Clinical trial NCT02101177: Evaluation of the National Treatment Program of Hepatitis C in Egypt
Official title: Evaluation of the National Treatment Program of Hepatitis C in Egypt, Using Data Coming From Two Treatment Centres.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Hepatitis C
Keywords: Viral Hepatitis C
Genotype 4
SVR
Egyptian National Program
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut Pasteur
name: National Hepatology & Tropical Medicine Research Institute
First posted: 2014-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients included in the study will be those with prior approval from the Ministry of Health to begin the bi-therapy and attending two centres of the National Treatment Program.

Brief summary: 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

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Age \< 18 years and \> 60 years
* Positive HCV antibodies using a third generation test
* Detectable HCV RNA by PCR
* Liver biopsy showing chronic hepatitis with either a METAVIR score F1 with elevated liver enzymes or scores F2/F3
* Naïve to treatment with PEG-IFN and RBV
* HBs antigen negative
* Prothrombin time ≥60 %, normal bilirubin, alpha-foeto protein \< 3\*normal range of the laboratory, anti-nuclear antibodies\<1/160
* Effective contraception during the treatment period; no breast-feeding
* Signed informed consent and willingness to participate in the study

Exclusion Criteria:

* Serious co-morbid conditions such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (HbA1C\>8%) , chronic obstructive pulmonary disease
* Major uncontrolled depressive illness
* Solid transplant organ (renal, heart, or lung)
* Untreated thyroid disease
* History of previous anti-HCV therapy
* Body mass index (BMI) greater than 30 kg/m²
* Known human immunodeficiency virus (HIV) coinfection: although HIV testing will not be proposed or done, patients with known HIV coinfection will not be included in the trial
* hypersensitivity to one of the two drugs (PEG-IFN, RBV)
* pregnancy or unwilling to comply with adequate contraception
* breast-feeding
* neutropenia (\<1500/mm3)
* anaemia (\<11g/dL for women ; \<12g/dL for men)
* thrombocytopenia (\<100.000/mm3)
* elevated creatinin (\>1.5mg/dL)
* concomitant liver disease other than hepatitis C (immuno-active chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson disease)
* liver biopsy showing severe steatosis (\>66%) and steatohepatitis; decompensated cirrhosis (Child Pugh\>A); hepatocellular carcinoma, METAVIR score F4.
* TSH\>5 mU/L

Primary outcomes:
measure: Estimate "real life" Sustained Virological Response rate
timeFrame: 60 weeks after initiation of treatment
Secondary outcomes:
measure: Compare the efficacy of Reiferon®, a biosimilar produced by a local company, Minapharm©, to that of other pegylated interferon of known efficacy (Pegasys®, Pegintron®)
timeFrame: 12 weeks, 24 weeks and 60 weeks after initiation of treatment
measure: Understand the determinants of not returning for follow-up among defaulting patients
timeFrame: 60 weeks after the initiation of dual-therapy
measure: Optimize selection criteria for patients to be enrolled in the National Treatment Program
timeFrame: 60 weeks after the initiation of dual therapy
measure: Estimate "real life" Response rate at the end of treatment
timeFrame: 48 weeks after initiation of treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Fahera El Fatemia
city: Cairo
country: Egypt
facility: NHTMRI
Study officials:
affiliation: National Hepatology & Tropical Medicine Research Institute
name: Wahid DOSS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Pasteur
name: Arnaud FONTANET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breban R, Doss W, Esmat G, Elsayed M, Hellard M, Ayscue P, Albert M, Fontanet A, Mohamed MK. Towards realistic estimates of HCV incidence in Egypt. J Viral Hepat. 2013 Apr;20(4):294-6. doi: 10.1111/j.1365-2893.2012.01650.x. Epub 2012 Sep 13.
citation: Guerra J, Garenne M, Mohamed MK, Fontanet A. HCV burden of infection in Egypt: results from a nationwide survey. J Viral Hepat. 2012 Aug;19(8):560-7. doi: 10.1111/j.1365-2893.2011.01576.x. Epub 2012 Feb 6.
citation: El Makhzangy H, Esmat G, Said M, Elraziky M, Shouman S, Refai R, Rekacewicz C, Gad RR, Vignier N, Abdel-Hamid M, Zalata K, Bedossa P, Pol S, Fontanet A, Mohamed MK. Response to pegylated interferon alfa-2a and ribavirin in chronic hepatitis C genotype 4. J Med Virol. 2009 Sep;81(9):1576-83. doi: 10.1002/jmv.21570.