Page 4 - EASL Recommendations on Treatment of Hepatitis C 2015 - Summary
P. 4
Introduction 3. Goals and endpoints of HCV therapy
Hepatitis C virus (HCV) infection is one of the main causes • The goal of therapy is to cure HCV infection to prevent
of chronic liver disease worldwide. The long-term impact hepatic cirrhosis, decompensation of cirrhosis, HCC,
of HCV infection is highly variable, ranging from minimal severe extra-hepatic manifestations and death (A1)
histological changes to extensive fibrosis and cirrhosis with
or without hepatocellular carcinoma (HCC). The number of • The endpoint of therapy is undetectable HCV RNA in a
chronically infected persons worldwide is estimated to be sensitive assay (≤15 IU/ml) 12 weeks (SVR12) and 24
about 160 million, but most are unaware of their infection. weeks (SVR24) after the end of treatment (A1)
The implementation of extended criteria for screening
for HCV is a subject of major debate among different • In patients with advanced fibrosis and cirrhosis, HCV
stakeholders. Clinical care for patients with HCV-related eradication reduces the rate of decompensation and
liver disease has advanced considerably during the will reduce, albeit not abolish, the risk of HCC. In these
last two decades, thanks to an enhanced understanding patients surveillance for HCC should be continued (A1)
of the pathophysiology of the disease, and because of
developments in diagnostic procedures and improvements • In patients with decompensated cirrhosis, HCV
in therapy and prevention. eradication reduces the need for liver transplantation.
These EASL Recommendations on Treatment of Hepatitis Whether HCV eradication impacts mid-to long-term
C are intended to assist physicians and other healthcare survival in these patients is unknown (B2)
providers, as well as patients and other interested
individuals, in the clinical decision-making process by 4. Pre-therapeutic assessment
describing the optimal management of patients with acute
and chronic HCV infections. These recommendations
apply to therapies that have been approved in the
European Union at the time of their publication.
1. Diagnosis of acute and chronic hepatitis C • The causal relationship between HCV infection and liver
disease should be established (A1)
• Anti-HCV antibodies are the first-line diagnostic test for
HCV infection (A1) • The contribution of comorbid conditions to the
progression of liver disease must be evaluated and
• In the case of suspected acute hepatitis C or in appropriate corrective measures implemented (A1)
immunocompromised patients, HCV RNA testing should
be part of the initial evaluation (A1) • Liver disease severity should be assessed prior to
therapy. Identifying patients with cirrhosis is of particular
• If anti-HCV antibodies are detected, HCV RNA should importance, as their prognosis is altered and their
be determined by a sensitive molecular method (A1) treatment regimen may be adapted (A1)
• Anti-HCV-positive, HCV RNA negative individuals • Fibrosis stage can be assessed by non-invasive
should be retested for HCV RNA three months later to methods initially, with liver biopsy reserved for cases
confirm true convalescence (A1) where there is uncertainty or potential additional
aetiologies (A1)
• HCV RNA detection and quantification should be made
by a sensitive assay with a lower limit of detection of
≤15 IU/ml (A1)
2. Screening for chronic hepatitis C • The HCV genotype and genotype 1 subtype (1a/1b)
must be assessed prior to treatment initiation and will
• Screening for HCV infection must be recommended determine the choice of therapy (A1)
in targeted populations defined according to the local
epidemiology of HCV infection, ideally within the • IL28B genotyping has no role in the indication for
framework of national plans (A1) treating hepatitis C with the new DAAs (A1)
• Screening for HCV infection must be based on the • HCV resistance testing should not be performed prior
detection of anti-HCV antibodies (A1) to therapy, because the SVR rates are very high both
in patients without and with detectable amounts of
• Rapid diagnostic tests can be used instead of classical resistance-associated variants by means of population
enzyme immunoassays to facilitate anti-HCV antibody sequencing at baseline (with the exception of patients
screening and improve access to care (B1) infected with subtype 1a who receive the combination of
PegIFN-α, ribavirin and simeprevir) (A1)
• If anti-HCV antibodies are detected, HCV RNA should
be determined by a sensitive molecular method to
identify patients with on-going infection (A1)
3
Hepatitis C virus (HCV) infection is one of the main causes • The goal of therapy is to cure HCV infection to prevent
of chronic liver disease worldwide. The long-term impact hepatic cirrhosis, decompensation of cirrhosis, HCC,
of HCV infection is highly variable, ranging from minimal severe extra-hepatic manifestations and death (A1)
histological changes to extensive fibrosis and cirrhosis with
or without hepatocellular carcinoma (HCC). The number of • The endpoint of therapy is undetectable HCV RNA in a
chronically infected persons worldwide is estimated to be sensitive assay (≤15 IU/ml) 12 weeks (SVR12) and 24
about 160 million, but most are unaware of their infection. weeks (SVR24) after the end of treatment (A1)
The implementation of extended criteria for screening
for HCV is a subject of major debate among different • In patients with advanced fibrosis and cirrhosis, HCV
stakeholders. Clinical care for patients with HCV-related eradication reduces the rate of decompensation and
liver disease has advanced considerably during the will reduce, albeit not abolish, the risk of HCC. In these
last two decades, thanks to an enhanced understanding patients surveillance for HCC should be continued (A1)
of the pathophysiology of the disease, and because of
developments in diagnostic procedures and improvements • In patients with decompensated cirrhosis, HCV
in therapy and prevention. eradication reduces the need for liver transplantation.
These EASL Recommendations on Treatment of Hepatitis Whether HCV eradication impacts mid-to long-term
C are intended to assist physicians and other healthcare survival in these patients is unknown (B2)
providers, as well as patients and other interested
individuals, in the clinical decision-making process by 4. Pre-therapeutic assessment
describing the optimal management of patients with acute
and chronic HCV infections. These recommendations
apply to therapies that have been approved in the
European Union at the time of their publication.
1. Diagnosis of acute and chronic hepatitis C • The causal relationship between HCV infection and liver
disease should be established (A1)
• Anti-HCV antibodies are the first-line diagnostic test for
HCV infection (A1) • The contribution of comorbid conditions to the
progression of liver disease must be evaluated and
• In the case of suspected acute hepatitis C or in appropriate corrective measures implemented (A1)
immunocompromised patients, HCV RNA testing should
be part of the initial evaluation (A1) • Liver disease severity should be assessed prior to
therapy. Identifying patients with cirrhosis is of particular
• If anti-HCV antibodies are detected, HCV RNA should importance, as their prognosis is altered and their
be determined by a sensitive molecular method (A1) treatment regimen may be adapted (A1)
• Anti-HCV-positive, HCV RNA negative individuals • Fibrosis stage can be assessed by non-invasive
should be retested for HCV RNA three months later to methods initially, with liver biopsy reserved for cases
confirm true convalescence (A1) where there is uncertainty or potential additional
aetiologies (A1)
• HCV RNA detection and quantification should be made
by a sensitive assay with a lower limit of detection of
≤15 IU/ml (A1)
2. Screening for chronic hepatitis C • The HCV genotype and genotype 1 subtype (1a/1b)
must be assessed prior to treatment initiation and will
• Screening for HCV infection must be recommended determine the choice of therapy (A1)
in targeted populations defined according to the local
epidemiology of HCV infection, ideally within the • IL28B genotyping has no role in the indication for
framework of national plans (A1) treating hepatitis C with the new DAAs (A1)
• Screening for HCV infection must be based on the • HCV resistance testing should not be performed prior
detection of anti-HCV antibodies (A1) to therapy, because the SVR rates are very high both
in patients without and with detectable amounts of
• Rapid diagnostic tests can be used instead of classical resistance-associated variants by means of population
enzyme immunoassays to facilitate anti-HCV antibody sequencing at baseline (with the exception of patients
screening and improve access to care (B1) infected with subtype 1a who receive the combination of
PegIFN-α, ribavirin and simeprevir) (A1)
• If anti-HCV antibodies are detected, HCV RNA should
be determined by a sensitive molecular method to
identify patients with on-going infection (A1)
3
