This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment course lasted 12 successive weeks; thereafter all the study participants entered into a 12-week treatment-free follow-up period and an additional 12-week extension 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. A simple, universal, non-genotype-specific treatment regimen is preferred for anti-HCV treatment in clinical practice and public health. KW-136 and sofosbuvir are potent anti-HCV agents targeting at different HCV proteins, namely, nonstructural protein 5A and 5B, respectively. The combination regimen of KW-136 and sofosbuvir is expected to completely suppress HCV replication in subjects chronically infected with HCV and achieve a sustained virologic response (SVR12), namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks after cessation of treatment. In a previous phase 2 exploratory study, an all-oral, ribavirin-free regiment of KW-136, an investigational HCV NS5A inhibitor, combined with sofosbuvir, demonstrated a \~99% SVR12 in treatment-naive adult subjects chronically infected with major genotypes of HCV found in China, including those with compensatory cirrhosis. This phase 3 study aimed to confirm the efficacy and safety of this combined regimen in a large scale of target patient population, including interferon-experienced subjects. This simple, uniform regimen is expected to be the solution to HCV eradication in China from the perspective of public health.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
KW-136 60 mg was provided in a single capsule of 60 mg.
Sofosbuvir was provided in a single tablet of 400 mg.
Chinese PLA 302 Hospital
Beijing, Beijing Municipality, China
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
371
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
Chinese PLA Third Military Medical University First Affiliated Hospital
Chongqing, Chongqing Municipality, China
Chongqing Sanxia Central Hospital
Wanzhou, Chongqing Municipality, China
Sun Yat-sen University Affiliated Third University
Guangzhou, Guangdong, China
Guangzhou Municipal Eighth People's Hospital
Guanzhou, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
He'nan Provincial Hospital of Infectious Disease (Zhengzhou Municipal Sixth People's Hospital)
Zhengzhou, He'nan, China
...and 9 more locations
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