Division of Antiviral Products, Office of Antimicrobial Products, Silver Spring, Maryland.
Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Clin Infect Dis. 2020 Jan 2;70(2):327-330. doi: 10.1093/cid/ciz385.
We analyzed post-treatment hepatitis C virus (HCV) RNA levels from 330 subjects who experienced virologic failure in clinical trials of direct-acting antivirals. We demonstrated that 97% had post-treatment Week 12 HCV RNA >10 000 IU/mL, above reported sensitivity limits of novel diagnostic assays being considered for simplified HCV treatment monitoring.
我们分析了 330 名在直接作用抗病毒药物临床试验中发生病毒学失败的受试者的治疗后丙型肝炎病毒（HCV）RNA 水平。我们证明，97%的患者在治疗后第 12 周 HCV RNA >10000IU/mL，高于新型诊断检测方法报告的敏感性限度，这些方法正在被考虑用于简化 HCV 治疗监测。
