sofosbuvir/ledipasvir方案治疗HCV 6a型慢性丙型肝炎的临床效果和安全性

目的 探讨sofosbuvir/ledipasvir(SOF+LDV)治疗HCV6a型慢性丙型肝炎的效果和安全性。方法 本研究为前瞻性观察研究,纳入2014年10月到2016年12月在河南省人民医院及南方医院感染科就诊的63例HCV6a型慢性丙型肝炎患者。将所纳入患者分为2组,分别给予SOF+LDV12周、PEG-IFN联合利巴韦林(PR)24周抗病毒治疗。在治疗期间及治疗终止后随访检测HCVRNA,评价病毒学应答。计数资料2组间比较采用χ2检验;计量资料2组间比较采用Mann-WhitneyU检验。结果 PR组和SOF+LDV组患者的快速病毒学应答率(85.3%vs100%)、治疗结束时病毒学应答率(94.1%vs100%)差异均无统计学意义(P值均>0.05)。SOF+LDV组持续病毒学应答率为96.4%,显著高于PR组的73.5%(χ2=4.38,P=0.036)。PR组总体不良反应发生率明显高于SOF+LDV组(χ2=7.54,P=0.006)。SOF+LDV组后续随访有1例肝硬化患者发生小肝癌。而PR组至随访截止时间无1例患者发生肝癌。结论 SOF+LDV12周治疗HCV6a型慢性丙型肝炎是高效和安全的,但肝硬化患者应注意检测肝癌的发生。

Clinical effect and safety of sofosbuvir-ledipasvir regimen in treatment of patients with HCV genotype 6a chronic hepatitis C

ObjectiveTo investigate the clinical effect and safety of sofosbuvir (SOF)-ledipasvir (LDV) in the treatment of patients with HCV genotype 6a chronic hepatitis C (CHC). MethodsA total of 63 patients with HCV genotype 6a CHC who visited Department of Infectious Diseases, Henan Provincial People’s Hospital and Nanfang Hospital, from October 2014 to December 2016 were enrolled in this prospective observational study. They were divided into SOF-LDV group (treated with SOF-LDV for 12 weeks) and PR group (treated with pegylated interferon combined with ribavirin for 24 weeks). HCV RNA was measured during treatment and follow-up, and virologic response was evaluated. The chi-square test was used for comparison of categorical data between two groups, and the Mann-Whitney U test was used for comparison of continuous data between two groups. ResultsThere were no significant differences between the PR group and the SOF-LDV group in rapid virologic response rate (85.3% vs 100%, P >0.05) and virologic response rate at the end of treatment (94.1% vs 100%, P >0.05). The SOF-LDV group had a significantly higher sustained virologic response rate than the PR group (96.4% vs 73.5%,χ 2=4.38, P =0.036). The PR group had a significantly higher incidence rate of adverse events than the SOF-LDV group(χ 2=7.54,P=0.006 ). During follow-up, one patient with liver cirrhosis in the SOF-LDV group developed small hepatocellular carcinoma, while no patient in the PR group developed liver cancer at the end of follow-up. ConclusionSOF-LDV for 12 weeks is safe and effective in the treatment of HCV genotype 6a CHC, but liver cancer should be closely monitored in patients with liver cirrhosis.