Montes María Luisa, Olveira Antonio, Ahumada Adriana, Aldámiz Teresa, García-Samaniego Javier, Clemente Ana, Berenguer Juan, González-García Juan, Martín-Carbonero Luz
aUnidad VIH, Servicio de Medicina Interna, Hospital Universitario La Paz, IdiPaz bUnidad de Hepatología, Servicio de Digestivo, Hospital Universitario La Paz, CIBERehd cUnidad de Hepatología, Servicio de Digestivo, Hospital General Universitario Gregorio Marañón, CIBERehd dUnidad VIH, Servicio de Enfermedades Infecciosas. Hospital General Universitario Gregorio Marañón, Instituto Investigación Sanitaria Gregorio Marañón (iSGM), Madrid, Spain.
AIDS. 2017 Jun 1;31(9):1253-1260. doi: 10.1097/QAD.0000000000001465.
We compared the baseline characteristics, effectiveness, and tolerance of direct-acting antiviral drug (DAA)-based regimens taken by hepatitis C virus (HCV)-monoinfected and HCV/HIV-coinfected individuals in clinical practice.
We performed a prospective observational study in two tertiary centres in Madrid, Spain, which included all HCV-monoinfected and HCV/HIV-coinfected patients undergoing HCV treatment with all-oral DAA regimens in a routine clinical setting, from April 2015 to November 2015. We evaluated sustained virological response 12 weeks after the end of therapy (SVR12), adverse events, and baseline and treatment characteristics.
The study population comprised 1634 patients: 1152 HCV-monoinfected patients (70%) and 482 HCV/HIV-coinfected patients (30%). Fifty percent had cirrhosis, and 47% were peginterferon/ribavirin-experienced. HCV/HIV-coinfected patients were younger [median age (interquartile range) 51 (48-54) years vs. 59 (50-68) years; P < 0.001), more frequently male (76 vs. 54%; P < 0.001), and infected with genotypes 1a (37 vs. 17%; P < 0.001), 3 (15 vs. 7%; P < 0.001), and 4 (23 vs. 4%; P < 0.001). One of every three patients took ribavirin. SVR12 was 94% (95% confidence interval 91.7-96%) and 97% (95% confidence interval 95.7-99.4%) in coinfected and monoinfected patients, respectively, with no significant differences between the groups after adjustment for cirrhosis, genotype, and DAA combination. DAA-based regimens were well tolerated, and only 1% of patients had severe adverse events, with no differences between the populations.
HCV/HIV-infected patients treated with all-oral DAA combinations achieved high rates of SVR12 that were similar to those of HCV-monoinfected patients under real-life conditions. Safety and tolerance were excellent, even in patients with end-stage liver disease.
我们比较了在临床实践中，丙型肝炎病毒（HCV）单一感染和HCV/人类免疫缺陷病毒（HIV）合并感染个体采用基于直接作用抗病毒药物（DAA）方案的基线特征、有效性和耐受性。
我们在西班牙马德里的两个三级中心进行了一项前瞻性观察性研究，纳入了2015年4月至2015年11月期间在常规临床环境中接受全口服DAA方案进行HCV治疗的所有HCV单一感染和HCV/HIV合并感染患者。我们评估了治疗结束后12周的持续病毒学应答（SVR12）、不良事件以及基线和治疗特征。
研究人群包括1634例患者：1152例HCV单一感染患者（70%）和482例HCV/HIV合并感染患者（30%）。50%的患者有肝硬化，47%的患者曾接受过聚乙二醇干扰素/利巴韦林治疗。HCV/HIV合并感染患者更年轻[中位年龄（四分位间距）51（48 - 54）岁对59（50 - 68）岁；P<0.001]，男性比例更高（76%对54%；P<0.001），感染1a型（37%对17%；P<0.001）、3型（15%对7%；P<0.001）和4型（23%对4%；P<0.001）基因型的频率更高。每三名患者中有一名服用利巴韦林。合并感染和单一感染患者的SVR12分别为94%（95%置信区间91.7 - 96%）和97%（95%置信区间95.7 - 99.4%），在对肝硬化、基因型和DAA组合进行调整后，两组之间无显著差异。基于DAA的方案耐受性良好，只有1%的患者出现严重不良事件，两组人群之间无差异。
在现实生活条件下，接受全口服DAA联合治疗的HCV/HIV感染患者实现了与HCV单一感染患者相似的高SVR12率。安全性和耐受性良好，即使在终末期肝病患者中也是如此。
