Liver Biopsy and Noninvasive Tests For Fibrosis
In The News
April 27
EASL: Liver Imaging Tests Vie to Replace Biopsy
April 16 2013
FDA Approves FibroScan for Noninvasive Liver Diagnosis
A painless alternative to liver biopsy for evaluating the
stage of liver fibrosis.
Feb 2013
Serum Bile Acid Levels as a Predictor for the Severity of Liver Fibrosis in Patients
With Chronic Hepatitis C
Although liver biopsy is considered the 'gold standard' for evaluating the presence and the degree of
liver fibrosis, concerns regarding its safety and the possibility of sampling
errors have led to the development of several noninvasive tools that can predict
the severity of liver fibrosis with a high degree of accuracy
Noninvasive Estimation of Fibrosis Progression Overtime Using
the FIB-4 Index in Chronic Hepatitis C
Jan 2013
The Age-Old Debate of Whether to Biopsy in HCV: My Answer for 2013
Also includes information on about Magnetic Resonance Elastography, or MRE
which is an non-invastive test for liver fibrosis.
Magnetic Resonance Elastography for Staging Liver Fibrosis in Chronic Hepatitis C
Nov 2012
Checkmate to liver biopsy in chronic hepatitis C?
Validation and comparison of simple noninvasive models for the prediction of
liver fibrosis in chronic hepatitis C
Aug 2012
Noninvasive markers of fibrosis: key concepts for improving accuracy in daily clinical practice
Andrés Duarte-Rojo, José Trinidad Altamirano, Jordan J. Feld
July 2012
National patterns and predictors of liver biopsy use for management of hepatitis C
FDA Submission for HepaFat™ Scan and update on Liver Fibrosis Test
June 2012
It’s Not Easy to Diagnose Intermediate-Stage Liver Fibrosis
Biopsy has a low level of diagnostic performance for liver fibrosis stages F2 and F1. The recommendation for biopsy
analysis, instead of non-invasive tests, for diagnosis of intermediate stages of fibrosis is therefore misleading, according to the June issue of Clinical Gastroenterology and Hepatology.
May 2012
Hepatitis B and C - Transient Elastography for Fibrosis Assessment Compared With Large Biopsies
New Tests Predict Clinical Outcomes in Chronic Hepatitis C Virus
Noninvasive Methods to Assess Liver Disease in Patients With
Hepatitis B or C
The prognosis and management of patients with
chronic viral hepatitis B and C depend on the amount and progression of liver
fibrosis and the risk for cirrhosis. Liver biopsy, traditionally considered to
be the reference standard for staging of...
Is there still a role for liver biopsy in managing hepatitis C virus
infections?
In comparison with peginterferon/ribavirin dual therapy, the telaprevir- and boceprevir-based regimens have superior
efficacy,4,10-14 but the field is moving forward quite rapidly, and we are currently learning about (1) far more potent DAA agents with better pharmacokinetic profiles, (2) interferon-sparing regiments, and (3) SVR rates approaching 100%. Thus, there is the likelihood that superior regimens will become available over the next few years. As physicians and patients with hepatitis C virus ponder their options, information obtained from liver biopsy samples may greatly assist in the decision to wait yet longer for future regimens with improved efficacy, shorter durations, and lower side-effect profiles.
Continue Reading..........
Ultrasound Dx of HCV Effective in Liver Transplant
Blood Test Instead of Biopsy Identifies Liver Damage
Siemens is marketing the first rapid, automated biomarker test for diagnosing and assessing liver fibrosis. The ELF
test (Enhanced Liver Fibrosis test) takes approximately one hour to complete and requires only a blood sample
The ELF test (Enhanced Liver Fibrosis test) takes approximately one hour to complete and requires only a blood sample. The
process is therefore less invasive but just as reliable as the previously required biopsy, and it usually takes about a week to deliver a biopsy result.
Jan 2012
How far is noninvasive assessment of liver fibrosis from replacing liver biopsy in hepatitis C?
Liver Biopsy and Noninvasive Tests For Fibrosis
There are several unapproved noninvasive tests that may be used to estimate the amount of fibrosis in the liver. These tests may replace the need for liver biopsy in some patients, although liver biopsy is still the “gold standard” for measuring the amount of liver damage. The goal today is to understand the available noninvasive tests for detecting fibrosis in HCV.
Some of the tests used today are biomarker tests or (blood tests) , one such test is better known as the (FibroTest) . These biochemical and hematological tests, such as ALT, AST, prothrombin time, platelets (APRI, AST/ALT ratio, Forns Index; those that include specific indirect markers of liver fibrosis, such as a-2 macroglobulin; those that incorporate only direct markers of liver fibrosis (MP3), or combinations of direct and indirect markers (Hepascore, Fibrometer). Sufficient evidence exists to support the view that algorithms perform well in the detection of significant fibrosis (METAVIR score F2-F4). Thus, their use in patients with chronic hepatitis C can be recommended for this purpose.
Other noninvasive tests for fibrosis are TE= transient elastography which is an (ultrasound-based scan), we know it as (FibroScan). The FibroScan is for evaluating liver fibrosis by measurement of liver stiffness
*See Below "Physical Non-invasive methods for the assessment of liver fibrosis"
_________________________________________________
Noninvasive Blood Tests (Biomarker Test)
What Are These BiomarkerTests Called?
,
FibroSure is a safe, convenient and inexpensive (about $300.00) blood test
The FibroTest is also known as the FibroSure in the US and is a biomarker test that uses six blood serum markers to create a score that correlates with the degree of liver damage in those with liver disease. It has the same prognostic value as having a liver biopsy. It has been used on patients with hepatitis C, hepatitis B, non-alcoholic fatty liver disease and alcoholic liver disease. It is used to diagnose and manage the degree of cirrhosis in patients suffering from the disease.
FibroSure requires only a small sample of blood to be drawn, which is then analyzed in six biochemical tests: Alpha 2-macroglobulin, haptoglobulin, apolipoprotein A, bilirubin, Gamma Glutamyl Transpeptidase (GGT), and alanine aminotransferase (ALT).
Gender, age, and the results of these tests are then computed to provide a score.
HCV FibroSure may be used for:
Assessment of liver status following a diagnosis of HCV
Baseline determination of liver status before initiating HCV therapy
Post-treatment assessment of liver status six months after completion of therapy
Noninvasive assessment of liver status in patients who are at increased risk of complications from a liver biopsy.
The FibroTest has a 95 percent degree of accuracy in determining the presence of fibrosis and liver disease. False positives run around 5 percent.
APRI AST: platelet ratio index (APRI),Abbreviation: (APRI), Definition: AST to platelet ratio index
APRI Score is an easy, low cost and practice alternative method which was described as an alternative for assessing structural changes in chronic hepatitis C .The APRI was designed to be a convenient marker of fibrosis because it incorporates laboratory data that are routinely obtained as the standard of care.Initial studies showed that it performed well in predicting fibrosis and cirrhosis in both a training and validation set of adults with chronic HCV infection. APRI, calculates only the AST to platelet ratio .
Fibrotest and APRI
Forns: A non-invasive method for monitoring liver disease . The Forns' score combines age, gGT, cholesterol, and platelet count.platelet count. .
Fib-4 A non-invasive method for monitoring liver disease. FIB-4 score, is based on a calculation of a person’s age, alanine transaminase (ALT) levels and the ratio of aspartate transaminase (AST) levels to platelet count.
SHASTA A non-invasive method for monitoring liver disease. The SHASTA index developed consists of serum hyaluronic acid, AST, and albumin
Fibrometer-FibroMeters are non-invasive blood tests for liver fibrosis . The score combines hyaluronate, prothrombin time, platelets, AST, a2 macroglobulin, urea, and age, and the formula is adjusted based on the cause of the liver disease. EASL 2011- FibroMeter This study, performed in several populations with C hepatitis, shows that the detailed classification in fibrosis stages of FibroMeter3G (1) is as performant as that of an expert pathologist and significantly superior to that of a first line pathologist or that of other non-invasive tests.
See the poster
CirrhoMeter is the first validated and marketed test for cirrhosis diagnosis EASL 2011-CirrhoMeter This study, performed in 1710 C hepatitis, shows that the CirrhoMeter (5) offers an excellent cirrhosis diagnosis: accuracy superior to that of Fibroscan, on an intention to diagnose basis, with a higher precision
See the poster
EASL 2011-During the last EASL meeting (Berlin), 5 communications on CirrhoMeter and FibroMeters were presented. FibroMeters / CirrhoMeter
Hepascore- Hepascore is an Australian blood test combining the following clinical and laboratory variables: age, gender, bilirubin, GGT, hyaluronic acid, alpha 2 macroglobin to create a score.
Hepascore(TM) liver fibrosis blood-serum test
http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=InfectDis/Hepatitis/TS_LiverFibrosisPnl_HepaScore.htm
Study Finds Noninvasive Blood Test For Liver Fibrosis May Alleviate Need For Liver Biopsies For Some Patients With Chronic Hepatitis C
"Hepatologists have long sought a noninvasive technique for assessing fibrosis without conducting a liver biopsy, a painful procedure that can miss cirrhosis in some patients," said Nezam H. Afdhal, M.D., study investigator and director, Hepatology, Beth Israel Deaconess Medical Center and associate professor, Medicine, Harvard Medical School.
"While Hepascore is unlikely to entirely replace liver biopsy as a staging test for liver fibrosis, one can envision an algorithm using Hepascore in the management of chronic HCV. In fact, the present study suggests that a unique Hepascore-based algorithm we developed that incorporates results of FIB-4 and APRI assessments would have spared 103 of the 391 study participants with chronic HCV the need for liver biopsy, with advanced fibrosis missed in one patient. We look forward to longitudinal studies that may prospectively assess the usefulness of Hepascore in clinical strategy for monitoring, treating and possibly alleviating the need for biopsy in a subset of chronic HCV patients."
Previous studies of Hepascore in populations in France and Australia have showed it is reliable at predicting different degrees of fibrosis in chronic HCV patients. The objective of the present study was to validate the Hepascore test in a U.S. population with chronic HCV infection, and to compare it with two indices that employ nonspecific biomarkers, aspartate aminotranaminase(AST)-platelet ratio index (APRI) and Fibrosis-4 (FIB-4).
Three hundred and ninety one patients with chronic HCV infection undergoing liver biopsy were enrolled from the Liver Center at Beth Israel Deaconess Medical Center in Boston. A reference range for a negative Hepascore was also determined from a study of 214 healthy volunteers. The diagnostic performance score for Hepascore by AUROC(1) was 0.81 for significant fibrosis, 0.83 for advanced fibrosis, and 0.88 for cirrhosis..
Read Complete Article
______________________________________________
Physical Non-invasive methods for the assessment of liver fibrosis
TE= transient elastography is an (ultrasound-based scan)
What is elastography?
Elastography, is a twist on the traditional ultrasound technique of using sound waves to create a picture of what's going on inside the body.
What Are These Noninvasive Tests Called ?
Fibroscan : The Fibroscan involves what’s known as ultrasound elastography. It uses a modified ultrasound probe to measure the velocity of a shear wave created by a vibratory source. It can predict stiffness of the liver to a 95 percent accuracy. It can be harder to assess the liver in patients who are older and in patients who are obese. The Fibroscan is the most consistently used test for evaluation of liver elasticity. Only 6 percent of people had false positives for liver disease.
Transient elastography (TE)
Transient elastography that uses ultrasound and low frequency elastic waves to measure liver elasticity has improved the ability to define the extent of fibrosis without a liver biopsy, particularly when combined with other noninvasive markers (blood tests) . However, it is not yet ready to replace the liver biopsy since it is not FDA approved, the failure rate is higher in obese patients, and there is now evidence that the transient elastography score can be unexpectedly increased in persons with acute hepatitis who have high necroinflammatory activity but no or minimal fibrosis.
Fib-4 A non-invasive method for monitoring liver disease. FIB-4 score, is based on a calculation of a person’s age, alanine transaminase (ALT) levels and the ratio of aspartate transaminase (AST) levels to platelet count.
SHASTA A non-invasive method for monitoring liver disease. The SHASTA index developed consists of serum hyaluronic acid, AST, and albumin
Fibrometer-FibroMeters are non-invasive blood tests for liver fibrosis . The score combines hyaluronate, prothrombin time, platelets, AST, a2 macroglobulin, urea, and age, and the formula is adjusted based on the cause of the liver disease. EASL 2011- FibroMeter This study, performed in several populations with C hepatitis, shows that the detailed classification in fibrosis stages of FibroMeter3G (1) is as performant as that of an expert pathologist and significantly superior to that of a first line pathologist or that of other non-invasive tests.
See the poster
CirrhoMeter is the first validated and marketed test for cirrhosis diagnosis EASL 2011-CirrhoMeter This study, performed in 1710 C hepatitis, shows that the CirrhoMeter (5) offers an excellent cirrhosis diagnosis: accuracy superior to that of Fibroscan, on an intention to diagnose basis, with a higher precision
See the poster
EASL 2011-During the last EASL meeting (Berlin), 5 communications on CirrhoMeter and FibroMeters were presented. FibroMeters / CirrhoMeter
Hepascore- Hepascore is an Australian blood test combining the following clinical and laboratory variables: age, gender, bilirubin, GGT, hyaluronic acid, alpha 2 macroglobin to create a score.
Hepascore(TM) liver fibrosis blood-serum test
http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=InfectDis/Hepatitis/TS_LiverFibrosisPnl_HepaScore.htm
Study Finds Noninvasive Blood Test For Liver Fibrosis May Alleviate Need For Liver Biopsies For Some Patients With Chronic Hepatitis C
"Hepatologists have long sought a noninvasive technique for assessing fibrosis without conducting a liver biopsy, a painful procedure that can miss cirrhosis in some patients," said Nezam H. Afdhal, M.D., study investigator and director, Hepatology, Beth Israel Deaconess Medical Center and associate professor, Medicine, Harvard Medical School.
"While Hepascore is unlikely to entirely replace liver biopsy as a staging test for liver fibrosis, one can envision an algorithm using Hepascore in the management of chronic HCV. In fact, the present study suggests that a unique Hepascore-based algorithm we developed that incorporates results of FIB-4 and APRI assessments would have spared 103 of the 391 study participants with chronic HCV the need for liver biopsy, with advanced fibrosis missed in one patient. We look forward to longitudinal studies that may prospectively assess the usefulness of Hepascore in clinical strategy for monitoring, treating and possibly alleviating the need for biopsy in a subset of chronic HCV patients."
Previous studies of Hepascore in populations in France and Australia have showed it is reliable at predicting different degrees of fibrosis in chronic HCV patients. The objective of the present study was to validate the Hepascore test in a U.S. population with chronic HCV infection, and to compare it with two indices that employ nonspecific biomarkers, aspartate aminotranaminase(AST)-platelet ratio index (APRI) and Fibrosis-4 (FIB-4).
Three hundred and ninety one patients with chronic HCV infection undergoing liver biopsy were enrolled from the Liver Center at Beth Israel Deaconess Medical Center in Boston. A reference range for a negative Hepascore was also determined from a study of 214 healthy volunteers. The diagnostic performance score for Hepascore by AUROC(1) was 0.81 for significant fibrosis, 0.83 for advanced fibrosis, and 0.88 for cirrhosis..
Read Complete Article
______________________________________________
Physical Non-invasive methods for the assessment of liver fibrosis
TE= transient elastography is an (ultrasound-based scan)
What is elastography?
Elastography, is a twist on the traditional ultrasound technique of using sound waves to create a picture of what's going on inside the body.
What Are These Noninvasive Tests Called ?
Fibroscan : The Fibroscan involves what’s known as ultrasound elastography. It uses a modified ultrasound probe to measure the velocity of a shear wave created by a vibratory source. It can predict stiffness of the liver to a 95 percent accuracy. It can be harder to assess the liver in patients who are older and in patients who are obese. The Fibroscan is the most consistently used test for evaluation of liver elasticity. Only 6 percent of people had false positives for liver disease.
Transient elastography (TE)
Transient elastography that uses ultrasound and low frequency elastic waves to measure liver elasticity has improved the ability to define the extent of fibrosis without a liver biopsy, particularly when combined with other noninvasive markers (blood tests) . However, it is not yet ready to replace the liver biopsy since it is not FDA approved, the failure rate is higher in obese patients, and there is now evidence that the transient elastography score can be unexpectedly increased in persons with acute hepatitis who have high necroinflammatory activity but no or minimal fibrosis.
Read More Here
July 2011- Is pre-treatment liver biopsy necessary for all hepatitis C genotypes?
The combination of blood tests or the combination of transient elastography and a blood test improve accuracy and reduce the necessity of using liver biopsy to resolve uncertainty
Excerpted From; 2011
EASL Clinical Practice Guidelines: Management of hepatitis C virus infection
Assessment of liver disease severity
Assessment of the severity of hepatic fibrosis is important in decision making in chronic hepatitis C treatment and prognosis. Liver biopsy is still regarded as the reference method to assess the grade of inflammation and the stage of fibrosis [22,23]. The shortcomings of biopsy have been highlighted in recent years and alternate non-invasive methods have been developed and extensively evaluated in patients with chronic HCV infection. They include serological markers and transient elastography [24,25]. Their performance,when used alone or together, has been reported to be comparable with liver biopsy [24,25]. Both non-invasive methods have been shown to accurately identify patients with mild fibrosis or cirrhosis. They are less able to discriminate moderate and severe fibrosis.[22,23].
Assessment of liver disease severity is recommended prior to therapy. Identifying patients with cirrhosis is of particular importance, as their likelihood of responding to therapy and post-treatment prognosis are altered, and surveillance for HCC is required. Assessment of the stage of fibrosis by biopsy is not required in patients with clinical evidence of cirrhosis. Since significant fibrosis may be present in patients with repeatedly normal ALT, evaluation of disease severity should be performed regardless of ALT patterns. Endoscopy to rule out esophageal varices and portal hypertension should be performed in patients with known cirrhosis.
Liver biopsy remains the reference method.
The risk of severe complications is very low (1/4000–10,000), but biopsy remains an invasive procedure. Histological features (necroinflammation = grading; fibrosis = staging) should be reported using a structured, semi-quantitative method. Various scoring systems have been validated for use in chronic hepatitis C. The most widely used in Europe are METAVIR, Scheuer, Ishak, and Knodell’s HAI [63]. Metavir and Scheuer’s scores are more reproducible and less prone to observer variation, but less discriminant both for fibrosis and for necroinflammation than Ishak and Knodell [64].
Based on the abundant literature in chronic hepatitis C, alternative, non-invasive methods can now be used instead of liver biopsy in patients with chronic hepatitis C to assess liver disease severity prior to therapy at a safe level of predictability.
Transient elastography (TE), can be used to assess liver fibrosis in patients with chronic hepatitis C, provided that consideration is given to factors that may adversely affect its performance such as obesity, age, and biochemical necroinflammatory activity. TE results should be evaluated relative to interquartile range and to the success rate of measurements. TE performs better at detecting cirrhosis than lesser degrees of fibrosis [65,66]. The well established panels of biomarkers of fibrosis can be broadly categorized as those that include commonly performed biochemical and hematological tests, such as ALT, AST, prothrombin time, platelets (APRI, AST/ALT ratio, Forns Index); those that include specific indirect markers of liver fibrosis, such as a-2 macroglobulin; those that incorporate only direct markers of liver fibrosis (MP3), or combinations of direct and indirect markers (Hepascore, Fibrometer). Sufficient evidence exists to support the view that algorithms perform well in the detection of significant fibrosis (METAVIR score F2-F4). Thus, their use in patients with chronic hepatitis C can be recommended for this purpose. They all perform less well in the detection of lesser degrees of fibrosis [66–69]. The combination of blood tests or the combination of TE and a blood test improve accuracy and reduce the necessity of using liver biopsy to resolve uncertainty. However, they increase the cost [70].[65,66].
Recommendations
(1) Liver disease severity should be assessed prior to therapy (B1).
(2) Identifying patients with cirrhosis is of particular importance, as their prognosis and likelihood to respond to therapy are altered, and they require surveillance for HCC (A1).
(3) As liver disease can progress in patients with repeatedly normal ALT levels, disease severity evaluation should be performed regardless of ALT levels (B2).
(4) Assessment of the severity of liver fibrosis is important in decision making in patients with chronic hepatitis C (A1).
(5) Liver biopsy is still regarded as the reference method to assess the grade of inflammation and the stage of fibrosis (A2).
(6) Transient elastography (TE) can be used to assess liver fibrosis in patients with chronic hepatitis C (A2).
(7) Non-invasive serum makers can be recommended for the detection of significant fibrosis (METAVIR score F2–F4) (A2). (8) The combination of blood tests or the combination of transient elastography and a blood test improve accuracy and reduce the necessity of using liver biopsy to resolve uncertainty
Updates; 2011
December
"Liverscore" is predictive of both liver fibrosis and activity in chronic hepatitis C
June 2011
Noninvasive liver tests may predict hepatitis C patient survival
Non-invasive tests for liver fibrosis, such as liver stiffness measurement or the FibroTest, can predict survival of patients with chronic hepatitis C, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.
"Liver stiffness measurement and/or the FibroTest could replace liver biopsy for the evaluation of hepatitis C, regardless of the stage of the disease," said Victor de Lédinghen, MD, PhD, of the Centre d' Investigation de la Fibrose Hépatique and lead author of this study. "Thus, these tools may help physicians assess prognosis early and discuss specific treatments."
Findings of this study are of major importance since liver stiffness, as a good predictive factor of survival, may help physicians evaluate the severity of liver disease earlier, decide with stronger arguments on a liver transplant or a portosystemic shunt (to bypass the liver), and evaluate more precisely the surgical risk of cirrhotic patients.
In chronic liver diseases, fibrosis assessment predicts liver-related complications and survival. In this study, doctors evaluated the five-year prognostic value of liver stiffness, non-invasive tests of liver fibrosis and liver biopsy to predict overall survival and survival without liver-related death in chronic hepatitis C.
A total of 1,457 patients with chronic hepatitis C were included. At five years, 77 patients died (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7 percent and survival without liver-related death was 94.4 percent. Survival was significantly decreased in patients diagnosed with severe fibrosis, no matter which non-invasive method was used.
All methods were able to predict shorter survival times; liver stiffness measurement and results of the FibroTest had higher predictive values. Doctors assessed fibrosis and — on the same day — liver stiffness, performed noninvasive tests of fibrosis (FibroTest, the aspartate aminotransferase to platelet ratio index, FIB-4), and analyzed liver biopsy samples.
"To our knowledge, this study is the first showing that liver stiffness has a prognostic value for overall survival and survival without liver-related death in patients with chronic hepatitis C virus infection," added Dr. Lédinghen. "The present study independently validated the prognostic value of the FibroTest and showed that liver stiffness and FibroTest can predict survival."
For more information on hepatitis, please read the AGA brochure "Understanding Hepatitis" at www.gastro.org/patient-center/digestive-conditions/hepatitis.
Also See
Fibroscan for assessing liver fibrosis: An acceptable alternative for liver biopsy
Hepatitis C Cirrhosis;Comparison of Fibroscan, King's Score and Liver Biopsy
Hepatitis C; FibroTest is a validated non-invasive marker of fibrosis in treatment-naive patients.
Hepatitis C:Fibrosis Liver Biopsy vs Transient Elastography
2010 Updates
Magnetic Resonance Elastography Holds Promise for Detecting, Staging Liver Fibrosis: Presented at AASLD
Hepatitis C Treatment / Noninvasive tests : Video
Utility of the Liver Biopsy and Noninvasive
Tests of Fibrosis
There are three primary reasons for performing a liver biopsy: it provides helpful information on the current status of the liver injury, it identifies features useful in the decision to embark on therapy, and it may reveal advanced fibrosis or cirrhosis that necessitates surveillance for hepatocellular carcinoma (HCC) and/or screening for varices.
The biopsy is assessed for grade and stage of the liver injury, but also provides information on other histological features that might have a bearing on liver disease progression.
The grade defines the extent of necroinflammatory activity, while the stage establishes the extent of fibrosis or the presence of cirrhosis.
Several scoring systems have been conceived, the most common being the French METAVIR, the Batts-Ludwig, the International Association for the Study of the Liver (IASL) and the Ishak Scoring systems..
Understanding Liver Biopsy: Grading & Staging
The two more common non-HCV conditions that might affect disease progression and possibly impede treatment response are steatosis and excess hepatocellular iron.
Identifying either of these two features does not preclude initiating treatment, but their presence provides additional information regarding the likelihood of response to treatment.
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The liver biopsy has been widely regarded as the “gold standard” for defining the liver disease status, but it has drawbacks that have prompted questions about its value.
The procedure is not without risks (including pain, bleeding and perforation of other organs), it is subject to sampling error, it requires special expertise for interpreting the histopathology, it adds cost to medical care, and it is anxiety-provoking for the implicated person.
Thus, efforts are underway to seek alternative means of establishing information on the extent of fibrosis by focusing on noninvasive blood marker panels.
These markers are useful for establishing the two ends of the fibrosis spectrum (minimal fibrosis and cirrhosis) but are less helpful in assessing the mid-ranges of fibrosis or for tracking fibrosis progression.
k
The recently developed transient elastography that uses ultrasound and low frequency elastic waves to measure liver elasticity has improved the ability to define the extent of fibrosis without a liver biopsy, particularly when combined with other noninvasive markers.
However, it is not yet ready to replace the liver biopsy since it is not FDA approved, the failure rate is higher in obese patients, and there is now evidence that the transient elastography score can be unexpectedly increased in persons with acute hepatitis who have high necroinflammatory activity but no or minimal fibrosis.
A liver biopsy may be unnecessary in persons with genotypes 2 and 3 HCV infection, since more than 80% of them achieve a sustained virlogical response (SVR) to standard-of-care treatment.
k
There is an ongoing debate about whether a biopsy is warranted for persons infected with HCV, genotype 1, whose response to such treatment approximates 50% among Caucasians and 30% among African Americans.
Even more uncertain is whether there is need for a liver biopsy in persons infected with the other less common genotypes (4 through 6).
Thus, although the liver biopsy was previously regarded as routine for defining the fibrosis stage in persons with genotype 1 infection the issue is now in a state of flux and possible transition.
Supporters of a biopsy cite the difficult nature and high cost of current antiviral therapy and are therefore willing to withhold or delay treatment if liver histology displays minimal to moderate fibrosis stage 2 , especially if the infection is known to have been long-standing. These individuals are regarded as having slowly progressive liver disease that may not be responsible for their ultimate demise
However, treatment is advised for those with more advanced fibrosis stage3 It must be noted, that while information obtained from a biopsy is useful, the procedure is not mandatory for deciding on treatment.
If performed and treatment is withheld, a common strategy is to repeat the liver biopsy 4 to 5 years later and to reconsider treatment should there be evidence of disease progression. The earlier views that persons with genotype 1 infection and persistently normal aminotransferase values did not require a liver biopsy because they were believed to have minimal liver disease, and that treatment may actually be harmful, are no longer valid
It is now apparent that as many as a quarter of such individuals have significant fibrosis,1 and that treatment response is similar to that of individuals with abnormal serum aminotransferase levels.
Therefore, the decision to perform a liver biopsy should be based on whether treatment is being considered, taking into account the estimated duration of infection and other indices of advancing liver disease (e.g., the platelet count), the viral genotype, and the patient’s willingness to undergo a liver biopsy and motivation to be treated.
If the biopsy is not performed and treatment not undertaken, the patient should continue to be monitored at least annually and a biopsy performed if the aminotransferase values become abnormal and other indicators of progressing liver disease become apparent.
Recommendations
A liver biopsy should be considered in patients with chronic hepatitis C infection if the patient and health care provider wish information regarding fibrosis stage for prognostic purposes or to make a decision regarding treatment (Class IIa, Level B)
Currently available noninvasive tests may be useful in defining the presence or absence of advanced fibrosis in persons with chronic hepatitis C infection, but should not replace the liver biopsy in routine clinical practice (Class IIb, Level C).
Magnetic Resonance Elastography (MRE
Researchers at Mayo Clinic have developed technology that uses sound waves to see if a patient’s liver is harder than it should be — if it’s developing fibrosis.
It’s called Magnetic Resonance Elastography (MRE), and it offers a noninvasive alternative to liver biopsy
Dec 2011
Article By Benjamin E. Tubb, M.D., Ph.D., Board Certified Radiologist, Intrinsic Imaging
Magnetic Resonance Elastography: Accurately identify the presence and progression of hepatic fibrosis
2009
Video From Mayo Clinic
Take Home Message on Elastography
What Is the Role of FibroScan in Diagnosing Liver Fibrosis?
In summary, ultrasound elastography will separate patients with minimal or no fibrosis from those with advanced fibrosis or cirrhosis, although it may occasionally underestimate fibrosis in some patients with advanced fibrosis or macronodular cirrhosis. Additional studies will establish the role of this technique in evaluating hepatic fibrosis in patients with chronic liver disease.
However, it is not yet ready to replace the liver biopsy since it is not FDA approved, the failure rate is higher in obese patients, and there is now evidence that the transient elastography score can be unexpectedly increased in persons with acute hepatitis who have high necroinflammatory activity but no or minimal fibrosis.
Source 2009 : Diagnosis, Management, and Treatment of Hepatitis C: An Update
..
For Acute Liver :
"Liver stiffness measurement by elastography-Fibroscan (FS) liver damage overestimate the real stage of fibrosis and may erroneously suggest the presence of liver cirrhosis"
FibroScan FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
;
Take Home Message on Noninvasive Blood Test
FibroTest is also known as the FibroSure appears relatively good at gauging both
1) very early or minimal
2) relatively advanced liver disease.
The test doesn't perform as well for people in the middle of the spectrum.
One independent evaluation comparing FibroTest to biopsy results concluded that "the FibroTest score " could not accurately predict the presence or absence of significant liver fibrosis.
The noninvasive tests look promising, but can’t substitute for liver biopsy at the present time. We need to get the quirks out first so that we can differentiate middle stages of disease, rather than just the ends,” says Melissa Palmer, MD, a hepatologist in private practice, Plainview, NY, and author of Dr. Melissa Palmer’s Guide to Hepatitis and Liver Disease.
“These tests give the physician an alternative before going straight to a liver biopsy, and are sensitive to changes associated with disease progression and/or response to therapy. They provide a means for more frequent monitoring as compared to a biopsy,” Faruki says.
Some of these new tests incorporate blood serum markers. LabCorp’s HCV FibroSure combines six biomarkers to determine fibrotic and necroinflammatory damage: alpha2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, gamma glutamyl transpeptidase, and ALT.
LabCorp licenses the FibroSure test from BioPredictive, SAS, a company based in Paris that focuses on the development of noninvasive liver diagnostics. FibroSure is not approved by the FDA but is available as a LabCorp offering. Turnaround is roughly 7 days, Faruki says.
“The correlations between a test like FibroSure and biopsy are somewhere between 70% and 80%. But studies have shown that the correlation between two biopsies on the same patient is also between 70% and 80%,” Faruki says.
She suggests that the tests’ flaws may not be solely a reflection of the biomarkers but rather of the imprecision in a liver biopsy. “[A liver biopsy] actually samples only about one fifty-thousandth of the liver. A combination of biochemical markers may give a more comprehensive view.”
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