Hepatitis C Clinical Trial
Official title:
Role of Rapid Virologic Response in Determining Treatment Duration of Peginterferon Alfa-2b/Ribavirin in Chronic Hepatitis C Genotype 4
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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