Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná

The aim of this study was to investigate adverse reactions to Dolutegravir, a drug recently made available by the Unified Health System (SUS) for treating HIV infections. The frequency, severity and sex distribution of adverse reactions to Dolutegravir were identified over the first 18 months of it...

Full description

Bibliographic Details
Main Authors: Bárbara Thaís Poliselo de Sá, Frederico Alves Dias, Flavia Helen Correia, Doroteia Aparecida Höfelmann, Yanna Dantas Rattmann
Format: Article
Language:English
Published: Universidade Estadual de Maringá 2022-01-01
Series:Acta Scientiarum. Health Sciences
Subjects:
Online Access:https://periodicos.uem.br/ojs/index.php/ActaSciHealthSci/article/view/53630
_version_ 1818280703107792896
author Bárbara Thaís Poliselo de Sá
Frederico Alves Dias
Flavia Helen Correia
Doroteia Aparecida Höfelmann
Yanna Dantas Rattmann
author_facet Bárbara Thaís Poliselo de Sá
Frederico Alves Dias
Flavia Helen Correia
Doroteia Aparecida Höfelmann
Yanna Dantas Rattmann
author_sort Bárbara Thaís Poliselo de Sá
collection DOAJ
description The aim of this study was to investigate adverse reactions to Dolutegravir, a drug recently made available by the Unified Health System (SUS) for treating HIV infections. The frequency, severity and sex distribution of adverse reactions to Dolutegravir were identified over the first 18 months of its availability in users in the state of Paraná. Information was obtained through the pharmacovigilance questionnaire prepared by the Ministry of Health, accessed through the Logistics Control System for Medicines (SICLOM). During the study period, dolutegravir was dispensed to 9,865 patients in the state. However, 9,207 users (93.3%) answered the pharmacovigilance questionnaire. Among them, 1.75% reported 279 adverse reactions. This population was composed mainly of male people (69.57%), in the ratio of 2.29 men for each woman, white (67.08%), aged between 20 and 29 years (26.71%), single (45.34%) and with education between 8 and 11 years of study (41.61%). Gastrointestinal (36.92%) and nervous system (14.34%) disorders were the most prevalent. 77.78% adverse reactions were considered non-serious by users. It can be concluded that dolutegravir had a low prevalence of adverse reactions in users in the state of Paraná, demonstrating to be safe for use by the population in therapy against HIV, in accordance with clinical trials
first_indexed 2024-12-12T23:53:26Z
format Article
id doaj.art-20c9a08a4d7c4d8fba22c17eb3867a56
institution Directory Open Access Journal
issn 1679-9291
1807-8648
language English
last_indexed 2024-12-12T23:53:26Z
publishDate 2022-01-01
publisher Universidade Estadual de Maringá
record_format Article
series Acta Scientiarum. Health Sciences
spelling doaj.art-20c9a08a4d7c4d8fba22c17eb3867a562022-12-22T00:06:37ZengUniversidade Estadual de MaringáActa Scientiarum. Health Sciences1679-92911807-86482022-01-0144110.4025/actascihealthsci.v44i1.53630Pharmacovigilance of antiretroviral dolutegravir in the state of ParanáBárbara Thaís Poliselo de Sá0Frederico Alves Dias1Flavia Helen Correia2Doroteia Aparecida Höfelmann3Yanna Dantas Rattmann4Universidade Federal do ParanáSecretaria de Estado da Saúde do ParanáUniversidade Federal do ParanáUniversidade Federal do ParanáUniversidade Federal do Paraná The aim of this study was to investigate adverse reactions to Dolutegravir, a drug recently made available by the Unified Health System (SUS) for treating HIV infections. The frequency, severity and sex distribution of adverse reactions to Dolutegravir were identified over the first 18 months of its availability in users in the state of Paraná. Information was obtained through the pharmacovigilance questionnaire prepared by the Ministry of Health, accessed through the Logistics Control System for Medicines (SICLOM). During the study period, dolutegravir was dispensed to 9,865 patients in the state. However, 9,207 users (93.3%) answered the pharmacovigilance questionnaire. Among them, 1.75% reported 279 adverse reactions. This population was composed mainly of male people (69.57%), in the ratio of 2.29 men for each woman, white (67.08%), aged between 20 and 29 years (26.71%), single (45.34%) and with education between 8 and 11 years of study (41.61%). Gastrointestinal (36.92%) and nervous system (14.34%) disorders were the most prevalent. 77.78% adverse reactions were considered non-serious by users. It can be concluded that dolutegravir had a low prevalence of adverse reactions in users in the state of Paraná, demonstrating to be safe for use by the population in therapy against HIV, in accordance with clinical trials https://periodicos.uem.br/ojs/index.php/ActaSciHealthSci/article/view/53630dolutegravir; HIV; Anti-retroviral agent; drug-related side effects; adverse reactions.
spellingShingle Bárbara Thaís Poliselo de Sá
Frederico Alves Dias
Flavia Helen Correia
Doroteia Aparecida Höfelmann
Yanna Dantas Rattmann
Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
Acta Scientiarum. Health Sciences
dolutegravir; HIV; Anti-retroviral agent; drug-related side effects; adverse reactions.
title Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
title_full Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
title_fullStr Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
title_full_unstemmed Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
title_short Pharmacovigilance of antiretroviral dolutegravir in the state of Paraná
title_sort pharmacovigilance of antiretroviral dolutegravir in the state of parana
topic dolutegravir; HIV; Anti-retroviral agent; drug-related side effects; adverse reactions.
url https://periodicos.uem.br/ojs/index.php/ActaSciHealthSci/article/view/53630
work_keys_str_mv AT barbarathaispoliselodesa pharmacovigilanceofantiretroviraldolutegravirinthestateofparana
AT fredericoalvesdias pharmacovigilanceofantiretroviraldolutegravirinthestateofparana
AT flaviahelencorreia pharmacovigilanceofantiretroviraldolutegravirinthestateofparana
AT doroteiaaparecidahofelmann pharmacovigilanceofantiretroviraldolutegravirinthestateofparana
AT yannadantasrattmann pharmacovigilanceofantiretroviraldolutegravirinthestateofparana