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首页> 外文期刊>International Journal of Women s Health >Elbasvir/grazoprevir in women with hepatitis C virus infection taking oral contraceptives or hormone replacement therapy
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Elbasvir/grazoprevir in women with hepatitis C virus infection taking oral contraceptives or hormone replacement therapy

机译：Elbasvir / Grazoprevir在患有丙型肝炎病毒感染的妇女服用口服避孕药或激素替代疗法

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Introduction: Some direct-acting antiviral regimens for hepatitis C virus (HCV) infection pose safety or efficacy concerns if coadministered with drugs containing ethinyl estradiol. The present analysis was conducted to examine the impact of concomitant oral contraceptive pills (OCP) or hormone replacement therapy (HRT) during treatment with elbasvir (EBR)/grazoprevir (GZR) in women with HCV genotype (GT)1 or GT4 infection. Methods: This is a post hoc, integrated retrospective analysis of female participants with HCV GT1 or GT4 infection who received EBR 50?mg/GZR 100?mg once daily for 12?weeks in phase 2/3 clinical trials. The primary end point was sustained virologic response at 12?weeks after therapy completion (SVR12). For this analysis, participants were stratified according to whether they received OCP or HRT during the original treatment study. Results: A total of 1,022 women with HCV GT1 or GT4 infection were included (receiving OCP/HRT, n=81; not receiving OCP/HRT, n=941). Most participants receiving OCP/HRT were treatment-naive (79%), noncirrhotic (91.4%), and aged 35?years (71.6%). SVR12 rates were similar in women receiving OCP/HRT and those not receiving OCP/HRT (95.1% vs 96.3%). SVR12 rates remained high across all subgroups within the population receiving OCP/HRT: SVR12 rates were 94.6%, 100%, and 100% in participants with GT1a, GT1b, and GT4 infection, and all women aged 18–35?years achieved SVR (21/21). Treatment-related adverse events occurred in 40.7% (33/81) and 30.1% (283/941) of women receiving and those not receiving OCP/HRT, respectively. Conclusion: The efficacy and safety of EBR/GZR administered for 12?weeks was similar in women receiving OCP/HRT and those not on OCP/HRT. These data indicate that EBR/GZR can be safely used for the treatment of HCV GT1 or GT4 infection in women receiving concomitant OCP/HRT.
机译：介绍：一些直接抗病毒治疗型丙型肝炎病毒（HCV）感染姿势安全性或疗效涉及，如果共同含有含有乙炔雌二醇的药物。进行本分析以检测伴随口腔避孕药（OCP）或激素替代治疗（HRT）在用HCV基因型（GT）1或GT4感染的妇女治疗过程中的伴随口腔避孕药（ECP）或激素替代治疗（HRT）的影响。方法：这是HCV GT1或GT4感染的女性参与者的综合回顾性分析，均每日收到EBR 50.MG / GZR 100？MG在2/3期临床试验中每天一次。主要终点在治疗完成后12个？持续的病毒学反应（SVR12）。对于这种分析，参与者根据在原始治疗研究中是否接受OCP或HRT来分层。结果：包括1,022名患有HCV GT1或GT4感染的妇女（接受OCP / HRT，N = 81;未接受OCP / HRT，N = 941）。大多数接受OCP / HRT的参与者是治疗 - 幼稚（79％），非增长率（91.4％），岁月为35岁（71.6％）。在接受OCP / HRT的女性中，SVR12率类似于接受OCP / HRT的速率相似（95.1％与96.3％）。在接受OCP / HRT的人口中的所有亚组中，SVR12率仍然很高：SVR12率为GT1A，GT1B和GT4感染的参与者中的94.6％，100％和100％，所有女性均为18-35岁的女性达到SVR（ 21/21）。治疗相关的不良事件发生在40.7％（33/81）和30.1％（283/941）的妇女接受和未接受OCP / HRT的那些。结论：埃布/ GZR的疗效和安全性12？周的妇女在接受OCP / HRT的妇女和不在OCP / HRT上的妇女相似。这些数据表明EBR / GZR可以安全地用于治疗接受伴随OCP / HRT的妇女中的HCV GT1或GT4感染。

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