Hepatitis C, Chronic Clinical Trial
Official title:
Evaluation of Efficacy and Safety of KW-136 Plus Sofosbuvir for Treatment-naive Adults Chronically Infected With Hepatitis C Virus: a Randomized, Open-label, Multicenter Phase 2 Trial
This study aimed to evaluate the safety and efficacy of KW-136, an investigational anti-hepatitis C virus (HCV) drug, combined with sofosbuvir for treatment of Chinese adults chronically infected with HCV. Thirty (30) non-cirrhotic subjects were medicated with KW-136 30 mg daily, 60 non-cirrhotic subjects with KW-136 60 mg daily, and 30 cirrhotic subjects with KW-136 60 mg daily; all the 120 subjects received sofosbuvir 400 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. 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, namely, HCV not detected or below a predefined limit in plasma, 12 or 24 weeks
after cessation of treatment.
As KW-136 and sofosbuvir are both pan-genotypic anti-HCV agents (in simple words, effective
for all known common genotypes of HCV), the combination of these two agents is also supposed
to be efficacious for treatment of subjects chronically infected with HCV of all major
genotypes and subtypes. An apparent clinical benefit of this pan-genotypic anti-HCV treatment
regimen is that no complex, delicate HCV genotype sequencing is required before initiation of
treatment to determine genotype-specific treatment alternatives of choice. This advantage is
of great significance in the primary care setting.
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