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Background The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported. Methods Adults aged 18–84 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses. Results Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%–88.8%). Vaccine efficacy was 100% (95% CI, 17.9%–100.0%) against severe disease and 76.3% (95% CI, 57.4%–86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein–specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. Conclusions A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through >6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated. Clinical Trials Registration EudraCT, 2020-004123-16.

HBV nucleos(t)ide reverse transcriptase inhibitors (NrtIs) do not completely suppress HBV replication. Previous reports indicate persistent viremia during NrtI treatment despite HBV DNA being undetectable. HBV core inhibitors may enhance viral suppression when combined with NrtIs. This phase II trial (NCT03576066) evaluated the efficacy and safety of the investigational core inhibitor, vebicorvir (VBR), in virologically- suppressed patients on NrtIs.Non-cirrhotic, NrtI-suppressed patients with chronic HBV were randomised to VBR 300 mg once daily or matching placebo (PBO) for 24 weeks. Treatment was stratified by hepatitis B e antigen (HBeAg) status. The primary endpoint was change from Baseline in serum HBeAg or hepatitis B surface antigen (HBsAg) after 24 weeks.Of 73 patients enrolled, 47 were HBeAg positive and 26 were HBeAg negative. In HBeAg-positive and -negative patients, there were no differences in the change from Baseline at Week 24 for HBsAg or HBeAg. Using a novel, high-sensitivity assay to detect HBV DNA, a greater proportion of patients with detectable HBV DNA at Baseline achieved undetectable HBV DNA at Week 24 in the VBR+NrtI vs. PBO+NrtI group. In HBeAg-positive patients, a greater change from Baseline in HBV pregenomic (pg)RNA was observed at Week 24 with VBR+NrtI vs. PBO+NrtI. Treatment-emergent adverse events (TEAEs) in VBR+NrtI patients included upper respiratory tract infection, nausea, and pruritus. No serious adverse events, Grade 4 TEAEs, or deaths were reported.In this 24-week study, VBR+NrtI demonstrated a favourable safety and tolerability profile. While there were no significant changes in viral antigen levels, enhanced viral suppression was demonstrated by greater changes in DNA and pgRNA with the addition of VBR compared to NrtI alone.NCT03576066.Core inhibitors represent a novel approach for the treatment of chronic hepatitis B virus (HBV) infection, with mechanisms of action distinct from existing treatments. In this study, vebicorvir added to existing therapy reduced HBV replication to a greater extent than existing treatment and was generally safe and well tolerated.

O Manifesto da cidadania digital é uma das principais referências orientadoras das reflexões e proposições fundantes neste texto, o qual apresenta síntese do projeto PIBIC-AF (Programa Institucional de Bolsas de Iniciação Científica-Ações Afirmativas) com vigência entre os anos de 2021 e 2022. Sua temática central de investigação é o ‘Net-Ativismo e a formação de educadores sociais para a sustentabilidade ambiental’ como caminho de formação didático-científica da bolsista-educadora aprovada pelo programa. O Net-Ativismo, ou ativismo digital, é caminho para o acompanhamento e prevenção relativos não apenas à reflexão sobre desastres naturais e ambientais, mas é modo formativo de uma verdadeira cultura ecológica para a sustentabilidade. A concepção de pesquisa é de natureza qualitativa, com base na fenomenologia e está organizada em três etapas, tendo uma delas destacada no presente texto, a Exploratória. Um dos eixos introdutórios é a consideração da natureza didático-epistemológica do processo de orientação do educador-bolsista ao longo do desenvolvimento do projeto. Os resultados apontam para a inclusão e melhoria didático-formativa do bolsista no campo do ativismo digital, com destaque para a formação sócioecológica (sustentabilidade ambiental) e a participação cidadã no mundo digital, que inclui as redes sociais. O estudo mobiliza o iniciante em pesquisa a fim de fazer-se multiplicador e profissional de relevância, na educação e na ciência brasileiras, considerando a construção de um conhecimento que inclua a participação efetiva no mundo digital.

BackgroundNVX-CoV2373 (Nuvaxovid™ or the Novavax COVID-19 Vaccine, Adjuvanted), the first protein-based COVID-19 vaccine, received emergency use authorization (EUA) as a primary series/booster and is available globally. NVX-CoV2373 primary series demonstrated efficacy rates of 89·7–90·4 % and an acceptable safety profile. This article summarizes safety in adult recipients (aged ≥18 years) of primary series NVX-CoV2373 in four randomized placebo-controlled trials.MethodsAll participants who received NVX-CoV2373 primary series or placebo (pre-crossover) were included according to actual received treatment. The safety period was from Day 0 (first vaccination) to unblinding/receipt of EUA-approved/crossover vaccine, end of each study (EOS), or last visit date/cutoff date minus 14 days. The analysis reviewed local and systemic solicited adverse events (AEs) within 7 days after NVX-CoV2373 or placebo; unsolicited AEs from after Dose 1 to 28 days after Dose 2; serious AEs (SAEs), deaths, AEs of special interest, and vaccine-related medically attended AEs from Day 0 through end of follow-up (incidence rate per 100 person-years).FindingsPooled data from 49,950 participants (NVX-CoV2373, n=30,058; placebo, n=19,892) were included. Solicited reactions after any dose were more frequent in NVX-CoV2373 recipients (local, 76%/systemic, 70%) than placebo recipients (29%/47%), and were mostly of mild-to-moderate severity. Grade 3+ reactions were infrequent, with greater frequency in NVX-CoV2373 recipients (6·28%/11·36%) than placebo recipients (0·48%/3·58%). SAEs and deaths occurred with similarly low frequency in NVX-CoV2373 (0·91% and 0·07%, respectively) and placebo recipients (1·0% and 0·06%).InterpretationTo date, NVX-CoV2373 has displayed an acceptable safety profile in healthy adults.FundingSupported by Novavax, Inc.

The feeling of thermal comfort is associated with the rhythm of heat exchange between the human body and the environment, occurs in different types of spaces and caused by various parameters that influence temperature, such as constructions, climatic factors and the presence of vegetation, which can make environments inadequate or not to be (Carfan et al., 2010).

SummaryBackgroundThe emergence of SARS-CoV-2 variants has significantly reduced the efficacy of some approved vaccines. A fourth dose of NVX-CoV2373 (5µg SARS-CoV-2 rS + 50µg Matrix-M™ adjuvant) was evaluated to determine induction of cross-reactive antibodies to variants of concern.MethodsA phase 2 randomized study assessed a fourth dose of NVX-CoV2373 in adults 18–84 years of age (2-dose primary series followed by third and fourth doses at 6-month intervals). Local/systemic reactogenicity was assessed the day of vaccination and for 6 days thereafter. Unsolicited adverse events (AEs) were reported. Immunogenicity was measured before, and 14 days after, fourth dose administration using anti-spike neutralization assays against the ancestral SARS-CoV-2 strain and Omicron sublineages. Antigenic cartography assessed antigenic distances between ancestral and variant strains.ResultsAmong 1283 enrolled participants, 258 were randomized to receive the 2-dose primary series, of whom 104 received a third dose, and 45 received a fourth dose of NVX-CoV2373. The incidence of local/systemic reactogenicity events increased after the first three doses of NVX-CoV2373, and leveled off after dose four. Unsolicited AEs were reported in 9% of participants after dose 4 (none severe or serious). Neutralization antibody titers increased following booster doses. Antigenic cartography demonstrated reductions in antigenic distance between ancestral and variant SARS-CoV-2 strains with increased number of NVX-CoV2373 doses.ConclusionsA fourth dose of NVX-CoV2373 enhanced immunogenicity without increasing reactogenicity. Antigenic cartography demonstrated a more universal-like response against SARS-CoV-2 variants after a fourth dose of NVX-CoV2373, indicating that updates to the vaccine composition may not be warranted.Trial registration numberNCT04368988

Treatment for chronic hepatitis B virus infection (cHBV) is mostly indefinite, with new finite-duration therapies needed. We report safety, pharmacokinetics, and antiviral activity of the investigational HBV core inhibitor ABI-H2158. This Phase 1a/b study (NCT03714152) had three parts: Part A, participants received a single ascending oral dose of ABI-H2158 (5-500 mg) or placebo; Part B, participants received multiple doses of ABI-H2158 300 mg once (QD) or twice (BID) daily or placebo, for 10 days; Part C, cHBV patients received ABI-H2158 (100, 300, or 500 mg QD or 300 mg BID) or placebo, for 14 days. Ninety-three participants enrolled. In Parts A/B, there were no serious adverse events (SAEs) or deaths, and all treatment-emergent AEs (TEAEs) were Grade 1. In Part C, two patients had Grade 3 TEAEs unrelated to ABI-H2158; there were no deaths, SAEs, or Grade 4 TEAEs. In Part A, median time to maximum ABI-H2158 plasma concentration (T

Acreditamos que a formação inicial qualificada deva unir o ensinamento, formando educadores, com condições de assumir a docência com competência e persistência, com conhecimentos dos conteúdos específicos e com conhecimento didático-pedagógicos indispensáveis ao exercício docente. Deve estar fundamentada em concepções críticas e reflexivas que articulem a realidade escolar. O Docente deverá ser um educador, com formação e visão ampla, em que exige saberes diversificados e exige um saber teórico e prático dos conteúdos pertinentes e suas respectivas metodologias, com competência para atuar nos diversos contextos do processo educativo. As competências e habilidades entendidas como essenciais a serem desenvolvidas no decorrer de sua experiência. Este artigo se introduz na linha atual de preocupações de uma sociedade brasileira em constante metamorfose, trazendo um alerta sobre a situação da docência no ensino superior em nosso país. Tem como perspectiva a exposição e discussão das transformações que afetam as instituições de ensino, buscando centrá-las na problematização encontrada ao pesquisar sobre o tema. A estrutura educacional está mudando e a educação vista anteriormente de forma individual amplia seu espaço passando a admitir que todos os componentes da educação estejam interligados e que exista a possibilidade de educar de maneira conjunta. Passa-se então a perceber a possibilidade de interação entre diferentes fontes do saber, na qual há uma visão coletiva da aprendizagem. Portanto, o presente artigo tem como objetivo identificar e analisar a docência universitária diante dos desafios da realidade nacional em um mundo informatizado.

Education is the basis of ecological awareness, thus, it is possible to guide practical questions regarding environmental awareness considering early childhood, as this is a period of significant learning. This work seeks to stimulate ecological awareness considering the playfulness and reuse of materials in the construction of eco-toys aimed at children in early childhood in a situation of social or educational vulnerability, with the objective of investigating the inclusion of Environmental Education practices in everyday life. as a strategy to understand the change in behavior and attitudes in children aged 0 to 3 years at social risk. Aiming at the environmental context within this relationship between child and caregiver, about 30 children were monitored weekly by the Happy Child Program in the city of Araripe-CE. To monitor the children's development, the act of playing was observed weekly. It is a fact that the act of playing awakens the imagination of children. When placed in front of reusable material with the challenge of transforming them, they find ways to use these items in their play. In order to assess and monitor child development, the children who participated in the research showed a satisfactory result, even though it was a partial result, the study showed that children who play develop better. With regard to playing, inserting toys with recycled materials makes it possible for the child to become aware of the preservation of the Environment through play. La educación es la base de la conciencia ecológica, por lo tanto, es posible orientar cuestiones prácticas sobre la conciencia ambiental considerando la primera infancia, ya que es un período de aprendizaje significativo. Este trabajo busca estimular la conciencia ecológica considerando la lúdica y la reutilización de materiales en la construcción de eco-juguetes dirigidos a niños de la primera infancia en situación de vulnerabilidad social o educativa, con el objetivo de investigar la inclusión de prácticas de Educación Ambiental en la vida cotidiana. como estrategia para comprender el cambio de comportamiento y actitudes en niños de 0 a 3 años en situación de riesgo social. Apuntando al contexto ambiental dentro de esta relación entre niño y cuidador, cerca de 30 niños fueron monitoreados semanalmente por el Programa Niño Feliz en la ciudad de Araripe-CE. Para monitorear el desarrollo de los niños, el acto de jugar se observó semanalmente. Es un hecho que el acto de jugar despierta la imaginación de los niños. Cuando se colocan frente a materiales reutilizables con el desafío de transformarlos, encuentran formas de utilizar estos elementos en su juego. Con el fin de evaluar y monitorear el desarrollo infantil, los niños que participaron en la investigación arrojaron un resultado satisfactorio, aunque fue un resultado parcial, el estudio mostró que los niños que juegan se desarrollan mejor. En cuanto al juego, la inserción de juguetes con materiales reciclados posibilita que el niño tome conciencia de la preservación del Medio Ambiente a través del juego. A educação é a base da consciência ecológica, assim, é possível nortear questões práticas quanto à conscientização ambiental considerando a primeira infância, por ser esse um período de aprendizagens significativas. Este trabalho procura estimular a consciência ecológica considerando o lúdico e a reutilização de materiais na construção de ecobrinquedos voltados para as crianças na primeira infância em situação de vulnerabilidade social ou educacional, com o objetivo de investigar a inclusão de práticas de Educação Ambiental no dia a dia como estratégia para perceber a mudança de comportamentos e atitudes nas crianças de 0 a 3 anos em risco social. Visando o contexto ambiental dentro dessa relação criança e cuidador, foram submetidos cerca de 30 crianças acompanhadas semanalmente pelo Programa Criança Feliz na cidade de Araripe-CE. Para acompanhar o desenvolvimento das crianças, observou-se semanalmente o ato de brincar. É fato que o ato de brincar desperta a imaginação das crianças. Quando colocadas diante de material reutilizável com o desafio de transformá-los, encontram maneiras de usar estes itens em suas brincadeiras. No sentido de avaliar e acompanhar o desenvolvimento infantil, as crianças que participaram da pesquisa apresentaram um resultado satisfatório, mesmo sendo um resultado parcial, o estudo mostrou que crianças que brincam se desenvolvem melhor. No que diz respeito ao brincar, inserindo brinquedos com materiais reciclados possibilita que a criança tome consciência da preservação do Meio Ambiente por meio do lúdico.

Nucleos(t)ide reverse transcriptase inhibitors do not completely suppress HBV DNA in chronic HBV infection (cHBV). Vebicorvir (VBR) is an investigational core inhibitor that interferes with multiple aspects of HBV replication. This phase II trial evaluated the safety and efficacy of VBR in combination with entecavir (ETV) in treatment-naïve patients with cHBV.HBeAg-positive, treatment-naïve patients without cirrhosis were randomised 1:1 in a double-blind manner to once-daily VBR 300 mg+ETV 0.5 mg or placebo (PBO)+ETV 0.5 mg for 24 weeks. The primary endpoint was change in mean logAll patients in both treatment groups (PBO+ETV: 12/12; VBR+ETV: 13/13) completed the study. At Week 12, VBR+ETV led to a greater mean (SD) reduction from Baseline in logIn this 24-week study, VBR+ETV provided additive antiviral activity over PBO+ETV in treatment-naïve patients with cHBV, with a favourable safety and tolerability profile.NCT03577171 LAY SUMMARY: Hepatitis B is a long-lasting viral infection of the liver. Current treatments can suppress hepatitis B virus but do not offer the opportunity of cure, hence, new treatment approaches are required. Herein, we show that the combination of the novel core inhibitor vebicorvir with an existing antiviral (entecavir) in treatment-naïve patients chronically infected with hepatitis B virus demonstrated greater antiviral activity than entecavir alone. Additionally, vebicorvir was safe and well tolerated. Thus, further studies evaluating its potential role in the treatment of chronic hepatitis B are warranted.

The rising curve of population aging returns to the main causes of morbidity and mortality in the elderly over 60 years, including a fracture of the femur. Objective: to analyze the frequency and time trends of hospitalizations and deaths due to fractures of the femur above 60 years of age in the North. Data were collected through the database behind the DataSUS Hospital Information System (SIH) between 2015 and 2019. Data analysis was performed using Microsoft Excel 2010 and JoinPoint version 4.8.0.0. Note that most hospitalizations due to a femur fracture occurred in women, with 2018 and 2019 being the years with the highest incidence of hospitalizations for this cause. It is not yet the states of Para and Amazonas that have the highest rate of hospitalizations for fracture of the femur, proportionally to the largest population in these places. Elderly people over 80 years old were those who were hospitalized for femur fracture and in all years analyzed, a femur fracture corresponded to the cause of 50% of deaths from total deaths from bone fractures in the elderly population. Keywords: Spine, neck pain, low back pain.

A educação é a base da consciência ecológica, assim, é possível nortear questões práticas quanto à conscientização ambiental considerando a primeira infância, por ser esse um período de aprendizagens significativas. Este trabalho procura estimular a consciência ecológica considerando o lúdico e a reutilização de materiais na construção de ecobrinquedos voltados para as crianças na primeira infância em situação de vulnerabilidade social ou educacional, com o objetivo de investigar a inclusão de práticas de Educação Ambiental no dia a dia como estratégia para perceber a mudança de comportamentos e atitudes nas crianças de 0 a 3 anos em risco social. Visando o contexto ambiental dentro dessa relação criança e cuidador, foram submetidos cerca de 30 crianças acompanhadas semanalmente pelo Programa Criança Feliz na cidade de Araripe-CE. Para acompanhar o desenvolvimento das crianças, observou-se semanalmente o ato de brincar. É fato que o ato de brincar desperta a imaginação das crianças. Quando colocadas diante de material reutilizável com o desafio de transformá-los, encontram maneiras de usar estes itens em suas brincadeiras. No sentido de avaliar e acompanhar o desenvolvimento infantil, as crianças que participaram da pesquisa apresentaram um resultado satisfatório, mesmo sendo um resultado parcial, o estudo mostrou que crianças que brincam se desenvolvem melhor. No que diz respeito ao brincar, inserindo brinquedos com materiais reciclados possibilita que a criança tome consciência da preservação do Meio Ambiente por meio do lúdico.

The monitoring of graduates is a requirement for higher education courses and it is a necessity for all educational institutions, but there is not a policy based on this line in Brazil yet. Due to the diversity of teaching levels and modalities of the Federal Network of Vocational, Scientific and Technological Education (FNVSTE), logistic proposals are necessary to facilitate the data collection and allow the application of statistical techniques that guarantee consistency and convergence of decisions, besides longitudinal comparisons. This project was proposed in order to make an initial protocol available to the Program for Monitoring Graduates for FNVSTE, Questionnaires for graduates and employers were structured and tested, which can be reorganized to meet the specific demands of levels, modalities and courses. Statistical techniques of simple application were proposed and specific results of the graduates of the first ten years of the three institutions of FNVSTE of Minas Gerais as well as the results of the possible IFSULDEMINAS employers were described. Keywords: Profile. Institutional evaluation. Course evaluation. Job Market. Resumo: O acompanhamento de egressos constitui uma exigência para os cursos superiores. Configura-se como necessidade de todas as instituições de ensino, embora ainda não exista no Brasil uma política fundamentada nessa linha. Há significativa diversidade dos níveis e das modalidades de ensino da Rede Federal de Educação Profissional, Científica e Tecnológica (RFEPCT). Por isso, é necessário propor logísticas que facilitem o levantamento de dados e possibilitem a aplicação de técnicas estatísticas para garantir consistência e convergência das decisões, além de permitir comparações longitudinais. Este projeto foi proposto com o objetivo de disponibilizar um protocolo inicial ao Programa de Acompanhamento de Egressos para a RFEPCT. Estruturaram-se e testaram-se questionários, para egressos e empregadores, que podem ser reorganizados para atender a demandas específicas de níveis, modalidades e cursos. Foram propostas técnicas estatísticas de simples aplicação e descritos resultados específicos dos egressos dos primeiros dez anos de três instituições da RFEPCT Mineira e dos possíveis empregadores do Instituto Federal do Sul de Minas (IFSULDEMINAS). Palavras-chave: Perfil. Avaliação institucional. Avaliação de curso. Mundo do trabalho.

Resumo: O acompanhamento de egressos constitui uma exigência para os cursos superiores. Configura-se como necessidade de todas as instituições de ensino, embora ainda não exista no Brasil uma política fundamentada nessa linha. Há significativa diversidade dos níveis e das modalidades de ensino da Rede Federal de Educação Profissional, Científica e Tecnológica (RFEPCT). Por isso, é necessário propor logísticas que facilitem o levantamento de dados e possibilitem a aplicação de técnicas estatísticas para garantir consistência e convergência das decisões, além de permitir comparações longitudinais. Este projeto foi proposto com o objetivo de disponibilizar um protocolo inicial ao Programa de Acompanhamento de Egressos para a RFEPCT. Estruturaram-se e testaram-se questionários, para egressos e empregadores, que podem ser reorganizados para atender a demandas específicas de níveis, modalidades e cursos. Foram propostas técnicas estatísticas de simples aplicação e descritos resultados específicos dos egressos dos primeiros dez anos de três instituições da RFEPCT Mineira e dos possíveis empregadores do Instituto Federal do Sul de Minas (IFSULDEMINAS). Palavras-chave: Perfil. Avaliação institucional. Avaliação de curso. Mundo do trabalho.

Introduction and aim: Approximately 650,000 people in Brazil have chronic hepatitis C virus (HCV) infection. We evaluated the safety and efficacy of ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus dasabuvir (DSV) with/without ribavirin (RBV) in an open-label multicenter phase 3b trial in treatment-naive or interferon (IFN) treatment-experienced Brazilian patients with advanced hepatic fibrosis (METAVIR F3/4) and HCV genotype (GT) 1 infection. Materials and methods: All patients received coformulated OBV/PTV/r daily + DSV twice daily (3-DAA). GT1a-infected patients received 3-DAA plus RBV for 12 weeks, except for prior pegIFN/RBV nonresponders with cirrhosis who were treated for 24 weeks. GT1b-infected patients received 3-DAA alone (F3) or in combination with RBV (F4) for 12 weeks. The primary endpoint was sustained virologic response (HCV RNA

The 3 direct-acting antiviral (3D) regimen of ombitasvir/paritaprevir/ritonavir plus dasabuvir has recently been approved in several Asian geographic regions for the treatment of hepatitis C virus (HCV) genotype (GT) 1 infection. The pharmacokinetics of the components of the 3D regimen with or without ribavirin were evaluated in healthy Chinese subjects and HCV GT1b-infected Chinese, South Korean, and Taiwanese patients, with or without cirrhosis, to determine how the drug exposures in Asian populations compare with historical data in Western populations. Participants received ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily plus dasabuvir 250 mg twice daily for 14 days (healthy subjects, n = 36) or 12 weeks (HCV patients, n = 754). Patients with compensated cirrhosis also received ribavirin 1000 or 1200 mg divided twice daily, per the local label. Intensive or sparse pharmacokinetic sampling was performed for assessments of plasma drug concentrations. The exposures [maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC)] of the components of the 3D regimen were comparable (

Glecaprevir (nonstructural protein 3/4A protease inhibitor) and pibrentasvir (nonstructural protein 5A inhibitor) (G/P), a coformulated once‐daily, all oral, ribavirin (RBV)‐free, direct‐acting antiviral regimen, was evaluated for safety and efficacy in hepatitis C virus genotype 2 (GT2)–infected Japanese patients, including those with compensated cirrhosis. CERTAIN‐2 is a phase 3, open‐label, multicenter study assessing the safety and efficacy of G/P (300/120 mg) once daily in treatment‐naive and interferon ± RBV treatment–experienced Japanese patients without cirrhosis but with GT2 infection. Patients were randomized 2:1 to receive 8 weeks of G/P (arm A) or 12 weeks of sofosbuvir (400 mg once daily) + RBV (600‐1000 mg weight‐based, twice daily) (arm B). The primary endpoint was noninferiority of G/P compared to sofosbuvir + RBV by assessing sustained virologic response at posttreatment week 12 (SVR12) among patients in the intent‐to‐treat population. SVR12 was also assessed in treatment‐naive and interferon ± RBV treatment‐experienced patients with GT2 infection and compensated cirrhosis who received G/P for 12 weeks in the CERTAIN‐1 study. A total of 136 patients were enrolled in CERTAIN‐2. SVR12 was achieved by 88/90 (97.8%) patients in arm A and 43/46 (93.5%) patients in arm B. No patient in arm A experienced virologic failure, while 2 did in arm B. The primary endpoint was achieved. In CERTAIN‐1, 100% (18/18) of GT2‐infected patients with compensated cirrhosis achieved SVR12. Treatment‐emergent serious adverse events were experienced by 2 patients without cirrhosis in each arm and no patient with cirrhosis. Conclusion: The results demonstrate high efficacy and favorable tolerability of G/P in GT2‐infected Japanese patients. (Hepatology 2018;67:505‐513).

Background Once-daily, orally administered, co-formulated glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) (G/P) demonstrated pangenotypic activity and high sustained virologic response (SVR) rates in studies outside Japan. Here we report safety and efficacy in a subset of Japanese patients with chronic HCV infection who received G/P 300/120 mg in a phase 3, open-label, multicenter study (CERTAIN-1). Methods This analysis focuses on three difficult-to-treat subgroups: HCV GT1/2-infected patients who failed to achieve SVR after treatment with a direct acting antiviral (DAA)-containing regimen; GT1/2-infected patients with severe renal impairment (estimated glomerular filtration rate

Treatment of HCV genotype (GT) 2-infected Japanese patients with paritaprevir (NS3/4A inhibitor boosted with ritonavir) and ombitasvir (NS5A inhibitor) without ribavirin for 12 weeks in the phase 2 study M12-536, and with ribavirin for 16 weeks in phase 3 study GIFT II resulted in SVR rates of 72.2% to 91.5%. Overall, 11 out of 125 patients with GT2a and 37 out of 79 patients with GT2b infection experienced virologic failure. The prevalence of baseline polymorphisms in NS3 and NS5A and their the impact on treatment outcome, as well as the development of viral resistance in GT2-infected patients experiencing virologic failure were evaluated by HCV NS3 and NS5A population and clonal sequence analyses. Baseline polymorphisms in NS3 that confer resistance to paritaprevir were rare in both GT2a- and GT2b-infected patients, while baseline polymorphisms in NS5A that confer resistance to ombitasvir were detected in 11.2% and 14.1% of the GT2a- and GT2b-infected patients, respectively. There was no significant impact of baseline polymorphisms on treatment outcome in Japanese patients. The most common treatment-emergent substitutions at the time of virologic failure occurred at amino acid positions 168 in NS3 and 28 in NS5A in both GT2a- and GT2b-infected patients. Although there was a higher rate of virologic failure in patients with GT2b infection, the resistance analyses presented in this report support the conclusion that testing for baseline resistance-associated polymorphisms is not warranted for HCV GT2-infected patients treated with a regimen of ombitasvir/paritaprevir/ritonavir + ribavirin for 16 weeks.

In Japan, hepatitis C virus (HCV) genotype (GT) 2 accounts for approximately 32% of HCV infections. Limited treatment options exist in Japan for HCV GT2-infected patients. GIFT-II was a phase 3, randomized, open-label study evaluating the efficacy and safety of 16- and 12-week regimens of co-formulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus ribavirin (RBV) in Japanese adults with HCV GT2 infection. Patients were randomized in a 1:1 ratio to once-daily, co-formulated OBV/PTV/r (25/150/100 mg) with weight-based RBV for 16 or 12 weeks. The primary efficacy endpoint was the sustained virologic response at 12 weeks post-treatment (SVR12) rate in the primary efficacy population of non-cirrhotic treatment-naive patients. A total of 171 patients were randomized to OBV/PTV/r + RBV. In the primary efficacy population, SVR12 rates were 91.5% (43/47; 95% confidence interval 83.5–99.5%) and 75.0% (36/48; 95% confidence interval 62.8–87.2%) in the 16-week arm and 12-week arm, respectively. No patient in the 16-week arm relapsed by post-treatment week 12. Among non-cirrhotic treatment-experienced patients, the overall SVR rate in the 16-week arm was 75.8% (25/33) and was highest [93.8% (15/16)] among those who had relapsed after previous interferon-based therapy. SVR12 rates were consistently higher in patients with HCV GT2a infection versus HCV GT2b infection [16-week treatment arm: 93.9% (31/33) versus 85.7% (12/14) and 93.8% (15/16) versus 56.3% (9/16) among non-cirrhotic treatment-naive and treatment-experienced patients, respectively]. No patient discontinued treatment because of an adverse event. The most common adverse events were anemia, increased blood bilirubin, and nasopharyngitis. OBV/PTV/r + RBV for 16 weeks resulted in high SVR12 rates in non-cirrhotic Japanese patients infected with HCV GT2 who were treatment-naive or who had relapsed after an interferon-based therapy. Higher SVR12 rates were observed among patients with HCV GT2a infection versus those with GT2b infection. This regimen demonstrated a favorable safety profile. Trial Registration: ClinicalTrials.gov identifier, NCT02023112. Funding: AbbVie.

O presente artigo objetiva apresentar reflexões e análises compartilhadas por pesquisadoras e profissionais com história de atuação no campo da primeira infância e na formação de professores. O mesmo dá destaque para a concepção de criança como sujeito de direitos e o paradigma da proteção integral que lhe dá sustentação, mas conhecido como Estatuto da Criança e do Adolescente (ECA) e os seu complemento, voltado para crianças pequenas, a saber o Marco Legal da Primeira Infância. Destaca também a Base Nacional Comum Curricular (BNCC) no que tange a Educação Infantil. Apesar de leis e declarações de significado, no entanto, o artigo sistematizou resultado que chama atenção para a violação dos direitos da criança, dando especial atenção à uma dessas violações tão presente no cotidiano brasileiro: o trabalho infantil. O texto finaliza com debate sobre o papel das instituições infantis (escola) no diagnóstico, prevenção e denúncia de abusos que levam a violação dos direitos infantis. A metodologia se baseou em pesquisa de natureza qualitativa, desenvolvidas pelas autoras em seus estudos acadêmicos, bem como na prática profissional no campo da Educação desde a Primeira infância e formação de professores. A fundamentação teórica se sustentou em ARIÈS(1981), FONSECA(1993), FUGYMOTO(2016), PEEN(2002), QUEIROZ(2002), SANTOS(2017;2006), ROMANOWSKY(2015) e documentos oficiais atuais (ECA, BNCC, Marco Legal da Primeira Infância).

One of the applications of Fisher's linear discriminant function (FDF) is its use in transforming multivariate data into a new univariate variable. This then makes possible a new option for the variance analysis of multivariate data, in addition to the multivariate analysis of variance (MANOVA). The aim of this work was to select groups of seven characteristics of quality in coffee seedlings using six criteria for selection, to use the FDF to transform such groupings of characteristics into a new variable, and then to compare interpretation of the results obtained from the univariate and multivariate analyses of variance of the characteristics and this new variable, with a view to its use in evaluating coffee seedlings. A randomised block design was used to assess the effect of organic fertiliser on the formation of seedlings in coffee cv. Catuaí Vermelho IAC-44, evaluating the following characteristics: seedling height, diameter, root length, dry weight of shoots and roots, leaf area, number of leaves and total dry weight. According to the selection criteria used, different subsets of the selected characteristics are possible. The use of the FDF is shown to be viable in discriminating between treatments. Univariate analysis of the new variable obtained with the FDF and multivariate analysis (MANOVA) was able to detect differences between the treatments, however, it is simpler to apply FDF methodology.

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The research objective was to present a speech-language therapy intervention for voice readjustment of a male transgender after the use of hormones. We will initially approach the issue from the social and biological perspectives, besides presenting the process of hormonal intervention. Subsequently, we will explain the role of Speech-Language Therapy in the vocal readjustment process, demonstrating the phases of care performed in the vocal readjustment project of the Veiga de Almeida University transgender public. Acoustic analysis of the voices of two transgender men before and after speech-language therapy will be presented. For this, speech samples of sentences were used.

Background The pangenotypic direct-acting antivirals (DAAs) glecaprevir (developed by AbbVie and Enanta)/pibrentasvir (G/P) are approved to treat chronic HCV genotype (GT)1–6 infection. In Phase 2 and 3 studies, G/P achieved high SVR12 rates with no virologic failures in 80 patients with GT5 or 6 infection. To increase the body of data for these genotypes, ENDURANCE-5,6 evaluates patients from countries where GT5 and GT6 are endemic, such as South Africa (GT5), Myanmar and Vietnam (GT6). This study evaluates the efficacy and safety of G/P in patients with chronic HCV GT5 or GT6 infection. Methods ENDURANCE-5,6 is an ongoing phase 3b, non-randomised, open-label, multicenter study conducted in adults with chronic HCV GT 5 or 6 infections with or without compensated cirrhosis who are HCV treatment-naive or experienced with interferon (IFN) or pegIFN with or without ribavirin (RBV) or sofosbuvir and RBV with or without pegIFN. G/P (300 mg/120 mg) was orally dosed once-daily for 8 or 12 weeks in patients without or with compensated cirrhosis, respectively. The primary efficacy endpoint was SVR12. Secondary endpoints were on-treatment virologic failure or relapse. Adverse events and clinical laboratory abnormalities were monitored in all patients. Results Seventy patients have enrolled to date, 61 and 9 in the 8- and 12 week treatment arms, respectively; 66 have completed treatment. Baseline demographics are shown in table 1. The SVR4 among patients with available data is 61/62 (98%). One HCV GT6c-l-infected patient with compensated cirrhosis experienced virologic breakthrough at treatment week 12, and one HCV GT5a-infected patient without compensated cirrhosis who achieved SVR4 relapsed at post-treatment week 12. To date, three patients (4%) have experienced treatment-emergent serious adverse events, none of which were related to G/P or led to discontinuation; no Grade 3 alanine aminotransferase elevations have occurred. Conclusions In this ongoing dedicated study, HCV genotype 5- and 6-infected patients without and with compensated cirrhosis treated with G/P for 8 and 12 weeks, respectively, achieved high rates of SVR4. Complete SVR4 and available SVR12 data will be presented.