The aim of the study is to analyse data coming from two treatment centres of the National Treatment Program Centres of hepatitis C in Egypt
Analyse data coming from two centres of the National Treatment Program of hepatitis C in Egypt: * 1500 patients who started treatment between April 1st 2013 and March 31st 2014 and will be seen for their week 60 visit between July 1st 2014 and June 30th 2015 (Cohort A). * 1000 patients recruited between July 1st 2014 and estimated March 31st 2015, of which 200 are expected to be early defaulters and will be contacted by the study team (Cohort B).
Study Type
OBSERVATIONAL
El Fahera El Fatemia
Cairo, Egypt
NHTMRI
Cairo, Egypt
Estimate "real life" Sustained Virological Response rate
Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 60 in the two project centres to obtain reliable estimates of response rates at this crucial time point.
Time frame: 60 weeks after initiation of treatment
Compare the efficacy of Reiferon®, a biosimilar produced by a local company, Minapharm©, to that of other pegylated interferon of known efficacy (Pegasys®, Pegintron®)
Response rates at week 12, week 24 and week 60 will be compared across the three treatment regimens available in Egypt. Reiferon's efficacy will be assessed by comparison of: * Complete early virological response (cEVR): defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV * Early virological response (EVR): defined by at least a 2 log-reduction of HCV RNA or undetectable HCV-RNA at 12 weeks of combination therapy. * Sustained virological response (SVR): defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment (week 60) * Normalization of ALT: Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment and 12 weeks after the end of treatment. * Adverse events: Evaluation of Incidence of AE and SAE related to dual therapy.
Time frame: 12 weeks, 24 weeks and 60 weeks after initiation of treatment
Understand the determinants of not returning for follow-up among defaulting patients
Describe the timing of premature termination of treatment, and understand factors associated with it, throughout the 60 weeks of follow-up. Patients compliance in terms of regularity of injections intake will be described
Time frame: 60 weeks after the initiation of dual-therapy
Optimize selection criteria for patients to be enrolled in the National Treatment Program
Explore various inclusion criteria combining fibrosis stage and serological markers of treatment response to optimize the selection of patients for the National Treatment Program
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Time frame: 60 weeks after the initiation of dual therapy
Estimate "real life" Response rate at the end of treatment
Put in place mechanisms to ensure systematic reporting of HCV RNA testing at week 48 in the two project centres to obtain reliable estimates of response rates at the end of treatment.
Time frame: 48 weeks after initiation of treatment