索磷布韦维帕他韦治疗慢性丙型肝炎的真实世界研究

A real-world study on the treatment of chronic hepatitis C patients with Sofosbuvir/Velpatasvir

目的评价索磷布韦维帕他韦(SOF/VEL)治疗慢性丙型肝炎(CHC)患者的疗效和安全性。方法回顾性分析2018年8月至2019年12月广州市第八人民医院门诊诊治的48例接受SOF/VEL治疗的CHC患者,疗程为12周,随访12周,观察其疗效及停药12周持续病毒学应答率(SVR12)及药物-药物间相互作用(DDI)。结果48例CHC患者治疗1、2、4、8、12周时血清HCV RNA转阴率分别为39.6%(19/48)、72.9%(35/48)、93.8%(45/48)、100.0%(48/48)和100.0%(48/48);SVR12为95.8%(46/48)。在治疗12周及停药12周时血清丙氨酸氨基转移酶(ALT)复常率分别为97.9%(47/48)、93.8%(45/48)、天冬氨酸氨基转移酶(AST)复常率分别为95.8%(46/48)、95.8%(46/48)。2例基线估算的肾小球滤过率(eGFR)<90 mL/(min·1.73 m^(2))患者未调整SOF/VEL剂量并完成疗程;1例基线eGFR正常患者在治疗8周及12周时出现eGFR下降,未调整SOF/VEL剂量并完成疗程,停药12周eGFR恢复正常;48例CHC患者中有16例同时合并其他疾病,占33.3%,其中10例患者有联合用药,联合1种药物3例,2种药物4例,3种药物1例,7种药物1例,9种药物1例,治疗期间无DDI发生。结论采用SOF/VEL治疗CHC患者可获得较高的SVR12和生化学应答,且安全性良好。

Objective To evaluate the efficacy and safety of Sofosbuvir/Velpatasvir(SOF/VEL)treatment on patients with chronic hepatitis C(CHC).Methods Forty-eight CHC patients who had received SOF/VEL treatment for 12 weeks and followed-up for 12 weeks were retrospectively analyzed.Sustained virological response(SVR)and drug-drug interactions(DDI)in these patients were observed during the 12-week’s follow-up period after drug withdrawal.Results Of the 48 patients,24 patients(50%)were HCV genotype 6a,14(29.2%)were genotype 3a,5(10.4%)were genotype 1b,4(8.3%)were genotype 3b and 1(2.1%)was genotype 2a.Four(8.3%)of the 8 patients(16.7%)with liver cirrhosis were HCV genotype 6a,2(4.2%)were genotype 3a,2(4.2%)were genotype 1b.The negative conversion rate of serum HCV RNA was 39.6%(19/48),72.9%(35/48),93.8%(45/48),100.0%(48/48)and 100.0%(48/48)respectively at 1,2,4,8 and 12 weeks of therapy.The overall SVR12 was 95.8%(46/48).The normalization rates of alanine aminotransferase(ALT)and aspartate aminotransferase(AST)was 97.9%(47/48)and 95.8(46/48)at 12 weeks of therapy,and 93.8%(45/48)and 95.8(46/48)at the 12-week’s follow-up period after drug withdrawal.Two patients whose estimated glomerular filtration rate(eGFR)less than 90 mL·min^(-1)·1.73 m^(2) at baseline had completed the treatment without adjustment of SOF/VEL dosage;One patient who had a decreased eGFR at 8,12 weeks therapy had completed the treatment without adjustment of SOF/VEL dosage,and the eGFR level returned to normal at the 12-week’s follow-up period after drug withdrawal.Among the 48 patients with CHC,16 cases were complicated with other diseases,accounting for 33.3%.Among these 16 cases,10 patients had combined medication,3 cases with 1,4 cases with 2,1 case with 3,1 case with 7,1 case with 9 kinds of drugs,without occurring DDI during their treatments.Conclusion CHC patients who received SOF/VEL treatment had a very high SVR12 and biochemical responses,and the therapy is safe.