| Autor: |
Mendes JC; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Ceccato MDGB; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.; Departamento de Farmácia Social, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Reis AMM; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.; Departamento de Produtos Farmacêuticos, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Costa AMGD; Departamento de Farmácia Social, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Pantuzza LLN; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Furtado Dos Santos S; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Crepalde-Ribeiro K; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil., Silveira MR; Programa de Pós Graduação em Medicamentos e Assistência Farmacêutica, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.; Departamento de Farmácia Social, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. |
| Abstrakt: |
A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness. |
