艾尔巴韦/格拉瑞韦治疗慢性丙型肝炎患者疗效初步观察

Virological response to erbavir/gragrevir treatment in patients with chronic hepatitis C

目的初步探讨应用艾尔巴韦/格拉瑞韦治疗慢性丙型肝炎(CHC)患者的疗效。方法2017年3月~2018年3月仙桃市第一人民医院感染病科收治的CHC患者82例,被随机分为对照组41例和观察组41例,分别给予聚乙二醇干扰素-α联合利巴韦林治疗和艾尔巴韦/格拉瑞韦治疗,两组均连续治疗24周。采用RT-PCR法检测血清HCV RNA,采用全基因序列测定法行病毒基因分型。比较两组早期病毒学应答(EVR)、治疗结束时病毒学应答(ETVR)和持续病毒学应答(SVR)。结果在治疗结束时,观察组血清丙氨酸氨基转移酶(ALT)水平为(47.9±19.7)U/L,显著低于对照组【(63.5±21.2)U/L,P<0.05】,天冬氨酸氨基转移酶(AST)水平为(55.5±22.3)U/L,显著低于对照组【(81.3±25.8)U/L,P<0.05】;观察组EVR、ETVR和SVR分别为48.8%、63.4%和70.7%,与对照组的41.5%、53.7%和65.8%比,无统计学差异(P>0.05);18例观察组非HCVⅠ型感染者EVR、ETVR和SVR分别为88.9%、94.4%和88.9%,显著高于同组23例HCVⅠ型感染者(分别为52.2%、60.9%和52.2%,P<0.05),而与对照组15例非HCVⅠ型感染者比,无统计学差异(分别为86.7%、93.3%和73.3%,P>0.05);观察组SVR 12为87.8%(36/41),显著高于对照组的73.2%(30/41,P<0.05)。结论应用直接抗病毒(DAA)药物艾尔巴韦/格拉瑞韦治疗CHC患者近期疗效达到,但远期疗效似优于标准治疗方案,值得临床进一步验证。

Objective The aim of this study was to investigate the virological response to direct antiviral agents(DAA),erbavir/gragrevir treatment in patients with chronic hepatitis C(CHC).Methods 82 patients with CHC were recruited in this study between March 2017 and March 2018,and were randomly divided into control(n=41)and observation group(n=41).The patients in the control group were treated with peginterferon-αand ribavirin combination,and those in the observation group were given erbavir/gragrevir.The regimen in the two groups lasted for 24 weeks.Serum HCV RNA was detected by RT-PCR,and virologic genotypes were determined by direct sequencing.The efficacy was assessed by early virological response(EVR),end-of-treatment response(ETVR)and sustained virological response(SVR).Results At the end of the treatment,serum alanine aminotransaminase level in the observation group was(47.9±19.7)U/L,much lower than【(63.5±21.2)U/L,P<0.05】,serum aspartate transaminase level was(55.5±22.3)U/L,significantly lower than【(81.3±25.8)U/L,P<0.05】in the control group;the EVR,ETVR and SVR in the DAA-treated group were 48.8%,63.4%and 70.7%,not significantly different as compared to 41.5%,53.7%and 65.8%in interferon-α-treated group(P>0.05);the EVR,ETVR and SVR in 18 patients with non-HCV genotypeⅠinfection receiving DAA were 88.9%,94.4%and 88.9%,significantly higher than 52.2%,60.9%and 52.2%(P<0.05)in 23 patients with HCV typeⅠinfection,while they were not significantly different compared to 86.7%,93.3%and 73.3%in 15 patients receiving interferon-αtreatment(P>0.05);the SVR 12 in DAA-treated patients was 87.8%(36/41),significantly higher than 73.2%(30/41,P<0.05)in patients receiving interferon-αtreatment.Conclusion The elbavir/gragrevir,a new DAAs,administration in the treatment of patients with CHC have a good short-term efficacy,which warrants further multi-centre,randomized,and control study.