Feasibility study of a long term cohort of patients with Hepatitis C related compensated cirrhosis in Cairo (ANRS 12332b)

Cirrhosis is a common complication of chronic hepatitis C. It is at this stage that patients are directly threatened by the occurrence of complications (i.e liver decompensation and hepatocellular carcinoma) and have a high risk of death due to these complications. It is therefore logical to prioritize, as recommended by international guidelines, treatment of patients with advanced forms of liver disease. Indeed, it is widely established that patients who achieve a sustained virological response (SVR) have a lower risk to develop liver failure and/or hepatocellular carcinoma. Due to this, Egyptian national guidelines have recently been updated; patients with bridging fibrosis (F3) and those with cirrhosis (F4) will be treated in priority either with a triple therapy containing peg-IFN, ribavirin and sofosbuvir for 12 weeks or with an IFN-free regimen containing sofosbuvir and ribavirin for 24 weeks. Still, even after they are cured, some patients may continue to experience hepatic and extra-hepatic complications of their past infection. Therefore, we would like to document the benefit of treating such patients and examine the impact of co-morbidities (e.g: metabolic syndrome) on the occurrence of liver complications. We will use the three-year period covered by this project to test the feasibility of long-term follow-up (observational cohort) of patients with treated compensated cirrhosis.


The primary objective of this research is to assess the feasibility of following up compensated F4 patients over the period of 3 years.


The secondary objectives of this research are to identify factors associated with being lost to follow-up, estimate the incidence of liver decompensation and/or hepatocellular carcinoma during the 3 years follow-up, and estimate the incidence of unplanned hospitalization and/or death during the 3 years follow-up. 


It is estimated that 300 treatment naive patients, with Child-Pugh scores of less than or equal to 6, and without evidence of hepatic decompensation or hepatocellular carcinoma, will be recruited to participate in this study.


This study is planned to commence in the beginning of 2015.



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fp7_01fp7_02 This project is funded
by the European Union