Provide professional treatment informations for patients with liver cirrhosis.
»Home | »Sitemap | »Contact us | »Link
HomeEASL Recommendations on Treatment of Hepatitis C 2014

EASL Recommendations on Treatment of Hepatitis C 2014

Introduction

Hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. The long-term impact of HCV infection is highly variable, ranging from minimal histological changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC). The number of chronically infected persons worldwide is estimated to be about 160 million, but most are unaware of their infection. The implementation of extended criteria for screening for HCV, such as targeting birth cohorts, is a subject of major debate among different stakeholders. Clinical care for patients with HCV-related liver disease has advanced considerably during the last two decades, thanks to an enhanced understanding of the pathophysiology of the disease, and because of developments in diagnostic procedures and improvements in therapy and prevention.

These EASL Recommendations on Treatment of Hepatitis C are intended to assist physicians and other healthcare providers, as well as patients and other interested individuals, in the clinical decisionmaking process by describing the optimal management of patients with acute and chronic HCV infections. These guidelines apply to therapies that will be approved within less than 6 months at the time of their publication.

The standard of care up to 2014

The primary goal of HCV therapy is to cure the infection. A sustained virological response (SVR) is defined as undetectable HCV RNA 12 weeks (SVR12) or 24 weeks (SVR24) after treatment completion. The infection is cured in more than 99% of patients who achieve an SVR. The SVR is generally associated with resolution of liver disease in patients without cirrhosis. Patients with cirrhosis remain at risk of life-threatening complications; however hepatic fibrosis may regress and the risk of complications such as hepatic failure and portal hypertension is reduced. More data is required to ascertain the lifetime residual risk of hepatocellular carcinoma after viral infection has been eradicated.

Until 2011, the combination of pegylated interferon (IFN)-α and ribavirin for 24 or 48 weeks was the approved treatment for chronic hepatitis C. With this regimen, patients infected with HCV genotype 1 had SVR rates of approximately 40% in North America and 50% in Western Europe. Higher SVR rates were achieved in patients infected with HCV genotypes 2, 3, 5, and 6 (up to about 80%, and higher for genotype 2 than for genotypes 3, 5, and 6) and intermediate SVR rates were achieved in those with HCV genotype 4.

In 2011, telaprevir and boceprevir were licensed for use in HCV genotype 1 infection. These two drugs are first-wave, first-generation direct-acting antivirals (DAAs). Both target the HCV NS3/4A serine protease and are thus referred to as protease inhibitors. Both telaprevir and boceprevir must be administered in combination with pegylated IFN-α and ribavirin. In the phase III trials of boceprevir and telaprevir in HCV genotype 1 treatment-naïve patients, triple therapy regimens achieved higher SVR rates than pegylated IFN-α/ribavirin dual therapy,of the order of 65% to 75%. However, the side effect profiles of these triple combination therapies are not favourable, and the costs per SVR in patients with advanced hepatic fibrosis are such that they should ideally no longer be used in patients infected with HCV genotype 1, as soon as other, more efficacious and better-tolerated options are available.

In addition to pegylated IFN-α and ribavirin, three new HCV DAAs will be licenced in the EU in the first half of 2014, for use as part of combination therapies for HCV infection. Sofosbuvir, a nucleotide analogue inhibitor of HCV RNA-dependent RNA polymerase, has been approved in January 2014. Simeprevir, a second-wave, firstgeneration NS3/4A protease inhibitor will be approved in May 2014. Daclatasvir, an NS5A inhibitor, is likely to be approved in August or September 2014. Other drugs may be approved later in 2014 or in 2015 and an update of these guidelines will be provided when this is the case.

The panel recognises the heterogeneity of per capita incomes and health insurance systems across Europe and in other regions,and therefore the possible necessity to continue to utilise current standards of care with pegylated IFN-α and ribavirin, with or without the first-generation protease inhibitors telaprevir or boceprevir. However the advent of new DAAs implies that these regimens are not considered optimal in 2014. It is hoped that the publication of up-todate recommendations will guide reimbursement (and discounting of drug costs) in order to harmonize treatments across different countries and regions.

Methodology

These EASL Recommendations have been updated by a panel of experts chosen by the EASL Governing Board. The recommendations were approved by the EASL Governing Board. The Recommendations have been based as far as possible on evidence from existing publications and presentations at international meetings, and, if evidence was unavailable, the experts’ personal experiences and opinion. Where possible, the level of evidence and recommendation are cited. The evidence and recommendations in these guidelines have been graded according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The strength of recommendations thus reflects the quality of underlying evidence. The principles of the GRADE system have been enunciated . The quality of the evidence in the CPG has been classified into one of three levels: high (A), moderate (B) or low (C). The GRADE system offers two grades of recommendation: strong(1) or weak (2) (Table 1). The CPGs thus consider the quality of evidence: the higher the quality of evidence, the more likely a strong recommendation is warranted; the greater the variability in values and preferences, or the greater the uncertainty, the more likely a weaker recommendation is warranted.

These recommendations are necessarily based on currently licenced drugs. Several major Phase III trials have been completed and filing for licencing has been completed or is imminent. The panel could not recommend treatments with these compounds, but provides a perspective at the end, given the likely importance of these imminent regimens under review. These Recommendations will be updated regularly, following approval of new drug regimens by the European Medicines Agency.

To be continued

Related articles

YHK effective: Fatty Liver(NASH)

YHK:Inhibitory effect for the liver cancerous

YHK effective: the treatment of Hepatitis C

Anti-fibrotic(liver) effect of YHK

What's YHK

About Liver Cirrhosis

Eight Causes of Liver Cirrhosis

Antifibrotic treatment is the last line of defense to prevent liver cirrhosis.

  • Liver dysfunction
  • liver cirrhosis, NASH, fatty liver, hepatitis
  • Patients with liver diseases troubled by the side effects of drugs
Woman
I was infected with hepatitis C and then it developed to liver cirrhosis.I started to take YHK in 2006, after one week, my ALT and AST values began to decrease. In Dec, I stopped the injection treatment.YHK help me a lot..
Men
I’m a liver cirrhosis patient. I was hospitalized three times within three years and the doctor told me that the prognosis was bad.Then my friend strongly recommended me to take YHK. After taking YHK, my liver function turned better, and the jaundice disappeared as well.
and more.... »
Copyright ⓒ 2012 cirrhosis-treatment.net All Rights Reserved