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

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.

Factors associated with HIV/syphilis co-infection initiating of antiretroviral therapy.

OBJECTIVE: To evaluate the prevalence and factors associated with HIV/syphilis co-infection in people initiating antiretroviral therapy in Belo Horizonte, capital of the state of Minas Gerais. METHODS: A sectional section of a prospective cohort study was carried out with people living with HIV, treatment-naive, initiating antiretroviral therapy, older than 16 years, and in follow-up treatment at specialized HIV/Aids care services in Belo Horizonte. Sociodemographic, behavioral, clinical, laboratory and pharmacological treatment-related data were obtained through interviews, medical records, and information systems for logistical control of antiretroviral medications and laboratory tests. The dependent variable was the first episode of active syphilis, recorded by the physician in clinical records, within 12 months after beginning of the antiretroviral therapy. Factors associated with HIV/syphilis co-infection were assessed using binary multiple logistic regression. RESULTS: Among the 459 individuals included, a prevalence of 19.5% (n = 90) of sexually transmitted infections (STI) was observed, with syphilis (n = 49) being the most frequent STI in these individuals. The prevalence of HIV/syphilis co-infection was 10.6% (n = 49), and the associated independent factors were alcohol use (OR = 2.30; 95%CI: 1.01-5.26), and having a diagnosis of other sexually transmitted infections (OR = 3.33; 95%CI: 1.24-8.95). CONCLUSIONS: There was a high prevalence of HIV/syphilis co-infection in people living with HIV initiating antiretroviral therapy in Belo Horizonte. HIV/syphilis co-infection was associated with behavioral and clinical factors, such as alcohol use and diagnosis of other sexually transmitted infections. Prior knowledge about the factors associated with this co-infection may support the decisions of health professionals engaged in the care to people living with HIV, with regard to timely diagnosis, guidance, follow-up and adequate treatment, both for syphilis and HIV.

Factors associated with HIV/syphilis co-infection initiating of antiretroviral therapy / Fatores associados à coinfecção HIV/sífilis no início da terapia antirretroviral

ABSTRACT OBJECTIVE To evaluate the prevalence and factors associated with HIV/syphilis co-infection in people initiating antiretroviral therapy in Belo Horizonte, capital of the state of Minas Gerais. METHODS A sectional section of a prospective cohort study was carried out with people living with HIV, treatment-naive, initiating antiretroviral therapy, older than 16 years, and in follow-up treatment at specialized HIV/Aids care services in Belo Horizonte. Sociodemographic, behavioral, clinical, laboratory and pharmacological treatment-related data were obtained through interviews, medical records, and information systems for logistical control of antiretroviral medications and laboratory tests. The dependent variable was the first episode of active syphilis, recorded by the physician in clinical records, within 12 months after beginning of the antiretroviral therapy. Factors associated with HIV/syphilis co-infection were assessed using binary multiple logistic regression. RESULTS Among the 459 individuals included, a prevalence of 19.5% (n = 90) of sexually transmitted infections (STI) was observed, with syphilis (n = 49) being the most frequent STI in these individuals. The prevalence of HIV/syphilis co-infection was 10.6% (n = 49), and the associated independent factors were alcohol use (OR = 2.30; 95%CI: 1.01-5.26), and having a diagnosis of other sexually transmitted infections (OR = 3.33; 95%CI: 1.24-8.95). CONCLUSIONS There was a high prevalence of HIV/syphilis co-infection in people living with HIV initiating antiretroviral therapy in Belo Horizonte. HIV/syphilis co-infection was associated with behavioral and clinical factors, such as alcohol use and diagnosis of other sexually transmitted infections. Prior knowledge about the factors associated with this co-infection may support the decisions of health professionals engaged in the care to people living with HIV, with regard to timely diagnosis, guidance, follow-up and adequate treatment, both for syphilis and HIV.

RESUMO OBJETIVO Avaliar a prevalência e os fatores associados à coinfecção HIV/sífilis em pessoas no início da terapia antirretroviral no município de Belo Horizonte, Minas Gerais. MÉTODOS Foi realizado um corte seccional de um estudo de coorte prospectivo, com pessoas vivendo com HIV, sem tratamento prévio da infecção, em início da terapia antirretroviral, maiores de 16 anos e em acompanhamento em serviços de assistência especializada em HIV/aids de Belo Horizonte. Dados sociodemográficos, comportamentais, clínicos, laboratoriais e relacionados ao tratamento farmacológico foram obtidos por meio de entrevistas, coleta em prontuários clínicos e nos sistemas de informação de controle de medicamentos antirretrovirais e exames laboratoriais. A variável dependente foi o primeiro episódio de sífilis ativa, registrado pelo médico em prontuário clínico, em um período de 12 meses após início da terapia antirretroviral. Os fatores associados à coinfecção HIV/sífilis foram avaliados por meio de regressão logística binária múltipla. RESULTADOS Dentre os 459 indivíduos avaliados, observou-se uma prevalência de 19,5% (n = 90) de infecções sexualmente transmissíveis, sendo a sífilis (n = 49) a infecção sexualmente transmissível mais frequente nesses indivíduos. A prevalência da coinfecção HIV/sífilis foi de 10,6% (n = 49) e os fatores independentes associados foram o uso de álcool (OR = 2,30; IC95% 1,01-5,26) e ter diagnóstico de outras infecções sexualmente transmissíveis (OR = 3,33; IC95% 1,24-8,95). CONCLUSÕES Houve alta prevalência de coinfecção HIV/sífilis em pessoas vivendo com HIV em início de terapia antirretroviral em Belo Horizonte. A coinfecção HIV/sífilis foi associada a fatores comportamentais e clínicos, como uso de álcool e diagnóstico de outras infecções sexualmente transmissíveis. O conhecimento prévio sobre os fatores associados à essa coinfecção pode subsidiar as decisões dos profissionais de saúde inseridos no cuidado às pessoas vivendo com HIV, no que diz respeito ao diagnóstico oportuno, orientações, acompanhamento e tratamento adequado, tanto da sífilis quanto do HIV.