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© Research
Project

ANRS 12332 HepNile: Evaluation of “Real Life” Efficacy and Safety of antiviral treatments including new Direct Antiviral Agents among patients treated for Chronic Hepatitis C at Egyptian National Treatment Centres

Starting Date
01
Sep 2015
Ending Date
31
Aug 2018
Status
Ongoing
Members
5
Structures
1

About

Background:

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 being 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” cohort will allow us to evaluate the efficacy, the tolerance profile and patient adherence with these new regimens in a resource limited country.

Primary Objective:

Assess the efficacy of the antiviral treatments, including new Direct Acting Antivirals, in “real life condition” in national treatment centers of Cairo.

Secondary objectives:

– 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

– Identify factors associated with treatment failure

Patients & sample size:

Around 3000 patients with chronic hepatitis C attending national treatment centers of Cairo will be recruited per year for the duration of the recruitment period (30 months). In total, 7500 patients will be evaluated in this cohort.

Selection criteria:

Inclusion criteria will follow the guidelines of the National Treatment Program: patients between 18 and 70 years old, positive PCR for HCV RNA, BMI<35 kg/m², liver fibrosis evaluated by biopsy or Fib4 as F2 to compensated F4 or F1 if ALAT>ULN , no HBV or HIV co-infection, no HCV treatment contraindications

Fundings