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Central nervous system disorders after use of dolutegravir: evidence from preclinical and clinical studies
Alicja Jakimiuk1, Agnieszka Piechal1, Alicja Wiercińska-Drapało2
1Department of Clinical and Experimental Pharmacology, Centre for Preclinical Research and Technology, Medical University of Warsaw, Banacha 1b, 02-097, Warsaw, Poland.
Abstract:
The evaluation of dolutegravir based on available preclinical and clinical studies reveals a risk of central nervous system (CNS) disorders associated with long-term use of the drug. The available literature on the pharmacokinetics of the drug, including its penetration of the blood-brain barrier, was reviewed, as well as clinical trials assessing the incidence of adverse effects in the CNS and the frequency of its discontinuation. This paper also summarizes the impact of factors affecting the occurrence of CNS disorders and indicates the key role of pharmacovigilance in the process of supplementing knowledge on the safety of drugs, especially those that are newly registered.
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