使用长效口服和注射药物进行疟疾化学预防:最新目标产品简介。

IF 2.4 3区 医学 Q3 INFECTIOUS DISEASES
Myriam El Gaaloul, Andre Marie Tchouatieu, Kassoum Kayentao, Brice Campo, Benedicte Buffet, Hanu Ramachandruni, Jean Louis Ndiaye, Timothy N C Wells, Celine Audibert, Jane Achan, Cristina Donini, Hellen C Barsosio, Halidou Tinto
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引用次数: 0

摘要

疟疾是可以预防的,但疾病负担仍然很重,2022 年报告的病例超过 2.49 亿例,死亡人数超过 60.8 万。从历史上看,最重要的保护性干预措施是病媒控制和化学预防药物,2023 年将有超过 5000 万儿童接受季节性疟疾化学预防。两种疫苗已获批准并开始使用,为 36 个月以下的儿童提供额外保护。然而,这些现有工具在各方面的影响有限。疫苗显示出部分疗效,成本相对较高,而且并非在所有环境中都能获得。化学预防面临的挑战是可接受性和可行性方面的障碍,包括用药频率,以及在怀孕头三个月和感染艾滋病毒的妇女中缺乏选择。此外,针对化学预防药物的抗药性的出现也令人担忧。针对这些局限性,我们提出了目标产品简介(TPP),作为指导创新和促进新型化学预防替代品探索的路线图。该目标产品简介描述了理想的产品属性,同时承认可能需要进行权衡。至关重要的是,它考虑到了风险最大的目标人群,主要是婴儿、儿童和孕妇。控制和消除疟疾需要适当的化学预防,不仅在疟疾高度流行和传播地区,而且在免疫力下降的低传播地区,以及来自已消除疟疾地区的旅行者。新药应具有可接受的安全性和耐受性,并具有长期的高保护效力。配方和成本需要支持操作的依从性、可及性和有效性。下一代长效口服和注射药物很可能成为预防疟疾的支柱。因此,《技术合作方案》采纳了疟疾预防一线专家、研究人员和药物开发人员的观点。这种包容性方法旨在集中力量,调整整个社区的应对措施,以开发具有变革意义的新药。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Chemoprevention of malaria with long-acting oral and injectable drugs: an updated target product profile.

Malaria is preventable, but the burden of disease remains high with over 249 million cases and 608,000 deaths reported in 2022. Historically, the most important protective interventions have been vector control and chemopreventive medicines with over 50 million children receiving seasonal malaria chemoprevention in the year 2023. Two vaccines are approved and starting to be deployed, bringing additional protection for children up to 36 months. However, the impact of these currently available tools is somewhat limited on various fronts. Vaccines exhibit partial efficacy, are relatively costly, and not accessible in all settings. The challenges encountered with chemoprevention are barriers to acceptability and feasibility, including frequency of dosing, and the lack of options in the first trimester of pregnancy and for women living with HIV. Also, the emergence of resistance against chemopreventive medicines is concerning. To address these limitations, a target product profile (TPP) is proposed as a road map to guide innovation and to boost the quest for novel chemopreventive alternatives. This TPP describes the ideal product attributes, while acknowledging potential trade-offs that may be needed. Critically, it considers the target populations most at risk; primarily infants, children, and pregnant women. Malaria control and elimination requires appropriate chemoprevention, not only in areas of high endemicity and transmission, but also in lower transmission areas where immunity is declining, as well as for travellers from areas where malaria has been eliminated. New medicines should show acceptable safety and tolerability, with high and long protective efficacy. Formulations and costs need to support operational adherence, access, and effectiveness. Next generation long-acting oral and injectable drugs are likely to constitute the backbone of malaria prevention. Therefore, the perspectives of front-line experts in malaria prevention, researchers, and those involved in drug development are captured in the TPP. This inclusive approach aims at concentrating efforts and aligning responses across the community to develop new and transformative medicines.

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来源期刊
Malaria Journal
Malaria Journal 医学-寄生虫学
CiteScore
5.10
自引率
23.30%
发文量
334
审稿时长
2-4 weeks
期刊介绍: Malaria Journal is aimed at the scientific community interested in malaria in its broadest sense. It is the only journal that publishes exclusively articles on malaria and, as such, it aims to bring together knowledge from the different specialities involved in this very broad discipline, from the bench to the bedside and to the field.
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