Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to
      treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to
      conventional interferon monotherapy. Recent reports showed that pegylated interferon and
      ribavirin combination therapy markedly increased the SVR rate to 55-70%. The duration of
      treatment has not been accurately defined. The main objective of this is to assess the
      duration of pegylated interferon ribavirin therapy in chronic hepatitis genotype 4 and assess
      the clinical utility of rapid and early virologic response in determining the optimal
      duration of peg interferon ribavirin therapy in chronic hepatitis C.
    

Detailed description: 
      Hepatitis C virus (HCV) genotype 4 is the most frequent cause of chronic hepatitis C in
      Middle East, North Africa and sub-Saharan Africa. In countries like Egypt, 73 to 90% of cases
      of chronic hepatitis C are caused by genotype 4. Recently, epidemiological reports showed
      spread of HCV-4 infection in Western countries such as France, Italy, Greece, Spain and the
      United States particularly among intravenous drug users.

      Genotype 4 is the least-studied hepatitis C virus genotype and was considered a difficult to
      treat genotype due to the disappointing response of chronic hepatitis C genotype 4 to
      conventional interferon monotherapy. Recent reports showed that pegylated interferon and
      ribavirin combination therapy markedly increased the SVR rate to 55-70%. We have previously
      shown that, treatment patients with chronic HVCG4with PEG-IFN α-2b plus ribavirin for 36 or
      48 weeks was more effective (SVR 66% and 69%, respectively) than for 24 weeks.

      It has been shown in previous studies on chronic hepatitis C genotype 1 that individuals who
      achieve an early virologic have a higher chance to achieve a sustained virologic response.
      Peg interferon and ribavirin therapy is associated with adverse events and is expensive;
      therefore, careful determination of the optimal treatment duration is crucial as it spares
      the patient unnecessary or prolonged therapy and enhances the cost-effectiveness of therapy.

      Therefore the main objective of this randomized, multicenter trial is to assess the clinical
      utility of rapid and early virologic response in determining the optimal duration of peg
      interferon ribavirin therapy in chronic hepatitis C.
    

Intervention name(s): Pegylated IFN- alpha 2b; Ribavirin
Intervention type(s): Drug; Drug
Other intervention name(s): PEG-IFN alpha-2b; PEG-Intron™; Rebetol; Virin; Ribavrin
Intervention MeSH terms: Ribavirin; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic hepatitis C;; peg-interferon alfa-2b;; ribavirin,; rapid virologic response,; sustained virological response