Simões Eric A F, DeVincenzo John P, Boeckh Michael, Bont Louis, Crowe James E, Griffiths Paul, Hayden Frederick G, Hodinka Richard L, Smyth Rosalind L, Spencer Keith, Thirstrup Steffen, Walsh Edward E, Whitley Richard J
Department of Pediatrics, University of Colorado School of Medicine, and Colorado School of Public Health, Aurora.
Department of Pediatrics, Division of Infectious Diseases, and Department of Microbiology, Immunology and Biochemistry, University of Tennessee School of Medicine Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis.
J Infect Dis. 2015 Mar 15;211 Suppl 1(Suppl 1):S1-S20. doi: 10.1093/infdis/jiu828.
Two meetings, one sponsored by the Wellcome Trust in 2012 and the other by the Global Virology Foundation in 2013, assembled academic, public health and pharmaceutical industry experts to assess the challenges and opportunities for developing antivirals for the treatment of respiratory syncytial virus (RSV) infections. The practicalities of clinical trials and establishing reliable outcome measures in different target groups were discussed in the context of the regulatory pathways that could accelerate the translation of promising compounds into licensed agents. RSV drug development is hampered by the perceptions of a relatively small and fragmented market that may discourage major pharmaceutical company investment. Conversely, the public health need is far too large for RSV to be designated an orphan or neglected disease. Recent advances in understanding RSV epidemiology, improved point-of-care diagnostics, and identification of candidate antiviral drugs argue that the major obstacles to drug development can and will be overcome. Further progress will depend on studies of disease pathogenesis and knowledge provided from controlled clinical trials of these new therapeutic agents. The use of combinations of inhibitors that have different mechanisms of action may be necessary to increase antiviral potency and reduce the risk of resistance emergence.
2012年由惠康信托基金会主办、2013年由全球病毒学基金会主办的两次会议，召集了学术、公共卫生和制药行业专家，以评估开发用于治疗呼吸道合胞病毒（RSV）感染的抗病毒药物所面临的挑战和机遇。在能够加速将有前景的化合物转化为获批药物的监管途径背景下，讨论了临床试验的实际操作以及在不同目标群体中建立可靠结局指标的问题。RSV药物开发受到相对较小且分散的市场认知的阻碍，这可能会阻碍大型制药公司的投资。相反，从公共卫生需求来看，RSV远不能被认定为罕见病或被忽视的疾病。在了解RSV流行病学、改进即时诊断以及鉴定候选抗病毒药物方面的最新进展表明，药物开发的主要障碍能够且必将被克服。进一步的进展将取决于对疾病发病机制的研究以及这些新型治疗药物对照临床试验所提供的知识。可能需要使用具有不同作用机制的抑制剂组合，以提高抗病毒效力并降低耐药性出现的风险。
