Hepatitis C, Chronic Clinical Trial
Official title:
Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study
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.
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