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Clinical trial : exposure to ribavirin predicts EVR and SVR in patients with HCV genotype 1 infection treated with peginterferon alpha-2a plus ribavirin . BACKGROUND The impact of reduced drug exposure on outcomes in patients with chronic hepatitis C has not been determined in routine clinical practice . AIM To examine the impact of exposure to peginterferon alpha-2a and ribavirin on early virological response ( EVR ) and sustained virological response ( SVR ) in treatment-naive patients with HCV genotype 1 infection enrolled in a large expanded access programme . METHODS Eight hundred and ninety-one patients treated for 48 weeks with an initial ribavirin dose of 800 or 1000/1200 mg/day were evaluated . Ribavirin 1000 mg/day ( < 75 kg ) or 1200 mg/day ( > or=75 kg ) and peginterferon alpha-2a 180 microg/week were considered optimal . The impact of reduced drug exposure ( expressed as a percentage of optimal ) on EVR and SVR was evaluated . RESULTS Mean ribavirin exposure in week 0-12 was 70 % and 96 % in patients assigned to ribavirin 800 and 1000/1200 mg/day , respectively . EVR and SVR rates were lower in patients assigned to ribavirin 800 than 1000/1200 mg/day ( EVR , 75 % vs. 84 % , respectively , P < 0.001 ; SVR , 45 % vs. 54 % , respectively , P = 0.011 ) . Furthermore , there was a strong correlation between achievement of EVR and SVR and ribavirin dose over the first 12 weeks expressed either as absolute dose or proportion of optimal dose received ( P < 0.001 for both ) . CONCLUSIONS Ribavirin exposure to week 12 is significantly associated with EVR and SVR in genotype 1 patients . Maintenance of an optimal ribavirin dose is the most important modifiable factor during combination therapy for chronic hepatitis C .
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Intervention_Pharmacological
ribavirin dose of 800 or 1000/1200 mg/day
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Intervention_Pharmacological
Ribavirin
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Intervention_Pharmacological
peginterferon alpha-2a 180
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Outcome_Physical
reduced drug exposure
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Outcome_Physical
EVR
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Outcome_Physical
SVR
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Outcome_Other
Mean ribavirin exposure
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Outcome_Physical
EVR
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Outcome_Physical
SVR rates
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Outcome_Physical
EVR
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Outcome_Physical
SVR
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Participant_Condition
HCV genotype 1 infection
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Participant_Condition
chronic hepatitis C
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Participant_Condition
HCV genotype 1 infection
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Participant_Sample-size
Eight hundred and ninety-one