This study aimed to evaluate the safety and efficacy of generic sofosbuvir, an investigational anti-hepatitis C virus (HCV) drug, combined with weight-adjusted ribavirin for treatment-naive Chinese adults chronically infected with genotype 2 HCV, the second most prevalent genotype in China. One hundred and thirty-two (132) subjects, including one hundred and twenty (120) non-cirrhotics and twelve (12) compensatory cirrhotics, were medicated with sofosbuvir 400 mg daily combined with weight-adjusted ribavirin 1000-1200 mg daily. The treatment course lasted 12 successive weeks and thereafter all the study participants entered into a 12-week treatment-free follow-up period.
It is estimated that China has a population of over 10 million infected with HCV and also a highly variable HCV genotype geographic distribution. Genotype 2 HCV is reported to be the second most common type (\~25%) in Chinese population and associated with a high risk of acute liver disease exacerbation and other extrahepatic diseases. Sofosbuvir is a pan-genotypic HCV ribonucleic acid (RNA) polymerase inhibitor directing at HCV RNA replication. Genotype 2 chronic hepatitis C has a high treatment response to the combined regimen of peginterferon and weight-adjusted ribavirin. The all-oral combination regimen of sofosbuvir and ribavirin is expected to completely suppress genotype 2 HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
136
Generic sofosbuvir tablet 400 mg
Ribavirin was provided in 100-mg tablets.
Chinese PLA 302 Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Capital Medical University Affiliated Beijing Youyi Hospital
Beijing, Beijing Municipality, China
Capital Medical University Affiliated Beijing You'an Hospital
Beijing, Beijing Municipality, China
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Chongqing Medical University Affiliated Second Hospital
Chongqing, Chongqing Municipality, China
Chinese PLA Third Military Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, China
He'nan Provincial People's Hospital
Zhengzhou, He'nan, China
He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)
Zhengzhou, He'nan, China
Hebei Medical University Affiliated Third Hospital
Shijiazhuang, Hebei, China
...and 7 more locations
Sustained virologic response at 12 weeks after end of treatment (SVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 12 weeks after end of treatment
Sustained virologic response at 4 weeks after end of treatment (SVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 4 weeks after end of treatment
Rapid virologic response at 1 week after initiation of treatment (RVR1)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 1 week after initiation of treatment
Rapid virologic response at 2 weeks after initiation of treatment (RVR2)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 2 weeks after initiation of treatment
Rapid virologic response at 4 weeks after initiation of treatment (RVR4)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 4 weeks after initiation of treatment
Rapid virologic response at 8 weeks after initiation of treatment (RVR8)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 8 weeks after initiation of treatment
Rapid virologic response at 12 weeks after initiation of treatment (RVR12)
Percentage of subjects with plasma HCV not detected or below the lower limit of quantitation (15 IU/mL)
Time frame: 12 weeks after initiation of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.