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Introduction: Sars-Cov-2 is a highly transmissible virus, with a large number of sick and occasionally infected individuals, which represents a risk of overload for the provision of care to symptomatic and more severe cases, which may have repercussions. in the strangulation of the health system and significantly increase the lethality of the disease.
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Introduction: The International Organization for the Study of Inflammatory Bowel Disease (IBD) has recommended vaccination of all patients with IBD as soon as they are able to receive the vaccine, regardless of immune-modifying therapies or disease activity. Nevertheless, some articles have shown a large percentage of individuals who are unwilling to receive the COVID-19 vaccine with fear of potential adverse events. Moreover, IBD patients were excluded from safety and efficacy phase III vaccine trials, as well as those treated with immunosuppressive therapies. Thus, we performed a monocentric real-life survey to assess the adverse events of COVID-19 vaccination among patients with IBD under biologic therapy. Methods: All adult individuals with IBD undergoing biological treatment and followed at Centro Hospitalar Universitário de São João were included. Each patient answered a telephone questionnaire conducted by a gastroenterologist. Results: A total of 301 patients agreed to participate in the study, the majority females (53.2%), with a median age of 42 years old (IQR 32-54). IBD diagnosis included Crohn's disease (76.7%) and ulcerative colitis (23.3%). The proportions of patients receiving tumor necrosis factor inhibitors, ustekinumab and vedolizumab were 75.4%, 13.0% and 11.6%, respectively. This cohort included 239 vaccinated patients (59.0% Pfizer-BioNTech, 20.5% Moderna, 14.2% Janssen and 6.3% AstraZeneca), 173 (57.5%) of whom had complete vaccination. Of the remaining individuals, only 12 did not intend to be vaccinated. The main reasons were: fear of potential adverse events (50.0%), lack of confidence in the vaccine development process (25.0%) and little information about vaccination in IBD patients (16.6%). Among vaccinated patients, the overall adverse events frequency was 56.8% after dose 1 (D1) and 74.1% after dose 2 (D2). The most common symptoms were localized injection-site reactions and fatigue. The vast majority of adverse events were mild and lasted only a few days. Only 4 (1.7%) patients had IBD exacerbation after the vaccine. No serious adverse events were reported and any patient was hospitalized. The percentage of adverse events was higher among patients younger than 50 years (77.6% vs 62.5% after D1, p=0.011;83.0% vs 58.8% after D2, p=0.002). No significant differences were seen based on sex, vaccine type, biologic drug or disease type. Compared to the general population, a lower percentage of IBD patients suffered from local or systemic reactions during the first week after vaccination (Figure 1). Conclusion: We found a high acceptance rate and a good safety profile of SARS-CoV-2 vaccination in IBD patients treated with biologics drugs. Indeed, adverse events were common but overall mild and transitory. These data support the prioritization and rapid vaccination of these individuals. (Figure Presented) Figure 1 – Adverse reactions occurring within seven days after vaccination in IBD patients compared with the general population.
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Introdução: A combinação de doxorrubicina, bleomicina, vinblastina e dacarbazina (ABVD) representa a principal opção de tratamento em primeira linha para o Linfoma Hodgkin classico (LH). Desde 2018, o desabastecimento de bleomicina no Brasil têm trazido consequências graves aos pacientes com LH. No âmbito da medicina privada, instituições têm feito o uso de A+AVD, esquema no qual a bleomicina é substituída por brentuximabe-vedotina, ou importado a bleomicina de forma independente. Para diversas instituições públicas, entretanto, estas opções não são acessíveis. Objetivo: Avaliar a segurança e a eficácia da combinação AEVD (doxorrubicina;etoposídeo, em substituição à bleomicina, na dose de 100 mg/m2;vinblastina e dacarbazina) para tratamento de LH em primeira linha, nos dias 1 e 15 de ciclos de 28 dias. Métodos: Realizamos estudo clínico aberto não-randomizado para avaliar o regime AEVD como tratamento de primeira linha em pacientes com diagnóstico recente de LH no Hospital Municipal São José em Joinville, Brasil. Resultados: Vinte e cinco pacientes com mais de 18 anos e diagnóstico de LHc entre junho e novembro de 2020 foram incluídos. Quatorze pacientes (56%) eram homens, com mediana de idade de 27 anos (variando de 18 a 66 anos). A maioria dos pacientes tinham doença Estágio II (60%, n = 15), tinham sintomas B (56%, n = 14) e lactate-desidrogenase (LDH, 52%, n = 13). Para estágios III-IV (n = 5), 3 pacientes apresentaram IPS alto risco (escore >2;60%). Para doença localizada (n = 20), alto risco conforme GHSG foi observado em 16 pacientes (n = 80%). Todos os pacientes passaram por 3 a 6 ciclos de quimioterapia e não se observou evento adverso com necessidade de internação hospitalar, interrupção ou descontinuação de tratamento. A realização de PET-CT ocorreu exclusivamente fora da nossa instituição. Oito pacientes tiveram acesso a PET-CT no ínterim, todos com escore Deauville de 1-3. A taxa de resposta global foi de 96%, com um paciente apresentando progressão da doença após 5 ciclos. Sete pacientes tiveram avaliação de final de tratamento (FT) apenas com TC, com 5 respostas completas (RC) e 2 respostas parciais (RP), com ambos os pacientes RP mantiveram remissão após 10 e 12 meses. Avaliação ao FT com PET-CT (n = 18) resultou em DS 1-3 em 72% (n = 13), 4 em 22% (n = 4) e 5 em 6% (n = 1). Todos os 5 pacientes DS 4-5 foram submetidos a biópsia após avaliação FT, com confirmação de LH recidivado ou refratário (RR) em 4 casos (mulher de 22 anos, estágio IV, alto risco com doença progressiva;homem de 65 anos, estágio III, baixo risco, com recidiva 11 meses após FT;homem de 26 anos, estágio II, alto risco com recidiva 6 meses após FT;mulher de 25 anos, estágio II, alto risco com recidiva 4 meses após FT). Dois pacientes LH RR (50%) tiveram atraso de mais de 30 dias no tratamento devido a fatores psicossociais ou financeiros secundários à pandemia Covid-19. Todos os pacientes LH RR tiveram acesso a terapia de resgate. Com mediana de seguimento de 16 meses (variando de 8 a 36 meses), nenhuma morte foi registrada e a probabilidade de sobrevida livre de progressão foi de 66% (IC95%: 72%-100%). Conclusões: A escassez de quimioterápicos tem sido um problema recorrente em todo o mundo, e é mais evidente em medicações citotóxicas sem substituições validadas, como é o caso da bleomicina. O uso do esquema AEVD para tratamento de LH recém-diagnosticado parece ser seguro, eficaz e factível, em uma população composta principalmente por pacientes de alto risco.
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Plain language summary Achievement of elimination of HCV as a major public health threat requires focus on vulnerable populations such as people in prison. The prison population is at high risk of HCV infection but their treatment is complicated by social issues such as mental health disorders and drug use. Simple and effective treatment regimens are required to increase access to treatment and improve cure rates. This real-world analysis across Europe and Canada analyzed data from 20 prison populations. HCV-infected individuals were treated with sofosbuvir/velpatasvir, a once daily treatment which requires minimal monitoring. This regimen achieved high cure rates in the prison population despite the existence of complicating social issues. Background: People in prison are at high risk of hepatitis C virus (HCV) infection and often have a history of injection drug use and mental health disorders. Simple test-and-treat regimens which require minimal monitoring are critical. Methods: This integrated real-world analysis evaluated the effectiveness of once daily sofosbuvir/velpatasvir (SOF/VEL) in 20 prison cohorts across Europe and Canada. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with a valid SVR status. Secondary outcomes were reasons for not achieving SVR, adherence and time between HCV RNA diagnosis and SOF/VEL treatment. Results: Overall, 526 people in prison were included with 98.9% SVR achieved in the EP (n = 442). Cure rates were not compromised by drug use or existence of mental health disorders. Conclusion: SOF/VEL for 12 weeks is highly successful in prison settings and enables the implementation of a simple treatment algorithm in line with guideline recommendations and test-and-treat strategies.
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[Formula presented] Introduction: Combination of doxorubicin, bleomycin, vinblastine and dacarbazine (ABVD) is the standard of care in frontline therapy for classic Hodgkin lymphoma (cHL). Since 2018, bleomycin shortages have been reported in Brazil, with severe consequences for cHL patients. In the private setting, many institutions chose to use A+AVD, in which bleomycin is replaced by brentuximab-vedotin, or to import bleomycin from vendors not registered at the national drug agency. For public institutions, however, these costly strategies are largely unattainable. Methods: We conducted a single-arm open-label study to evaluate the substitution of bleomycin with etoposide 100 mg/m2 on days 1 and 15 of every 28-day cycle (AEVD) in previously untreated cHL, at Hospital Municipal São José, in Joinville, Brazil. Here we present preliminary data on the safety and efficacy of this combination in a scenario of lack of approved treatment options for this patient population. Results: Twenty-five patients aged 18 or more with cHL diagnosed between June 2018 and November 2020 were included. Fourteen patients (56%) were male, with median age of 27 years (range: 18-66). Most patients were stage II (60%, n=15), presented with B symptoms (56%, n=14) and high lactate dehydrogenase (LDH, n=13, 52%). For stage III-IV (n=5), high-risk IPS was present in 3 patients (score >2;60%). For localized disease (n=20), unfavorable features according to the GHSG were seen in 16 patients (n=80%). All patients received between 3 and 6 chemotherapy cycles, with no recorded adverse event requiring hospitalization, treatment interruption or discontinuation. PET-CT was performed solely outside of our institution. Eight patients had access to interim PET-CT, all with Deauville scores (DS) 1-3. Overall response rate was 96%, with one disease progression after 5 cycles. Seven patients had CT scan-alone end-of-treatment (EOT) assessment, with 5 complete responses (CR) and 2 partial responses (PR), with both PR patients sustaining remissions after 10 and 12 months. EOT assessment with PET-CT (n=18) resulted in DS 1-3 in 72% (n=13), 4 in 22% (n=4) and 5 in one (6%). All 5 patients with DS 4-5 underwent biopsy after EOT assessment, with confirmation of relapsed or refractory (RR) cHL in 4 cases (22 year-old, stage IV high-risk female with progressive disease;65 year-old, stage III low-risk male with relapse 11 months after EOT;26 year-old, stage II high-risk male with relapse 6 months after EOT;25 year-old, stage II high-risk female with relapse 4 months after EOT). Two RR cHL patients (50%) had treatment delays exceeding 30 days due to psychosocial or financial impacts emerging from the COVID-19 pandemic. All RR cHL patients had access to salvage treatments. At a median follow-up of 16 months (range: 8-36), no death was recorded and 12-month progression-free survival probability was 86% (95%CI: 72%-100%). Conclusions: Drug shortages impacting chemotherapy treatments have been a recurring problem worldwide, most noticeably among cytotoxic agents without in-class validated substitutions, as is the case with bleomycin. AEVD, as a novel approach to newly diagnosed cHL, appears to be safe, feasible and highly active in a population composed mostly of high-risk patients. [Formula presented] Disclosures: Boettcher: Novartis: Speakers Bureau.
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Introduction: In December 2019, the first group of patients with symptoms of atypical pneumonia was discovered in Wuhan, China. On January 7, 2020, the etiologic agent was identified;it was a new betacoronavirus, genetically similar to SARS-CoV-1, consisting of a simple RNA strand, an enveloped virus of 50-200nm in diameter, which was called SARS-CoV-2. Soon after, the disease was named COVID-19. On January 30, WHO declared a Public Health Emergency of International Importance due to the spread of the coronavirus. Tests for serological detection of IgM and IgG antibodies are those that provide an estimate of the immune response to SARS-CoV-2, highlighting the Rapid Diagnostic Tests (RDT), simple and accessible with a result within 5-30 minutes, based on sensitization of antigens/antibodies conjugated to colloidal gold capturing specific proteins present in the infected serum, plasma or blood. Objective: This work aims to show the analysis carried out with RDT for COVID-19 diagnosis in compliance with the current legislation from 02.04 to 18.08.2020. Method: In March of 2020, 25 serum/plasma samples were donated, without any identification. These samples were the remaining samples of tests performed on individuals with a confirmed diagnosis of SARS-CoV-2 infection by the RT-PCR technique from health services (National Institute of Infectious Diseases Evandro Chagas - INI and State Institute of the Brain Paulo Niemeyer - IEC) located in the metropolitan region of the state of Rio de Janeiro. The samples obtained in order to become a serological panel were stored at -20 degrees C until the moment of use. Simultaneously, a panel of samples with confirmed reactivity for IgM and IgG antibodies from COVID-19 was being made, throughout the pandemic and the samples used were evaluated against three Rapid Tests, of different antigenic compositions or different brands;two ELISA tests for IgM and IgG;two chemiluminescence tests and when applicable, a molecular test. In order to assess the specificity of the products sent, surplus donation plasma samples were selected, known to be negative for HIV, HTLV, hepatitis b and c, chagas and syphilis, collected between 2013 and 2014, in the southern regions of the country, period in which SARS-CoV-2 was nonexistent in the world. In addition to True Positive (VP) and True Negative (VN) samples, interfering serum or plasma samples with reactivity for HIV, HCV, HTLV, HBsAg, chagas disease, syphilis and dengue were also included in the evaluation. Results: Out of 178 TR lots, 74.1%, 132 lots were from China and 25.9%, 46 TR lots were from Brazil;Germany;South Korea;Canada;USA;Singapore;Ireland and Switzerland. The analytical result showed that 57.0%, 101 TR lots obtained a Satisfactory result and 43%, 77 lots had Unsatisfactory results, when compared to the Sensitivity and Specificity values declared by the manufacturer, in the Instructions for Use. Conclusions: The results obtained show the need for constant monitoring of TRs for COVID-19 with the primary purpose of guaranteeing the quality of products sold in the country, one of the National Health Surveillance System pillars of action.
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The pandemic of coronavirus Sars-CoV-2 that causes Covid-19 disease has infected a high number of people and caused deaths in Brazil. Thus, this study seeks to identify and understand the impact of this sanitary crisis on small-scale farmers who comprise one of the vulnerable groups of the Brazilian society. We applied questionnaires and gathered reports of participants from different regions and the results indicate that farmers have suffered from the negative impacts of pandemic on multiple dimensions regarding production, commercialization, income, human health, and forms of communication. However, they have been able to overcome some of the challenges brought by the pandemic due to a set of factors, mainly collective actions and solidarity network, individual creative solutions, and public policies. © 2021 Museu Paraense Emilio Goeldi. All rights reserved.
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Background: Stigma and poor linkage to care, amplified in the setting of the COVID-19 pandemic, are significant barriers for treating hepatitis C (HCV) in vulnerable patients, reducing our ability to implement a rapid test and treat (TnT) strategy with minimal monitoring within a simple patient cascade, as currently available HCV therapies would allow us to do This real-world analysis evaluates our ability to implement this approach in both general (GP) and vulnerable (VP) populations Methods: HCV-infected patients from 32 clinical cohorts in 8 countries treated with sofosbuvir/ velpatasvir without a history of decompensation or prior NS5A-inhibitor exposure were included in this analysis The VP included prisoners, homeless patients and patients with mental disorders Time to treatment (TT) between the most recent HCV RNA measurement and treatment initiation was estimated based on available data Results: A total of 2449 patients were included, 937 in GP (58% males), 1512 (72% males) in VP (59% with mental disorders, 31% homeless, 10% imprisoned) Mean age [standard deviation] was 55 [14] and 50 [14] years in GP and VP respectively Genotype 3 was observed in 35% and 33% respectively, compensated cirrhosis confirmed in 20% and 18% of GP versus VP. The median TT [MTT, interquartile range] was 55 days [23- 107] in GP and 60 days [27-132] in VP The longest MTT of 66 days [32-134] was observed in patients with mental disorders MTT was 63 days [29-149] in prisoners and 27 days [13-71] among the homeless Only 13% of GP and 8% of VP were treated the same day of diagnosis, and 70% of GP and 63% of VP were treated within 3 months In patients with mental disorders only 4% were treated the same day of diagnosis Cure rates were high and consistent with previously reported cure rates Conclusion: MTT varies across HCV patient groups, from over 6 months to 1 day This analysis shows that a quick treatment start is possible, both in general population and in vulnerable populations, supporting the feasibility of a TnT approach in all populations New strategies should be considered to engage patients with mental disorders in this model of care more effectively.