Janssen Diagnostics , Beerse , Belgium.
Janssen Infectious Diseases , Leiden , The Netherlands.
Open Forum Infect Dis. 2015 Nov 3;2(4):ofv166. doi: 10.1093/ofid/ofv166. eCollection 2015 Dec.
Background. Efficacy endpoints in influenza clinical trials may include clinical symptoms and virological measurements, although virology cannot serve as the primary endpoint. We investigated the relationship between influenza A RNA copy number and quantity of infectious viruses in hospitalized influenza patients. Methods. One hundred fifty influenza-infected, hospitalized patients were included in this prospective cohort study spanning the 2012-2013 influenza season. Daily nasopharyngeal samples were collected during hospitalization, and influenza A RNA copy number and infectious viral titer were monitored. Results. The decay rate for 50% tissue culture infectious dose (TCID50) was 0.51 ± 0.14 log10 TCID50/mL per day, whereas the RNA copy number decreased at a rate of 0.41 ± 0.04 log10 copies/mL per day (n = 433). The log ratio of the RNA copy number to the infectious viral titer within patient changes significantly with -0.25 ± 0.09 units per day (P = .0069). For a 12-day observation period, the decay corresponds to a decline of this ratio of 3 log influenza RNA copies. Conclusions. Influenza RNA copy number in nasal swabs is co-linear with culture, although the rate of decay of cell culture-based viral titers was faster than that observed with molecular methods. The study documented a clear decreasing log ratio of the RNA copy number to the infectious viral titer of the patients over time.
流感临床试验的疗效终点可能包括临床症状和病毒学测量,但病毒学不能作为主要终点。我们研究了住院流感患者中流感 A 病毒 RNA 拷贝数与传染性病毒数量之间的关系。
本前瞻性队列研究纳入了 2012-2013 流感季节期间的 150 例流感感染住院患者。在住院期间每天采集鼻咽拭子,监测流感 A 病毒 RNA 拷贝数和传染性病毒滴度。
50%组织培养感染剂量(TCID50)的衰减率为每天 0.51 ± 0.14 log10 TCID50/mL,而 RNA 拷贝数的下降速度为每天 0.41 ± 0.04 log10 拷贝/mL(n = 433)。患者内 RNA 拷贝数与传染性病毒滴度的对数比值随时间显著变化,每天减少-0.25 ± 0.09 个单位(P =.0069)。在 12 天的观察期内,该比值下降对应于流感 RNA 拷贝数下降 3 个对数。
鼻拭子中的流感 RNA 拷贝数与培养结果呈线性相关,尽管基于细胞培养的病毒滴度的衰减速度快于分子方法观察到的速度。该研究记录了患者的 RNA 拷贝数与传染性病毒滴度的对数比值随时间逐渐降低。