This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 16 weeks
1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 24 weeks
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
RECRUITINGSoon Chun Hyang University Bucheon Hospital
Bucheon-si, South Korea
RECRUITINGPusan National University Hospital
Busan, South Korea
Sustained virologic response (SVR)
Time frame: 24 weeks post-treatment (week 40 or week 48)
AEs
1. 16 weeks treatment arm: 40 weeks 2. 24 weeks treatment arm: 48 weeks
Time frame: up to 24 weeks after last treatment visit
laboratory parameters
1. 16 weeks treatment arm: 40 weeks 2. 24 weeks treatment arm: 48 weeks
Time frame: up to 24 weeks after last treatment visit
vital signs
1. 16 weeks treatment arm: 40 weeks 2. 24 weeks treatment arm: 48 weeks
Time frame: up to 24 weeks after last treatment visit
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Inje University Pusan Paik Hospital
Busan, South Korea
RECRUITINGInje University Haeundae Paik Hospital
Busan, South Korea
RECRUITINGInje University Ilsan Paik Hospital
Goyang, South Korea
ACTIVE_NOT_RECRUITINGIncheon St. Mary's Hospital
Incheon, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITING