Garg Anita B, Nuttall Jeremy, Romano Joseph
International Partnership for Microbicides, Inc, Silver Spring, MD, USA.
Antivir Chem Chemother. 2009;19(4):143-50. doi: 10.1177/095632020901900401.
HIV microbicides are topical, self-administered products aimed at preventing or reducing HIV infection in women and may represent the most promising strategy for combating the HIV/AIDS epidemic at the present time. Although a safe and effective microbicide has yet to be identified, all products tested in Phase III trials to date have been vaginal gels containing non-specific compounds with modest potency that had to be applied close to the time of sexual intercourse. Issues regarding these early generation products were further complicated by widely publicized cases of halted efficacy trials. However, as a result of each of these challenges, new information and essential lessons have emerged for the field. These lessons have resulted in a meaningful increase in microbicide development efforts focusing on compounds with highly potent and HIV-specific mechanisms of action, combination products, novel formulations, and carefully designed pharmacokinetic and pharmacodynamic evaluations, all of which are reasons for renewed confidence that a safe and effective microbicide is achievable.
艾滋病毒杀微生物剂是局部使用、自我给药的产品，旨在预防或减少女性感染艾滋病毒，可能是目前抗击艾滋病毒/艾滋病流行最有前景的策略。尽管尚未确定一种安全有效的杀微生物剂，但迄今为止在III期试验中测试的所有产品都是阴道凝胶，含有效力适中的非特异性化合物，必须在接近性交时使用。广泛宣传的疗效试验中止案例使这些早期产品的问题更加复杂。然而，由于应对这些挑战，该领域出现了新的信息和重要经验教训。这些经验教训使杀微生物剂的研发工作显著增加，重点是具有高效力和艾滋病毒特异性作用机制的化合物、联合产品、新型制剂以及精心设计的药代动力学和药效学评估，所有这些都是人们重新相信能够实现安全有效的杀微生物剂的原因。
