Efficacy and Safety of Pegylated Interferon Plus Ribavirin Therapy for Chronic Hepatitis C Genotype 6: A Meta-Analysis

BackgroundHepatitis C genotype 6 (HCV-6) is prevalent in Southeast Asia. Data on the efficacy of direct-acting antiviral agents in chronic HCV-6 patients is limited and pegylated interferon (Peg-IFN) plus ribavirin (RBV) combination therapy remains standard therapy for those patients.AimMeta-analysis was performed to assess the efficacy and safety of Peg-IFN plus RBV combination therapy for chronic HCV-6 patients.MethodsRelevant studies were found by database search through Medline, Embase, Web of Science and The Cochrane Library. All published clinical trials assessing the efficacy of Peg-IFN plus RBV combination therapy for chronic HCV-6 patients were included. Sustained virological response rate (SVR) was pooled. We performed additional meta-analyses to compare the SVR outcomes of 24 versus 48 weeks of treatment in four head-to-head trials. Another second meta-analysis was also conducted to compare the efficacy of combination Peg-IFN plus RBV therapy in HCV-6 versus HCV-1 patients.ResultsThirteen studies met the inclusion criteria. The pooled SVR of all single arms was 75% (95% CI: 0.68–0.81). The SVR of 24 weeks treatment was significantly lower than that at 48 weeks, with a risk difference of −14% (95% CI: −0.25 to −0.02, p = 0.02). However, when restricted to the patients with rapid virological response (RVR), there was no significant effect on SVR between these two treatment groups, with a risk difference of −1% (95% CI: −0.1 to 0.07, p = 0.67). The SVR in HCV-6 patients was significantly higher than that in HCV-1 patients, with a relative risk of 1.35 (95% CI: 1.16–1.57, pConclusionsThe results of this meta-analysis suggest that Peg-IFN plus RBV is effective and safe for HCV-6 patients. Shortening treatment seems to be feasible in HCV-6 patients with RVR when tolerance to treatment is poor. However, this decision should be made cautiously.

背景：丙型肝炎病毒基因型6型（HCV-6）在东南亚地区流行。目前关于直接抗病毒药物（direct-acting antiviral agents）治疗慢性HCV-6感染者的疗效数据较为有限，聚乙二醇化干扰素（Peg-IFN）联合利巴韦林（RBV）仍是该类患者的标准治疗方案。研究目的：本研究通过荟萃分析评估聚乙二醇化干扰素联合利巴韦林治疗慢性HCV-6感染者的疗效与安全性。方法：通过Medline、Embase、Web of Science及Cochrane图书馆数据库进行文献检索，纳入所有评估聚乙二醇化干扰素联合利巴韦林治疗慢性HCV-6感染者疗效的已发表临床试验，合并计算持续病毒学应答率（sustained virological response, SVR）。此外，针对4项头对头临床试验开展额外荟萃分析，对比24周与48周治疗方案的SVR结局；同时开展另一项荟萃分析，比较HCV-6感染者与HCV-1感染者接受聚乙二醇化干扰素联合利巴韦林治疗的疗效差异。结果：共计13项研究符合纳入标准。所有单一治疗组的合并SVR为75%（95%置信区间：0.68~0.81）。24周治疗组的SVR显著低于48周治疗组，风险差为-14%（95%置信区间：-0.25~-0.02，p=0.02）。但当仅纳入存在快速病毒学应答（rapid virological response, RVR）的患者时，两组间的SVR无显著差异，风险差为-1%（95%置信区间：-0.1~0.07，p=0.67）。HCV-6感染者的SVR显著高于HCV-1感染者，相对风险为1.35（95%置信区间：1.16~1.57，p）。结论：本荟萃分析结果表明，聚乙二醇化干扰素联合利巴韦林用于HCV-6感染者安全有效。对于治疗耐受性较差且存在快速病毒学应答的HCV-6感染者，缩短治疗疗程似乎具备可行性，但相关决策应谨慎制定。