A phase Ⅱ clinical study of the efficacy and safety of antaitasvir phosphate combined with yiqibuvir for the treatment of chronic hepatitis C in adults
Objective To evaluate the efficacy and safety of antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir for 12 weeks in patients with various genotypes of chronic hepatitis C,without cirrhosis or compensated stage cirrhosis.Methods Patients with chronic hepatitis C(without cirrhosis or compensated stage cirrhosis)were randomly assigned to the antaitasvir phosphate 100 mg+yiqibuvir 600 mg group(100 mg group)or the antaitasvir phosphate 200 mg+yiqibuvir 600 mg group(200 mg group)in a 1∶1 ratio.The drugs were continuously administered once a day for 12 weeks and observed for 24 weeks after drug withdrawal.The drug safety profile was assessed concurrently with the observation of the sustained virological response(SVR12)in the two patient groups 12 weeks following the drug cessation.The intention-to-treat concept was used to define as closely as possible a full analysis set,including all randomized cases who received the experimental drug at least once.The safety set was collected from all subjects who received the experimental drug at least once(regardless of whether they participated in the randomization group)in this study.All efficacy endpoints and safety profile data were summarized using descriptive statistics.The primary efficacy endpoint was SVR12.The primary analysis was performed on a full analysis set.The frequency and proportion of cases were calculated in the experimental drug group(antaitasvir phosphate capsules combined with yiqibuvir tablets)that achieved"HCV RNA＜lower limit of quantification."The safety profile analysis was summarized based on the safety analysis set.Results A total of 120 cases were enrolled,with 59 in the 100 mg group and 61 in the 200 mg group.119 subjects completed the study,and one subject withdrew early due to a loss of follow-up.Three subjects had a virological recurrence.The results of the full analysis set showed that the overall SVR12 was 96.7％(116/120),with 98.3％(58/59)in the 100 mg group and 95.1％(58/61)in the 200 mg group.The overall SVR12 of subjects with compensated stage cirrhosis was 100％(14/14),while those without cirrhosis had 96.2％(102/106).Among them,the SVR12 of subjects without cirrhosis in the 100 mg group was 98.1％(52/53),and in the 200 mg group,it was 94.3％(50/53).A total of 55.0％of subjects had treatment-emergent adverse events(TEAEs).A total of 33.3％of subjects had TEAEs occurrences related to the experimental drug.The TEAE incidences in the two groups were comparable.Hyperuricemia and hypercholesterolemia were TEAEs associated with the experimental drug,with an incidence rate of ≥5％.There were no TEAEs occurrences with a CTCAE grade ≥3 and severity that were causing treatment suspension or cessation,termination,early withdrawal,or death with relation to the experimental drug.Conclusion Antaitasvir phosphate 100 mg or 200 mg combined with yiqibuvir 600 mg has apparent efficacy and a good safety profile in subjects with various genotypes of chronic hepatitis C,without cirrhosis or compensated stage cirrhosis.
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