Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed. In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (\<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment. Our hypothesis is that there is no important difference in the effect in the two groups. This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Panyu People's Hospital
Guangzhou, Guangdong, China
Zhongshan second people's hospital
Zhongshan, Guangdong, China
Sustained virological response (SVR)
Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment
Time frame: 24 weeks after the end of treatment
Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
Time frame: 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment
Time frame: 48 weeks
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patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks