Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C
Long-term follow-up of patients receiving boceprevir for treatment of chronic hepatitis C
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DOI：
10.1016/j.antiviral.2014.10.010
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发表时间：
2015-01-01
影响因子：
7.6
通讯作者：
Wahl, Janice
中科院分区：
文献类型：
--
作者：
Howe, Anita Y. M.;Long, Jianmin;Wahl, Janice
目前还没有关于丙型肝炎病毒（HCV）感染患者接受以博赛泼韦为基础的治疗后持续病毒学应答（SVR）的持久性的报道。此外，在接受基于蛋白酶通道的治疗的患者中，耐药性的发展可能导致治疗失败。本研究的目的是跟踪在2/3期临床试验中接受博赛泼韦治疗的患者的临床进展，这是对参加博赛泼韦2/3期研究的患者进行的3年长期随访分析。随访期间未给予治疗。评估了SVR患者的病毒根除持久性。对1148例非SVR患者（SVR组，696例;病毒学失败组，452例）的RAV寿命进行评估。中位随访时间约为3.4年（范围为0.0 - 4.1年）。总体而言，696例SVR患者中有3例在随访期间可检测到HCV RNA（复发率为0.4%或13例复发/1000人年）。在初始治疗研究期间发生RAV的大多数患者（228/314，73%）在3年内恢复为野生型（WT）（27%的患者持续存在RAV）。所有RAV变为不可检测的中位时间为1.11年（95%置信区间为1.05 - 1.20年）。V36 M、T54 A、A156 S、I/V170 A和V36 M + R155 K似乎具有更快的恢复至WT的速率（恢复至WT的中位时间为
The durability of sustained virologic response (SVR) following boceprevir-based therapy in patients with hepatitis C virus (HCV) infection has not been reported. Furthermore, in patients receiving protease inhibitor-based therapies, development of resistance can contribute to treatment failure. The aim of the present study was to follow the clinical progression of patients treated with boceprevir after treatment in phase 2/3 clinical trials.This was a 3-year, long-term follow-up analysis of patients enrolled in boceprevir phase 2/3 studies. No treatment was administered during follow-up. Patients with SVR were assessed for durability of viral eradication. Non-SVR patients with on-treatment resistance-associated variants (RAVs) were assessed for longevity of RAVs.A total of 1148 patients (SVR, n = 696; virologic failure, n = 452) were enrolled in this follow-up analysis. The median duration of follow-up was approximately 3.4 years (range of 0.0-4.1 years). Overall, 3 of 696 patients with SVR had detectable HCV RNA during the follow-up period (relapse rate of 0.4% or 13 relapses/1000 person-years). The majority of patients who developed RAVs during the initial treatment study (228/314, 73%) reverted to wild-type (WT) within 3 years (RAVs persisted in 27% of patients). The median time for all RAVs to become undetectable was 1.11 years (95% confidence interval 1.05-1.20 years). V36M, T54A, A156S, I/V170A and V36M + R155K appeared to have a faster rate of return to WT (median times to return to WT of