Safe Biopsy: Validated Method for Staging Liver Fibrosis in Hep C

Study results in Hepatology indicate that safe biopsy is a rational and validated method for staging liver fibrosis in hepatitis C with a marked reduction in the need for liver biopsy. It is an attractive tool for large-scale screening of hepatitis C virus carriers.

The staging of liver fibrosis is pivotal for defining the prognosis and indications for therapy in hepatitis C. Although liver biopsy remains the gold standard, several noninvasive methods are under evaluation for clinical use. Researchers validated the recently described sequential algorithm for fibrosis evaluation biopsy. The safe biopsy detects significant fibrosis and cirrhosis by combining the AST-to-platelet ratio index and Fibrotest-Fibrosure, thereby limiting liver biopsy to cases not adequately classifiable by noninvasive markers.

The researchers enrolled hepatitis C virus patients in nine locations in Europe and the U.S. The diagnostic accuracy of safe biopsy versus histology, which is the gold standard, was investigated. The reduction in the need for liver biopsies achieved with safe biopsy was also assessed. Safe biopsy identified significant fibrosis with 90 percent accuracy, and reduced the number of liver biopsies needed by 47 percent. Safe biopsy had 93 percent accuracy for the detection of cirrhosis, obviating 82 percent of liver biopsies. A third algorithm identified significant fibrosis and cirrhosis simultaneously with high accuracy and a 36 percent reduction in the need for liver biopsy. The patient's age and body mass index influenced the performance of safe biopsy, which was improved with adjusted Fibrotest-Fibrosure cutoffs.
The team found that 10 percent of cases had discordant results for significant fibrosis with safe biopsy versus histology, whereas 8 percent of cases were discordant for cirrhosis detection. The research team also found that 71 of the former cases and 56 of the latter cases had a Fibroscan measurement within two months of histological evaluation. Fibroscan confirmed safe biopsy findings in 83 percent and 75 percent, respectively.

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