One-year observational study of palivizumab prophylaxis on infants at risk for respiratory syncytial virus infection in Latin America / Estudo observacional de um ano da profilaxia com palivizumabe em neonatos com risco para infecção por vírus sincicial respiratório na América Latina

Abstract Objective: This study aims to describe real world palivizumab use and effectiveness in high-risk Latin American infants and young children. Method: Prospective, multicenter observational study with infants at risk for severe RSV infection who received palivizumab according to routine clinical practice. Subjects were followed for one year with monthly visits after the first dose of palivizumab. An infant was considered adherent if receiving all the expected injections or five or fewer injections within appropriate inter-dose intervals. Annual incidence rates and risk factors of lower respiratory tract infection (LRTI) hospitalization were determined through Poisson regression models (α = 0.05). Results: The study enrolled 458 children from seven countries in Latin America, from February 2011 to September 2012. The majority (98%) were born <36 weeks gestation. Overall, patients received 83.7% of their expected injections and 86.7% completed one year of follow-up. Of the 61 LRTI hospitalizations, 12 episodes were due to RSV infection. The RSV-associated hospitalization rate was 2.9 per 100 patient-years. Bronchopulmonary dysplasia was identified as an independent risk factor for LRTI hospitalization. A total of 1165 adverse events were recorded during one year of follow-up. One hundred and two patients (22.3%) had a total of 135 serious adverse events, but no events were considered to be related to palivizumab. Conclusions: The rate of RSV hospitalization in high-risk infants in Latin America was low and aligned with those observed in randomized control trials and observational studies. Palivizumab prophylaxis appeared effective and had a good safety profile in this population.

Resumo Objetivo: Descrever o uso e a eficácia do palivizumabe no mundo real em neonatos e jovens crianças de alto risco latino-americanas. Método: Estudo observacional prospectivo multicêntrico com neonatos em risco devido a infecção grave por VSR que receberam palivizumabe de acordo com a prática clínica de rotina. Os indivíduos foram acompanhados por um ano, com visitas mensais após a primeira dose de palivizumabe. Um neonato foi considerado adepto se recebeu todas as injeções esperadas ou ≤ 5 injeções nos intervalos entre doses adequados. As taxas de incidência anuais e os fatores de risco de internação por infecção do trato respiratório inferior (ITRI) foram determinados por meio dos modelos de regressão de Poisson (α = 0,05). Resultados: O estudo inscreveu 458 crianças de sete países da América Latina, de fevereiro de 2011 a setembro de 2012. A maioria (98%) nasceu com < 36 semanas. Em geral, os pacientes receberam 83,7% de suas injeções esperadas e 86,7% completaram um ano de acompanhamento. Das 61 internações por ITRI, 12 episódios foram devidos a infecção por VSR. A taxa de internação associada ao VSR foi de 2,9 em cada 100 pacientes-ano. A displasia broncopulmonar foi identificada como um fator de risco independente da internação por ITRI. Foram registrados 1.165 eventos adversos durante um ano de acompanhamento; 122 (22,3%) apresentaram 135 eventos adversos graves, porém nenhum deles foi considerado relacionado ao palivizumabe. Conclusões: A taxa de internação por VSR em neonatos de alto risco na América Latina foi baixa e em linha com as observadas em ensaios clínicos controlados randomizados e estudos observacionais. A profilaxia com palivizumabe pareceu eficaz e com bom perfil de segurança nessa população.

Variación de la incidencia de tumores asociados o no al sida en un centro ambulatorio, 1997-2005 / Incidence variation in malignancies associated or not with AIDS at an outpatient care center, 1997-2005

En Argentina no existe información publicada sobre la incidencia de tumores asociados (TAS) y no asociados al sida (TnoAS) en pacientes con infección por HIV. Nuestro objetivo fue establecer la incidencia de estos tumores en un centro de atención ambulatoria entre 1997 y 2005. Se reconocieron 103 tumores malignos, de los cuales 73 eran TAS y 30 TnoAS. No hubo diferencias en edad, distribución por sexo y porcentaje de pacientes bajo tratamiento antirretroviral de gran eficacia (TARGA) en ambos grupos. Entre los pacientes con TAS fue más frecuente el diagnóstico simultáneo de tumor e infección HIV (p <0.001), así como el diagnóstico de SIDA (p = 0.015). Entre los TnoAS, fue mayor la antigüedad de la infección HIV y la duración promedio del TARGA (p = 0.038 y 0.002 respectivamente); también en este grupo fue más alto el recuento de linfocitos CD4 nadir (p = 0.009) y al diagnóstico del tumor (p <0.001). La incidencia de los TAS fue 18 casos/ 1000 pacientes-año en 1997 y descendió hasta 3.1 casos/1000 pacientes-año en 2005 (p = 0.001). La incidencia de los TnoAS fue siempre más baja y similar en todos períodos anuales. En conclusión, los TAS fueron más frecuentes que los TnoAS, no obstante los primeros disminuyeron su incidencia en relación a la utilización masiva del TARGA, mientras que los últimos se mantuvieron estables. El alto porcentaje de diagnóstico simultáneo de infección por HIV y TAS debería ser un alerta para llegar a un diagnóstico más precoz del HIV.

In Argentina there are no published data on the incidence of AIDS (ARM) and non-AIDS related malignancies (non-ARM) in the HIV positive population. Our aim was to establish the incidence of these malignancies at an ambulatory care center between 1997 and 2005. We describe 103 cases of malignancies, 73 out of them were ARM and 30 were non-ARM. There were no differences in terms of age, gender and proportion of patients on highly active antiretroviral treatment (HAART). Among those patients with ARM, simultaneous diagnosis of malignancy and HIV infection was more frequently seen (p <0.001) and the proportion of patients with AIDS was higher (p = 0.015). Among those patients with non-ARM the mean duration of HIV infection and HAART was higher (p = 0.038 and 0.002 respectively); also was higher the mean CD4 count nadir (p = 0.009), and CD4 count at the time of malignancy diagnosis (p <0.001). The incidence of ARM was 18 cases/1000 patients- year in 1997 and dropped to 3.1 cases/1000 patients-year in 2005 (p = 0.001). The incidence of non-ARM was always lower than ARM, and similar in each year. In conclusion, ARM were more frequent than non-ARM, but their incidence dropped significantly because of massive use of HAART, while non-ARM remained stable. The high proportion of simultaneous diagnosis of ARM and HIV infection should enable much earlier HIV diagnosis.

Bacteremia por Achromobacter xylosoxidans en un paciente con neumonía adquirida en la comunidad / Achromobacter xylosoxidans bacteremia in a patient with community-acquired pneumonia

La bacteriemia causada por Achromobacter xylosoxidans es rara y hay poca información con repecto a su tratamiento. La mayoría de los pacientes que han desarrollado bacteriemia por Achromobacter han presentado causas predisponentes a la infección. Se informa aquí un caso de bacteriemia y neumonía adquirida en la comunidad en un paciente previamente sano. Achromobacter es usualmente resistente a amplicilina, cefalosporinas de primera, segunda y tercera generación, aminoglucósidos y quinolomas. Piperacilina sola o en combinación con tazobactama, impenem y trimetoprima-sulfametozaxol inhiben la mayoría de los aislamientos.