The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection

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:

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

Exclusion Criteria:

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