More Precise Diagnostic Algorithm Reduces Need for Liver Biopsy
A new classification for diagnosing fibrosis in patients with chronic
hepatitis C virus (HCV) has shown to be as accurate as currently used
algorithms, but required no further liver biopsy. The study appearing in
the January issue of Hepatology,
a journal published by Wiley-Blackwell on behalf of the American
Association for the Study of Liver Diseases, details a method that
synchronously combines two fibrosis tests, providing a non-invasive and
more precise fibrosis diagnosis.
HCV affects up to 170,000 million individuals worldwide and is a leading
cause of chronic liver disease and a primary indication for liver
transplantation according to the World Health Organization (WHO). The
Centers for Disease Control and Prevention (CDC) estimates that 2.7 to
3.9 million Americans are living with chronic HCV with roughly 12,000
deaths reported each year. WHO has reported up to 20% of HCV patients
develop cirrhosis and 1% to 5% die from cirrhosis or liver cancer.
“Fibrosis progression can be highly unpredictable and accurate
classification of the stage of fibrosis is extremely important,” said
Dr. Jérôme Boursier from Centre Hospitalier Universitaire d’Angers in
France. “A diagnostic algorithm that provides similar accuracy as
successive classifications without the need of liver biopsy to determine
the extent of fibrosis is highly beneficial to patients.”
Dr. Boursier and colleagues evaluated the Sequential Algorithm for
Fibrosis Evaluation (SAFE) and Bordeaux algorithm (BA), compared to a
more detailed classification for determining fibrosis severity. The team
used data for 1785 patients with chronic HCV who were enrolled in 3
previous study populations (SNIFF, VINDIAG, and FIBROSTAR), representing
a total of 31 centers throughout France. Data included liver biopsy,
blood fibrosis test, and Fibroscan—an ultrasound technology used to
assess liver fibrosis (stiffness).
The team found that successive SAFE diagnostic accuracy was
87%—significantly lower than the individual SAFE devoted for the
diagnosis of significant fibrosis (F≥2) at 95% or for cirrhosis (F4) at
90%. The number of liver biopsies required with successive SAFE was
significantly higher than individual SAFE for F≥2 or SAFE for F4 at 71%
compared to 64% and 6%, respectively. Researchers also reported similar
results with successive BA diagnostic accuracy at 85% compared to
individual BA at 88% (F≥2) and 94% (F4). More biopsies were required for
successive versus individual BA at 50% compared to 35% and 25%,
respectively.
“Our findings show that SAFE and BA diagnostic testing are highly
accurate in determining fibrosis or cirrhosis in patients with HCV,”
said Dr. Boursier. However, a high percentage of patients also required
liver biopsy to confirm the diagnosis. The authors creation of a new
classification which synchronously combines two fibrosis tests
(FibroMeter + Fibroscan) was as accurate as successive SAFE or BA at
87%, and did not require any liver biopsy. “The new non-invasive
classification of fibrosis is as accurate as successive SAFE or BA, but
is more precise with six fibrosis classes and entirely non-invasive with
no liver biopsy required,” concludes Dr. Boursier.
