2014年至2019年慢性丙型肝炎患者抗病毒治疗方案的变化与疗效分析

Analysis of the changes and efficacy of antiviral treatment regimens in patients with chronic hepatitis C from 2014 to 2019

目的探讨慢性丙型肝炎(chronic hepatitis C,CHC)患者抗病毒治疗方案的变化及疗效的差异。方法本研究为回顾性单中心临床研究。纳入2014年1月至2019年2月在上海复旦大学附属华山医院诊断并接受治疗的157例CHC患者,收集其抗病毒治疗和随访相关信息。比较2017年前和2017年后采用不同抗病毒治疗方案的CHC患者的持续病毒学应答(sustained virologic response,SVR)率和不良反应发生率。统计学分析采用χ^2检验。结果157例CHC患者中,133例患者有完整随访信息。2017年前治疗的患者71例,其中63例接受干扰素治疗,SVR率为74.65%(53/71);2017年后治疗的患者62例,其中61例接受直接抗病毒药物(direct-acting antiviral agents,DAA)治疗,SVR率为98.39%(61/62);2017年前治疗组SVR率低于2017年后治疗组,差异有统计学意义(χ^2=15.230,P<0.01)。2014年至2019年共69例患者接受DAA治疗,其中66例(95.65%)获得SVR12。43例接受含索磷布韦方案的患者中,15例丙型肝炎病毒基因1型患者均获得SVR12,6例基因3型患者中5例获得SVR12,其他基因型患者的SVR12率为90.91%(20/22);26例接受不含索磷布韦方案的患者均获得SVR12;两组比较差异无统计学意义(χ^2=5.243,P=0.263)。2017年前治疗组和2017年后治疗组的不良反应发生率分别为84.62%(77/91)和6.06%(4/66),差异有统计学意义(χ^2=94.520,P<0.01);主要包括中性粒细胞下降、血红蛋白降低和血小板计数下降,6例因不良反应提前终止治疗。结论随着抗病毒治疗方案由聚乙二醇干扰素联合利巴韦林方案转变为DAA方案,2017年以后进行抗病毒治疗CHC患者的SVR率升高,不良反应发生率下降。不同HCV基因型患者采用DAA治疗方案均可获得较高的SVR12率。

Objective To analyze the changes and efficacy of antiviral treatment regimens in patients with chronic hepatitis C.Methods This was a single center retrospective study.A total of 157 patients with chronic hepatitis C in Huashan Hospital,Fudan University from January 2014 to February 2019 were included.Clinical informations of antiviral treatment and follow-up were collected.The sustained virologic response(SVR)rate and adverse events in patients receiving different antiviral regimens were compared.Chi-square test was used for statistical analysis.Results Among the 157 patients,133 patients had sufficient follow-up data.Seventy-one patients received treatment before 2017,among which 63 patients received interferon regimens and the SVR rate was 74.65%(53/71).Sixty-two patients received treatment after 2017,among which 61 patients received direct-acting antiviral agents(DAA)regimens and the SVR rate was 98.39%(61/62).The difference in SVR rate between the two groups was statistically significant(χ^2=15.230,P<0.01).In 69 patients who received DAA regimens from 2014 to 2019,the SVR at post-treatment week 12(SVR12)was 95.65%(66/69).Among 43 patients who received DAA regimens containing sofosbuvir,the SVR12 rates of patients with hepatitis C virus genotype 1,3 and other genotypes were 15/15,5/6 and 90.91%(20/22),respectively.All the 26 patients who received DAA regimens non-containing sofosbuvir achieved SVR12.The SVR12 rates of patients with different hepatitis C virus genotypes and DAA regimens were not significantly different(χ^2=5.243,P=0.263).The incidences of adverse events in pre-2017 group and post-2017 group were 84.62%(77/91)and 6.06%(4/66),respectively.The difference was statistically significant(χ^2=94.520,P<0.01).The most common adverse events were decreases in neutrophil cell count,decreases in hemoglobin level and decreases in platelet count.Treatment was ceased in six patients due to adverse events.Conclusions After 2017,the majority of patients with chronic hepatitis C received DAA regimens instead of interferon regimens.The SVR rate increases and the incidence of adverse events decreases along with the changes of leading treatment regimens.The SVR12 rate is higher in patients receiving DAA regimens,regardless of hepatitis C virus genotypes.