Page 5 - EASL Recommendations on Treatment of Hepatitis C 2014
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Assessment of the stage of fibrosis is not required in patients Recommendations with clinical evidence of cirrhosis. Patients with cirrhosis need surveillance for HCC. Since significant fibrosis may be present Recommendations in patients with repeatedly normal ALT, evaluation of disease severity should be performed regardless of ALT patterns. Liver biopsy remains the reference method for grading the • The causal relationship between HCV infection and liver activity and histological progression (staging) of the disease. disease should be established (Recommendation A1) The risk of severe complications of liver biopsy is very low (1/4,000-10,000). In chronic hepatitis C, considerable evidence • The contribution of co-morbid conditions to the suggest that non-invasive methods can now be used instead progression of liver disease must be evaluated of liver biopsy to assess liver disease severity prior to therapy and appropriate corrective measures implemented at a safe level of predictability. Liver stiffness measurement (Recommendation A1) (LSM) can be used to assess liver fibrosis in patients with chronic hepatitis C, provided that consideration is given to • Liver disease severity should be assessed prior to factors that may adversely affect its performance such as therapy. Identifying patients with cirrhosis is of particular importance, as their prognosis is altered and their obesity. Well-established panels of biomarkers of fibrosis can treatment regimen may be adapted also be applied. Both LSM and biomarkers perform well in the (Recommendation A1) identification of cirrhosis or no fibrosis, but they perform less well in resolving intermediate degrees of fibrosis. • Fibrosis stage can be assessed by non-invasive methods initially, with liver biopsy reserved for cases where there is uncertainty or potential additional The combination of blood biomarkers or the combination of aetiologies (Recommendation A1) LSM and a blood test improve accuracy and reduce the need for liver biopsy to resolve uncertainty [12, 13]. These tests are • HCV RNA detection and quantification should be made of particular interest in patients with coagulation disorders, by a sensitive assay (lower limit of detection of though transjugular liver biopsy may also be used safely in <15 IU/ml) (Recommendation A1) this situation with the bonus that portal pressure can also be assessed. In case of contradictory results with non-invasive • The HCV genotype and genotype 1 subtype (1a/1b) markers, liver biopsy may be indicated. Also, histology may must be assessed prior to treatment initiation and will be required in cases of known or suspected mixed aetiologies determine the choice of therapy (Recommendation A1) (e.g., HCV infection with HBV infection, metabolic syndrome, alcoholism or autoimmunity). • IL28B genotyping has no role in the indication for treating hepatitis C with the new DAAs (Recommendation A1) 4.3.3. HCV RNA level and genotype determination HCV RNA quantification is indicated for the patient who may 4.4. Contra-indications to therapy undergo antiviral treatment. HCV quantification should be made by a reliable sensitive assay, and levels should be expressed 4.4.1. IFN-α and ribavirin in IU/ml. The HCV genotype should also be assessed prior to treatment initiation. Genotype 1 subtyping (1a/1b) provides Treatment of chronic hepatitis C with pegylated IFN-α/ribavirin- relevant information with respect to different response rates, containing regimens is absolutely contra-indicated in the following genetic barriers to resistance, and treatment modalities. patient groups: uncontrolled depression, psychosis or epilepsy; Genotyping/subtyping should be performed with an assay that pregnant women or couples unwilling to comply with adequate discriminates well subtypes 1a and 1b [14]. contraception; severe concurrent medical diseases and comorbidities including retinal disease, autoimmune thyroid disease; decompensated liver disease. The use of pegylated IFN-α is not recommended in 4.3.4. Determination of host genetics patients with absolute neutrophil counts <1500/mm and/or platelet 3 counts ≤90,000/mm . Treatment of patients with advanced liver 3 IL28B genotyping has lost predictive value with the new disease whose parameters fall outside of label recommendations highly efficacious IFN-free treatment regimens. Thus, IL28B may be feasible in experienced centres under careful monitoring and genotyping is useful only in settings where only pegylated IFN-α informed consent. and ribavirin can be used or to select cost-effective treatment options in settings with economical restrictions. 4.4.2. Approved DAAs Based on existing knowledge, no absolute contra-indications to the DAAs in the EU region in 2014 exist. 4.5. Indications for treatment: Who should be treated? All treatment-naïve and -experienced patients with compensated chronic liver disease related to HCV, who are willing to be treated and who have no contraindications to treatment, should be considered for therapy. Treatment should be prioritized in patients with advanced fibrosis (METAVIR score F3 to F4) and in those patients with clinically significant extra-hepatic manifestations (symptomatic cryoglobulinaemia or HCV immune complex nephropathy). Treatment is justified in patients with moderate fibrosis (METAVIR score F2). For patients with minimal or no fibrosis (METAVIR score F0-F1), the timing 3
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