Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C

Phase II: Exploring the efficacy and safety of different doses of Antaitavir Hasophate combined with fixed-dose Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials.

Phase III: Confirmation of the efficacy and safety of Antaitavir Hasophate combined with Yiqibuvir in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

Inclusion criteria

• Willing and able to provide written informed consent;
• Male or female, age≥18 years;
• Body mass index (BMI)≥18.0 and≤32.0 kg/m2, and Weight≥40 kg;
• Serological detection of anti-HCV antibodies was positive at screening;
• HCV RNA≥1×104 IU/mL at Screening;
• HCV genotype 1~6, mixed genotype or indeterminate assessed at Screening by the Central Laboratory.

Exclusion criteria

• Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage);
• Chronic liver disease of a non-HCV etiology (Including but not limited to hemochromatosis, Wilson's disease,alfa-1 antitrypsin deficiency);
• Significant cardiac disease(Including but not limited to myocardial infarction, bradycardia) ;
• Psychiatric illness or psychological disease or relevant medical history;
• Solid organ transplantation;
• Subjects have any other medical disorder that may interfere with subjects treatment, assessment or compliance with the protocol.