Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
Unit of Infectious Pathology, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain.
Clin Microbiol Infect. 2017 Jun;23(6):409.e5-409.e8. doi: 10.1016/j.cmi.2016.12.034. Epub 2017 Jan 28.
The aim of this study was to determine the predictive capacity of response at treatment week (TW) 4 for the achievement of sustained virological response 12 weeks after the scheduled end of therapy date (SVR) to treatment against hepatitis C virus (HCV) genotype 3 (GT3) infection with all-oral direct-acting antiviral (DAA) -based regimens.
From a prospective multicohort study, HCV GT3-infected patients who completed a course of currently recommended DAA-based therapy at 33 Spanish hospitals and who had reached the SVR evaluation time-point were selected. TW4 HCV-RNA levels were categorized as target-not-detected (TND), below the lower limit of quantification (LLOQ) and ≥LLOQ.
A total of 123 patients were included, 86 (70%) received sofosbuvir/ daclatasvir±ribavirin, 27 (22%) received sofosbuvir/ ledipasvir/ ribavirin and 10 (8.1%) received sofosbuvir/ ribavirin, respectively. In all, 114 (92.7%) of the 123 patients presented SVR in an on-treatment approach, but nine (7.3%) patients relapsed, all of them had presented cirrhosis at baseline. In those who achieved TND, LLOQ and ≥LLOQ, SVR was observed in 81/83 (98%; 95% CI 91.5%-99.7%), 24/28 (85.7%; 95% CI 67.3%-96%) and 9/12 (75%; 95% CI 42.8%-94.5%), respectively; p 0.001. Corresponding numbers for subjects with cirrhosis were: 52/54 (96.3%; 95% CI 87.3%-95.5%), 14/18 (77.8%; 95% CI 52.4%-93.6%) and 7/10 (70%; 95% CI 34.8%-93.3%); p 0.004.
TW4-response indicates the probability of achieving SVR to currently used DAA-based therapy in HCV genotype 3-infected individuals with cirrhosis. This finding may be useful to tailor treatment strategy in this setting.
本研究旨在确定治疗第 4 周（TW4）时的应答情况能否预测慢性丙型肝炎病毒（HCV）基因型 3（GT3）感染者接受基于直接作用抗病毒药物（DAA）的全口服抗病毒治疗后，在治疗结束日期后 12 周达到持续病毒学应答（SVR）的情况。
从一项前瞻性多队列研究中，选取了在西班牙 33 家医院接受了目前推荐的 DAA 治疗方案并达到 SVR 评估时间点的 HCV GT3 感染患者。将 TW4HCV-RNA 水平分为目标未检测到（TND）、低于定量下限（LLOQ）和≥LLOQ。
共纳入 123 例患者，86 例（70%）接受索磷布韦/达卡他韦±利巴韦林，27 例（22%）接受索磷布韦/雷迪帕韦/利巴韦林，10 例（8.1%）接受索磷布韦/利巴韦林。在所有患者中，114 例（92.7%）采用治疗方案获得 SVR，但有 9 例（7.3%）患者复发，他们均在基线时存在肝硬化。在达到 TND、LLOQ 和≥LLOQ 的患者中，SVR 分别在 81/83 例（98%；95%CI91.5%-99.7%）、24/28 例（85.7%；95%CI67.3%-96%）和 9/12 例（75%；95%CI42.8%-94.5%）中观察到，差异具有统计学意义（p<0.001）。在存在肝硬化的患者中，相应数字为：52/54 例（96.3%；95%CI87.3%-95.5%）、14/18 例（77.8%；95%CI52.4%-93.6%）和 7/10 例（70%；95%CI34.8%-93.3%）；差异具有统计学意义（p<0.004）。
TW4 应答情况可以提示肝硬化的 HCV GT3 感染者接受基于目前 DAA 的治疗方案后达到 SVR 的概率。这一发现可能有助于调整这一人群的治疗策略。
