在初治患者中，基于替拉那韦的治疗按种族或族裔评估的持续病毒学应答率。

Sustained virologic response rates with telaprevir-based therapy in treatment-naive patients evaluated by race or ethnicity.

作者信息

Flamm Steven L, Muir Andrew J, Fried Michael W, Reddy K Rajender, Nelson David R, Bzowej Natalie H, Sullivan James C, Bengtsson Leif, DeMasi Ralph, Wright Christopher I, Kieffer Tara L, George Shelley, Adda Nathalie, Dusheiko Geoffrey M

机构信息

*Department of Medicine and Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL †Duke Clinical Research Institute, Durham ‡University of North Carolina at Chapel Hill, Chapel Hill, NC §University of Pennsylvania School of Medicine, Philadelphia, PA ∥Department of Medicine, University of Florida, Gainesville, FL ¶California Pacific Medical Center, San Francisco, CA #Vertex Pharmaceuticals Incorporated, Cambridge, MA **Janssen Research & Development, Titusville, NJ ††Royal Free and University College, London, UK.

出版信息

J Clin Gastroenterol. 2015 Apr;49(4):336-44. doi: 10.1097/MCG.0000000000000150.

DOI:10.1097/MCG.0000000000000150

PMID:24828357

Abstract

BACKGROUND

The phase 3 studies of telaprevir (T) in combination with peginterferon α-2a and ribavirin (PR) in treatment-naive genotype 1 chronic hepatitis C virus-infected patients (ADVANCE/ILLUMINATE) were not designed a priori to assess the effect of race and ethnicity on treatment response. However, these factors are important given the lower sustained virologic response (SVR) rates observed in black and Hispanic/Latino patients treated with PR.

GOALS

This retrospective pooled analysis evaluated the effect of race or ethnicity on treatment-naive patient response to telaprevir-based therapy and assessed resistant variant profiles.

MATERIALS AND METHODS

This analysis comprised patients enrolled in ADVANCE (N=363) and ILLUMINATE (N=540) who received 12 weeks of telaprevir in combination with PR followed by 12 or 36 weeks of PR alone and patients in ADVANCE (N=361) who received 48 weeks of PR alone. Race and ethnicity were self-reported and not mutually exclusive.

RESULTS

Higher SVR rates were observed with telaprevir-based therapy compared with PR in blacks [n=99 (62%) vs. n=28 (29%), respectively] and in Hispanics/Latinos [n=89 (72%) vs. n=38 (39%)]. The SVR was lower in telaprevir-treated blacks [n=99 (62%)] compared with nonblacks [n=791 (78%)] and in Hispanic/Latinos compared with non-Hispanics/Latinos [n=89 (72%) vs. n=801 (76%)]. Low discontinuation rates due to adverse events, including rash and anemia, were observed across subgroups. Resistance profiles were similar among the subgroups.

CONCLUSIONS

Treatment-naive black and Hispanic/Latino patients with genotype 1 chronic hepatitis C virus infection may benefit from telaprevir-based therapy, an important finding given the lower SVR rates observed in these patients when they are treated with PR alone.

摘要

背景

特拉匹韦（T）联合聚乙二醇干扰素α-2a和利巴韦林（PR）用于初治的基因1型慢性丙型肝炎病毒感染患者的3期研究（ADVANCE/ILLUMINATE），并非预先设计用于评估种族和民族对治疗反应的影响。然而，鉴于接受PR治疗的黑人和西班牙裔/拉丁裔患者的持续病毒学应答（SVR）率较低，这些因素很重要。

目标

这项回顾性汇总分析评估了种族或民族对初治患者接受基于特拉匹韦治疗的反应的影响，并评估了耐药变异谱。

材料与方法

该分析纳入了ADVANCE研究（N = 363）和ILLUMINATE研究（N = 540）中接受12周特拉匹韦联合PR治疗，随后单独接受12周或36周PR治疗的患者，以及ADVANCE研究（N = 361）中单独接受48周PR治疗的患者。种族和民族由患者自我报告，并非相互排斥。

结果

与PR相比，基于特拉匹韦的治疗在黑人患者中观察到更高的SVR率[分别为n = 99（62%）对n = 28（29%）]以及西班牙裔/拉丁裔患者中[n = 89（72%）对n = 38（39%）]。接受特拉匹韦治疗的黑人患者的SVR低于非黑人患者[n = 99（62%）对n = 791（78%）]，西班牙裔/拉丁裔患者低于非西班牙裔/拉丁裔患者[n = 89（72%）对n = 801（76%）]。各亚组中因不良事件（包括皮疹和贫血）导致的停药率较低。各亚组的耐药谱相似。