艾尔巴韦格拉瑞韦在伴有丙型肝炎病毒感染的黑人成人中的应用：2/3 期临床试验的汇总分析。
Elbasvir/grazoprevir in black adults with hepatitis C virus infection: a pooled analysis of phase 2/3 clinical trials.
机构信息
Carolinas Healthcare system, Charlotte, NC, USA. Baylor St. Luke's Medical Center, Houston, TX, USA. Texas clinical Research institute, Arlington, TX, USA. McGuire Research institute, McGuire Department of Veterans Affairs Medical center and Virginia commonwealth university, Richmond, VA, usA. Digestive Disease Associates, Baltimore, MD, USA. Tulane university school of Medicine, New Orleans, LA, USA. Merck & co., inc., Kenilworth, NJ, USA. Atlanta Medical center, Atlanta, GA, USA.
出版信息
Am J Gastroenterol. 2018 Jun;113(6):863-871. doi: 10.1038/s41395-018-0053-4. Epub 2018 Apr 26.
OBJECTIVES
Although direct-acting antiviral regimens have dramatically improved the treatment of hepatitis C virus (HCV) infection, there is some evidence that black race may be an independent predictor of treatment failure. We report a retrospective analysis of black participants receiving elbasvir/grazoprevir (EBR/GZR) in nine phase 2/3 clinical trials.
METHODS
Black participants with chronic HCV genotype 1 or 4 (GT1 or GT4) infection who received EBR 50 mg/GZR 100 mg once daily for 12 weeks, or in combination with ribavirin for 16 weeks, were included. The primary end point was sustained virologic response 12 weeks after completion of therapy (SVR12, HCV RNA < 15 IU/mL).
RESULTS
Compared with nonblack participants (n = 1310), black participants (n = 332) were more likely to have chronic kidney disease stage 4/5 (9.2% vs. 31.0%, respectively), while other comorbidities were similar between the groups. In black and nonblack participants receiving EBR/GZR for 12 weeks, SVR12 rates were 93.7% (282/301) and 94.2% (1072/1138) in those with GT1 infection, and 93.8% (15/16) and 94.6% (88/93) in those with GT4 infection. SVR12 was 100.0% (15/15) in black participants and 97.5% (77/79) in nonblack participants with GT1 infection receiving EBR/GZR plus ribavirin for 16 weeks. Rates of drug-related adverse events (AEs) were 30% vs. 36.6%, and serious AEs were 7.6% vs. 3.4% in black and nonblack participants, respectively.
CONCLUSION
EBR/GZR showed high efficacy in black participants with HCV GT1 or GT4 infection and was generally well tolerated, with a safety profile similar to that reported overall in phase 2/3 clinical trials.
目的
尽管直接作用抗病毒药物治疗方案显著改善了丙型肝炎病毒（HCV）感染的治疗效果，但有一些证据表明，黑种人可能是治疗失败的独立预测因素。我们报告了九项 2/3 期临床试验中接受 Elbasvir/Grazoprevir（EBR/GZR）治疗的黑种参与者的回顾性分析。
方法
本研究纳入了慢性 HCV 基因 1 或 4 型（GT1 或 GT4）感染、接受 EBR 50mg/GZR 100mg 每日一次治疗 12 周、或联合利巴韦林治疗 16 周的黑种参与者。主要终点为治疗结束后 12 周持续病毒学应答（SVR12，HCV RNA < 15 IU/mL）。
结果
与非黑种参与者（n=1310）相比，黑种参与者（n=332）更易患有慢性肾脏病 4/5 期（分别为 9.2%和 31.0%），但两组的其他合并症相似。在接受 EBR/GZR 治疗 12 周的黑种和非黑种参与者中，GT1 感染患者的 SVR12 率分别为 93.7%（282/301）和 94.2%（1072/1138），GT4 感染患者分别为 93.8%（15/16）和 94.6%（88/93）。接受 EBR/GZR 联合利巴韦林治疗 16 周的 GT1 感染黑种参与者的 SVR12 率为 100.0%（15/15），非黑种参与者的 SVR12 率为 97.5%（77/79）。药物相关不良事件（AE）发生率分别为 30%和 36.6%，黑种和非黑种参与者的严重 AE 发生率分别为 7.6%和 3.4%。
结论
EBR/GZR 对 HCV GT1 或 GT4 感染的黑种参与者显示出高疗效，且总体耐受性良好，安全性与 2/3 期临床试验报告的总体安全性相似。
Zotero 插件