Cattaneo Dario, Andreoni Massimo, Carosi Gianpiero, Cauda Roberto, Lazzarin Adriano, Rizzardini Giuliano
Int J Clin Pharmacol Ther. 2017 May;55(5):381-393. doi: 10.5414/CP202775.
The introduction of generic antiretroviral medications in developing countries has resulted in significant CD4 cell restoration, HIV viral decline, and a noteworthy reduction in the time to initiation of therapy. Projection models have also predicted significant cost saving associated with the extensive diffusion of generic antiretrovirals in developed countries. However, some uncertainties on generics have recently been raised. These concerns mainly relate to the adequacy of the study design for bioequivalence testing, the potential for uncontrolled switching from one generic to another, and the loss of adherence if patients switched from fixed-dose coformulations to single components in order to incorporate the new generic drugs. In the present review, we deal with current evidence and potential controversial issues regarding generic antiretrovirals and their underlying economic implications and provide some proposals on how to favor the widespread diffusion of generics in HIV medicine. This may be particularly relevant considering that the safe, systematic switch from patented to generic antiretrovirals could potentially guarantee access to therapies for HIV-infected patients worldwide and lead to money savings that would compensate the expenditure increase resulting from new, innovative HIV drugs. .
在发展中国家引入通用抗逆转录病毒药物已使CD4细胞显著恢复、HIV病毒载量下降，且治疗开始时间大幅缩短。预测模型还预计，通用抗逆转录病毒药物在发达国家广泛传播将带来显著的成本节约。然而，最近人们对通用药物提出了一些疑问。这些担忧主要涉及生物等效性测试研究设计的充分性、从一种通用药物无节制转换到另一种的可能性，以及如果患者从固定剂量复方制剂转换为单一成分以纳入新的通用药物时依从性的丧失。在本综述中，我们探讨了关于通用抗逆转录病毒药物的现有证据和潜在争议问题及其潜在的经济影响，并就如何促进通用药物在HIV医学中的广泛传播提出了一些建议。考虑到从专利抗逆转录病毒药物安全、系统地转换为通用药物可能会保证全球HIV感染患者获得治疗，并带来资金节省，以补偿因新型创新HIV药物导致的支出增加，这一点可能尤为重要。
