Page 13 - NON-INVASIVE TESTS FOR EVALUATION OF LIVER DISEASE SEVERITY AND PROGNOSIS
P. 13
Clinical Practice Guidelines Hepatitis C
(HIV coinfection)
Comparison of performance of TE and serum biomarkers for staging Treatment-naive
liver fibrosis
Combine
Many studies have compared the performances of TE and serum Two non-invasive
biomarkers, mostly in viral hepatitis [124–126,143,196–203] but
also in NAFLD and ALD [85,165]. TE and serum biomarkers have tests:
been shown to have equivalent performance for detecting signifi- TE + serum
cant fibrosis [124–126] but TE outperforms serum biomarkers for biomarker
detecting cirrhosis [124,196,199]. However, given the lower
applicability of TE (80% vs. 95% for serum biomarkers), perfor- Discordance Concordance
mance could finally not differ for intention-to-diagnose analysis
[125]. Repeat exams and No severe fibrosis- Severe fibrosis-
search for cirrhosis cirrhosis
Recommendations
explanations No liver biopsy No liver biopsy
• TE and serum biomarkers have equivalent follow-up or antiviral antiviral treatment
performance for detecting significant fibrosis in patients Discordance
with viral hepatitis (A1) treatment screening for
Liver biopsy (if extra-hepatic varices
• TE is the most accurate non-invasive method for if results influence manifestations)
detecting cirrhosis in patients with viral hepatitis (A1) screening for HCC
management
Algorithms combining different tests (LS and/or serum biomarkers)
Fig. 1. Proposed algorithm for the use of non-invasive tests in treatment-
Since the first proposal of a strategy combining TE and naive patients with Hepatitis C with or without HIV coinfection.
FibroTestÒ to increase diagnostic accuracy in patients with hep-
atitis C [126], many algorithms combining either TE and serum Recommendations
biomarkers [125,143,198–200,202,204,205] or several serum
biomarkers [122,206–210] have been proposed, mainly in • Among the different available strategies, algorithms
patients with viral hepatitis. Although these algorithms are combining TE and serum biomarkers appear to be the
more effective in detecting significant fibrosis than individual most attractive and validated one (A2)
tests, they do not increase diagnostic accuracy for cirrhosis
[125,196,199]. However, given the important clinical implica- • In patients with viral hepatitis C, when TE and serum
tions, in terms of prognosis, monitoring and treatment decisions biomarkers results are in accordance, the diagnostic
that follow the diagnosis of cirrhosis, it seems justified to con- accuracy is increased for detecting significant
firm a diagnosis of cirrhosis by two concordant but unrelated fibrosis but not for cirrhosis. In cases of unexplained
tests. Also ultrasound and other imaging methods hold a high discordance, a liver biopsy should be performed if
specificity for the diagnosis of cirrhosis in this context, and the results would change the patient management.
may be useful as an unrelated method. Such strategy remains to be validated in patients with
hepatitis B and NAFLD (A1)
The advantage of combining two unrelated methods, such
as TE and serum biomarkers, over the combination of two Indications for non-invasive tests for staging liver disease in viral
serum biomarkers is that TE provides more direct measure- hepatitis
ment of the liver structure than biomarkers, and that there
is no relationship between the applicability of TE (success HCV including HIV-HCV
rate and interquartile range) and that of a biomarker In the clinical management of HCV patients including those coin-
[204,211]. Also, the combination of TE and serum biomark- fected with HIV, there are several specific indications where the
ers might be more effective than the combination of two clinician can use non-invasive tests to aid in disease manage-
serum biomarkers for detecting significant fibrosis (signifi- ment. Either alone or in combination these tests allow for rapid
cantly greater number of saved liver biopsies) [200,212]. staging of liver disease without the need for liver biopsy. The cur-
However, this strategy has only been validated in studies rent gold standard for utilization of non-invasive tests to stage
of patients with hepatitis C, is more costly, and could be liver disease is to combine a serum biomarker with TE. The key
hampered by the lower applicability of TE, compared with for accuracy is to have concordance between the tests, which
biomarkers. Most importantly, in case of unexplained discor- increases the diagnostic accuracy (Fig. 1). Every patient with
dance of non-invasive tests, a liver biopsy should still be chronic HCV infection should have liver disease staging at least
performed.
12 Journal of Hepatology 2015 vol. xxx j xxx–xxx
Please cite this article in press as: EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J
Hepatol (2015), http://dx.doi.org/10.1016/j.jhep.2015.04.006
(HIV coinfection)
Comparison of performance of TE and serum biomarkers for staging Treatment-naive
liver fibrosis
Combine
Many studies have compared the performances of TE and serum Two non-invasive
biomarkers, mostly in viral hepatitis [124–126,143,196–203] but
also in NAFLD and ALD [85,165]. TE and serum biomarkers have tests:
been shown to have equivalent performance for detecting signifi- TE + serum
cant fibrosis [124–126] but TE outperforms serum biomarkers for biomarker
detecting cirrhosis [124,196,199]. However, given the lower
applicability of TE (80% vs. 95% for serum biomarkers), perfor- Discordance Concordance
mance could finally not differ for intention-to-diagnose analysis
[125]. Repeat exams and No severe fibrosis- Severe fibrosis-
search for cirrhosis cirrhosis
Recommendations
explanations No liver biopsy No liver biopsy
• TE and serum biomarkers have equivalent follow-up or antiviral antiviral treatment
performance for detecting significant fibrosis in patients Discordance
with viral hepatitis (A1) treatment screening for
Liver biopsy (if extra-hepatic varices
• TE is the most accurate non-invasive method for if results influence manifestations)
detecting cirrhosis in patients with viral hepatitis (A1) screening for HCC
management
Algorithms combining different tests (LS and/or serum biomarkers)
Fig. 1. Proposed algorithm for the use of non-invasive tests in treatment-
Since the first proposal of a strategy combining TE and naive patients with Hepatitis C with or without HIV coinfection.
FibroTestÒ to increase diagnostic accuracy in patients with hep-
atitis C [126], many algorithms combining either TE and serum Recommendations
biomarkers [125,143,198–200,202,204,205] or several serum
biomarkers [122,206–210] have been proposed, mainly in • Among the different available strategies, algorithms
patients with viral hepatitis. Although these algorithms are combining TE and serum biomarkers appear to be the
more effective in detecting significant fibrosis than individual most attractive and validated one (A2)
tests, they do not increase diagnostic accuracy for cirrhosis
[125,196,199]. However, given the important clinical implica- • In patients with viral hepatitis C, when TE and serum
tions, in terms of prognosis, monitoring and treatment decisions biomarkers results are in accordance, the diagnostic
that follow the diagnosis of cirrhosis, it seems justified to con- accuracy is increased for detecting significant
firm a diagnosis of cirrhosis by two concordant but unrelated fibrosis but not for cirrhosis. In cases of unexplained
tests. Also ultrasound and other imaging methods hold a high discordance, a liver biopsy should be performed if
specificity for the diagnosis of cirrhosis in this context, and the results would change the patient management.
may be useful as an unrelated method. Such strategy remains to be validated in patients with
hepatitis B and NAFLD (A1)
The advantage of combining two unrelated methods, such
as TE and serum biomarkers, over the combination of two Indications for non-invasive tests for staging liver disease in viral
serum biomarkers is that TE provides more direct measure- hepatitis
ment of the liver structure than biomarkers, and that there
is no relationship between the applicability of TE (success HCV including HIV-HCV
rate and interquartile range) and that of a biomarker In the clinical management of HCV patients including those coin-
[204,211]. Also, the combination of TE and serum biomark- fected with HIV, there are several specific indications where the
ers might be more effective than the combination of two clinician can use non-invasive tests to aid in disease manage-
serum biomarkers for detecting significant fibrosis (signifi- ment. Either alone or in combination these tests allow for rapid
cantly greater number of saved liver biopsies) [200,212]. staging of liver disease without the need for liver biopsy. The cur-
However, this strategy has only been validated in studies rent gold standard for utilization of non-invasive tests to stage
of patients with hepatitis C, is more costly, and could be liver disease is to combine a serum biomarker with TE. The key
hampered by the lower applicability of TE, compared with for accuracy is to have concordance between the tests, which
biomarkers. Most importantly, in case of unexplained discor- increases the diagnostic accuracy (Fig. 1). Every patient with
dance of non-invasive tests, a liver biopsy should still be chronic HCV infection should have liver disease staging at least
performed.
12 Journal of Hepatology 2015 vol. xxx j xxx–xxx
Please cite this article in press as: EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J
Hepatol (2015), http://dx.doi.org/10.1016/j.jhep.2015.04.006
