Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review.
Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review.
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DOI：
10.7326/m16-2575
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发表时间：
2017-05-02
影响因子：
39.2
通讯作者：
Sulkowski MS
中科院分区：
文献类型：
--
作者：
Falade-Nwulia O;Suarez-Cuervo C;Nelson DR;Fried MW;Segal JB;Sulkowski MS
丙型肝炎病毒（HCV）治疗的快速进步使得美国食品药品监督管理局（FDA）批准了多种口服直接作用抗病毒（DAA）方案用于慢性丙型肝炎感染的治疗。
总结已发表的关于口服直接作用抗病毒药物治疗慢性丙型肝炎感染者的疗效和安全性的文献。
从建库至2016年11月1日的MEDLINE和EMBASE数据库。
42项针对丙型肝炎感染成人的对照和单组注册临床试验的英文研究，这些研究评估了至少8周的包含至少两种直接作用抗病毒药物的经美国食品药品监督管理局批准的无干扰素丙型肝炎治疗方案。
两名研究者依次提取关于研究设计、患者特征以及病毒学和安全性结果的数据，并独立评估质量。
六种直接作用抗病毒药物方案在无肝硬化的丙型肝炎基因1型感染患者（包括合并感染人类免疫缺陷病毒的患者）中显示出高持续病毒学应答（SVR）率（>95%）。丙型肝炎基因3型感染的有效治疗方法有限（两种直接作用抗病毒药物方案）。肝功能失代偿患者，特别是Child - Turcotte - Pugh C级疾病患者，其持续病毒学应答率（78% - 87%）低于其他人群。对于某些直接作用抗病毒药物方案和患者群体，添加利巴韦林与持续病毒学应答率提高相关。严重不良事件和治疗中断的总体发生率较低（一般人群中<10%）；包含利巴韦林的方案比不含利巴韦林的方案有更多轻度或中度不良事件。
23项研究存在中等偏倚风险（10项为开放标签单组试验，11项关于分配方案隐藏的信息有限，5项有选择性结果报告）。除1项外，所有研究均由企业资助。干预措施的异质性妨碍了汇总分析。
多种口服直接作用抗病毒药物方案在治疗丙型肝炎基因1型感染方面显示出高安全性、耐受性和疗效，特别是在无肝硬化患者中。
患者为中心的结果研究所。（PROSPERO：CRD42014009711）
Rapid improvements in hepatitis C virus (HCV) therapy have led to the approval of multiple oral direct-acting antiviral (DAA) regimens by the U.S. Food and Drug Administration (FDA) for treatment of chronic HCV infection. To summarize published literature on the efficacy and safety of oral DAAs for treatment of persons with chronic HCV infection. MEDLINE and EMBASE from inception through 1 November 2016. 42 English-language studies from controlled and single-group registered clinical trials of adults with HCV infection that evaluated at least 8 weeks of an FDA-approved interferon-free HCV regimen that included at least 2 DAAs. Two investigators abstracted data on study design, patient characteristics, and virologic and safety outcomes sequentially and assessed quality independently. Six DAA regimens showed high sustained virologic response (SVR) rates (>95%) in patients with HCV genotype 1 infection without cirrhosis, including those with HIV co-infection. Effective treatments for HCV genotype 3 infection are limited (2 DAA regimens). Patients with hepatic decompensation, particularly those with Child–Turcotte–Pugh class C disease, had lower SVR rates (78% to 87%) than other populations. The addition of ribavirin was associated with increased SVR rates for certain DAA regimens and patient groups. Overall rates of serious adverse events and treatment discontinuation were low (<10% in the general population); regimens that included ribavirin had more mild or moderate adverse events than those without. Twenty-three studies had moderate risk of bias (10 were open-label single-group trials, 11 had limited information on concealment of the allocation scheme, and 5 had selective outcome reporting). All but 1 of the studies were industry-funded. Heterogeneity of interventions precluded pooling. Multiple oral DAA regimens show high rates of safety, tolerability, and efficacy for treatment of HCV genotype 1 infection, particularly among persons without cirrhosis. Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42014009711)