Chronic Hepatitis C Treatment by Pegylated Interferon and Ribavirin in Naive Egyptian Patients (ANRS 1211)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Chronic hepatitis C is a liver disease related to a virus: hepatitis C virus (HCV). The type
      of HCV present in Egypt (genotype 4), has the reputation to respond poorly to Interferon
      treatment at the chronic stage. Pegylated Interferon is a new form of Interferon that stays
      in the body for longer time and allows the patient to take less injection per week. It has
      proved to be more effective than standard Interferon. The combination of two drugs,
      Interferon and Ribavirin, is considered to be the best treatment available for chronic
      hepatitis C.
    

Detailed description: 
      Egypt is the country with the highest HCV prevalence worldwide, and the number of infected
      Egyptians is estimated around 8 million. The HCV genotype circulating in Egypt is genotype 4.
      This genotype has the reputation, based on the few available data, to respond poorly to
      treatment. This study will estimate the safety and efficacy of the combination of peg-IFNα-2a
      plus Ribavirin, in Egyptian patients with chronic hepatitis C. This treatment has been chosen
      based on its better expected efficacy compared to pegylated interferon alone.

      The primary objective of the study is to assess the efficacy and tolerance of the combination
      of pegylated interferon (peg-IFNα-2a) plus ribavirin in Egyptian patients with chronic
      hepatitis C and with no prior treatment for HCV.

      Methods: Open trial. Follow-up duration: 72 weeks. Enrolment duration: 18 months. Total trial
      duration: 3 years and a half, including trial analysis (carried out in the 6 months following
      the follow-up completion of the last patient). Total number of patients: 100. Precision
      around the expected efficacy rate (40% in intention-to-treat analysis): 9.6%.

      Treatment strategy: Peg-IFNα-2a 180microg/week for 48 weeks, Ribavirin at least 11 mg/kg/day
      for 48 weeks Main inclusion criteria: HCV RNA positive by PCR; METAVIR score : >A2 and >= F1
      or >= A1 and > F2; ALAT over 1.5*N; no prior treatment with IFNalpha, PEG-IFNalpha and
      ribavirin Main exclusion criteria : Liver disease other than hepatitis C; advanced liver
      disease; negative HCV RNA.

      Patient from a cohort follow-up conducted in a village in rural Egypt with High HCV
      prevalence (Menoufia governorate) will be proposed to participate in the trial. Pre-enrolment
      investigations, liver biopsy, and patients follow-up will be carried out at a local hospital.
      Blood test analyses will be carried out under the responsibility of Hepatitis Virology
      Reference Laboratory at the National Hepatology and Tropical Medicine Institute, Cairo; trial
      monitoring will be carried out by the Department of Community Medicine of Ain Shams;
      methodological assistance from the "Unite des Maladies Emergentes" at Pasteur Institute and
      INSERM U444, Paris.

      Treatment for patients with HCV RNA by qualitative PCR still positive after 24 weeks of the
      combination Peg-IFNα-2a with ribavirin, will be stopped.
    

Intervention name(s): pegylated interferon alpha2a; ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Genotype 4; Pegylated Interferon; Ribavirin; Egypt