Chronic Hepatitis C Clinical Trial
Official title:
Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
The purposes of this study are:
1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in
combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV)
genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a
rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of
treatment).
2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon
alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve
chronic hepatitis C patients who have no RVR.
The recommended regimen for treating HCV genotype 2 patients is peginterferon plus low dose
ribavirin (800 mg/day) for 24 weeks. Recently studies have demonstrated that a shorter
treatment duration of 12-16 weeks of peginterferon plus standard weight-based dose of
ribavirin (800-1400 mg/day) is as effective as a 24-week regimen among HCV genotype 2
patients with a RVR at week 4 of treatment (rate of sustained virological response, SVR,
approximately 90%). However, for patients without a RVR at week 4 the efficacy of 24 week
treatment remains unsatisfied. Individualized therapy with tailored regimen according to
baseline and on-treatment virological factors, without compromising efficacy, is the future
strategy in the management of chronic hepatitis C.
The aims of the present study are
1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in
combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV)
genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a
rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of
treatment).
2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon
alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve
chronic hepatitis C patients who have no RVR.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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