With the morbidity and mortality associated with the COVID‐19 pandemic that we are witnessing this year, the risks posed by emerging viral diseases to global health are all too obvious. This pandemic highlights the importance of antiviral drug discovery, which targets emerging viral pathogens, as well as existing pathogenic viruses that undergo continuous evolution. Drug discovery and development is a long and resource intensive process; however, the use of biomarkers can accelerate clinical development of antivirals by providing information regarding diagnosis of specific viral infections, status of infection, potential safety parameters, and antiviral responses. In clinical practice, many of the biomarkers initially utilized to support clinical development are also used for patient care. While viral load is a standard and essential biomarker used to detect the desired viral suppression induced by an antiviral agent, it has become apparent that additional biomarkers, whether related to the virus, the host or as a consequence of the drug's mechanistic effects, are also important for monitoring clinical outcomes associated with an antiviral therapy. This review summarizes the biomarkers used in the clinical development (as well as in clinical practice, where appropriate) of antiviral therapies for hepatitis C virus, hepatitis B virus, human immunodeficiency virus, and severe acute respiratory syndrome coronavirus 2.

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用于抗病毒疗法临床开发的生物标志物

由于我们今年目睹了与 COVID-19 大流行相关的发病率和死亡率，新出现的病毒性疾病对全球健康构成的风险非常明显。这次大流行凸显了抗病毒药物发现的重要性，它针对的是新出现的病毒病原体，以及不断进化的现有病原病毒。药物发现和开发是一个长期且资源密集型的过程；然而，生物标志物的使用可以通过提供有关特定病毒感染的诊断、感染状态、潜在安全参数和抗病毒反应的信息来加速抗病毒药物的临床开发。在临床实践中，许多最初用于支持临床开发的生物标志物也用于患者护理。虽然病毒载量是用于检测抗病毒剂诱导的所需病毒抑制的标准和必要生物标志物，但很明显，其他生物标志物，无论是与病毒、宿主有关还是由于药物的机械作用，也很明显对于监测与抗病毒治疗相关的临床结果很重要。本综述总结了丙型肝炎病毒、乙型肝炎病毒、人类免疫缺陷病毒和严重急性呼吸系统综合症冠状病毒 2 的抗病毒疗法的临床开发（以及临床实践，如适用）中使用的生物标志物。的机械效应，对于监测与抗病毒治疗相关的临床结果也很重要。本综述总结了丙型肝炎病毒、乙型肝炎病毒、人类免疫缺陷病毒和严重急性呼吸系统综合症冠状病毒 2 的抗病毒疗法的临床开发（以及临床实践，如适用）中使用的生物标志物。的机械效应，对于监测与抗病毒治疗相关的临床结果也很重要。本综述总结了丙型肝炎病毒、乙型肝炎病毒、人类免疫缺陷病毒和严重急性呼吸系统综合症冠状病毒 2 的抗病毒疗法的临床开发（以及临床实践，如适用）中使用的生物标志物。