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首页> 外文期刊>Gastroenterology >Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis
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Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis

机译：Elbasvir / Grazoprevir在丙型肝炎病毒感染和补偿肝硬化患者中的安全性和有效性：综合分析

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BACKGROUND & AIMS: Persons with hepatitis C virus (HCV) infection are at risk of progressive liver disease, cirrhosis, and decompensation. We analyzed the effects of the direct-acting antiviral agents elbasvir and grazoprevir in patients with HCV infection and compensated cirrhosis, combining data from 6 clinical trials. METHODS: We performed an integrated analysis of 402 patients with HCV genotype 1, 4, or 6 infection and Child-Pugh A compensated cirrhosis enrolled in 6 clinical trials. All patients received elbasvir/grazoprevir 50 mg/100 mg once daily, with or without ribavirin, for 12-18 weeks. The primary end point was sustained virologic response 12 weeks after completion of therapy (SVR12), defined as a level of HCV RNA <15 IU/mL. RESULTS: Among treatment-naive and treatment-experienced patients receiving elbasvir/grazoprevir for 12 weeks, 97.8% (135 of 138) and 88.9% (48 of 54) achieved SVR12, respectively. Among patients receiving elbasvir/grazoprevir for 12 weeks, addition of ribavirin did not increase the proportion of treatment-naive patients (90.3%, 28 of 31) or treatment-experienced patients who achieved an SVR12 (91.4%, 74 of 81). All (49 of 49) treatment-experienced patients receiving elbasvir/grazoprevir with ribavirin for 16 or 18 weeks, and 93.9% (46 of 49) of patients receiving elbasvir/grazoprevir without ribavirin for 16 or 18 weeks achieved SVR12. Virologic failure was higher among patients with HCV genotype 1a infections compared with patients with genotype 1b or 4 infections, particularly in patients who had not responded to previous interferon therapy. Baseline tests for resistance-associated substitutions (RASs) led to an individualized approach for selecting treatment duration and established a need for ribavirin for patients with HCV genotype 1a infection and RASs, regardless of treatment history. Among patients with HCV genotype 1a infection with and without baseline RASs in HCV nonstructural protein 5A who received elbasvir/grazoprevir for 12 weeks, 73% (8 of 11) and 98% (96 of 98) achieved SVR12, respectively. Both patients with HCV genotype 1a infection with baseline RASs who received 16 or 18 weeks of elbasvir/grazoprevir and ribavirin achieved SVR12. Grade 3 or 4 increases in levels of alanine aminotransferase and aspartate aminotransferase, which did not cause symptoms, were reported in 2.3% (6 of 264) of patients receiving elbasvir/grazoprevir. Serious adverse events were reported in 3% (8 of 264) patients and no patient had a decompensation-related event. CONCLUSIONS: In an analysis of data from 6 clinical trials, rates of SVR12 ranged from 89% to 100% in patients with HCV genotype 1, 4, or 6 infections and compensated cirrhosis treated with elbasvir/grazoprevir, with or without ribavirin. Addition of ribavirin to a 12-week regimen of elbasvir/grazoprevir had little effect on the proportion of treatment-naive or treatment-experienced patients who achieved an SVR12. However, virologic failure did not occur in any treatment-experienced patients when the duration of elbasvir/grazoprevir and ribavirin therapy was extended to 16 or 18 weeks. Baseline analysis of RASs (or in the absence of this test, a history of nonresponse to interferon) can be used to determine treatment duration and the need for ribavirin in patients with HCV genotype 1a infection.
机译：背景和目标：丙型肝炎病毒（HCV）感染的人面临进步性肝病，肝硬化和失代偿的风险。我们分析了直效抗病毒剂Elbasvir和Grazophevir在HCV感染和补偿肝硬化患者中的影响，将数据组合在6临床试验中。方法：我们对402例HCV基因型1,4或6患者进行了综合分析，患有6名临床试验的补偿肝硬化。所有患者每天一次接受Elbasvir / Grazopher 50mg / 100mg，有或没有利巴韦林，12-18周。初级终点是治疗完成（SVR12）后12周的病毒学反应，定义为HCV RNA <15IU / mL的水平。结果：在接受Elbasvir / GrazoPrevir的治疗幼稚和治疗经验丰富的患者中，97.8％（135个）和88.9％（48个）分别达到SVR12。在接受Elbasvir / Grazoprevir的患者中12周，添加利巴韦林未增加治疗幼稚患者的比例（90.3％，31个）或达到SVR12的治疗患者（91.4％，共81个中的91％）。所有（49个中的49个）治疗 - 经验丰富的患者接受Elbasvir / Grazoprevir的患者16或18周，93.9％（46个中49个）接受Elbasvir / Grazoprevir的患者，没有利巴韦林16或18周获得SVR12。 HCV基因型1A感染患者的病毒学衰竭较高，与基因型1B或4例感染的患者相比，特别是在没有反应以前干扰素治疗的患者中。抵抗相关替换（RASS）的基线试验导致了用于选择治疗持续时间的个性化方法，并为HCV基因型1A感染和RAS的患者建立了利巴韦林，无论治疗史如何。在接受Elbasvir / GrazoPrevir的HCV非结构蛋白5A中，HCV基因型1A感染和没有基线RAS的感染12周，73％（8个）和98％（98个）分别达到SVR12。患有HCV基因型的患者1a感染，患有16或18周的Elbasvir / Grazoprevir和利巴韦林的基线Rass达到SVR12。在接受Elbasvir / GrazoPrevir的患者的2.3％（664个）患者中报道了丙氨酸氨基转移酶和天冬氨酸氨基转移酶的3级或4级增加。报告了3％（共264例）患者的严重不良事件，并且没有患者有一个与失控相关的事件。结论：在临床试验中的数据分析中，SVR12的率在HCV基因型1,4或6例感染和补偿肝硬化中的89％至100％，用Elbasvir / Grazophir，有或没有利巴韦林治疗。添加利巴韦林到Elbasvir / Grazoprevir的12周的方案对达到SVR12的治疗幼稚或治疗经验丰富的患者的比例几乎没有影响。然而，当Elbasvir / GrazoPrevir和利巴韦林治疗的持续时间延长至16或18周时，任何治疗经验丰富的患者都没有发生病毒学衰竭。 RAS的基线分析（或在没有该测试的情况下，对干扰素的非响应史）可用于确定HCV基因型1A感染患者的治疗持续时间和利巴韦林的需求。

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