Cloherty Gavin, Chevaliez Stephane, Sarrazin Christoph, Herman Christine, Holzmayer Vera, Dawson George, Maasoumy Benjamin, Vermehren Johannes, Wedemeyer Heiner, Feld Jordan J, Pawlotsky Jean-Michel
Abbott Laboratories, Abbott Park, IL, USA.
National Reference Center for Viral Hepatitis B, C and delta, Hopital Henry Mondor, Université Paris-Est, Créteil, France.
Sci Rep. 2016 Oct 20;6:35410. doi: 10.1038/srep35410.
Approval of Ledipasvir/Sofosbuvir for the treatment of chronic hepatitis C (HCV) includes the truncation of therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic patients with baseline HCV RNA levels <6 million IU/mL (6.8 log10 IU/mL). The aim of this study was to evaluate this clinical cutoff with a different widely used commercially available HCV RNA test. Results from samples tested prospectively with Roche High Pure TaqMan HCV 2.0 test (HPS) were compared to those tested retrospectively with the Abbott RealTime HCV RNA test (ART). Using 6 million IU/mL as the cut-off, pre-treatment results were concordant in 70.4% of cases. When results with the same test measured at screening and baseline, clinical decisions could be impacted in 14.4% and 6.2% of cases for HPS and ART respectively. Using only HCV RNA cutoff of 6 million IU/mL, 29.55% of subjects would receive a different and potentially incorrect treatment duration based solely on HCV RNA test method used. A further 6-14% of subjects would have treatment decision change based on the day the sample was taken.
来迪派韦/索磷布韦获批用于治疗慢性丙型肝炎（HCV），这包括将初治、无肝硬化且基线HCV RNA水平<600万国际单位/毫升（6.8 log10国际单位/毫升）的患者的治疗疗程从12周缩短至8周。本研究的目的是使用另一种广泛使用的市售HCV RNA检测方法评估这一临床截断值。将使用罗氏高纯TaqMan HCV 2.0检测（HPS）进行前瞻性检测的样本结果与使用雅培实时HCV RNA检测（ART）进行回顾性检测的结果进行比较。以600万国际单位/毫升作为截断值，70.4%的病例治疗前结果一致。当在筛查和基线时使用相同检测方法的结果时，HPS和ART分别有14.4%和6.2%的病例临床决策可能受到影响。仅使用600万国际单位/毫升的HCV RNA截断值，29.55%的受试者仅基于所使用的HCV RNA检测方法就会接受不同且可能错误的治疗疗程。另外6%-14%的受试者会根据样本采集日期改变治疗决策。
