The best magazine
Abstract and Introduction
Abstract
Assessment of liver fibrosis is important in determining prognosis, disease progression and need for treatment in patients with chronic hepatitis B (CHB). Limitations to the use of liver biopsy in assessing fibrosis are well recognized, and noninvasive tests are being increasingly evaluated including transient elastography (TE) and serum markers such as the Enhanced Liver Fibrosis (ELF) test. We assessed performance of ELF and TE in detecting liver fibrosis with reference to liver histology in a cohort of patients with CHB (n = 182), and compared the performance of these modalities. Median age was 46 and mean AST 70 IU/L. Cirrhosis was reported in 20% of liver biopsies. Both modalities performed well in assessing fibrosis at all stages. Area under receiver operator characteristic (AUROC) curves for detecting METAVIR fibrosis stages F ≥ 1, F ≥ 2, F ≥ 3 and F4 were 0.77, 0.82, 0.80 and 0.83 for ELF and 0.86, 0.86, 0.90 and 0.95 for TE. TE performed significantly better in the assessment of severe fibrosis (AUROC 0.80 for ELF and 0.90 for TE,P < 0.01) and cirrhosis (0.83 for ELF and 0.95 for TE,P < 0.01). This study demonstrates that ELF has good performance in detection of liver fibrosis in patients with CHB, and when compared, TE performs better in detection of severe fibrosis/cirrhosis.
Introduction
Chronic hepatitis B (CHB) caused by infection with the hepatitis B virus (HBV) is characterized by periods of continuous or fluctuating inflammation of the liver, leading to fibrosis, which may remain occult, with no clinical signs or symptoms at the time of diagnosis of CHB. Morbidity and mortality in patients with CHB are related to persistence of viral replication and the development of liver fibrosis that may progress to cirrhosis and its complications, particularly portal hypertension and liver cancers including hepatocellular cancer, and an increased risk of intra- and extrahepatic biliary cancer. The assessment of liver fibrosis is therefore an essential component in the initial evaluation of patients with CHB and informs the decision to commence antiviral therapy. Liver fibrosis assessment using invasive or noninvasive tests is a key feature of international guidelines. Continued monitoring of fibrosis is critical to determine changes in fibrosis over time and to assess the efficacy of therapy and the necessity for interventions to manage portal hypertension and screen for liver cancer and progression to cirrhosis.
The traditional method for assessing liver fibrosis has been needle biopsy of the liver, however this is expensive, frequently painful and potentially hazardous for the patient, and subject to sampling error and variation in interpretation. While many patients with CHB can be persuaded to undergo a first biopsy, most will be reluctant to accept subsequent follow-up biopsies to evaluate disease progression or response to treatment. Noninvasive methods of assessing liver fibrosis in a range of chronic liver diseases are being explored. Principal among these are transient elastography (TE) and serum markers, and these are now being evaluated in patients with CHB. The Enhanced Liver Fibrosis (ELF) test (Siemens Healthcare Diagnostics Inc., Tarrytown, New York, USA) is a panel of biomarkers comprising hyaluronic acid (HA), tissue inhibitor of matrix metalloproteinase-1 (TIMP-1) and aminoterminal propeptide of procollagen type III (PIIINP), derived from studies in patients with a range of chronic liver diseases including CHB.
Previous studies comparing the performance of noninvasive markers of liver fibrosis in CHB have reported contradictory results. Performance defined by the area under the receiver operator curve (AUROC) of TE to identify F ≥ 2 has been reported in several studies to range from 0.61 to 0.87.
The aim of this primary study was to evaluate and validate the performance of ELF in a cohort of patients with CHB and to compare ELF to a different noninvasive modality, TE, in the assessment of liver fibrosis defined by histological staging of liver biopsies.
Source: ...