Imunoprofilaxia do vírus sincicial respiratório com palivizumabe em crianças em hospital da zona sul de São Paulo

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Abstract

RESUMO As infecções agudas do trato respiratório inferior (IATRIs) são a primeiras causas de mortes nos países de baixa renda e a quarta nos países de média renda, que incluem o Brasil. O vírus sincicial respiratório (VSR) é o principal agente de infecções agudas do trato respiratório inferior, a causa mais conhecida bronquiolite, entre lactentes e jovens crianças. O palivizumabe é um anticorpo monoclonal imunoglobulina G subclasse 1 (IgG1) humanizado indicado para infecções do trato respiratório causado pelo VSR. Desenvolvimento de protocolo de imunização, e monitoramento do uso do palivizumabe em pacientes pediátricos de alto risco; verificando se a profilaxia com o palivizumabe reduz as taxas de internações e de mortalidade por VSR. O farmacêutico é parte fundamental no desenvolvimento dos protocolos clínicos, pois realiza um importante trabalho no seguimento farmacoterapêutico. Estudo observacional, prospectivo, em crianças com o risco de infecção grave por VSR que receberam palivizumabe de acordo com os critérios clínicos estabelecidos no Protocolo Federal da Portaria nº 522 de 13/05/2013. Os indivíduos foram seguidos por meio de visitas mensais. Implantação do protocolo de uso do palivizumabe dentro da instituição de saúde, nele foram estabelecidos, parâmetros e padrões, visando uma maior agilidade e eficiência dos processos. Foram acompanhados 14 neonatos e jovens crianças, 42,8% foram prematuros, 28,5% apresentavam displasia broncopulmonar e 28,5% cardiopatia congênita. Três óbitos (21,4%) foram registrados durante o acompanhamento. Os resultados mostraram que a imunização passiva com o palivizumabe é uma ferramenta importante na prevenção de infecções pelo VSR.

Translated abstract

SUMMARY Acute lower respiratory tract infections (IATRIs) are the main cause of death in low-income countries and the fourth in middle-income countries, which include Brazil. Respiratory syncytial virus (RSV) is the main agent of acute lower respiratory tract infections, the most well known cause of bronchiolitis, among infants and young children. Palivizumab is a humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody indicated for respiratory tract infections caused by RSV. The pharmacist is a fundamental part in the development of clinical protocols, as it performs an important work in the pharmacotherapeutic follow-up. Development of an immunization protocol and monitoring the use of palivizumab in high-risk pediatric patients; verifying whether prophylaxis with palivizumab reduces hospitalization rates and RSV mortality. Observational prospective study in children at risk of severe RSV infection who received palivizumab according to the clinical criteria established in the Federal Protocol of Administrative Rule nº 522 of 05/13/2013. Children were followed through monthly visits. Implementation of the protocol for the use of palivizumab on the health institution, in which parameters, standards and parameters were established, aim at greater agility and efficiency of the processes. 14 neonates and young children were followed, 42.8% were premature, 28.5% had bronchopulmonary dysplasia and 28.5% had congenital heart disease. Three deaths (21.4%) were recorded during follow-up. The results showed that passive immunization with palivizumab are an important tool in the prevention of RSV infections.

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Respiratory syncytial virus-neutralizing monoclonal antibodies motavizumab and palivizumab inhibit fusion.

Herren Wu, Nancy Ulbrandt, Kelly Huang … (2010)

Respiratory syncytial virus (RSV) is a major cause of virus-induced respiratory disease and hospitalization in infants. Palivizumab, an RSV-neutralizing monoclonal antibody, is used clinically to prevent serious RSV-related respiratory disease in high-risk infants. Motavizumab, an affinity-optimized version of palivizumab, was developed to improve protection against RSV. These antibodies bind RSV F protein, which plays a role in virus attachment and mediates fusion. Determining how these antibodies neutralize RSV is important to help guide development of new antibody drugs against RSV and, potentially, other viruses. This study aims to uncover the mechanism(s) by which palivizumab and motavizumab neutralize RSV. Assays were developed to test the effects of these antibodies at distinct steps during RSV replication. Pretreatment of virus with palivizumab or motavizumab did not inhibit virus attachment or the ability of F protein to interact with the target cell membrane. However, pretreatment of virus with either of these antibodies resulted in the absence of detectable viral transcription. These results show that palivizumab and motavizumab act at a point after F protein initiates interaction with the cell membrane and before virus transcription. Palivizumab and motavizumab also inhibited F protein-mediated cell-to-cell fusion. Therefore, these results strongly suggest that these antibodies block both cell-to-cell and virus-to-cell fusion, since these processes are likely similar. Finally, palivizumab and motavizumab did not reduce viral budding. Based on models developed from numerous studies of viral fusion proteins, our results indicate that these antibodies may prevent conformational changes in F protein required for the fusion process.

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Clinical and epidemiological aspects related to the detection of adenovirus or respiratory syncytial virus in infants hospitalized for acute lower respiratory tract infection

Eduardo A Ferone, Eitan N. Berezin, Giuliana Durigon … (2014)

OBJECTIVE: To characterize and compare clinical, epidemiological, and laboratory aspects ofinfants with acute lower respiratory infection (ALRI) associated with the detection of adenovirus(ADV) or respiratory syncytial virus (RSV). METHODS: A preliminary respiratory infection surveillance study collected samples of nasopharyngeal aspirate (NPA) for viral research, linked to the completion of a standard protocol, from children younger than two years admitted to a university hospital with ALRI, between March of 2008 and August of 2011. Polymerase chain reaction (PCR) was used for eight viruses: ADV, RSV, metapneumovirus, Parainfluenza 1, 2, and 3, and Influenza A and B. Cases with NPA collectedduring the first 24 hours of admission, negative results of blood culture, and exclusive detection of ADV (Gadv group) or RSV (Grsv group) were selected for comparisons. RESULTS: The preliminary study included collection of 1,121 samples of NPA, 813 collected in thefirst 24 hours of admission, of which 50.3% were positive for at least one virus; RSV was identifiedin 27.3% of cases surveyed, and ADV was identified in 15.8%. Among the aspects analyzed inthe Gadv (n = 58) and Grsv (n = 134) groups, the following are noteworthy: the higher meanage, more frequent prescription of antibiotics, and the highest median of total white blood cellcount and C-reactive protein values in Gadv. CONCLUSIONS: PCR can detect persistent/latent forms of ADV, an aspect to be considered wheninterpreting results. Additional studies with quantitative diagnostic techniques could elucidatethe importance of the high frequency observed.

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Respiratory infections in children up to two years of age on prophylaxis with palivizumab

Ana Isabel M. P. Monteiro, Nancy Cristina J. Bellei, Alessandra Ramos Sousa … (2014)

OBJECTIVE: To identify the viruses involved in acute respiratory tract infections and to analyze the rates of hospitalization and death in children on palivizumab prophylaxis. METHODS: Prospective cohort of 198 infants up to one year old who were born before 29 weeks of gestational age and infants under two years old with hemodynamically unstable cardiopathy or chronic pulmonary disease who received prophylactic palivizumab against severe respiratory syncytial virus infections in 2008. During the study period, in each episode of acute respiratory tract infection, nasopharyngeal aspirate was collected to identify respiratory syncytial virus, adenovirus, parainfluenza 1, 2 and 3, influenza A and B by direct immunofluorescence, rhinovirus and metapneumovirus by polymerase chain reaction preceded by reverse transcription. Data regarding hospitalization and deaths were monitored. RESULTS: Among the 198 studied infants, 117 (59.1%) presented acute respiratory tract infections, with a total of 175 episodes. Of the 76 nasopharyngeal aspirates collected during respiratory tract infections, 37 were positive, as follow: rhinovirus (75.7%), respiratory syncytial virus (18.9%), parainfluenza (8.1%), adenovirus 2 (2.7%), metapneumovirus (2.7%) and three samples presented multiple agents. Of the 198 children, 48 (24.4%) were hospitalized: 30 (15.2%) for non-infectious etiology and 18 (9.1%) for respiratory causes. Among these 18 children, one case of respiratory syncytial virus was identified. Two deaths were reported, but respiratory syncytial virus was not identified. CONCLUSIONS: During the prophylaxis period, low frequency of respiratory syncytial virus infections and low rates of hospitalization were observed, suggesting the benefit of palivizumab prophylaxis.