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Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.

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Title: Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.
Authors: Mendes, Jullye Campos, Ceccato, Maria das Graças Braga, Reis, Adriano Max Moreira, Costa, André Moura Gomes da, Pantuzza, Lais Lessa Neiva, Furtado dos Santos, Simone, Crepalde-Ribeiro, Kennedy, Silveira, Micheline Rosa
Source: AIDS Care. May2023, Vol. 35 Issue 5, p729-738. 10p. 3 Charts, 2 Graphs.
Subjects: HIV infections, HIV-positive persons, Pharmacology, Research methodology, Antiretroviral agents, Quantitative research, Health outcome assessment, Comparative studies, Questionnaires, Descriptive statistics, Research funding, Drug side effects, Patient safety
Geographic Terms: 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. [ABSTRACT FROM AUTHOR]
Copyright of AIDS Care is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.
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  Data: <searchLink fieldCode="AR" term="%22Mendes%2C+Jullye+Campos%22">Mendes, Jullye Campos</searchLink><br /><searchLink fieldCode="AR" term="%22Ceccato%2C+Maria+das+Graças+Braga%22">Ceccato, Maria das Graças Braga</searchLink><br /><searchLink fieldCode="AR" term="%22Reis%2C+Adriano+Max+Moreira%22">Reis, Adriano Max Moreira</searchLink><br /><searchLink fieldCode="AR" term="%22Costa%2C+André+Moura+Gomes+da%22">Costa, André Moura Gomes da</searchLink><br /><searchLink fieldCode="AR" term="%22Pantuzza%2C+Lais+Lessa+Neiva%22">Pantuzza, Lais Lessa Neiva</searchLink><br /><searchLink fieldCode="AR" term="%22Furtado+dos+Santos%2C+Simone%22">Furtado dos Santos, Simone</searchLink><br /><searchLink fieldCode="AR" term="%22Crepalde-Ribeiro%2C+Kennedy%22">Crepalde-Ribeiro, Kennedy</searchLink><br /><searchLink fieldCode="AR" term="%22Silveira%2C+Micheline+Rosa%22">Silveira, Micheline Rosa</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22AIDS+Care%22">AIDS Care</searchLink>. May2023, Vol. 35 Issue 5, p729-738. 10p. 3 Charts, 2 Graphs.
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  Data: <searchLink fieldCode="DE" term="%22HIV+infections%22">HIV infections</searchLink><br /><searchLink fieldCode="DE" term="%22HIV-positive+persons%22">HIV-positive persons</searchLink><br /><searchLink fieldCode="DE" term="%22Pharmacology%22">Pharmacology</searchLink><br /><searchLink fieldCode="DE" term="%22Research+methodology%22">Research methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Antiretroviral+agents%22">Antiretroviral agents</searchLink><br /><searchLink fieldCode="DE" term="%22Quantitative+research%22">Quantitative research</searchLink><br /><searchLink fieldCode="DE" term="%22Health+outcome+assessment%22">Health outcome assessment</searchLink><br /><searchLink fieldCode="DE" term="%22Comparative+studies%22">Comparative studies</searchLink><br /><searchLink fieldCode="DE" term="%22Questionnaires%22">Questionnaires</searchLink><br /><searchLink fieldCode="DE" term="%22Descriptive+statistics%22">Descriptive statistics</searchLink><br /><searchLink fieldCode="DE" term="%22Research+funding%22">Research funding</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+side+effects%22">Drug side effects</searchLink><br /><searchLink fieldCode="DE" term="%22Patient+safety%22">Patient safety</searchLink>
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  Data: <searchLink fieldCode="DE" term="%22Brazil%22">Brazil</searchLink>
– Name: Abstract
  Label: Abstract
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  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
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  Data: <i>Copyright of AIDS Care is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=163520501
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      – Type: doi
        Value: 10.1080/09540121.2022.2062289
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      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 10
        StartPage: 729
    Subjects:
      – SubjectFull: HIV infections
        Type: general
      – SubjectFull: HIV-positive persons
        Type: general
      – SubjectFull: Pharmacology
        Type: general
      – SubjectFull: Research methodology
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      – SubjectFull: Antiretroviral agents
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      – SubjectFull: Quantitative research
        Type: general
      – SubjectFull: Health outcome assessment
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      – SubjectFull: Comparative studies
        Type: general
      – SubjectFull: Questionnaires
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      – SubjectFull: Descriptive statistics
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      – SubjectFull: Research funding
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      – SubjectFull: Drug side effects
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      – SubjectFull: Patient safety
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      – SubjectFull: Brazil
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    Titles:
      – TitleFull: Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.
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            NameFull: Mendes, Jullye Campos
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            NameFull: Ceccato, Maria das Graças Braga
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            NameFull: Costa, André Moura Gomes da
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            NameFull: Pantuzza, Lais Lessa Neiva
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            – D: 01
              M: 05
              Text: May2023
              Type: published
              Y: 2023
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            – TitleFull: AIDS Care
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