Durham Veterans Affairs Health Care System, Durham, NC, USA.
Department of Medicine, Infectious Diseases Division, Duke University Hospital, Durham, NC, USA.
Ann Pharmacother. 2020 Nov;54(11):1057-1064. doi: 10.1177/1060028020921166. Epub 2020 May 14.
Response-guided hepatitis C therapy was standard with interferon-based regimens but is not used for direct-acting antivirals (DAAs). Week 4 viral kinetics may predict sustained virological response (SVR) with DAAs, but it is unclear whether extending therapy in slow responders affects outcomes.
The primary objective was to compare SVR rates between traditional and extended duration groups. Secondary objectives were to compare SVR rates among subgroups and to determine factors associated with SVR.
This institutional review board-approved, retrospective, single-center study identified patients with chronic hepatitis C virus (HCV) infection with detectable week 4 HCV RNA who were treated with DAAs. Patients were excluded for early discontinuation, treatment regimen not recommended first-line, or missing HCV RNA labs. Patients were stratified into traditional and extended duration groups. The primary end point was SVR. Secondary end points included factors associated with SVR and rationale for extension of therapy duration.
A total of 363 patients were included; 58 (16%) received extended therapy. Patients were primarily genotype 1a (70%) and treatment naïve (80%). More than half had advanced fibrosis or cirrhosis. SVR12 rates were 100% in the extended duration group and 96.7% in the traditional duration group ( = 0.37). There were no associations with SVR and prespecified patient-specific factors. Sample size was limited.
Based on these findings, a recommendation for extension of therapy cannot be made for patients with detectable HCV RNA at week 4 of treatment at this time. Cost analyses may help guide recommendations to re-treat rare failures versus extend therapy in all slow responders.
基于干扰素的方案的应答指导的丙型肝炎治疗是标准治疗，但不适用于直接作用抗病毒药物（DAA）。第 4 周的病毒动力学可能可以预测 DAA 的持续病毒学应答（SVR），但尚不清楚延长治疗对慢应答者的结局是否有影响。
主要目的是比较传统治疗时间组和延长治疗时间组的 SVR 率。次要目的是比较亚组的 SVR 率，并确定与 SVR 相关的因素。
这项经机构审查委员会批准的回顾性单中心研究纳入了有可检测到的第 4 周 HCV RNA 的慢性丙型肝炎病毒（HCV）感染患者，这些患者接受了 DAA 治疗。排除了早期停药、治疗方案不推荐为一线治疗或缺少 HCV RNA 实验室检测结果的患者。患者分为传统治疗时间组和延长治疗时间组。主要终点是 SVR。次要终点包括与 SVR 相关的因素以及延长治疗时间的理由。
共纳入 363 例患者，其中 58 例（16%）接受了延长治疗。患者主要为基因型 1a（70%）且初治（80%）。超过一半的患者有晚期纤维化或肝硬化。延长治疗时间组的 SVR12 率为 100%，传统治疗时间组为 96.7%（=0.37）。未发现与 SVR 相关的、预设的患者特异性因素。样本量有限。
根据这些发现，目前不能推荐在治疗第 4 周时可检测到 HCV RNA 的患者延长治疗。成本分析可能有助于指导对罕见失败的再治疗与对所有慢应答者延长治疗的建议。
