Beyond access to medication: the role of SUS and the characteristics of HIV care in Brazil / Para além do acesso ao medicamento: papel do SUS e perfil da assistência em HIV no Brasil

ABSTRACT OBJECTIVE To estimate the public-private composition of HIV care in Brazil and the organizational profile of the extensive network of public healthcare facilities. METHODS Data from the Qualiaids-BR Cohort were used, which gathers data from national systems of clinical and laboratory information on people aged 15 years or older with the first dispensation of antiretroviral therapy between 2015-2018, and information from SUS healthcare facilities for clinical-laboratory follow-up of HIV, produced by the Qualiaids survey. The follow-up system was defined by the number of viral load tests requested by any SUS healthcare facility: follow-up in the private system - no record; follow-up at SUS - two or more records; undefined follow-up - one record. SUS healthcare facilities were characterized as outpatient clinics, primary care and prison system, according to the respondents' self-classification in the Qualiaids survey (72.9%); for non-respondents (27.1%) the classification was based on the terms present in the names of the healthcare facilities. RESULTS During the period, 238,599 people aged 15 years or older started antiretroviral therapy in Brazil, of which 69% were followed-up at SUS, 21.7% in the private system and 9.3% had an undefined system. Among those followed-up at SUS, 93.4% received care in outpatient clinics, 5% in primary care facilities and 1% in the prison system. CONCLUSION In Brazil, antiretroviral treatment is provided exclusively by SUS, which is also responsible for clinical and laboratory follow-up for most people in outpatient clinics. The study was only possible because SUS maintains records and public information about HIV care. There is no data available for the private system.

RESUMO OBJETIVO Estimar a composição público-privada da assistência em HIV no Brasil e o perfil organizacional da extensa rede de serviços públicos. MÉTODOS Foram utilizados dados da Coorte Qualiaids-BR, que reúne dados dos sistemas nacionais de informações clínicas e laboratoriais de pessoas com 15 anos ou mais com primeira dispensação de terapia antirretroviral, entre 2015-2018, e informações dos serviços do SUS de acompanhamento clínico-laboratorial do HIV, produzidas pelo inquérito Qualiaids. O sistema de acompanhamento foi definido pelo número de exames de carga viral solicitados por algum serviço do SUS: acompanhamento no sistema privado - nenhum registro; acompanhamento no SUS - dois ou mais registros; acompanhamento indefinido - um registro. Os serviços do SUS foram caracterizados como ambulatórios, atenção básica e sistema prisional, segundo autoclassificação dos respondentes ao inquérito Qualiaids (72,9%); para os não respondentes (27,1%) a classificação baseou-se nos termos presentes nos nomes dos serviços. RESULTADOS No período, 238.599 pessoas com 15 anos ou mais iniciaram a terapia antirretroviral no Brasil, das quais, 69% receberam acompanhamento no SUS, 21,7% no sistema privado e 9,3% tiveram o sistema indefinido. Entre os acompanhados no SUS, 93,4% foram atendidos em serviços do tipo ambulatório, 5% em serviços de atenção básica e 1% no sistema prisional. CONCLUSÃO No Brasil o tratamento antirretroviral é fornecido exclusivamente pelo SUS, que também é responsável pelo acompanhamento clínico-laboratorial da terapia da maior parte das pessoas em serviços ambulatoriais. O estudo só foi possível porque o SUS mantêm registros e informações públicas acerca do acompanhamento em HIV. Não há nenhum dado disponível para o sistema privado.

Biomarcadores para el diagnóstico del síndrome de reconstitución inmune / Biomarkers for the diagnosis of immune reconstitution syndrome

Introducción: el síndrome inflamatorio de reconstitución inmune es una complicación clínica dada en algunas personas infectadas con el virus de la inmunodeficiencia humana (VIH) luego de empezar la terapia antirretroviral; se destaca por la producción de citoquinas proinflamatorias, que se han estudiado como posibles biomarcadores que puedan orientar para el diagnóstico y pronóstico de esta condición clínica. Objetivo: llevar a cabo una revisión actualizada de los avances en los biomarcadores para el diagnóstico de SIRI, resaltando la importancia de las moléculas inflamatorias y los exosomas, tanto en su patogénesis como un posible Gold estándar para la confirmación de este estado inflamatorio. Metodología: se realizó una revisión bibliográfica en bases de datos, como Science Direct, PubMed, Scopus y Medline, partiendo de los siguientes términos MeSH: síndrome inflamatorio de reconstitución, enfermedades del sistema inmune, biomarcadores, fármacos antiVIH, plasma. Conclusión: cada vez existen más avances en la identificación de moléculas que pueden servir como biomarcadores de SIRI, buscando un oportuno diagnóstico, monitoreo de la progresión clínica, mejor respuesta al tratamiento y más hallazgos sobre la fisiopatología, pero persiste la necesidad de encontrar un Gold estándar que proporcione criterios para su sospecha y confirmación.

Introduction: The inflammatory syndrome of immune reconstitution (IRIS) is a clinical complication given in some people infected with the human immunodeficiency virus (HIV), after they begin antiretroviral therapy (ART), which stands out for the production of abundant proinflammatory cytokines, which have been studied as possible biomarkers that can guide the diagnosis and prognosis of this clinical condition. Objective: Review the advances in biomarkers for the diagnosis of IRIS,and the importance of inflammatory molecules and exosomes, so their pathogenesis and as a possible Gold standard for confirmation of this inflammatory. Methodology: A bibliographic review was carried out in databases, such as Science Direct, Pubmed, Scopus and Medline based on the following MeSH terms: Inflammatory reconstitution syndrome, Immune system diseases, Biomarkers, Anti-HIV drugs, Plasma. Conclusion: There are more and more advances in the identification of various molecules that can serve as biomarkers of IRIS, seeking timely diagnosis, monitoring of clinical progression, better response to treatment and more findings on the pathophysiology of IRIS, but the urgent need to find a gold standard that provides criteria for its suspicion and confirmation persists.

Barriers to Pre-Exposure Prophylaxis (PrEP) use for HIV: an integrative review / Barreras para el uso de la Profilaxis Previa a la Exposición (PrEP) para el VIH: una revisión integradora / Barreiras para o uso da Profilaxia Pré-Exposição (PrEP) ao HIV: uma revisão integrativa

ABSTRACT Objectives: to identify and synthesize scientific evidence on the barriers and difficulties for Pre-exposure Prophylaxis (PrEP) use and compliance for HIV. Methods: an integrative literature review, using the MEDLINE/PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier and Scopus (Elsevier) databases. Results: all (100%) the articles included identified that PrEP users experience some type of structural barrier related to health services such as long distance from the units, suboptimal logistics for taking pills and professional resistance to prescribing PrEP. Furthermore, 63.21% identified social barriers, such as stigma about sexuality and HIV, in addition to individual barriers such as alcohol use, adverse effects, and concerns about long-term toxicity. Conclusions: the barriers to PrEP use are multifactorial. Effective interventions are needed to support PrEP users in accessing, complying with, and retaining health services.

RESUMEN Objetivos: identificar y sintetizar evidencias científicas sobre las barreras y dificultades para el uso y la adherencia a la Profilaxis Pre-Exposición (PrEP) para el VIH. Métodos: revisión integrativa de la literatura, utilizando las bases de datos MEDLINE/PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier y Scopus (Elsevier). Resultados: todos (100%) de los artículos incluidos identificaron que los usuarios de PrEP experimentan algún tipo de barrera estructural relacionada con los servicios de salud, como la larga distancia de las unidades, la logística subóptima para la toma de pastillas y la resistencia profesional a prescribir la PrEP. Además, el 63,21% identificó barreras sociales, como el estigma sobre la sexualidad y el VIH, además de las barreras individuales como el consumo de alcohol, los efectos adversos y las preocupaciones sobre la toxicidad a largo plazo. Conclusiones: las barreras para el uso de la PrEP son multifactoriales. Se necesitan intervenciones eficaces para ayudar a los usuarios de la PrEP a acceder, adherirse y conservar los servicios de salud.

RESUMO Objetivos: identificar e sintetizar as evidências científicas sobre as barreiras e dificuldades para o uso e adesão da Profilaxia Pré-exposição (PrEP) para o HIV. Métodos: revisão integrativa da literatura, utilizando as bases de dados MEDLINE/PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Academic Search Premier e Scopus (Elsevier). Resultados: todos (100%) os artigos incluídos identificaram que os usuários da PrEP experimentam algum tipo de barreira estrutural relacionada aos serviços de saúde, como longa distância das unidades, logística subótima para retirada de pílulas e resistência profissional para prescrição da PrEP. Ademais, 63,21% identificaram barreiras sociais, como estigma sobre a sexualidade e HIV, além de barreiras individuais, como uso de álcool, efeitos adversos e preocupações com a toxicidade a longo prazo. Conclusões: multifatoriais são as barreiras para o uso da PrEP. Intervenções efetivas são necessárias para apoiar os usuários da PrEP no acesso, adesão e retenção nos serviços de saúde.

Suppression of HIV in the first 12 months of antiretroviral therapy: a comparative analysis of dolutegravir- and efavirenz-based regimens

ABSTRACT Objective To compare viral suppression in treatment-naïve adults starting antiretroviral therapy with dolutegravir (50mg)- and efavirenz (600mg)-based regimens. Methods We analyzed secondary data from Brazilian health information systems of people living with human immunodeficiency virus who started antiretroviral therapy between 2015 and 2017 in Minas Gerais, Brazil. The outcome was viral suppression, defined as the achievement of the first viral load <50 copies/mL within 12 months after initiating antiretroviral therapy. This outcome was also compared with viral load <1,000 copies/mL and analyzed in two scenarios: intention-to-treat versus per-protocol. Time to viral suppression and adjusted odds ratio accompanied by 95% confidence intervals were estimated. Results Of the 2,599 participants enrolled, 77.5% were men, and the median age was 34 years. In the intention-to-treat analysis, viral suppression was 58.1% for efavirenz and 76.7% for dolutegravir. People living with HIV on dolutegravir-based regimen were more likely to achieve viral suppression (aOR: 2.44; 95%CI: 2.01-2.95) and had a shorter median time to viral suppression (p<0.0001). Antiretroviral therapy initiation within <120 days, baseline CD4⁺T-cells ≥200 cells/mm3, and viral load <100,000 copies/mL had higher odds of viral suppression. According to the per-protocol analysis, viral suppression ≥90% was observed by considering viral load <1,000 copies/mL. Conclusion Our study demonstrated that viral suppression improved after introducing dolutegravir, although the proportion of patients with viral load <50 copies/mL was lower than expected. Improved access to routine viral load examinations and continuous surveillance of the effectiveness of antiretroviral therapy should be considered.

Avaliação do uso da Profilaxia Pré-Exposição ao HIV: coorte retrospectiva / Evaluation of the use of pre-exposure HIV prophylaxis: retrospective cohort / Evaluación del uso de profilaxis pre-exposición al VIH: cohorte retrospectiva

Objetivo: Identificar o perfil da população que buscou a Profilaxia Pré-Exposição ao HIV (PrEP) no Paraná e, entre os usuários da PrEP, avaliar modificações nos comportamentos de risco de adquirir infecções sexualmente transmissíveis (IST's), além de alterações nos exames laboratoriais de monitoramento. Métodos: Coorte retrospectiva com dados secundários obtidos do Sistema de Controle Logístico de Medicamentos acessados em 2018 e 2019. Investigou-se o perfil sociodemográfico da população que buscou a PrEP, de forma a correlacioná-lo aos segmentos prioritários para o uso do medicamento profilático. Entre os usuários, avaliaram-se dados comportamentais, testes diagnósticos para IST's, funções renal e hepática referentes a diferentes momentos no decorrer do uso. Os resultados comparados deram-se por meio dos testes Wilcoxon e Exato de Fisher. Resultados: 255 pessoas buscaram a PrEP. Predominaram-se o sexo masculino (92,28%), homossexuais (78,04%), de 20 a 39 anos (83,53%), brancos (71,76%), com 12 ou mais anos de estudo (74,90%). Para uso da PrEP elegeram-se 188 pessoas. Entre estas, durante o uso, observou-se aumento de práticas sexuais sem preservativo (p=0,012), diminuição no número de parceiros e do consumo de álcool (p=0,001), aumento da atividade de enzimas hepáticas ALT/AST (p=0,018), sem diferença no diagnóstico do HIV e outras IST's. Conclusão: Homens que fazem sexo com homens predominaram na busca pela profilaxia. Entre os usuários da PrEP, apesar do aumento de práticas sexuais desprotegidas, não houve aumento do diagnóstico de IST's no período do estudo. O medicamento da PrEP demonstrou bom perfil de segurança nos exames laboratoriais de seguimento.

Objective: To identify the profile of the population that sought HIV Pre-Exposure Prophylaxis (PrEP) in Paraná; and assess, among PrEP users, changes in risk behaviors for acquiring sexually transmitted infections (STIs) as well as changes in monitoring laboratory tests. Methods: Retrospective cohort with secondary data obtained from the Drug Logistics Control System accessed in 2018 and 2019. The sociodemographic profile of the population that sought PrEP was investigated to correlate it with priority segments for the use of prophylactic medication. Among users, behavioral data, diagnostic tests for STIs, kidney, and liver functions were evaluated at different times during use. The results were compared using the Wilcoxon and Fisher's Exact tests. Results: 255 people sought PrEP. Males predominated (92.28%), homosexuals (78.04%), from 20 to 39 years old (83.53%),white people (71.76%), with 12 or more years of schooling (74.90%). For the use of PrEP, 188 people were elected. Among them, during the usage, was noticed an increase in sexual practices without a condom (p=0.012), a decrease in the number of partners and alcohol consumption (p=0.001), an increase in the activity of liver enzymes ALT/AST (p=0.018), with no difference in the diagnosis of HIV and other STI's. Conclusion: Men who have sex with men predominated in the search for prophylaxis. Among PrEP users, despite the increase in unprotected sexual practices, there was no increase in the diagnosis of STIs during the study period; PrEP drugs showed a good safety profile in follow-up laboratory tests.

Objetivo: Identificar el perfil de la población que fue en busca de la Profilaxis pre-exposición al VIH (PrEP) en Paraná y, de entre los usuarios de la PrEP, evaluar los cambios de conducta de riesgo para tener infecciones de transmisión sexual (ITS) además de las alteraciones de las pruebas de laboratorios para el monitoreo. Métodos: Cohorte retrospectiva con datos secundarios del Sistema de Control Logístico de Medicamentos con acceso en 2018 y 2019. Se investigó el perfil sociodemográfico de la población que fue en busca de la PrEP, para correlacionarlo con los segmentos prioritarios para el uso del medicamento profiláctico. De los usuarios se ha evaluado los datos comportamentales, las pruebas de diagnósticos para las ITS, las funciones renales y hepática referente a distintos momentos durante el uso. Los resultados comparados se han dado a través de las pruebas de Wilcoxon y el Exacta de Fisher. Resultados: 255 personas han buscado la PrEP. Hubo el predominio para el sexo masculino (92,28%), homosexuales (78,04%), entre los 20 y 39 años (83,53%), blancos (71,76%), con 12 o más años de estudio (74,90%). Se há elegido 188 personas para el uso de la PrEP. De entre ellas, durante el uso, se observó el aumento de las prácticas sexuales sin condón (p=0,012), la disminución del número de compañeros y del consumo del alcohol (p=0,001), el aumento de la actividad de enzimas hepáticas ALT/AST (p=0,018), sin diferencia en el diagnóstico del VIH y de otras ITS. Conclusión: Los hombres que tienen sexo con hombres prevalecieron para la búsqueda de la profilaxis. De entre los usuarios de la PrEP, a pesar del aumento de las prácticas sexuales sin protección no hubo el aumento del diagnóstico de ITS en el período del estudio. El medicamento de la PrEP demostró un perfil bueno de seguridad en las pruebas de laboratorios de seguimiento.

Factors associated to the control of viral load in HIV positive patients / Factores asociados con el control de la carga viral en pacientes con VIH

Objective: to evaluate factors associated with inadequate control of viral load in individuals with Human Immunodeficiency Virus (HIV) in the The Center for Assistance to Sexually Transmitted Infections/SIDA/Viral Hepatitis (CAP) of Itajubá, MG, Brazil. The acquired immunodeficiency syndrome remains a health challenge in Brazil. Therapeutic failures, characterized by detectable viral load, must have their causes evaluated. Among the most relevant reasons is the lack of adherence to treatment. Materials and methods: this is an observational, cross-sectional and documentary study of 261 medical records. The variables analyzed were socio-epidemiological characteristics and laboratory tests for viral load and CD4+ T lymphocytes, poor adherence in history or currently, duration of antiretroviral therapy (ART) use, depression and/or anxiety, use of illicit drugs, follow-up time at the CAP. Results: among the patients, 90.42% had an undetectable viral load and 64.37% had a CD4+ T count ≥500 in the last available test. Some characteristics were related to detectable viral load in the last exam: history of poor adherence during treatment (p<0,0001), inconsistent use of ART (p<0,0001) and use of illicit drugs (p=0,0155). Anxiety and/or depression were not statistically significant (p=0,3321). Conclusion: history of poor adherence, inconsistent use of ART and use of illicit drugs were associated with an increased risk of virologic failure. Early identification of groups at risk of poor adherence to treatment can support the development of intervention strategies in an transdisciplinary way to improve adherence and generate better results in the control of HIV infection..Au

Objetivo: evaluar los factores asociados con el control inadecuado de la carga viral en individuos con virus de inmunodeficiencia humana (VIH) en el Centro de Asistencia para Infecciones de Transmisión Sexual/SIDA/Hepatitis Viral (CAP) de Itajubá, MG, Brazil. El síndrome de inmunodeficiencia adquirida sigue siendo un desafío para la salud en Brasil. Las fallas terapéuticas, caracterizadas por una carga viral detectable, deben tener sus causas evaluadas. Entre las razones más relevantes está la falta de adherencia al tratamiento. Materiales y métodos: estudio observacional, transversal y documental con 261 registros médicos. Las variables analizadas fueron características socioepidemiológicas y pruebas de laboratorio para carga viral y linfocitos T CD4+, pobre adherencia en la historia o en la actualidad, duración del uso de terapia antirretroviral (ARTE), depresión. y/o ansiedad, uso de drogas ilícitas, tiempo de seguimiento en el CAP. Resultados: de los pacientes, el 90.42% tenía una carga viral indetectable y el 64.37% tenía un recuento de CD4 + T ≥500 en la última prueba disponible. Fueron evidenciadas características relacionadas con la carga viral detectable en el último examen: antecedentes de mala adherencia durante el tratamiento (p <0,0001), uso inestable de ARTE (p <0,0001) y uso de drogas ilícitas (p = 0 , 0155). La ansiedad y / o depresión no fue estadísticamente significativa (p = 0.3321). Conclusión: el historial de adherencia deficiente, el uso inconsistente de ART y el uso de drogas ilícitas se asociaron con un mayor riesgo de falla virológica. La identificación de grupos en riesgo de mala adherencia al tratamiento puede ayudar a desarrollar estrategias de intervención de manera temprana y entre disciplinas para mejorar la adherencia y generar mejores resultados en el control de la infección por VIH..Au

Experiencias de homofobia y adherencia al tratamiento antirretroviral (TAR) en hombres que tienen sexo con hombres (HSH) / Experiences of homophobia and adherence to antiretroviral treatment (ART) in men who have sex with men (MSM)

Resumen El objetivo del estudio fue conocer la relación de las experiencias de homofobia con la adherencia al tratamiento anti-retroviral (TAR) en hombres que tienen sexo con hombres (HSH). Para ello, se realizó una encuesta transversal con una muestra por conveniencia de HSH que vivían con VIH (n=340) atendidos en dos instituciones públicas de salud de la Ciudad de México. La información sobre la adherencia al TAR en el mes previo de los participantes y sus experiencias de violencia, discriminación y homofobia internalizada se recopiló mediante un cuestionario. Entre 14% y 33% de los HSH reportaron alguna experiencia de discriminación y entre 41% y 60% experimentaron violencia. Cuando los HSH habían experimentado ambos tipos de estresores, el riesgo de baja adherencia TAR fue mayor (RP=6.49 para mes previo) que cuando habían experimentado sólo una de ellas (RP=4.36 para violencia y RP=5.67 para discriminación). Los profesionales de la salud deben ser sensibles a cómo el ambiente sociocultural puede afectar las prácticas de autocuidado de HSH, incluyendo la adherencia al TAR.

Abstract The aim of the study was to know the relationship of homophobic experiences with adherence to antiretroviral treatment (ART) in men who have sex with men (MSM) in Mexico City (CDMX). A cross-sectional study was conducted with a convenience sampling of MSM who lived with HIV, treated at two public health institutions at Mexico City (n=340). A questionnaire was applied to record information related to the adherence to ART of the participants and their experiences of violence and discrimination associated with homophobia and internalized homophobia. Between 14% and 33% of MSM reported experiences of discrimination and between 41% and 60% experienced violence. When participants had jointly experienced both types of stressors, the risk of low adherence to ART in the previous month was higher (RP=6.49) than when they had experienced only one of them (RP=4.36 for violence and RP=5.67 for discrimination). Health professionals must be sensitive to how the sociocultural environment can affect self-care among MSM including ART adherence.

Quality of life in individuals initiating antiretroviral therapy: a cohort study / Qualidade de vida em indivíduos iniciando a terapia antirretroviral: um estudo de coorte

ABSTRACT 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.

RESUMO OBJETIVO Avaliar longitudinalmente a alteração da qualidade de vida em pessoas que vivem com HIV iniciando a terapia antirretroviral, atendidas em três serviços públicos de referência na assistência especializada ao HIV em Belo Horizonte. MÉTODOS Estudo de coorte prospectivo, com o acompanhamento de pessoas que vivem com HIV, com 18 anos de idade ou mais, e iniciando terapia antirretroviral. Dados sociodemográficos, comportamentais, clínicos, relacionados ao tratamento farmacológico e ao serviço foram obtidos por entrevistas, complementados com informações dos prontuários clínicos e dos sistemas de informação do Programa Brasileiro de HIV/AIDS. A qualidade de vida foi avaliada utilizando o instrumento WHOQOLHIV-bref, por meio de entrevista face a face, com intervalo mínimo de seis meses entre as entrevistas. A alteração média na qualidade de vida entre as duas entrevistas foi avaliada utilizando o teste t pareado. Os fatores associados foram avaliados por meio de regressão linear múltipla. RESULTADOS A qualidade de vida global, assim como a qualidade de vida nos domínios físico, psicológico, nível de independência, ambiente e espiritual foram estatisticamente melhores em pessoas que vivem com HIV usando terapia antirretroviral no final do tempo de acompanhamento. Fatores independentemente associados ao incremento na qualidade de vida foram possuir crença religiosa e morar com outras pessoas. Enquanto ter sinais ou sintomas de ansiedade e depressão e o número de reações adversas a medicamentos reportadas foram preditores associados à piora da qualidade de vida. CONCLUSÕES Os resultados evidenciam melhora na qualidade de vida em pessoas vivendo com HIV iniciando a terapia antirretroviral ao longo do tempo. Evidenciam ainda a necessidade de se acompanhar e prover cuidados de saúde, em especial para indivíduos com sinais e sintomas de ansiedade e depressão e que relatam reações adversas a medicamentos no início do tratamento.

Exposure of a patient with systemic lupus erythematosus, under immunosuppression therapy, to human immunodeficiency virus by accidental needlestick contamination / Exposição de um paciente com lúpus eritematoso sistêmico, sob imunossupressão, ao vírus HIV por contaminação acidental por agulha

Introduction: Systemic lupus erythematosus and infection by the human immunodeficiency virus are diseases that affect the immune system. There are few reported cases of the concomitance of both pathologies. Objective: To describe a clinical case of lupus who had a needlestick injury and had also HIV exposure. Method: Case report description. Results: A patient with lupus had a needlestick injury from an HIV positive patient. This person had several intolerances or side effects to retroviral prophylaxis, lupus flare was also observed; however, in the end of 24 weeks his serology was negative and viral load was also undetectable. Conclusion: This is the first case report of a patient diagnosed with SLE, using an immunosuppressive, exposed to HIV through a needlestick accident while working.

Introdução: O lúpus eritematoso sistêmico e a infecção pelo vírus da imunodeficiência humana são doenças que afetam o sistema imunológico. Existem poucos casos relatados da concomitância de ambas as patologias. Objetivo: Descrever um relato de caso de uma paciente com lúpus que teve um ferimento penetrante produzido por agulha e foi exposta ao vírus HIV. Método: relato de caso. Resultado: Um paciente com lúpus teve um ferimento penetrante produzido por agulha proveniente de um paciente com HIV positivo. Esta pessoa teve várias intolerâncias ou efeitos colaterais na profilaxia retroviral, também foi observado a atividade do lúpus; no entanto, no final de 24 semanas, sua sorologia foi negativa e a carga viral também não era detectável. Conclusão: Este relato é a primeira descrição de um acidente com lúpus que se contaminou acidentalmente por agulha com o vírus HIV.

Study on the relationship between HIV drug resistance and CD4+T cell counts among antiretroviral therapy patients with low viral load / 中华预防医学杂志

Objective@#To explore drug resistance of different viral loads, and investigate the relationship between drug resistance and CD4+T cell counts in patients with HIV antiretroviral therapy (ART) in China from 2003 to 2015.@*Methods@#Data were extracted from the Chinese National HIVDR Surveillance database from 2003 to 2015. For this study, the data collected were as follows: having received ART for ≥12 months; 18 years or older; demographic characteristics, information of ART, CD4+T cell counts, viral load (VL) and HIV drug resistance of a total of 8 362 patients were collected. Multi-variables non-conditional logistic regression model was used to study the relationship between viral load, HIV drug resistance and CD4+T cell counts.@*Results@#Participants with age of (41.8±10.5) years were enrolled in this study. Among them, 59.9% (5 009 cases) were men. The percentage of CD4+T cell counts <200 cells/μl in the total population was 17.9% (1 496 cases), the highest was in VL ≥1 000 copies/ml with drug resistance, which was 43.0% (397/923) , followed by VL 50-999 copies/ml with drug resistance, which was 31.1% (69/222), and the lowest was in VL 50-999 copies/ml without drug resistance 13.2% (273/2 068). Compared to VL 50-999 copies/ml without drug resistance, VL<50 copies/ml, VL 50-999 with drug resistance, VL≥1 000 copies/ml without drug resistance, and VL ≥1 000 copies/ml with drug resistance, the OR (95%CI) of CD4 <200 cells/μl were 0.9 (0.7-1.0), 3.2 (2.3-4.4), 2.6 (2.1-3.2), and 4.9 (4.0-5.9), respectively. Among 222 patients with VL 50-999 and HIVDR, the most frequent antiretroviral drugs were EFV and NVP, both of which were NNRTI, and whose percentage both were 94.1% (209 cases). The most frequent mutations were M184V/I (NNRTI), and the percentage was 26.1% (58 cases). The second one was K103N (NNRTI), and the percentage was 22.5% (50 cases). The percentage of V32L/E (PI) and V82A (PI) were lower, they were 0.9% (2 cases) and 0.5% (1 case) respectively.@*Conclusion@#Decreased CD4+T cell counts were associated with HIV drug resistance at low viraemia. In the case of low viral load, the most vulnerable were the NNRTI antiviral drugs such as EFV and NVP.

Effectiveness of antiretroviral therapy in the single-tablet regimen era / Efetividade da terapia antirretroviral na era de medicamentos em dose fixa combinada

ABSTRACT OBJECTIVE To evaluate the effectiveness of antiretroviral therapy and the associated factors according to the type of regimen used: Single Tablet Regimen or Multiple Tablet Regimen. METHODS Prospective cohort of 440 patients (male, 74.3%, median age, 36 years old) who initiated antiretroviral therapy between Jan/14 and Dec/15 at a referral service in Belo Horizonte. Efficacy was defined as viral suppression (viral load, VL < 50 copies/ml) and evaluated after six and twelve months of treatment. Sociodemographic, clinical and behavioral data were collected from clinical charts and from Information Systems. Multivariate analysis of overall effectiveness was performed by logistic regression. RESULTS Most patients initiated Multiple Tablet Regimen antiretroviral therapy (n = 255, 58%). At six months, overall viral suppression was 74.6%, being higher among patients who used Single Tablet Regimen (80.6%, p = 0.04). At twelve months, 83.2% of patients reached viral suppression, with no difference between groups (p = 0.93). Factors independently associated with viral suppression at six and twelve months varied, being negatively associated with effectiveness: VL ≥ 100,000 copies/ml, symptoms of AIDS, longer interval time between diagnosis and initiation of antiretroviral therapy, antiretroviral switching, smoking or current illicit drugs usage (p < 0.05). Factors positively associated with viral suppression included adherence to antiretroviral therapy and category of risk/exposure of men who have sex with men (p < 0.05). Reaching viral suppression at six months was the main predictor of effectiveness at one year (OR = 8.96 and p < 0.01). CONCLUSIONS Viral suppression was high and better results were achieved for patients who used Single Tablet Regimen regimens at six months. Clinical, behavioral, and antiretroviral therapy -related factors influence viral suppression and highlight the need for interventions to increase early diagnosis and initiation of antiretroviral therapy, patient's adherence, and to reduce illicit drugs and cigarette smoking in this population.

RESUMO OBJETIVO Avaliar a efetividade da terapia antirretroviral e fatores associados segundo o tipo de esquema utilizado: medicamento em dose fixa combinada ou múltiplos medicamentos e doses. MÉTODOS Coorte prospectiva não concorrente de 440 pacientes que iniciaram terapia antirretroviral entre janeiro de 2014 e dezembro de 2015 em Belo Horizonte, MG. A efetividade foi definida como supressão viral (carga viral [CV] < 50 cópias/ml) e avaliada após seis e 12 meses de tratamento. Dados sociodemográficos, clínicos e comportamentais foram coletados de prontuário clínico e de sistemas de informação. A análise múltipla da efetividade global foi realizada por regressão logística. RESULTADOS A maioria dos pacientes iniciou terapia antirretroviral com múltiplos medicamentos e doses (58%). Aos seis meses, a supressão viral global foi 74,6%, maior entre pacientes que utilizaram dose fixa combinada (80,6%; p = 0,04). Aos 12 meses, 83,2% dos pacientes atingiram supressão viral, sem diferença entre os grupos (p = 0,93). Fatores independentemente associados à supressão viral em seis e 12 meses variaram, e foram negativamente associados à efetividade: CV ≥ 100.000 cópias/ml, sintomas definidores de aids, maior intervalo de tempo entre diagnóstico e início da terapia antirretroviral, troca de antirretroviral e consumo de tabaco ou drogas ilícitas (p < 0,05). Fatores positivamente associados à supressão viral incluíram adesão à terapia antirretroviral e categoria de risco/exposição de homens que fazem sexo com homens (p < 0,05). Atingir supressão viral aos seis meses foi o principal preditor de efetividade em um ano (OR = 8,96; p < 0,01). CONCLUSÕES A supressão viral foi elevada e superior para pacientes que utilizaram esquemas de dose fixa combinada aos seis meses. Fatores clínicos, comportamentais e relacionados à terapia antirretroviral influenciaram a supressão viral e evidenciam a necessidade de intervenções para aumentar o diagnóstico, o início precoce e a adesão dos pacientes à terapia antirretroviral, bem como reduzir o uso de drogas ilícitas e tabaco nesta população.

Development and validation of the WebAd-Q Questionnaire to monitor adherence to HIV therapy / Desenvolvimento e validação do Questionário WebAd-Q para monitorar adesão à terapia do HIV

ABSTRACT OBJECTIVE To present the development and validation of the WebAd-Q Questionnaire, a self-report instrument to monitor adherence to antiretroviral therapy in HIV/AIDS centers in Brazil. METHODS The WebAd-Q is an electronic questionnaire that has three questions about the use of antiretrovirals in the last week. It was constructed from interviews and focus groups with 38 patients. Its validity was tested in a study with a sample of 90 adult patients on antiretroviral therapy for at least three months. We used electronic monitoring bottles, pill counting, and self-report interview to compare adherence. The WebAd-Q was answered on the sixtieth day, twice, with at least one hour of interval. The viral load of the patients was obtained from the service records. We have analyzed the agreement between the answers to the WebAd-Q, the associations, and the correlations with viral load and performance compared to other measures of adherence. RESULTS Among the invited patients, 74 (82.2%) answered the WebAd-Q. No difficulties were reported to answer the questionnaire. The average answer time was 5 min 47 sec. The set of three questions of the WebAd-Q obtained agreement of 89.8%, with Kappa of 0.77 (95%CI 0.61-0.94). The non-adherence answers of the WebAd-Q were associated with detectable viral load. We obtained moderate viral load correlations with the non-adherence scale according to the WebAd-Q. For the three questions of the WebAd-Q, patients with non-adherence answers were also reported as less adherent according to the other measures of adherence. CONCLUSIONS The WebAd-Q answered all the issues considered relevant in the validation of questionnaires, was well understood by patients, was associated with viral load, and obtained good agreement and good performance compared to the other measures. The feasibility analysis of its implementation still depends on a national study on its applicability.

RESUMO OBJETIVO Apresentar o desenvolvimento e a validação do Questionário WebAd-Q, um instrumento de autorrelato para monitorar a adesão à terapia antirretroviral em serviços de HIV/Aids no Brasil. MÉTODOS O WebAd-Q é um questionário eletrônico que contém três perguntas sobre a tomada dos antirretrovirais na última semana. Foi construído a partir de entrevistas e grupos focais com 38 pacientes. Sua validade foi testada em estudo com uma amostra de 90 pacientes maiores de 18 anos, sob terapia antirretroviral há pelo menos três meses. Foram utilizadas as seguintes medidas de adesão comparativas: monitoramento eletrônico, contagem de pílulas e entrevista de autorrelato. O WebAd-Q foi respondido no sexagésimo dia por duas vezes, com intervalo mínimo de uma hora. A carga viral dos pacientes foi obtida nos registros do serviço. Analisamos a concordância entre as respostas ao WebAd-Q, associações e correlações com a carga viral e o desempenho em comparação às demais medidas de adesão. RESULTADOS Entre os pacientes convidados, 74 (82,2%) responderam ao WebAd-Q. Não foram relatadas dificuldades em responder ao questionário. O tempo médio de resposta foi de 5 min 47 seg. O conjunto das três questões do WebAd-Q obteve concordância de 89,8%, com Kappa de 0,77 (IC95% 0,61-0,94). As respostas de não adesão do WebAd-Q associaram-se à carga viral detectável. Foram obtidas correlações moderadas da carga viral com escala de não adesão segundo o WebAd-Q. Para as três perguntas do WebAd-Q, pacientes com respostas de não adesão foram também apontados como menos aderentes segundo as demais medidas de adesão. CONCLUSÕES O WebAd-Q atendeu a todos os quesitos considerados relevantes na validação de questionários, foi bem entendido por pacientes, apresentou associação com a carga viral e obteve boa concordância e bom desempenho em comparação a medidas concorrentes. A análise da viabilidade de sua implementação ainda depende de um estudo nacional de aplicabilidade.

Seguimiento del primer año de tratamiento antirretroviral en pacientes naive en un hospital de tercer nivel / First year monitoring of antiretroviral therapy in naïve patients in a tertiary hospital

Objetivo: El objetivo principal de este trabajo es determinar la tasa de fracaso virológico (FV) en pacientes naive que inician tratamiento antirretroviral (TAR) a 24 y 48 semanas en vida real en un hospital de tercer nivel. Material y método: Estudio retrospectivo de 3 años de duración. Se seleccionaron pacientes adultos VIH naive que iniciaron TAR entre 2012 y 2014. Se registraron datos demográficos (edad, sexo y nacionalidad), clínicos (mecanismo de trasmisión y estadio clínico), de laboratorio (carga viral (CV), linfocitos CD4 basales y existencia de test de mutaciones previo) y TAR elegido. Tras 24 y 48 semanas se registraron: CV y CD4, adherencia, seguimiento, problemas relacionados con la medicación, cambios de TAR y motivos de cambio. Resultados: Se seleccionaron 253 pacientes. 244 y 226 contaban con datos analíticos a las 24 y 48 semanas respectivamente. 142 (58,23%) tenían CV<50 copias/ml y 204 (83,6%) CV<200 copias/ml tras 24 semanas. 198 (88,4%) tenían CV<50 copias/ml y 217 (96,0%) CV<200 copias/ml tras 48. La CV basal superior a 100.000 copias/ml y la mala adherencia se asociaron con un mayor riesgo de FV. Al 30,0% de pacientes se les cambió el TAR durante el primer año, principalmente por efectos secundarios (31,6%) y simplificación del tratamiento (23,7%). Discusión y Conclusiones: Un alto porcentaje de pacientes que inician TAR están indetectables o con menos de 200 copias/ml dentro del primer año de tratamiento. A pesar de tener fármacos altamente eficaces y cada vez mejor tolerados, los efectos secundarios siguen siendo el motivo mayoritario de cambio de TAR.

Background and objective: The main objective of this work is to determine the rate of virologic failure (VF) intreatment-naïve patients, 24 and 48 weeks after starting antiretroviral therapy (ART) in real life in a tertiary hospital. Patients and Methods: A retrospective study of 3 years duration. Naïve HIV adult patients who started ART between 2012 and 2014 were selected. Demographics (age, sex and nationality), clinical (transmission mechanism and clinical stage), laboratory (viral load (VL), baseline CD4 and existence of prior mutations test) and TAR chosen were recorded. VL and CD4, adherence, monitoring, medication-related problems, changes and reasons for changing ART were registered at 24 and 48 weeks. Results: Of 253 patients selected, analytical data was available for 244 and 226 at 24 and 48 weeks, respectively. After 24 weeks, VL was <50 copies/ml in 142 (58.23%) patients and <200 copies/ml in 204 (83.6%). After 48 weeks, the same values were 198 (88.4%) and 217 (96.0%), respectively. Baseline VL above 100,000 copies/ml and poor adhesion to treatment were associated with an increased risk of VF. Thirty per cent of patients switched ART during the first year, mainly because of side effects (31.6%) and simplification of treatment (23.7%). Conclusions: VL became undetectable or under 200 copies/ml in a high percentage of patients starting ART within the first year of treatment. Despite the increasingeffectiveness and tolerability of available drugs, side effects remain as the major reason for changing ART.

Adverse reactions to antiretroviral therapy: a prevalent concern / Las reacciones adversas al tratamiento antirretroviral: una preocupación frecuente / Reações adversas à terapia antirretroviral: uma preocupação frequente

ABSTRACT The risk-benefit ratio of antiretroviral therapy (ART) is usually considered favorable due to the urgent need to control the HIV/AIDS epidemic. Current studies have shown that combined ART (two or more drugs, from two different classes) is the most effective, with benefits that go beyond clinical management of the disease playing a crucial role in preventing HIV transmission. Therefore, early identification of HIV infection followed by immediate initiation of ART has been encouraged worldwide. However, the success of this strategy has been threatened by poor engagement of patients in HIV care, which may be related to drug harms. In addition, ART is required for the life course, creating the potential for adverse drug reactions (e.g., lipodystrophies). Therefore, adverse drug reactions are a prevalent concern among people living with HIV/AIDS, even in the current era of early initiation of ART ("early ART"), with most drugs considered much safer than those used in previous eras. Accurate diagnosis, recording, and reporting, followed up with proper management and prevention, and intensive surveillance, of new and known adverse reactions to ART, should be strongly encouraged as part of the care continuum.

RESUMEN La relación entre los riesgos y beneficios del tratamiento antirretroviral (TAR) generalmente se considera favorable debido a la urgente necesidad de controlar la epidemia de VIH/SIDA. Los estudios actuales han revelado que la politerapia antirretrovírica (dos o más medicamentos de dos clases diferentes) es la más eficaz porque no solo trata la enfermedad, sino que tiene una función crucial como método preventivo de la transmisión del VIH. Por consiguiente, en todo el mundo se ha promovido el diagnóstico temprano de la infección por el VIH seguido del inicio inmediato del TAR. Sin embargo, la efectividad de esta estrategia ha sido comprometida por la baja retención de pacientes en los servicios de salud, que puede estar asociada a seguridad en el uso de los medicamentos. Además, dado que estos pacientes deben recibir TAR durante toda la vida, aumenta la probabilidad de que presenten reacciones adversas a los medicamentos (por ejemplo, lipodistrofias). De esta forma, las reacciones adversas a los antirretrovirales se tornaron una constante preocupación, incluso en la era actual de inicio precoz de la TAR, en que los medicamentos son considerados más seguros que aquellos utilizados en el pasado. El diagnóstico preciso, registro y notificación de las reacciones adversas, seguidos de manejo y prevención adecuados, y vigilancia intensiva para detectar reacciones adversas (nuevas y conocidas) deben ser fuertemente recomendadas como parte de la cascada del cuidado continuado.

RESUMO A relação risco-benefício da terapia antirretroviral (TARV) é considerada favorável devido à urgente necessidade de controlar a epidemia de HIV/aids. Estudos recentes demonstram que a TARV combinada (dois ou mais medicamentos de duas classes distintas) é altamente efetiva, apresentando benefícios que ultrapassam o objetivo do manejo clínico da doença, pois contribui de forma significativa para a prevenção da transmissão do HIV. Recomenda-se, portanto, o diagnóstico precoce da infecção pelo HIV e o início imediato da TARV em todo o mundo. Todavia, a efetividade dessa estratégia tem sido comprometida pela baixa retenção de pacientes nos serviços de saúde, que pode estar associada à segurança no uso dos medicamentos. Além disso, o uso da TARV se faz necessário por toda a vida, o que possibilita a ocorrência de reações adversas (como lipodistrofias). Dessa forma, as reações adversas aos antirretrovirais se tornaram uma constante preocupação, mesmo na era atual de início precoce da TARV, em que os medicamentos são considerados mais seguros do que aqueles utilizados no passado. O diagnóstico preciso, o registro e a notificação das reações adversas, acompanhados de tratamento e prevenção adequados, além de intensiva vigilância para detecção de reações adversas (novas e conhecidas) devem ser fortemente recomendadas como parte da cascata do cuidado contínuo.

Clinical study of the Chinese medicine syndrome differentiation combined with HAART for the acquried immune deficiency syndrom dementia complex / 国际中医中药杂志

Objecve To observe the clinical effect and safety of the Chinese medicine syndrome differentiation combined with HAART for the ADC(acquried immune deficiency syndrom dementia complex). Methods A total of 80 patients with ADC were divided into the treatment group and control group based on random number table, 40 in each group. The patients in the control group were treated by highly active anti-retrovital therapy (HAART). The patients in the treatment group were treated with TCM treatment on the based of the control group. Both groups received the treatment for 3 months.These outcomes were measured: TCM syndrome integral, mini mental state examination(MMSE), daily behavior scale(ADL), change of clinical stage, and adverse reactions. Results The effect rate of treatment group was 82.5%, which was significant higher than 65% of the control group (χ2=8.115,P=0.024). After the treatment, the ADL integral of the treatment group (37.69 ± 5.31vs.33.67 ± 5.16;t=2.528,P=0.021) was significantly higher than that before the treatment; and the ADL integral of the control group(36.96 ± 5.52vs.34.54 ± 4.98;t=2.747,P=0.027) was significantly higher than that before the treatment.But there was no significant difference between the two groups after the treatment (t=2.003,P=0.139). After the treatment, the MMSE integral of the treatment group (24.76 ± 4.43 vs.19.97 ± 5.46;t=1.006,P=0.013) was significantly higher than that before the treatment; the MMSE integral of the control group(24.65 ± 4.36 vs. 20.11 ± 4.87;t=1.035,P=0.014) was significantly higher than that before the treatment. But there was no significant difference between the two groups after the treatment (t=0.953, P=0.347).There was no significant difference between the two groups in the clinical stage change (phase1χ2=1.231,P=0.954; phase2χ2=2.726,P=1.053). There was no adverse reaction in the two groups during the treatment.Conclusions The Traditional Chinese medcine combined with HAART was better than HAART alonein the treatment of ADC.

Review of HIV treatment progress, gaps, and challenges in the Caribbean, 2005-2015 / Examen del progreso, los retos y las brechas en torno al tratamiento de la infección por el VIH en el Caribe, 2005-2015

ABSTRACT Objective To highlight the current context of the HIV response in the Caribbean and what remains to be addressed to close gaps in HIV treatment and care and end AIDS by 2030. Methods We reviewed and analyzed reports from peer-reviewed and gray literature for the period of 2005–2015 on HIV treatment progress and gaps in the Caribbean, based on searches done in four bibliographic databases and three organizations’ websites and/or libraries. Data were extracted using forms detailing study objectives, thematic areas for HIV care and treatment in the Caribbean, results, and other key information. Before being included in the descriptive review, each publication was assessed for its relevance to the HIV response in the Caribbean. Results We carefully analyzed a total of 62 sources addressing HIV treatment coverage in the Caribbean, including peer-reviewed articles, gray literature reports, and abstracts. The Caribbean has made remarkable progress in reducing new infections and in increasing health care access. Coverage with antiretroviral (ARV) treatment rose between 2005 and 2015, and HIV-related mortality fell by half. Despite the decline in HIV incidence rates, some Caribbean countries have reported challenges with linkages to care, access and adherence to ARV treatment, and viral suppression. Conclusion The risk of HIV infection in the Caribbean among at-risk populations, including men who have sex with men, transgender persons, and sex workers, is disproportionately high. Caribbean countries need to work together to face the HIV threat. National programs need to fast-track HIV treatment services and accelerate other responses to HIV by 2020, and then maintain sustained actions up through 2030.

RESUMEN Objetivo Destacar el contexto actual de la respuesta a la infección por el VIH en el Caribe y las acciones pendientes para subsanar las brechas en el tratamiento y la atención de la infección por el VIH y poner fin al sida para el 2030. Métodos Se examinaron y analizaron informes tanto de la bibliografía revisada por pares como la bibliografía gris en el período comprendido entre el 2005 y el 2015 sobre el progreso y las brechas en el tratamiento de la infección por el VIH en el Caribe, encontrados por medio de búsquedas en cuatro bases de datos bibliográficas y sitios web o bibliotecas de tres organizaciones. Los datos se extrajeron empleando formularios que detallaban los objetivos del estudio, las áreas temáticas de la atención y el tratamiento de la infección por el VIH en el Caribe, los resultados y otra información de importancia. Antes de incluirlos en el examen descriptivo, se evaluó la relevancia de cada publicación en lo concerniente a la respuesta a la infección por el VIH en el Caribe. Resultados Se hizo un análisis pormenorizado de un total de 62 fuentes que abordaban la cobertura del tratamiento de la infección por el VIH en el Caribe, entre las que se incluyeron artículos sometidos a revisión de pares, informes de bibliografía gris y resúmenes. El Caribe ha logrado avances notables en la reducción del número de nuevas infecciones y el aumento del acceso a la atención de salud. La cobertura del tratamiento antirretroviral (ARV) se incrementó entre el 2005 y el 2015 y la mortalidad atribuible a la infección por el VIH se redujo a la mitad. Si bien las tasas de incidencia de la infección por el VIH han disminuido, algunos países del Caribe han informado que los vínculos entre la atención, el acceso y el cumplimiento del tratamiento antirretroviral, así como la supresión de la carga viral, plantean retos. Conclusiones El riesgo de contraer la infección por el VIH en las poblaciones en riesgo, especialmente en el caso de los hombres que tienen relaciones sexuales con otros hombres, las personas transgénero y los profesionales del sexo, es desproporcionadamente alto en el Caribe. Los países del Caribe deben unir esfuerzos para enfrentarse a la amenaza del VIH. Los programas nacionales deben agilizar los servicios de tratamiento de la infección por el VIH y acelerar otras respuestas a la infección por el VIH para el 2020 y, posteriormente, aplicar medidas sostenidas para mantener los logros hasta el 2030.

Potential drug interactions in patients given antiretroviral therapy / Potenciais interações de drogas em pacientes de terapia antirretroviral / Posibles interacciones de drogas en los pacientes que recibieron terapia antiretroviral

ABSTRACT Objective: to investigate potential drug-drug interactions (PDDI) in patients with HIV infection on antiretroviral therapy. Methods: a cross-sectional study was conducted on 161 adults with HIV infection. Clinical, socio demographic, and antiretroviral treatment data were collected. To analyze the potential drug interactions, we used the software Micromedex(r). Statistical analysis was performed by binary logistic regression, with a p-value of ≤0.05 considered statistically significant. Results: of the participants, 52.2% were exposed to potential drug-drug interactions. In total, there were 218 potential drug-drug interactions, of which 79.8% occurred between drugs used for antiretroviral therapy. There was an association between the use of five or more medications and potential drug-drug interactions (p = 0.000) and between the time period of antiretroviral therapy being over six years and potential drug-drug interactions (p < 0.00). The clinical impact was prevalent sedation and cardiotoxicity. Conclusions: the PDDI identified in this study of moderate and higher severity are events that not only affect the therapeutic response leading to toxicity in the central nervous and cardiovascular systems, but also can interfere in tests used for detection of HIV resistance to antiretroviral drugs.

RESUMO Objetivo: investigar potenciais interações droga-droga (PDDI) em pacientes infectados com HIV em terapia de antirretroviral. Métodos: um estudo de corte transversal foi conduzido em 161 pessoas infectadas com o HIV. Dados de tratamentos clínicos, sociodemográficos e antirretrovirais foram coletados. Para analisar a possível interação medicamentosa, nós usamos o software Micromedex(r). A análise estatística foi feita por regressão logística binária, com um valor P de ≤0.05, considerado estatisticamente significativo. Resultados: dos participantes, 52.2% foram expostos a potenciais interações droga-droga. No total, houve 218 interações droga-droga, das quais 79.8% ocorreram entre drogas usadas para a terapia antirretroviral. Houve uma associação entre o uso de cinco ou mais medicamentos e possíveis interações droga-droga (p = 0.000), e entre o período de tempo de terapia antirretroviral acima de seis anos e possíveis interações droga-droga (p < 0.00). O impacto clínico foi sedação prevalente e cardiotoxicidade. Conclusões: as PDDI identificadas neste estudo de severidade moderada e superior são eventos que não somente afetam o resultado terapêutico levando a toxicidade nos sistema nervoso central e cardiovascular, mas também podem interferir em testes utilizados para a detecção da resistência do HIV aos medicamentos antirretrovirais.

RESUMEN Objetivo: investigar las posibles interacciones fármaco-fármaco (PDDI en inglés) en pacientes con infección por VIH que reciben terapia antirretroviral. Métodos: un estudio transversal se llevó a cabo en 161 adultos con infección por VIH. Se recogieron datos clínicos, socio demográficos, y de tratamiento antirretroviral. Para analizar las posibles interacciones entre medicamentos, se utilizó el software Micromedex(r). El análisis estadístico se realizó mediante regresión logística binaria, considerando estadísticamente significativo un valor de p de ≤0.05. Resultados: de todos los participantes, el 52,2% fueron expuestos a posibles interacciones entre fármacos. En total, aparecieron 218 interacciones entre fármacos potenciales, de las que el 79,8% se produjo entre los fármacos utilizados para el tratamiento antirretroviral. Se observó una asociación entre el uso de cinco o más medicamentos y posibles interacciones fármaco-fármaco (p = 0,000) y entre el período de tiempo de la terapia antirretroviral de más de seis años y las posibles interacciones fármaco-fármaco (p <0.00). El impacto clínico fue la sedación prevalente y cardiotoxicidad. Conclusiones: las PDDI identificadas en este estudio de gravedad moderada y superior son eventos que no sólo afectan a la respuesta terapéutica con riesgo de toxicidad en el sistema nervioso central y cardiovascular, pero también pueden interferir en las pruebas utilizadas para la detección de la resistencia del VIH a los antirretrovirales.

Strategies for price reduction of HIV medicines under a monopoly situation in Brazil / Estratégias de redução de preços de medicamentos para aids em situação de monopólio no Brasil

ABSTRACT OBJECTIVE To analyze Government strategies for reducing prices of antiretroviral medicines for HIV in Brazil. METHODS Analysis of Ministry of Health purchases of antiretroviral medicines, from 2005 to 2013. Expenditures and costs of the treatment per year were analyzed and compared to international prices of atazanavir. Price reductions were estimated based on the terms of a voluntary license of patent rights and technology transfer in the Partnership for Productive Development Agreement for atazanavir. RESULTS Atazanavir, a patented medicine, represented a significant share of the expenditures on antiretrovirals purchased from the private sector. Prices in Brazil were higher than international references, and no evidence was found of a relationship between purchase volume and price paid by the Ministry of Health. Concerning the latest strategy to reduce prices, involving local production of the 200 mg capsule, the price reduction was greater than the estimated reduction. As for the 300 mg capsule, the amounts paid in the first two years after the Partnership for Productive Development Agreement were close to the estimated values. Prices in nominal values for both dosage forms remained virtually constant between 2011 (the signature of the Partnership for Productive Development Agreement), 2012 and 2013 (after the establishment of the Partnership). CONCLUSIONS Price reduction of medicines is complex in limited-competition environments. The use of a Partnership for Productive Development Agreement as a strategy to increase the capacity of local production and to reduce prices raises issues regarding its effectiveness in reducing prices and to overcome patent barriers. Investments in research and development that can stimulate technological accumulation should be considered by the Government to strengthen its bargaining power to negotiate medicines prices under a monopoly situation.

RESUMO OBJETIVO Analisar as estratégias governamentais para redução de preço de medicamentos antirretrovirais para aids no Brasil. MÉTODOS Realizada análise das compras de medicamentos antirretrovirais pelo Ministério da Saúde, de 2005 a 2013. Foram analisados o gasto e o custo do tratamento por ano e comparados com os preços internacionais para o atazanavir. Foram estimadas as reduções com base no contrato da Parceria para Desenvolvimento Produtivo para obtenção de licença voluntária de patente e transferência de tecnologia do atazanavir. RESULTADOS O atazanavir teve peso expressivo nos gastos com antirretrovirais adquiridos no setor privado. Os preços praticados no Brasil foram mais altos que aqueles de referência internacional e não houve evidências da relação entre volume de compra e preço pago pelo Ministério da Saúde, por ser medicamento patenteado. Em relação à estratégia mais recente para reduzir preços, envolvendo produção local da cápsula de 200 mg, as reduções foram menores do que as estimadas. Quanto à cápsula de 300 mg, os valores pagos nos dois primeiros anos após a Parceria para Desenvolvimento Produtivo foram próximos aos estimados. Os preços em valores nominais mantiveram-se praticamente constantes entre 2011 (assinatura da Parceria para Desenvolvimento Produtivo), 2012 e 2013 (após estabelecida a Parceria). CONCLUSÕES A redução do preço de medicamentos é complexa em ambiente de concorrência limitada. O uso da Parceria para Desenvolvimento Produtivo como método para aumentar a capacidade de produção local e reduzir preços levanta questões em relação à redução efetiva dos preços e ao enfrentamento da barreira patentária. Investimentos em pesquisa e desenvolvimento que possam estimular a acumulação tecnológica devem ser considerados pelo governo para fortalecer seu poder de barganha ao negociar preços de medicamentos em situação de monopólio.

Primary drug resistance of human immunodeficiency virus (HIV) among the treat-ment-naive individuals with HIV in China:a meta-analysis / 北京大学学报(医学版)

Objective:To estimate the prevalence of antiretroviral drug resistance in treatment-naive in-dividuals with human immunodeficiency virus ( HIV ) in China. Methods: Five electronic databases [ Chinese BioMedical Literature Database ( CBM) , Chinese Journal Full-text Database ( CNKI) , Chinese Science-Technology Journal Database ( VIP) , Wanfang Data, and PubMed] were searched for studies of HIV drug resistance in untreated individuals. Drug resistance data were abstracted then pooled using the random effect model. Subgroup analysis was done across sampling time, location, study population ( mean age and infection status) , and sample size. Results: Seventy-six studies were included for our meta-analysis (46 in Chinese, 30 in English). The pooled rates of drug resistance to total, to non-nucleoside reverse transcriptase inhibitor ( NNRTI ) , to nucleoside reverse transcriptase inhibitor (NRTI), and to protease inhibitor ( PI) were 4. 7% (95%CI:4. 0% -5. 4%), 2. 3% (95%CI:1. 8% -2. 8%), 1. 8% (95%CI:1. 3% -2. 3%), and 1. 4% (95%CI:1. 1% -1. 8%), respective-ly. All the rates before 2007 were higher than those for 2008 or later. Meanwhile, significant differences were found in the sample areas (P <0. 05), in which, the rates in South-central and Southwest were both higher than 5%. The difference was complex between mean age and infection status subgroup, and we found the total prevalence in the group under 25 years and the newly infected, and confirmed group was lower than in the others. For sample size, all the rates in the group under 100 samples were higher than in the others, and the difference was significant (P<0. 05). Conclusion: The prevalence of HIV primary drug resistance in China was 4. 7%, which stayed low, but was also close to the line set by WHO. Enhanced surveillance for drug resistance is necessary in high epidemic areas including the South-central and Southwest China whose prevalence has crossed the line.