Laboratory for the Identification of Prognostic Factors of Response to the Treatment Against Infectious Diseases, University of Campania, Naples, Italy.
Infectious Diseases and Viral Hepatitis, Department of Mental and Physical Health and Preventive Medicine, University of Campania, Naples, Italy.
Liver Int. 2019 May;39(5):844-853. doi: 10.1111/liv.14025. Epub 2019 Jan 4.
The aim of the present study was to identify, among the patients with failure to DAA regimen, those with a late relapse (after the achievement of a sustained virological response at week 12) and to characterize the clinical, epidemiological and virological features of these patients.
A total of 129 HCV patients with non-response to an IFN-free regimen were enrolled. Sanger sequencing of NS3, NS5A and NS5B was performed at failure by home-made protocols.
Of the 129 patients enrolled, 8 (6.2%) experienced a breakthrough, 15 (11.7%) non-response, 99 (76.7%) a relapse by week 12 after the end of DAA therapy, and 7 (5.4%) a late relapse (after week 12; median 24 weeks, range 24-72). For two of the seven patients with a late relapse, a serum sample collected before the start of the DAA regimen was available; phylogenetic analysis showed no change in sequences of NS3, NS5A and NS5B regions, suggesting a reactivation of the initial HCV strain; for the remaining five patients, no serum collected before the DAA regimen was available, and thus, a re-infection cannot be excluded.
Although a late relapse is infrequent, the study suggests a post-treatment follow-up of 72 weeks.
本研究旨在确定 DAA 方案失败的患者中，那些出现晚期复发（在第 12 周达到持续病毒学应答后）的患者，并对这些患者的临床、流行病学和病毒学特征进行分析。
共纳入 129 例无干扰素治疗方案失败的 HCV 患者。采用自制方案在失败时对 NS3、NS5A 和 NS5B 进行 Sanger 测序。
在纳入的 129 例患者中，8 例（6.2%）出现突破，15 例（11.7%）无应答，99 例（76.7%）在 DAA 治疗结束后第 12 周时发生复发，7 例（5.4%）发生晚期复发（在第 12 周后；中位数 24 周，范围 24-72 周）。在 7 例晚期复发的患者中，有 2 例在开始 DAA 方案前有血清样本可用；系统进化分析显示 NS3、NS5A 和 NS5B 区域的序列无变化，提示初始 HCV 株的再激活；对于其余 5 例患者，没有在 DAA 方案前采集的血清，因此不能排除再感染。
尽管晚期复发较为罕见，但研究提示治疗后随访时间需要 72 周。
