS+FT) showed similar AUROC levels (0.885, 0.905, and 0.915), while another multiplying LS by FT (LS×FT) showed the best AUROCs (0.941, 0.931, and 0.929 for F≥2, F≥3, and F4, respectively).ConclusionsFT provides good fibrosis prediction, with comparable outcomes to LS in Asian CHB patients. FT substantially reduces need for liver biopsy, especially when used in combination with LS.

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Comparison of non-invasive assessment to diagnose liver fibrosis in chronic hepatitis B and C patients

Cited by 51 publications

References 41 publications

Cost-effectiveness of non-invasive methods for assessment and monitoring of liver fibrosis and cirrhosis in patients with chronic liver disease: systematic review and economic evaluation

Cost-effectiveness of non-invasive methods for assessment and monitoring of liver fibrosis and cirrhosis in patients with chronic liver disease: systematic review and economic evaluation

Serum HBsAg and HBeAg levels are associated with liver pathological stages in the immune clearance phase of hepatitis B virus chronic infection

Prospective Validation of FibroTest in Comparison with Liver Stiffness for Predicting Liver Fibrosis in Asian Subjects with Chronic Hepatitis B

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