Self-reported historic human immunodeficiency virus (HIV) testing in a Brazilian blood donor HIV case-control study.

BACKGROUND: There has been increased worldwide emphasis on the many benefits of human immunodeficiency virus (HIV) serostatus awareness for both infection prevention and improved treatment outcomes. Previous studies indicate that donors may use blood donation to be tested; the objectives of this analysis were to assess, among donors with previously undisclosed risk behavior in the 12 months before donation, the frequency of those who have previously been tested for HIV and the demographic and behavioral factors associated with such testing. STUDY DESIGN AND METHODS: In this secondary analysis from an HIV case-control study of blood donors in Brazil, we analyzed the response to the question, "Other than blood donation, have you ever been tested for HIV?" Demographic and disclosed risk behaviors associated with previous testing were determined. RESULTS: The study included 341 HIV-positive cases and 791 HIV-negative controls (1:2 case/control ratio). Overall, 31% of blood donors (40% of cases and 26% of controls) reported having been tested for HIV outside of blood donation. History of HIV testing varied according to sex, HIV status, and reported sexual risk behavior. CONCLUSION: Although it is encouraging that previous testing was more frequent in donors with acknowledged sexual risk behavior in Brazil, 60% still had not been tested for HIV outside of the blood donation setting. Educating donors on the importance of not using blood centers as a means to get tested for HIV in Brazil, especially if they engage in higher risk behaviors, and seeking alternate testing venues instead could improve the safety of donated blood.

Subversion of early innate antiviral responses during antibody-dependent enhancement of Dengue virus infection induces severe disease in immunocompetent mice.

Dengue is a mosquito-borne disease caused by one of four serotypes of Dengue virus (DENV-1-4). Epidemiologic and observational studies demonstrate that the majority of severe dengue cases, dengue hemorrhagic fever and dengue shock syndrome (DHF/DSS), occurs predominantly in either individuals with cross-reactive immunity following a secondary heterologous infection or in infants with primary DENV infections born from dengue-immune mothers, suggesting that B-cell-mediated and antibody responses impact on disease evolution. We demonstrate here that B cells play a pivotal role in host responses against primary DENV infection in mice. After infection, µMT(-/-) mice showed increased viral loads followed by severe disease manifestation characterized by intense thrombocytopenia, hemoconcentration, cytokine production and massive liver damage that culminated in death. In addition, we show that poly and monoclonal anti-DENV-specific antibodies can sufficiently increase viral replication through a suppression of early innate antiviral responses and enhance disease manifestation, so that a mostly non-lethal illness becomes a fatal disease resembling human DHF/DSS. Finally, treatment with intravenous immunoglobulin containing anti-DENV antibodies confirmed the potential enhancing capacity of subneutralizing antibodies to mediate virus infection and replication and induce severe disease manifestation of DENV-infected mice. Thus, our results show that humoral responses unleashed during DENV infections can exert protective or pathological outcomes and provide insight into the pathogenesis of this important human pathogen.

Human immunodeficiency virus prevalence, incidence, and residual risk of transmission by transfusions at Retrovirus Epidemiology Donor Study-II blood centers in Brazil.

BACKGROUND: In Brazil nationally representative donor data are limited on human immunodeficiency virus (HIV) prevalence, incidence, and residual transfusion risk. The objective of this study was to analyze HIV data obtained over 24 months by the Retrovirus Epidemiology Donor Study-II program in Brazil. STUDY DESIGN AND METHODS: Donations reactive to third- and fourth-generation immunoassays (IAs) were further confirmed by a less-sensitive (LS) IA algorithm and Western blot (WB). Incidence was calculated for first-time (FT) donors using the LS-EIA results and for repeat donors with a model developed to include all donors with a previous negative donation. Residual risk was projected by multiplying composite FT and repeat donor incidence rates by HIV marker-negative infectious window periods. RESULTS: HIV prevalence among FT donors was 92.2/10(5) donations. FT and repeat donor and composite incidences were 38.5 (95% confidence interval [CI], 25.6-51.4), 22.5 (95% CI, 17.6-28.0), and 27.5 (95% CI, 22.0-33.0) per 100,000 person-years, respectively. Male and community donors had higher prevalence and incidence rates than female and replacement donors. The estimated residual risk of HIV transfusion transmission was 11.3 per 10(6) donations (95% CI, 8.4-14.2), which could be reduced to 4.2 per 10(6) donations (95% CI, 3.2-5.2) by use of individual-donation nucleic acid testing (NAT). CONCLUSION: The incidence and residual transfusion risk of HIV infection are relatively high in Brazil. Implementation of NAT will not be sufficient to decrease transmission rates to levels seen in the United States or Europe; therefore, other measures focused on decreasing donations by at-risk individuals are also necessary.

Vasovagal reactions in whole blood donors at three REDS-II blood centers in Brazil.

BACKGROUND: In Brazil little is known about adverse reactions during donation and the donor characteristics that may be associated with such events. Donors are offered snacks and fluids before donating and are required to consume a light meal after donation. For these reasons the frequency of reactions may be different than those observed in other countries. STUDY DESIGN AND METHODS: A cross-sectional study was conducted of eligible whole blood donors at three large blood centers located in Brazil between July 2007 and December 2009. Vasovagal reactions (VVRs) along with donor demographic and biometric data were collected. Reactions were defined as any presyncopal or syncopal event during the donation process. Multivariable logistic regression was performed to identify predictors of VVRs. RESULTS: Of 724,861 donor presentations, 16,129 (2.2%) VVRs were recorded. Rates varied substantially between the three centers: 53, 290, and 381 per 10,000 donations in Recife, São Paulo, and Belo Horizonte, respectively. Although the reaction rates varied, the donor characteristics associated with VVRs were similar (younger age [18-29 years], replacement donors, first-time donors, low estimated blood volume [EBV]). In multivariable analysis controlling for differences between the donor populations in each city younger age, first-time donor status, and lower EBV were the factors most associated with reactions. CONCLUSION: Factors associated with VVRs in other locations are also evident in Brazil. The difference in VVR rates between the three centers might be due to different procedures for identifying and reporting the reactions. Potential interventions to reduce the risk of reactions in Brazil should be considered.

Demographic profile of blood donors at three major Brazilian blood centers: results from the International REDS-II study, 2007 to 2008.

BACKGROUND: The profile of blood donors changed dramatically in Brazil over the past 20 years, from remunerated to nonremunerated and then from replacement to community donors. Donor demographic data from three major blood centers establish current donation profiles in Brazil, serving as baseline for future analyses and tracking longitudinal changes in donor characteristics. STUDY DESIGN AND METHODS: Data were extracted from the blood center, compiled in a data warehouse, and analyzed. Population data were obtained from the Brazilian census. RESULTS: During 2007 to 2008, there were 615,379 blood donations from 410,423 donors. A total of 426,142 (69.2%) were from repeat (Rpt) donors and 189,237 (30.8%) were from first-time (FT) donors. Twenty percent of FT donors returned to donate in the period. FT donors were more likely to be younger, and Rpt donors were more likely to be community donors. All were predominantly male. Replacement donors still represent 50% of FT and 30% of Rpt donors. The mean percentage of the potentially general population who were donors was approximately 1.2% for the three centers (0.7, 1.5, and 3.1%). Adjusting for the catchment's area, the first two were 2.1 and 1.6%. CONCLUSIONS: Donors in the three Brazilian centers tended to be younger with a higher proportion of males than in the general population. Donation rates were lower than desirable. There were substantial differences in sex, age, and community/replacement status by center. Studies on the safety, donation frequencies, and motivations of donors are in progress to orient efforts to enhance the availability of blood.

Contribution of the Retrovirus Epidemiology Donor Study (REDS) to research on blood transfusion safety in Brazil.

The Retrovirus Epidemiology Donor Study (REDS) program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

Logistic model for determining factors associated with HIV infection among blood donor candidates at the Fundação HEMOPE.

OBJECTIVE: To determine factors associated with HIV infection in blood donor candidates in Recife, Brazil. METHODS: A transversal study was performed of 106,203 blood donor candidates found eligible by the routine clinical screening process in the blood bank in Recife of the Fundação de Hematologia e Hemoterapia de Pernambuco (HEMOPE) in the period from January 1998 to November 2003. Additional indirect immune and western blot confirmation tests for HIV infection were performed and the candidates were classified as HIV positive or negative. The Chi-squared test and stepwise multiple logistic regression were conducted to examine any association between HIV infection and age, gender, place of residence, schooling, number of donations and serological tests for core hepatitis B antigen virus (anti-HBc), the hepatitis C antivirus (anti-HCV), human T-type antivirus lymph cells (anti-HTLV 1 and 2), serological tests for syphilis (VDRL) and the hepatitis B virus surface antigen (HBsAg). RESULTS: In the observed sample, 0.204% of blood donor candidates were found to be HIV positive. Among the studied variables, the age, education level, residency, donation type, and serologic status for anti-HBc and VDRL tests were found to be associated with HIV infection. CONCLUSIONS: The younger, spontaneous donor candidates living in the Recife metropolitan area with a low level of education and positive for anti-HBc and VDRL have an higher risk of HIV infection than the other candidates. Data such as these are useful to understand the dynamics of infection and to guide healthcare policies.

Contribution of the Retrovirus Epidemiology Donor Study (REDS) to research on blood transfusion safety in Brazil

The Retrovirus Epidemiology Donor Study (REDS) program was established in the United States in 1989 with the purpose of increasing blood transfusion safety in the context of the HIV/AIDS and human T-lymphotropic virus epidemics. REDS and its successor, REDS-II were at first conducted in the US, then expanded in 2006 to include international partnerships with Brazil and China. In 2011, a third wave of REDS renamed the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) was launched. This seven-year research program focuses on both blood banking and transfusion medicine research in the United States of America, Brazil, China, and South Africa. The main goal of the international programs is to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transfusion, and to address research questions aimed at understanding global issues related to the availability of safe blood. This article describes the contribution of REDS-II to transfusion safety in Brazil. Articles published from 2010 to 2013 are summarized, including database analyses to characterize blood donors, deferral rates, and prevalence, incidence and residual risk of the main blood-borne infections. Specific studies were developed to understand donor motivation, the impact of the deferral questions, risk factors and molecular surveillance among HIV-positive donors, and the natural history of Chagas disease. The purpose of this review is to disseminate the acquired knowledge and briefly summarize the findings of the REDS-II studies conducted in Brazil as well as to introduce the scope of the REDS-III program that is now in progress and will continue through 2018.

Logistic model for determining factors associated with HIV infection among blood donor candidates at the Fundação HEMOPE

OBJECTIVE: To determine factors associated with HIV infection in blood donor candidates in Recife, Brazil. METHODS:A transversal study was performed of 106,203 blood donor candidates found eligible by the routine clinical screening process in the blood bank in Recife of the Fundação de Hematologia e Hemoterapia de Pernambuco (HEMOPE) in the period from January 1998 to November 2003. Additional indirect immune and western blot confirmation tests for HIV infection were performed and the candidates were classified as HIV positive or negative. The Chi-squared test and stepwise multiple logistic regression were conducted to examine any association between HIV infection and age, gender, place of residence, schooling, number of donations and serological tests for core hepatitis B antigen virus (anti-HBc), the hepatitis C antivirus (anti-HCV), human T-type antivirus lymph cells (anti-HTLV 1 and 2), serological tests for syphilis (VDRL) and the hepatitis B virus surface antigen (HBsAg). RESULTS: In the observed sample, 0.204% of blood donor candidates were found to be HIV positive. Among the studied variables, the age, education level, residency, donation type, and serologic status for anti-HBc and VDRL tests were found to be associated with HIV infection. CONCLUSION: The younger, spontaneous donor candidates living in the Recife metropolitan area with a low level of education and positive for anti-HBc and VDRL have an higher risk of HIV infection than the other candidates. Data such as these are useful to understand the dynamics of infection and to guide healthcare policies.

A new methodology for polyvalent intravenous immunoglobulin solution production with a two-stage process of viral inactivation

Highly purified intravenous immunoglobulin G concentrate (IV IgG) was produced with the use of polyethylene glycol associated to a single-stage precipitation by ethanol, instead of the classic Cohn-Oncley process, which employs cold alcohol as the precipitating agent, in a three-stage process. Precipitation of crude fraction containing more than 95% of immunoglobulin G was performed by liquid chromatography with a cation exchanger, CM-Sepharose, as a stationary phase. During the process, the product was subjected to two-stage viral inactivation. The first stage was performed by the action of sodium caprylate, 30 mM at pH 5.1+/- 0.1, and the second stage was performed by the action of a solvent-detergent mixture. The finished product was formulated at 5% with 10% sucralose as the stabilizing agent. The process yields 3.3g of IgG/liter of plasma. The finished product analysis showed an anti-complementary activity lower than 1CH50. Polymer and aggregate percent levels were lower than 3% in the five batches studied. The analysis of neutralizing capacity showed the presence of antibacterial and antiviral antibodies in at least three times higher concentrations than the levels found in source plasma. The finished product fulfilled all purity requirements stated in the 4th edition of the European pharmacopeia.

Obteve-se concentrado de imunoglobulina G intravenosa IgGIV, altamente purificado, utilizando-se polietilenoglicol associado a uma única etapa de precipitação por etanol, em substituição ao tradicional método descrito por Cohn-Oncley, que emprega, em três etapas, o mesmo álcool resfriado, como agente precipitante. A purificação da fração bruta contendo mais de 95% de imunoglobulina G foi realizada utilizando-se cromatografia líquida com um trocador de cátion, a CM-Sepharose, como fase estacionária. Durante o processamento o produto foi submetido a dupla inativação viral sendo a primeira pela ação do caprilato de sódio, 30 mM a pH 5,1+/- 0,1 e a segunda por ação de mistura de solvente/detergente. O produto acabado foi formulado a 5% utilizando-se sucralose 10% como estabilizante. O rendimento da metodologia foi de 3,3g de IgG/litro de plasma. A análise do produto acabado demonstrou atividade anti-complementar inferior a 1CH50. O valor percentual de polímeros e agregados em cinco lotes realizados foi inferior a 3%. O estudo da capacidade de neutralização demonstrou a presença de anticorpos anti-bacterianos e anti-virais em concentração pelo menos três vezes maior que o plasma de origem. O produto acabado apresentou conformidade com todos os requisitos de pureza dispostos na farmacopéia européia IV edição.

Custo médio do Módulo de Coleta de sangue total pelo método ABC / The mean cost of collection of whole blood units by the ABC method

Os procedimentos em hemoterapia são complexos e caros. Exigem processos controlados e validados, equipamentos calibrados e monitorados e insumos qualificados, validados e inspecionados antes e durante o uso. Isto acarreta, além dos gastos diretos, gastos indiretos especificamente relacionados à garantia da qualidade e da segurança transfusionais, além dos gastos indiretos usuais de qualquer produto ou serviço. Procurando avaliar com maior aproximação estes custos e buscando evitar as distorções das apropriações de custos por rateios, o presente estudo utilizou o sistema de Custeio Baseado em Atividades - ABC, para apurar o custo médio do Módulo de Coleta de sangue total no Hemocentro de Ribeirão Preto - SP, unidade sede, no primeiro semestre de 2006. O maior impacto no custo médio apurado se deveu aos custos monetários diretos, entretanto os custos indiretos não foram desprezíveis. O custo médio obtido para desempenho das atividades que compõem o Módulo de Coleta foi de R$ 35,20, que é 68,75 por cento superior ao valor pago na tabela SIA/SUS para este módulo. A metodologia desenvolvida pode ser aplicada aos outros procedimentos dos serviços de hemoterapia, permitindo a avaliação dos custos de seus processos, evitando desperdícios, aprimorando o seu funcionamento e gerando evidências objetivas que demonstrem os custos reais da hemoterapia de qualidade para as instâncias financiadoras públicas e privadas.

The procedures in hemotherapy are complex and expensive. They demand a controlled and validated process. They also require calibrated and monitored equipment and qualified and validated materials, inspected before and during use. This causes, apart from direct expenses, indirect expenses related to the guarantee of quality and transfusional safety, as well as the usual indirect costs of any product or service. The present study used the Activity-Based Costing system - ABC, to find the mean cost of collection of whole blood units in a Regional Blood Center in Ribeirão Preto, during the first semester of 2006, in order to assess these costs more carefully and to try to avoid the cost distortions due to separation of blood components. Although the indirect costs were not negligible, the major impact on the mean cost was related to direct monetary costs. The mean cost to perform the activities that compose the collection of blood units was R$ 35.20, which is 68.75 percent higher than the value paid by the Brazilian government for this unit. The developed methodology can be applied to other procedures of services in hemotherapy allowing the evaluation of process costs, avoiding waste, improving performance and generating objective evidence to demonstrate the real cost of quality hemotherapy activities for public and private fund source.

Weekly monitoring of the effects of conventional external beam radiation therapy on patients with head and neck, chest, and pelvis cancer by means of blood cells count / Avaliação semanal dos efeitos da radioterapia externa convencional pela contagem dos leucócitos e plaquetas de pacientes portadores de câncer nas áreas de cabeça e pescoço, tórax e pelve

OBJETIVO: Avaliar a necessidade de monitoração semanal, pela contagem de leucócitos e plaquetas, dos pacientes portadores de câncer das áreas de cabeça e pescoço, tórax e pelve submetidos a radioterapia externa convencional. MATERIAIS E MÉTODOS: Cento e um adultos, portadores de câncer das áreas de cabeça e pescoço (11 pacientes), tórax (35 pacientes) e pelve (55 pacientes), submetidos a radioterapia, avaliados semanalmente com leucograma e contagem de plaquetas, comparando-se as contagens das células antes do início do tratamento com as obtidas nas semanas ao longo do tratamento, área tratada, sexo e faixa etária. RESULTADOS: A maior queda dos leucócitos e plaquetas ocorreu na quarta semana, quando linfócitos, leucócitos totais, neutrófilos, monócitos e plaquetas apresentaram diminuição de 53,5 por cento, 26,8 por cento, 19,4 por cento, 22,2 por cento e 14,6 por cento, respectivamente, ao serem comparados aos valores do início do tratamento. Durante o tratamento, as médias geométricas da pelve foram estatisticamente menores do que as de tórax e cabeça e pescoço. Os linfócitos foram os mais sensíveis à irradiação. Não houve alteração da contagem de leucócitos e plaquetas relacionadas ao sexo ou à faixa etária. CONCLUSÃO: A partir dos resultados obtidos não parece ser necessária a contagem semanal de leucócitos e plaquetas para pacientes submetidos a radioterapia externa convencional em campos localizados.

OBJECTIVE: To evaluate the necessity of weekly monitoring by means of leukocyte and platelet counts of patients with head and neck, chest, and pelvis cancer submitted to conventional radiotherapy. MATERIALS AND METHODS: A hundred and one adult patients with cancer of head and neck (n = 11), chest (n = 35) and pelvis (n = 55), submitted to radiotherapy were assessed by means of leukocyte and platelet counts on a weekly basis, with a comparison between the results before and during the treatment and in correlation with the area treated, patient's sex and age group. RESULTS: The most significant decrease in leukocytes was observed in the fourth week, when lymphocytes, total leukocytes, neutrophils, monocytes and platelets presented a decrease of 53.5 percent, 26.8 percent, 19.4 percent, 22.2 percent and 14.6 percent, respectively, in comparison with the values found before the beginning of the therapy. Geometric means for pelvis during the treatment were lower than those for chest, and head and neck. Lymphocytes demonstrated to be more sensitive to radiation therapy. No alteration was found in leukocyte or platelet counts in correlation with patients' sex or age. CONCLUSION: Based on the results of the present study, weekly leukocyte and platelet counts do not seem to be useful in the assessment patients submitted to conventional radiotherapy for localized cancer.