XIE Ying, MA Xiao, ZHAO Yanling. Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B[J]. 2021,21(8):905-907.
XIE Ying, MA Xiao, ZHAO Yanling. Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B[J]. 2021,21(8):905-907. DOI: 10.14009/j.issn.1672-2124.2021.08.002.
OBJECTIVE: To compare the efficacy and safety between generic and original entecavir in the treatment of chronic hepatitis B. METHODS: Multi-center
retrospective real-world research. Patients with chronic hepatitis B admitted into the outpatient of three characteristic hospitals for infectious diseases from Sept. 2018 to Mar.2019 were involved
the enrolled patients were divided into entecavir generics group and original drug group
both groups were administered at a dose of 0. 5 mg/d. HBV DNA
HBV serologic markers
platelet counts
blood creatine kinase and blood creatinine levels of patients were collected at enrollment and 24 weeks of treatment. After matching by propensity score
the virological response rate
negative conversion rate of HBeAg
serological conversion rate of HBeAg
thrombocytopenia rate
creatine kinase elevation rate and creatinine elevation rate were compared between two groups. RESULTS: There were 2 471 patients in original drug group and 10 909 patients in generics group. The differences in virological response rate
negative conversion rate of HBeAg
serological conversion rate of HBeAg
thrombocytopenia rate
creatinine kinase elevation rate and creatinine elevation rate between two groups were not statistically significant( P> 0. 05). CONCLUSIONS: The efficacy and safety of generic entecavir in the treatment of patients with chronic hepatitis B were not inferior to those of the original drug.