临床肝胆病杂志2025，Vol.41Issue(6)：1075-1082,8.DOI:10.12449/JCH250612
盐酸可洛派韦联合索磷布韦治疗基因3型HCV感染者的效果及安全性分析
Efficacy and safety of coblopasvir hydrochloride combined with sofosbuvir in treatment of patients with genotype 3 hepatitis C virus infection
摘要
Abstract
Objective To investigate the efficacy and safety of the direct-acting antiviral agents coblopasvir hydrochloride/sofosbuvir(CLP/SOF)regimen used alone or in combination with ribavirin(RBV)in the treatment of patients with genotype 3 hepatitis C virus(HCV)infection in terms of virologic response rate,liver function recovery,improvement in liver stiffness measurement(LSM),and adverse drug reactions,and to provide a reference for clinical medication.Methods A total of 98 patients with genotype 3 HCV infection who attended The Third People's Hospital of Kunming from January 2022 to December 2023 were enrolled,and according to the treatment method,the patients were divided into CLP/SOF+RBV treatment group with 55 patients and CLP/SOF treatment group with 43 patients.The patients were observed in terms of rapid virologic response at week 4(RVR4),sustained virologic response(SVR),previous treatment experience,underlying diseases,laboratory and imaging indicators,and adverse reactions during treatment.The course of treatment was 12 weeks,and the patients were followed up for 12 weeks after drug withdrawal.The independent-samples t test was used for comparison of normally distributed continuous data between two groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups;the Friedman test was used for comparison within each group at different time points,and the Bonferroni method was used for further comparison and correction of P value;the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups.The univariate and multivariate Logistic regression analyses were used to investigate the influencing factors for SVR12.Results Before treatment,there were significant differences between the CLP/SOF+RBV treatment group and the CLP/SOF treatment group in terms of LSM,total bilirubin(TBil),gamma-glutamyl transpeptidase(GGT),HCV genotype,and the presence or absence of liver cirrhosis and compensation(all P<0.05).The 98 patients with genotype 3 HCV infection had an RVR4 rate of 81.6%and an SVR12 rate of 93.9%.The patients with genotype 3a HCV infection had an RVR4 rate of 84.44%and an SVR12 rate of 97.78%,while the patients with genotype 3b HCV infection had an RVR4 rate of 79.25%and an SVR12 rate of 90.57%.There were significant differences in RVR4 and SVR12 rates between the patients without hepatocellular carcinoma and those with hepatocellular carcinoma,there was a significant difference in RVR4 rate between the patients without HIV infection and those with HIV infection,and there was a significant difference in SVR12 rate between the previously untreated patients and the treatment-experienced patients(all P<0.05).The univariate Logistic regression analysis showed that treatment history,hypertension,hepatocellular carcinoma,ascites,albumin(Alb),and platelet count were influencing factors for SVR12(all P<0.05),and the multivariate Logistic regression analysis showed that hepatocellular carcinoma(odds ratio=0.034,95%confidence interval:0.002-0.666,P=0.026)was an independent influencing factor for SVR12.After treatment with CLP/SOF combined with RBV or CLP/SOF alone,the patients with genotype 3 HCV infection showed gradual reductions in the liver function parameters of TBil,GGT,and alanine aminotransferase(all P<0.05)and a gradual increase in the level of Alb(P<0.05).As for renal function,there were no significant changes in blood urea nitrogen and creatinine after treatment(P>0.05).For the patients with or without liver cirrhosis,there was a significant reduction in LSM from baseline after treatment for 12 weeks(P<0.05).Among the 98 patients with genotype 3 HCV infection,9 tested positive for HCV-RNA at 12 weeks after treatment,2 showed no response during treatment,4 showed virologic breakthrough,and 3 experienced recurrence.The overall incidence rate of adverse events during treatment was 17.35%for all patients.Conclusion CLP/SOF alone or in combination with RBV has a relatively high SVR rate in the treatment of genotype 3 HCV infection,with good tolerability and safety in patients during treatment,and therefore,it holds promise for clinical application.关键词
丙型肝炎,慢性/基因3型/盐酸可洛派韦/索磷布韦/治疗结果Key words
Hepatitis C,Chronic/Genotype 3/Coblopasvir/Sofosbuvir/Treatment Outcome引用本文复制引用
张映媛,木唤,许丹青,牟春燕,王远珍,刘春云,李卫昆,刘立..盐酸可洛派韦联合索磷布韦治疗基因3型HCV感染者的效果及安全性分析[J].临床肝胆病杂志,2025,41(6):1075-1082,8.基金项目
佑安专科联盟科研专项基金(LM202014) Research Special Fund of You'an Vocational Alliance(LM202014) （LM202014）
