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. 2019 Mar;98(10):e14828.
doi: 10.1097/MD.0000000000014828.

The Brazilian experience of implementing the active pharmacovigilance of dolutegravir

Cynthia Julia Braga Batista  1 , Renato Girade Correa  1 , Livia Ramalho Evangelista  2 , Karen Fleck  2 , Leandro Silva  2 , Francoise Renaud  3 , Marco Vitoria  3 , Meg Doherty  3 , Adele Schwartz Benzaken  1
Affiliations

The Brazilian experience of implementing the active pharmacovigilance of dolutegravir

Cynthia Julia Braga Batista et al. Medicine (Baltimore). 2019 Mar.

Abstract

In 2017, the Ministry of Health Brazilian started using dolutegravir (DTG) 50 mg to all people living with HIV who began antiretroviral therapy (ART) or rescue regimens. Although DTG is thought to have better tolerability levels and a lower possibility of causing adverse reactions, it is necessary to continuously evaluate the safety profile of the drug in the population. Therefore, an active pharmacovigilance project for DTG was implemented. The objective of this study was to describe the Brazilian experience of implementing pharmacovigilance and the results obtained during the period between April and December 2017.Active pharmacovigilance was implemented through patient interviews and an online questionnaire developed in the Medication Logistics Control System (SICLOM).Of the total number of people on DTG in Brazil (79,742) 90.33% participated in the project, and 2.24% of those who participated reported adverse reactions to the drug; of those who reported adverse reactions, 73.86% were on first-line ART regimens, and 26.13% were on third-line regimens. The mean age of the patients who had adverse reactions to DTG was 39 years; 68.79% were male, and 31.21% were female. Of the adverse reactions reported, 50.39% were considered persistent. The 3 most frequent reactions were nausea (13.34%), diarrhea (9.83%), and headaches (9.23%).The Brazilian experience with this project has been deemed successful by federal and local managers, and the online tool to collect data has proved to be an important strategy for the pharmacovigilance of DTG as well as that of other drugs.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Main adverse reactions reported via SICLOM during the DTG pharmacovigilance project and their relative frequency (%).SICLOM = Medication Logistics Control System, DTG = dolutegravir.
See this image and copyright information in PMC

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