Neuropsychiatric adverse drug reactions and associated factors in a cohort of individuals starting dolutegravir-based or efavirenz-based antiretroviral therapy in Belo Horizonte, Brazil.

OBJECTIVE: To measure the incidence of neuropsychiatric adverse drug reactions (ADRs) in individuals living with HIV who initiated antiretroviral therapy (ART) with first-line regimens containing dolutegravir (DTG) or efavirenz (EFV) and associated factors. METHODS: Prospective cohort study with individuals living with HIV who started ART with DTG or EFV associated with tenofovir disoproxil and lamivudine in Belo Horizonte, Brazil. Sociodemographic, clinical, and laboratory data were collected from September 2015 to October 2018 in three specialized HIV care services through interviews, clinical records, and computerized systems. We analysed the frequency of neuropsychiatric ADRs recorded in clinical records 12 months after starting antiretroviral use, and the associated factors were investigated using binary logistic regression. RESULTS: A total of 152 (35.1%) of the 433 individuals included had neuropsychiatric ADRs. The incidence density was 35.3/100 person-years. The subjects mainly had sleep disorders and disturbances (21.3%), neurological disorders (13.9%), headaches (8.1%), and anxiety disorders and symptoms (3.0%), more frequently in individuals using EFV. A lower likelihood of neuropsychiatric ADRs was associated with using a DTG-based antiretroviral regimen (OR = 0.24; 95% CI = 0.14-0.40) and anxiety or depression signs and symptoms at the onset of treatment (OR = 0.57; 95% CI = 0.37-0.89). CONCLUSION: The incidence of neuropsychiatric ADRs was high in individuals starting ART with a lower likelihood of using a DTG-based regimen. The DTG-based regimen had a better safety profile for neuropsychiatric ADRs than the EFV-based regimen.

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.

Diagnóstico e tratamento da sífilis em gestantes nos serviços de Atenção Básica / Diagnosis and treatment of syphilis in pregnant women at the services of Primary Care

Resumo O objetivo deste artigo é avaliar as condições dos serviços de Atenção Básica (AB) brasileiros quanto a disponibilidade de testes rápidos (TR) para o diagnóstico precoce e de Benzilpenicilina (BZP) para o tratamento das gestantes com sífilis. Estudo transversal com dados dos serviços de AB que participaram do Programa de Melhoria da Qualidade da Atenção Básica. Os serviços que não dispunham de TR sempre disponível ou não dispunham de BZP em quantidade suficiente foram categorizados como "inadequados" e aqueles que dispunham de TR sempre disponível e de BZP em quantidade suficiente, como "adequados". Foi realizada análise bivariada e estimados os Odds ratios com seus respectivos Intervalos de Confiança de 95%. A amostra incluiu 20.286 serviços de AB de todas as regiões do país. A prevalência de serviços com condições inadequadas para diagnóstico e tratamento da sífilis foi de 47,7%. A região Centro-Oeste e as cidades que não eram capitais apresentaram maiores prevalências de serviços de AB com condições inadequadas para diagnóstico e tratamento da sífilis em gestantes (p<0,05). Diferenças regionais e de localização dos serviços de AB impactam na disponibilidade de TR e de BZP.

Abstract The aim of this article is to evaluate the conditions of Primary Care (PC) services in Brazil as regards the availability of quick tests (QTs) for early diagnoses and of Benzylpenicillin (BZP) for the treatment of pregnant women with syphilis. This was a cross-sectional study, conducted with data from PC services that participated in the National Program for Access and Quality Improvement in Primary Care (PMAQ-AB, in Portuguese). The services where QTs were not readily available or where BZP was not available in a sufficient quantity were categorized as "inadequate", while those where the QTs were readily available and BZP was found in sufficient quantities were categorized as "adequate". A bivariate analysis and Odds Ratio (OR) estimates, together with their respective 95% confidence intervals (CI), were performed. The sample included 20,286 PC services from regions throughout the country. The prevalence of services with inadequate conditions for the diagnosis and treatment of syphilis was 47.7%. The Midwest region and non-capital cities presented the highest prevalence rates for PC services with inadequate conditions for the diagnosis and treatment of syphilis in pregnant women (p<0.05). Differences in the regions and locations of the PC services impact the availability of QTs and BZP.

Trends in HIV post-exposure prophylaxis following sexual exposure in Brazil (2011-2019).

We examined trends in the prevalence of post-exposure prophylaxis following sexual exposure (PEPSE) per million population (2011-2019) and the proportion of repeated PEPSE within 365 days of the first PEPSE dispensing (2011-2018) in Brazil. We also compared the prevalence of repeated PEPSE according to patient and health services characteristics in 2018. The prevalence of PEPSE increased 55.5% from 2011 to 2019. Repeated PEPSE increased 11.8%, reaching 8.4% among people with their first dispensing in 2018. The prevalence of repeated PEPSE was higher in cis men or trans women (versus cisgender women); homosexuals (versus heterosexuals); and people aged 25-29 years (versus other age groups). We also observed greater prevalence of repeated PEPSE in HIV services in populous cities or services with elevated caseloads. Our findings highlight the need for strategies to reduce repeated PEPSE and promote other HIV-prevention technologies, particularly among young adults, cisgender men, transgender women, and homosexuals.

RESUMEN: Examinamos las tendencias de la prevalencia de uso de la profilaxis posterior a la exposición sexual (PEPSE) por millón de población (2011­2019) y la proporción de PEPSE repetida dentro de los 365 días de la primera dispensación de PEPSE (2011­2018) en Brasil. También comparamos la prevalencia de PEPSE repetida según las características del paciente y de los servicios de salud en 2018. La prevalencia de PEPSE aumentó un 55,5% de 2011 a 2019. La PEPSE repetida aumentó un 11,8%, alcanzando el 8,4% entre las personas con su primera dispensación en 2018. La prevalencia de PEPSE repetida fue mayor en hombres cis o mujeres trans (versus mujeres cisgénero); homosexuales (versus heterosexuales); y personas de 25 a 29 años (versus otros grupos de edad). También observamos una mayor prevalencia de repetición en los servicios de VIH de las ciudades más pobladas o con un elevado número de clientes. Nuestros hallazgos ponen de manifiesto la necesidad de estrategias para reducir la repetición de la PEPSE y promover otras tecnologías de prevención del VIH entre los adultos jóvenes, especialmente los hombres, las trans y los homosexuales.

Diagnosis and treatment of syphilis in pregnant women at the services of Primary Care. / Diagnóstico e tratamento da sífilis em gestantes nos serviços de Atenção Básica.

The aim of this article is to evaluate the conditions of Primary Care (PC) services in Brazil as regards the availability of quick tests (QTs) for early diagnoses and of Benzylpenicillin (BZP) for the treatment of pregnant women with syphilis. This was a cross-sectional study, conducted with data from PC services that participated in the National Program for Access and Quality Improvement in Primary Care (PMAQ-AB, in Portuguese). The services where QTs were not readily available or where BZP was not available in a sufficient quantity were categorized as "inadequate", while those where the QTs were readily available and BZP was found in sufficient quantities were categorized as "adequate". A bivariate analysis and Odds Ratio (OR) estimates, together with their respective 95% confidence intervals (CI), were performed. The sample included 20,286 PC services from regions throughout the country. The prevalence of services with inadequate conditions for the diagnosis and treatment of syphilis was 47.7%. The Midwest region and non-capital cities presented the highest prevalence rates for PC services with inadequate conditions for the diagnosis and treatment of syphilis in pregnant women (p<0.05). Differences in the regions and locations of the PC services impact the availability of QTs and BZP.

O objetivo deste artigo é avaliar as condições dos serviços de Atenção Básica (AB) brasileiros quanto a disponibilidade de testes rápidos (TR) para o diagnóstico precoce e de Benzilpenicilina (BZP) para o tratamento das gestantes com sífilis. Estudo transversal com dados dos serviços de AB que participaram do Programa de Melhoria da Qualidade da Atenção Básica. Os serviços que não dispunham de TR sempre disponível ou não dispunham de BZP em quantidade suficiente foram categorizados como "inadequados" e aqueles que dispunham de TR sempre disponível e de BZP em quantidade suficiente, como "adequados". Foi realizada análise bivariada e estimados os Odds ratios com seus respectivos Intervalos de Confiança de 95%. A amostra incluiu 20.286 serviços de AB de todas as regiões do país. A prevalência de serviços com condições inadequadas para diagnóstico e tratamento da sífilis foi de 47,7%. A região Centro-Oeste e as cidades que não eram capitais apresentaram maiores prevalências de serviços de AB com condições inadequadas para diagnóstico e tratamento da sífilis em gestantes (p<0,05). Diferenças regionais e de localização dos serviços de AB impactam na disponibilidade de TR e de BZP.

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.

Quality of life in individuals initiating antiretroviral therapy: a cohort study.

OBJECTIVE: To assess longitudinally the change in quality of life in people living with HIV initiating antiretroviral therapy in three public reference services specialized in HIV care in Belo Horizonte, Brazil. METHODS: Prospective cohort study among people living with HIV, aged 18 years or older, and initiating antiretroviral therapy. We obtained sociodemographic, behavioral, clinical data related to pharmacological treatment and to the service by face-to-face interviews, and supplemented these data with information from clinical records and Information Systems of the Brazilian HIV/AIDS Program. We measured the quality of life using the WHOQOL-HIV bref instrument, with a minimum interval of six months between the baseline and the follow-up interviews. We used paired t-test to assess the mean change in quality of life between the two interviewsand evaluated factors associated with this outcome using multiple linear regression. RESULTS: The overall quality of life, as well as the physical, psychological, level of independence, environment and spiritual quality of life domains were statistically higher in people living with HIV using antiretroviral therapy at the end of the follow-up. Factors independently associated with the increase in quality of life were having religious belief and living with other people. Having signs or symptoms of anxiety and depression and the number of adverse drug reactions reported were predictors associated with worsening quality of life. CONCLUSIONS: These results show an improvement in the quality of life over time in people living with HIV on antiretroviral therapy. They also highlight the need to monitor and provide health care support, especially for individuals with signs and symptoms of anxiety and depression and that report adverse reactions to medicines at the beginning of treatment.

Prevalence of smoking and associated factors in people living with HIV undergoing treatment.

OBJECTIVE: To estimate the prevalence of smoking and evaluate the factors associated with this outcome in people living with HIV (PLHIV). METHODS: This is a cross-sectional study of a prospective concurrent cohort of 462 individuals initiating antiretroviral therapy at three HIV/AIDS specialized services in Belo Horizonte between 2015 and 2017. The following smoking status were used: current smoker (CS), former smoker (FS) and non-smoker (NS). Multinomial logistic regression was performed with NS as the reference category. RESULTS: Most participants were men (81.4%), young (up to 34 years old; 57.2%) and non-white (75.7%). Of the total number of individuals, 27.7% were CS, 22.9% FS, and 49.4% NS. Most smokers were light smokers (65.1%), consumed up to 10 cigarettes per day and had been smoking for more than 10 years (63.3%), starting on average at 17.2 years of age (SD = 5.1). In the multivariate analysis, higher chances of being CS were associated with: being female, having up to 9 years of schooling, current or prior use of alcohol and illicit drugs (marijuana, cocaine and crack) and presenting signs and/or symptoms of anxiety or depression. Higher chances of being FS were associated with having up to 9 years of schooling and current or prior use of alcohol and illicit drugs (marijuana and crack). CONCLUSIONS: The results show that smoking is highly prevalent among PLHIV, indicating the need for HIV specialized services to prioritize smoking cessation interventions. These interventions should consider the use of alcohol and illicit drugs and be targeted especially to young people, those with low schooling and with signs and/or symptoms of anxiety or depression.

Prevalence of smoking and associated factors in people living with HIV undergoing treatment / Prevalência e fatores associados ao tabagismo em pessoas vivendo com HIV em tratamento

ABSTRACT OBJECTIVE: To estimate the prevalence of smoking and evaluate the factors associated with this outcome in people living with HIV (PLHIV). METHODS: This is a cross-sectional study of a prospective concurrent cohort of 462 individuals initiating antiretroviral therapy at three HIV/AIDS specialized services in Belo Horizonte between 2015 and 2017. The following smoking status were used: current smoker (CS), former smoker (FS) and non-smoker (NS). Multinomial logistic regression was performed with NS as the reference category. RESULTS: Most participants were men (81.4%), young (up to 34 years old; 57.2%) and non-white (75.7%). Of the total number of individuals, 27.7% were CS, 22.9% FS, and 49.4% NS. Most smokers were light smokers (65.1%), consumed up to 10 cigarettes per day and had been smoking for more than 10 years (63.3%), starting on average at 17.2 years of age (SD = 5.1). In the multivariate analysis, higher chances of being CS were associated with: being female, having up to 9 years of schooling, current or prior use of alcohol and illicit drugs (marijuana, cocaine and crack) and presenting signs and/or symptoms of anxiety or depression. Higher chances of being FS were associated with having up to 9 years of schooling and current or prior use of alcohol and illicit drugs (marijuana and crack). CONCLUSIONS: The results show that smoking is highly prevalent among PLHIV, indicating the need for HIV specialized services to prioritize smoking cessation interventions. These interventions should consider the use of alcohol and illicit drugs and be targeted especially to young people, those with low schooling and with signs and/or symptoms of anxiety or depression.

RESUMEN OBJETIVO: Estimar a prevalência do tabagismo e avaliar os fatores a ele associados em pessoas vivendo com HIV (PVHIV). MÉTODOS: Trata-se de estudo transversal de uma coorte prospectiva concorrente com 462 indivíduos em início de terapia antirretroviral atendidos em três serviços de assistência especializada ao HIV/aids em Belo Horizonte entre 2015 e 2017. Os status de tabagismo utilizados foram: fumante atual (FA), ex-fumante (EF) e não fumante (NF). Realizou-se regressão logística multinomial, sendo NF a categoria de referência. RESULTADOS: A maioria dos participantes eram homens (81,4%), jovens (de até 34 anos; 57,2%) e não brancos (75,7%). Do total de indivíduos, 27,7% eram FA, 22,9% EF, e 49,4% NF. A maioria dos tabagistas eram fumantes leves (65,1%), consumiam até 10 cigarros por dia e fumavam havia mais de 10 anos (63,3%), tendo começado em média aos 17,2 anos de idade (DP = 5,1). Na análise multivariada, maiores chances de ser FA se associaram a: ser do sexo feminino, ter até 9 anos de escolaridade, usar ou já ter usado álcool e drogas ilícitas (maconha, cocaína e crack) e apresentar sinais e/ou sintomas de ansiedade ou depressão. Maiores chances de ser EF se associaram a ter até 9 anos de escolaridade e usar ou já ter usado álcool e drogas e ilícitas (maconha e crack). CONCLUSÕES: Os resultados mostram que o tabagismo é altamente prevalente entre PVHIV, indicando a necessidade de os serviços de assistência especializada em HIV priorizarem intervenções a fim de cessá-lo, com abordagem sobre o uso de álcool e drogas ilícitas, especialmente voltadas para pessoas jovens, com baixa escolaridade e com sinais e/ou sintomas de ansiedade ou depressão.

Adverse reactions associated with first-line regimens in patient initiating antiretroviral therapy.

OBJECTIVE: To evaluate the prevalence of adverse drug reactions (ADR) and associated factors during the use of Highly Active Antiretroviral Therapy (HAART) in patients initiating treatment. METHODS: This is a cross-sectional analysis of a prospective study conducted in three public referral services specialized in HIV/AIDS care in Belo Horizonte, Brazil. Self-reported ADR and explanatory variables were obtained from face-to-face interview and from Information Systems. Associated factors with ADR were evaluated by logistic regression in SPSS software v.22. RESULTS: We included 399 patients, of which 85.5% reported at least one and 72.7% up to 5 ADRs after HAART initiation. Neurological reactions were the most frequent, with self-reported ADRs being distinct according to HAART regimen used. The global model showed higher chance of ADRs among females (OR = 3.52) and illicit drug users (OR = 2.28). Lower chance of ADRs was found for patients aged > 33 years (OR = 0.37), DTG/TDF/3TC users (OR = 0.41), and higher physical domain of quality of life (OR = 0.78). The model restricted to patients using the single-tablet regimen EFV/TDF/3TC showed lower ADRs among patients with CD4+ T lymphocyte count > 200 cells/mm3 (OR = 0.23) and higher independence domain of quality of life (OR = 0.74). The model restricted to DTG/TDF/3TC and to other regimens showed lower ADRs with higher physical domain of quality of life (OR = 0.74 and OR = 0.55, respectively). CONCLUSIONS: The prevalence of self-reported ADRs to first-line antiretroviral regimens was high and patients using DTG/TDF/3TC had a smaller number of ADRs. In addition to HAART regimen, sociodemographic, clinical, and quality of life characteristics were associated with ADRs.