Neukam Karin, Morano-Amado Luis E, Rivero-Juárez Antonio, Mancebo María, Granados Rafael, Téllez Francisco, Collado Antonio, Ríos María J, de Los Santos-Gil Ignacio, Reus-Bañuls Sergio, Vera-Méndez Francisco, Geijo-Martínez Paloma, Montero-Alonso Marta, Suárez-Santamaría Marta, Pineda Juan A
a Unit of Infectious Diseases and Microbiology , Hospital Universitario de Valme , Seville , Spain.
b Instituto de Biomedicina de Sevilla (IBiS) , Seville , Spain.
HIV Clin Trials. 2017 May;18(3):126-134. doi: 10.1080/15284336.2017.1330801.
HIV/HCV-coinfected patients and hepatitis C virus (HCV) monoinfected subjects are thought to respond equally to direct-acting antiviral (DAA)-based therapy despite the lack of data derived from clinical trials. This study is aimed to evaluate the impact of HIV coinfection on the response to DAA-based treatment against HCV infection in the clinical practice.
In a prospective multicohort study, patients who initiated DAA-based therapy at the Infectious Disease Units of 33 hospitals throughout Spain were included. The primary efficacy outcome variables were the achievement of sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12).
A total of 908 individuals had reached the SVR12 evaluation time-point, 426 (46.9%) were HIV/HCV-coinfected, and 472 (52%) received interferon (IFN)-free therapy. In an intention-to-treat analysis, SVR12 rates in subjects with and without HIV-coinfection were 55.3% (94/170 patients) versus 67.3% (179/266 subjects; p = 0.012) for IFN-based treatment and 86.3% (221/256 subjects) versus 94.9% (205/216 patients, p = 0.002) for IFN-free regimens. Relapse after end-of-treatment response to IFN-free therapy was observed in 3/208 (1.4%) HCV-monoinfected subjects and 10/231 (4.4%) HIV/HCV-coinfected individuals (p = 0.075). In a multivariate analysis adjusted for age, sex, transmission route, body-mass index, HCV genotype, and cirrhosis, the absence of HIV-coinfection (adjusted odds ratio: 3.367; 95% confidence interval: 1.15-9.854; p = 0.027) was independently associated with SVR12 to IFN-free therapy.
HIV-coinfection is associated with worse response to DAA-based therapy against HCV infection. In patients receiving IFN-free therapy, this fact seems to be mainly driven by a higher rate of relapses among HIV-coinfected subjects.
尽管缺乏来自临床试验的数据，但人们认为，合并感染人类免疫缺陷病毒（HIV）/丙型肝炎病毒（HCV）的患者与单纯感染丙型肝炎病毒（HCV）的受试者对基于直接抗病毒药物（DAA）的治疗反应相同。本研究旨在评估在临床实践中，HIV合并感染对基于DAA治疗HCV感染反应的影响。
在一项前瞻性多队列研究中，纳入了在西班牙33家医院的传染病科开始接受基于DAA治疗的患者。主要疗效结局变量为治疗预定结束日期后12周持续病毒学应答（SVR12）的实现情况。
共有908名个体达到SVR12评估时间点，其中426名（46.9%）为HIV/HCV合并感染，472名（52%）接受了无干扰素（IFN）治疗。在意向性分析中，接受基于IFN治疗的合并HIV感染和未合并HIV感染受试者的SVR12率分别为55.3%（94/170例患者）和67.3%（179/266例受试者；p = 0.012），接受无IFN方案治疗的分别为86.3%（221/256例受试者）和94.9%（205/216例患者，p = 0.002）。在3/208（1.4%）的HCV单纯感染受试者和10/231（4.4%）的HIV/HCV合并感染个体中观察到无IFN治疗结束后复发（p = 0.075）。在对年龄、性别、传播途径、体重指数、HCV基因型和肝硬化进行校正的多变量分析中，未合并HIV感染（校正比值比：3.367；95%置信区间：1.15 - 9.854；p = 0.027）与无IFN治疗的SVR12独立相关。
HIV合并感染与基于DAA治疗HCV感染的反应较差有关。在接受无IFN治疗的患者中，这一情况似乎主要是由HIV合并感染受试者中较高的复发率所致。
