TY - JOUR
T1 - The Brazilian experience of implementing the active pharmacovigilance of dolutegravir
AU - Batista, Cynthia Julia Braga
AU - Correa, Renato Girade
AU - Evangelista, Livia Ramalho
AU - Fleck, Karen
AU - Silva, Leandro
AU - Renaud, Francoise
AU - Vitoria, Marco
AU - Doherty, Meg
AU - Benzaken, Adele Schwartz
N1 - Funding Information:
Funding financial support for this study was provided by Brazilian Ministry of Health, through its Secretariat for Health Surveillance and its Department of Prevention, Surveillance and Control of Sexually Transmitted Infections, HIV/AIDS and Viral Hepatitis.
Publisher Copyright:
© 2019 Lippincott Williams and Wilkins. All rights reserved.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - In 2017, the Ministry of Health Brazilian started using dolutegravir (DTG) 50mg 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.
AB - In 2017, the Ministry of Health Brazilian started using dolutegravir (DTG) 50mg 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.
KW - AIDS
KW - HIV
KW - adverse reactions to drugs
KW - dolutegravir
KW - pharmacovigilance
UR - http://www.scopus.com/inward/record.url?scp=85062704362&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062704362&partnerID=8YFLogxK
U2 - 10.1097/MD.0000000000014828
DO - 10.1097/MD.0000000000014828
M3 - Article
C2 - 30855509
AN - SCOPUS:85062704362
SN - 0025-7974
VL - 98
JO - Medicine (United States)
JF - Medicine (United States)
IS - 10
M1 - e14828
ER -