Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil

ABSTRACT

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.

KEYWORDS:

• Dolutegravir
• pharmacovigilance
• adverse drug reaction reporting systems
• drug-related side effects and adverse reactions
• antiretroviral therapy

Acknowledgments

MedDRA^® trademark is registered by ICH. All authors have contributed significantly to this study and are aware of and agree with this submission. Mendes JC contributed to the work’s conception and design, interpretation of the findings and was responsible for drafting the paper and approved the manuscript’s final version. Costa AMG was responsible for data management (data access and cleaning) and performed the analysis of the data. Santos SF, Crepalde-Ribeiro K and Pantuzza LLN critically reviewed the work and approved its final version. Ceccato MGB, Reis AMM and Silveira MR contributed to the study’s design and conception, participated in the drafting of the article and interpretation of the findings, critically reviewed the work and approved the manuscript’s final version.

Availability of data

Data not available due to ethical/legal restrictions.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

JCM, SFS and LLNP received national Doctoral Scholarships from the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES).