Liver cirrhosis was diagnosed when typical clinical features, endoscopical findings, laboratory results, imaging results or results of liver biopsy or transient elastography were present. Diagnosis of chronic hepatitis C infection was based on a positive HCV antibody screening test at least six months before treatment and detection of HCV RNA in the blood by a quantitative assay. Goethe University Hospital in Frankfurt, Germany. In this retrospective cohort study we investigated 68 consecutive patients with advanced liver cirrhosis due to hepatitis C infection that were treated with pegylated interferon alfa-2a or 2b and ribavirin between the years 20 at the outpatient liver clinic of the J. Clinical events indicating hepatic decompensation (ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization) as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks. The aim of this retrospective cohort study was to define baseline characteristics that can help to predict the risk for hepatic decompensation in HCV patients with advanced liver cirrhosis during antiviral therapy with peginterferon and ribavirin. Moreover, predictive factors in cirrhotic patients that are associated with serious adverse events and/or hepatic decompensation during antiviral therapy are poorly defined. Thus, decision making for antiviral therapy in patients with (advanced) liver cirrhosis remains a clinical challenge facing the dilemma of increased SVR rates on the one hand and therapeutic schedules that are associated with increased complications and fatal outcomes on the other hand. About 38–48% of the cirrhotic patients experienced serious adverse events during the first 16 weeks of antiviral triple therapy and 8 patients died. Recently, preliminary data from the French early access program for telaprevir and boceprevir (CUPIC study) reporting antiviral efficacies and the occurrence of adverse events in more than 400 cirrhotic patients receiving antiviral triple therapy were presented. However, SVR rates in those patients have been shown to be poorer (approximately 25%) and peginterferon and ribavirin in those patients is associated with potentially life-threatening side effects and discontinuation rates ranged from 20–100%. patients with advanced cirrhosis and those on the waiting list for liver transplantation, successful antiviral therapy in selected cases may halt the progression of liver disease, can prevent HCV re-infection of the transplanted liver and subsequently leads to a decrease of post-transplant morbidity and mortality, ,,. In patients with more severe disease, e.g. Albeit still unsatisfactory, subanalyses of the pivotal boceprevir and telaprevir trials have shown that SVR rates for patients with advanced fibrosis and liver cirrhosis receiving triple therapy are higher as compared to those receiving peginterferon and ribavirin alone (52–62% vs. In turn, patients with advanced disease may benefit most from antiviral therapy since it was demonstrated in several long-term follow up cohort studies that SVR can prevent hepatic decompensation, development of hepatocellular carcinoma, and is associated with reduced overall mortality,. It is well established, that the presence of advanced fibrosis or compensated liver cirrhosis negatively influence a patient’s individual chance for achieving an SVR. Patients with a previous virologic relapse, partial response, or non-response to peginterferon and ribavirin also benefit when retreated with boceprevir or telaprevir-containing triple therapies. Untreated patients undergoing triple therapy achieve significantly higher SVR rates (66–75%) as compared to those receiving the dual therapy alone (37–44%). Licensing of the new HCV protease inhibitors boceprevir and telaprevir, as part of a triple therapy for untreated HCV genotype 1 patients and those who failed previous treatment, represents a milestone in HCV treatment. įor more than one decade, available antiviral treatment consisted of a dual therapy with pegylated interferon alfa-2a or -2b (peginterferon) in combination with the guanosine analog ribavirin leading to sustained virologic response (SVR) rates in approximately half of the patients. Progression to liver cirrhosis is observed in 2–35% of the patients after 20–25 years of chronic infection and once liver cirrhosis is established, the cumulative 5-year risk to develop hepatocellular carcinoma (HCC) is estimated to be 17%. Chronic hepatitis C virus (HCV) infection is a major health burden with more than 170 million infected individuals worldwide.
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