Discontinued drugs in 2012-2013: hepatitis C virus infection

Discontinued drugs in 2012-2013: hepatitis C virus infection
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DOI:
10.1517/13543784.2015.982274
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发表时间:
2015-02-01
影响因子:
6.1
通讯作者:
Borgia, Guglielmo
Borgia, Guglielmo
中科院分区:
医学2区
文献类型:
--
作者:
Gentile, Ivan;Buonomo, Antonio Riccardo;Borgia, Guglielmo

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简介:丙型肝炎病毒(HCV)慢性感染全球约1.5亿人。抗病毒治疗可以阻止甚至逆转疾病的发展。已经开发了几种抗病毒药物。然而,每一种最终进入市场的药物都要经过大约1万种化合物的测试。从这些失败中吸取教训是有益的,例如,报告停药的候选药物和停药的原因。涵盖领域:本文重点关注2012年1月1日至2014年1月1日期间停用的抗hcv候选药物。专家意见:17种药物被停用。其中:10种是NS5B抑制剂,3种是NS5A抑制剂,2种是免疫刺激剂,1种是治疗性和预防性疫苗,1种是NS3抑制剂。只有3个候选药物在临床前阶段停药,14个在临床开发阶段停药(8个在II期,6个在I期)。大多数停产都归因于公司的战略决策。这组作者认为,从HCV药物开发失败中吸取教训将有助于制药公司和研究人员为未来制定更好的策略。因此,提供这些资料是很重要的。
Introduction: Hepatitis C virus (HCV) chronically infects about 150 million people worldwide. Antiviral treatment can stop and even reverse the progression of the disease. Several antivirals have been developed. However, about 10,000 compounds are tested for each drug that eventually reaches the market. It would be useful to learn from these failures, for example, by reporting the candidate drugs that were discontinued and the reason for discontinuation.Areas covered: This article focuses on the anti-HCV drug candidates discontinued between 1 January 2012 and 1 January 2014.Expert opinion: In detail, 17 drugs were discontinued. Of these: 10 were NS5B inhibitors, 3 were NS5A inhibitors, 2 were immunostimulants, 1 was a therapeutic and prophylactic vaccine and 1 an NS3 inhibitor. Only 3 candidates were discontinued in the preclinical phase, and 14 were discontinued during clinical development (8 in Phase II and 6 in Phase I). Most discontinuations were attributed to corporate strategic decisions. The authors believe that learning from HCV drug development failures will help pharmaceutical companies and researchers to develop better strategies for the future. It is therefore important that this information is made available.