Revisão sistemática da eficácia da vacina da dengue
Revisão sistemática da eficácia da vacina da dengue
Data
2016
Autores
Silveira, Lúcia Teresa Côrtes da
Journal Title
Journal ISSN
Volume Title
Publisher
Instituto Nacional de Cardiologia
Resumo
Dengue é uma doença infecciosa viral, causada por arbovírus do gênero Flavivirus, do qual são reconhecidos quatro sorotipos circulantes, sendo eles Dengue Vírus (DENV) tipo 1 (DENV-1), tipo 2 (DENV-2), tipo 3 (DENV-3) e tipo 4 (DENV-4). Seus principais vetores no ambiente urbano são os mosquitos do gênero Aedes, o aegypti e o albopictus. O presente estudo realizou uma revisão sistemática, seguida de metanálise da eficácia da vacina da dengue em prevenir dengue sintomática, com o intuito de obter uma estimativa mais precisa dos parâmetros de eficácia da vacina. Foi realizada busca sistemática na base de dados Medline via Pubmed, na Biblioteca Cochrane, no LILACS e no EMBASE, identificando Ensaios Clínicos Randomizados (ECR) publicados entre 2000 e 2016 e avaliados por dois revisores independentes. Na metanálise foram incluídos sete ECR, somando uma população de 36.371, onde 30 não foram randomizados e 24.257 foram randomizados para receber a vacina e 12.114 para receber o placebo ou outra não intervenção. A eficácia da vacina foi de 44%, variando entre 25% e 59%, com uma heterogeneidade de 80,1%. Que não pode ser explicada pela meta-regressão que avaliou o efeito da soropositividade, do vírus e da idade, mas que pode ser devida ao efeito não uniforme da vacina na prevenção de casos sintomáticos de dengue de acordo com o sorotipo, observada na metanálise estratificada que mostrou pequena heterogeneidade (10,3%) para o sorotipo 4 e heterogeneidade significativa (64,5%) para o sorotipo 2. O impacto orçamentário foi calculado para um prevalência de 70% de soropositividade na população entre 9 e 45 anos, os valores foram retirados da Câmara de Regulação do Mercado de Medicamentos (CMED) e do Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos, Órteses, Próteses e Materiais de Síntese do SUS (SIGTAP). O total calculado foi R$ 16.256.587.187,80, R$ 18.062.874.620,20 e R$ 25.288.024.349,80, vacinando respectivamente 45%, 50% e 70% da população, o que representa aproximadamente 14%, 16% e 22% do orçamento do Ministério da Saúde para 2016. Em conclusão, a eficácia da vacina é baixa em prevenir dengue sintomática. E por outro lado, o impacto orçamentário é muito alto.
Dengue is an arboviral infectious disease with four main circulating serotypes- dengue viruses – DENV -1, DENV-2, DENV- 3 and DENV-4. Its main vectors in the urban environment are the Aedes mosquitoes, both aegypti and albopictus. This study aimed to perform a systematic review, followed by a meta-analysis of vaccine efficacy in preventing clinically symptomatic dengue, in order to get a more accurate estimation of vaccine efficacy parameters. The search was conducted in MEDLINE by PubMed, Cochrane Library, LILACS and EMBASE, identifying randomized controlled trials (RCTs) published between 2000 and 2016 and always evaluated by two independent reviewers. In the meta-analysis were included seven randomized and placebo-controlled studies, with a total population of 36,371: 24,257 randomized to receive the vaccine and 12,114 to receive placebo or other nonintervention. The vaccine efficacy was 44%, between 25% and 59% with heterogeneity of 80.1%. This cannot be explained by the meta-regression that evaluated the effect of seropositivity, virus and age, but may be due to the non-uniform effect of the vaccine in the prevention of symptomatic cases of dengue according to the serotype, observed in the stratified meta-analysis which showed small heterogeneity (10.3%) for serotype 4 and significant heterogeneity (64.5%) for serotype 2.The impact in the budget was calculated for a prevalence of 70% seropositivity in the population between 9 and 45 years old, values were taken from the CMED (medical market regulation) and the SIGTAP (Medicines, orthoses, prostheses and synthesis materials management regulation system of SUS). The estimated total was R$ 16,256,587,187.80, R$ 18,062,874,620.20 and R$ 25,288,024,349.80, respectively vaccinating 45%, 50% and 70% of the population, which represents approximately 14%, 16% and 22% of the Ministry of Health's budget for 2016. In conclusion, the efficacy of the vaccine is low in preventing symptomatic dengue and, on the other hand, the budgetary impact is very high.
Dengue is an arboviral infectious disease with four main circulating serotypes- dengue viruses – DENV -1, DENV-2, DENV- 3 and DENV-4. Its main vectors in the urban environment are the Aedes mosquitoes, both aegypti and albopictus. This study aimed to perform a systematic review, followed by a meta-analysis of vaccine efficacy in preventing clinically symptomatic dengue, in order to get a more accurate estimation of vaccine efficacy parameters. The search was conducted in MEDLINE by PubMed, Cochrane Library, LILACS and EMBASE, identifying randomized controlled trials (RCTs) published between 2000 and 2016 and always evaluated by two independent reviewers. In the meta-analysis were included seven randomized and placebo-controlled studies, with a total population of 36,371: 24,257 randomized to receive the vaccine and 12,114 to receive placebo or other nonintervention. The vaccine efficacy was 44%, between 25% and 59% with heterogeneity of 80.1%. This cannot be explained by the meta-regression that evaluated the effect of seropositivity, virus and age, but may be due to the non-uniform effect of the vaccine in the prevention of symptomatic cases of dengue according to the serotype, observed in the stratified meta-analysis which showed small heterogeneity (10.3%) for serotype 4 and significant heterogeneity (64.5%) for serotype 2.The impact in the budget was calculated for a prevalence of 70% seropositivity in the population between 9 and 45 years old, values were taken from the CMED (medical market regulation) and the SIGTAP (Medicines, orthoses, prostheses and synthesis materials management regulation system of SUS). The estimated total was R$ 16,256,587,187.80, R$ 18,062,874,620.20 and R$ 25,288,024,349.80, respectively vaccinating 45%, 50% and 70% of the population, which represents approximately 14%, 16% and 22% of the Ministry of Health's budget for 2016. In conclusion, the efficacy of the vaccine is low in preventing symptomatic dengue and, on the other hand, the budgetary impact is very high.
Description
Palavras-chave
Economia da Saúde, Vírus da Dengue, Vacinas, Dengue, Vaccines, Dengue virus, Economia e Organizações de Saúde, Health Care Economics and Organizations, Health Economics
Citação
Silveira LTC. Revisão sistemática da eficácia da vacina da dengue. Rio de Janeiro. Dissertação [mestrado Profissional em Avaliação de Tecnologias em Saúde] - Instituto Nacional de Cardiologia; 2016.