Evaluation of “Real Life” Efficacy and Safety of Antiviral treatments including new Direct Acting Antivirals among patients treated for Chronic Hepatitis C at El Kahera El Fatemia (National treatment program center) (ANRS 12332a)

Clinical trials are performed under optimal conditions where patients are highly selected without co-morbidities, clinical supervision is provided by specialists, and strict protocols are used to enhance patient compliance. Due to this, results may not be generalizable to “real life” clinical practice. Observational studies are now gaining attention, showing a wide range of results for treatment effectiveness given by a SVR rate ranging from 21% to 63% under the previous treatment (pegIFN + RBV). A “real-life” evaluation will be particularly relevant now that new Direct Acting Antivirals (DAAs), such as sofosbuvir, are introduced in Egypt. Several pivotal studies on genotype 4 have demonstrated the efficacy of this new drug in regimens which yield SVR rates ranging from 65.4% to 100%, even for patients with advanced forms of liver disease (i.e F3/F4). However, to our knowledge, there are no data on “real-life” response rates with these new DAAs in HCV G4 patients with advanced forms of liver disease. The set-up of this “real-life” observational cohort will allow us to evaluate the efficacy, the tolerance profile and patient adherence with these new regimens in a resource limited country.

 

The primary objective of this research will be to assess the efficacy of the antiviral treatments, including new Direct Acting Antivirals (DAAs) under "real life" conditions in a treatment center in Cairo.

 

The secondary objectives of the research will be to assess the safety, tolerance and resistance profiles of the new drugs “in real life condition”, determine the varying proportions of patient and health care staff adherence to the HCV treatment plan, and identify factors associated with treatment failure. 

 

Around 3000 chronic hepatitis C patients, with F2 to F4 compensated cirrhosis, will be included in each year of the 2.5 year study in order to evaluate a total of 7500 patients.

 

This study is scheduled to start in the beginning of 2015.

 

 

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NEWS & EVENT

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fp7_01fp7_02 This project is funded
by the European Union