CHC may progress to cirrhosis (in approximately 20% of patients, with a mean duration of 20 years) and subsequently, decompensation and complications, including HCC, develop in about 30% of cases over a period of approximately 4 years (DiBisceglie 2008). Histologically significant liver disease can be also present in patients without symptoms and with normal ALT levels. In theses cases, deferring treatment until liver function is depressed (low albumin, altered PT) may decrease SVR rate and increase the risk of AEs (Pradat 2002). Evaluation of liver fibrosis is thus compulsory.
Liver biopsy
Liver biopsy (LB) is the gold standard for (i) liver disease staging, (ii) treatment decisions and (iii) prognostication, as it may reveal advanced fibrosis or cirrhosis that necessitates surveillance for HCC and/or screening for varices.
Before treatment LB is indicated for prognostic purposes and guiding treatment decisions. If LB shows significant fibrosis treatment should be initiated, otherwise, treatment can be deferred (Afdhal 2009). Individualized treatment decisions are based on the severity of liver disease. Treatment is indicated in patients with compensated cirrhosis provided they do not have contraindications to therapy.
Post-treatment LB is essential to demonstrate regression of cirrhosis after viral supression. It is not recommended for assessment of the efficacy of therapeutic regimens, unless hepatic safety issues impose it.
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Different scoring systems have been defined in order to classify the extent of necroinflammatory activity (grading) and the extent of fibrosis (staging) in LB. However, LB is invasive and has a number of drawbacks:
– substantial sampling error (extracts only 1/50,000 of the liver)
– variability in interpretation
– potential serious adverse outcomes (bleeding)
– high cost (approximately $1000–$1500 per biopsy)
– low patient’s acceptability/reluctance to undergo repeated biopsies
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Non invasive methods
Non-invasive assessment of liver fibrosis based on either biochemical methods or imaging techniques have emerged over the past ten years as an alternative to the systematic use of LB. These methods are easy-to-do, reliable and can be repeated in follow-up visits. However, these noninvasive tests are more adequate for identifying patients with advanced fibrosis/cirrhosis than in differentiating those with moderate and mild fibrosis. According to the current recommendations, these methods should not replace LB in routine clinical practice. Transient elastography (FibroScan™) uses ultrasound and low frequency elastic waves to measure liver elasticity/stiffness in kilopascals (kPa).
With a cutoff value of about 7-8 kPa, it can identify about 70% of patients with histological signs of moderate to severe fibrosis. With a cutoff of 14-15 kPa, it can identify about 85% of patients with histological signs of cirrhosis.