Once-daily dolutegravir is superior to once-daily darunavir/ritonavir in treatment-naïve HIV-1-positive individuals: 96 week results from FLAMINGO.

INTRODUCTION: Dolutegravir (DTG) 50 mg once daily was superior to darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily through Week 48, with 90% vs. 83% of participants achieving HIV RNA 50 c/mL (p=0.025) [1]. We present data through Week 96. MATERIAL AND METHODS: FLAMINGO is a multicentre, randomized, open-label, Phase IIIb non-inferiority study, in which HIV-1-positive ART-naïve adults with HIV-1 RNA≥1000 c/mL and no evidence of viral resistance were randomized 1:1 to receive DTG or DRV/r, with investigator-selected backbone NRTIs (TDF/FTC or ABC/3TC). Participants were stratified by screening HIV-1 RNA (≤100K c/mL) and NRTI backbone. RESULTS: A total of 484 adults were randomized and treated; 25% had baseline HIV RNA 100K c/mL. At Week 96, the proportion of participants with HIV RNA 50 c/mL was 80% in the DTG arm vs. 68% in the DRV/r arm (adjusted difference 12.4%; 95% CI 4.7, 20.2%; p=0.002). Secondary analyses supported primary results: per-protocol [(DTG 83% vs. DRV/r 70%), 95% CI 12.9 (5.3, 20.6)] and treatment-related discontinuation = failure [(98% vs. 95%), 95% CI 3.2 (-0.3, 6.7)]. Overall virologic non-response (DTG 8%; DRV/r 12%) and non-response due to other reasons (DTG 12%; DRV/r 21%) occurred less frequently on DTG. As at Week 48, the difference between arms was most pronounced in participants with high baseline viral load (82% vs. 52% response through Week 96) and in the TDF/FTC stratum (79% vs. 64%); consistent responses were seen in the ABC/3TC stratum (82% vs. 75%). Six participants (DTG 2, none post-Week 48; DRV/r 4, two post-Week 48) experienced protocol-defined virologic failure (PDVF; confirmed viral load 200 c/mL on or after Week 24); none had treatment-emergent resistance to study drugs. Most frequent drug-related adverse events (AEs) were diarrhoea, nausea and headache, with diarrhoea significantly more common on DRV/r (24%) than DTG (10%). Significantly more participants had Grade 2 fasting LDL toxicities on DRV/r (22%) vs. DTG (7%), p<0.001; mean changes in creatinine for DTG (~0.18 mg/dL) observed at Week 2 were stable through Week 96. CONCLUSIONS: Once-daily DTG was superior to once-daily DRV/r in treatment-naïve HIV-1-positive individuals, with no evidence of emergent resistance to DTG in virologic failure and relatively similar safety profiles for DTG and DRV/r through 96 Weeks.

Importância da Avaliação das Instituições e Cursos do Ensino Superior em Cabo Verde

Em Cabo Verde, a expansão do ensino superior, mormente a partir do início da primeira década do século XXI não foi acompanhada da institucionalização de um sistema de regulação e avaliação do seu desempenho, em ordem a aferir-se a observância das normas adoptadas pelo Poder Público e a salvaguardar-se a qualidade do bem público por excelência que é a educação superior, da qual depende, em larga medida, a performance dos demais níveis educativos. Desta sorte, no contexto actual do ensino superior cabo-verdiano, torna-se imperiosa a institucionalização de um sistema credível de avaliação da qualidade de desempenho das instituições do ensino superior, conjugando as componentes de avaliação externa e interna e tendo por premissas essenciais: o imperativo de o ensino superior pátrio evoluir na senda das melhores referências internacionais de qualidade académica; a necessidade da devida consideração, nos processos avaliativos, do contexto e das especificidades nacionais em que as mesmas actuam para o cumprimento das respectivas missões.

The functions of sleep.

Here we report on The Satellite Symposium on Sleep Function that was held in Lausanne during 6(th) FENS forum and brought together neuroscientists from basic and clinical sleep research. We illustrate the principal questions that arose during this interdisciplinary gathering and introduce the contents of nine review articles on aspects of sleep that are contained in this Special Issue of the European Journal of Neuroscience.

Implementação do sistema de custeio baseado em actividades (CBA) numa Instituição de Ensino Superior em Cabo Verde

Actualmente, a gestão de gastos assume um papel fundamental nas empresas modernas. A globalização, aliada às novas tecnologias, exige que essas empresas sejam ágeis e competentes. Neste contexto, a gestão eficiente dos recursos e a obtenção de informações precisas que apoiem na tomada de decisão, dependerão em grande parte, de um sistema de custo. A utilização de diversas tecnologias e ferramentas faz com que as empresas tenham cada vez mais gastos indiretos relativamente aos gastos diretos. Logo, o método CBA surgiu como alternativa aos sistemas de custeio tradicionais numa tentativa de solucionar ou, pelo menos, minimizar o problema de atribuição dos gastos indiretos. O presente trabalho pretende abordar o método CBA e propor uma metodologia de implementação do sistema numa Instituição de Ensino Superior, evidenciando e discutindo as principais vantagens e desvantagens associadas a esta metodologia e identificando as suas contribuições para a gestão das IES. De acordo com as pesquisas feitas, conclui-se que nenhuma das IES em São Vicente possui um sistema de contabilidade de gestão, mas verificou-se que todas têm conhecimento deste sistema e consideram-no o melhor método de gestão para análise dos gastos. Os resultados obtidos no estudo de caso demonstram que o objetivo foi atingido, apurandose que o método CBA é o mais adequado para o suporte à gestão, tendo em conta que ultrapassa as insuficiências de informação sobre os gastos. Currently, cost management plays a key role in modern business. The globalization, allied to the new technologies, demands that those companies are agile and qualified. In this context, an efficient management of the resources and the gathering of precise information which support the decision-making process will depend, largely, of an effective cost management system. The use of different technologies and tools makes companies have more indirect costs than direct. Therefore, the ABC method was devised as an alternative to the conventional means of costing in an attempt of solving or, at least, minimizing the problem of the attribution of indirect costs. Our work intends to analyze the ABC method and to propose a methodology of implementation of such system in an Institution of Higher Education, showing and discussing the main advantages and disadvantages associated with this methodology and identifying its contributions for the administration of these Institutions. Our research has shown that, none of the IHEs in São Vicente has a management accounting system, although all have knowledge of it and consider it as being the best administration method for the analysis of expenses. The results obtained in the case study demonstrate that the objective was reached: to conclude the ABC method is the most adequate to support the administration, as it overcomes the problem of lack of information on the running costs.

Clinical characteristics and outcome of isolated extracerebral relapses of primary central nervous system lymphoma: a case series.

There is very limited data on isolated systemic relapses of primary central nervous system lymphomas (PCNSL). We retrospectively reviewed the clinical characteristics and outcome of 10 patients with isolated systemic disease among 209 patients with PCNSL mainly treated with methotrexate-based chemotherapy (CT) with or without radiation therapy (RT). Isolated systemic relapse remained rare (4.8%, 10/209 patients). Median time from initial diagnosis to relapse was 33 months (range, 3-94). Sites of relapse were mostly extranodal. Three patients presented with early extra-cerebral (EC) relapse 3, 5 and 8 months from the beginning of initial treatment, respectively, and 7 patients had later relapses (range, 17-94 months). Treatment at relapse included surgery alone, RT alone, CT with or without radiotherapy, or CT with autologous stem cell transplantation (ASCT). Median overall survival (OS) after relapse was 15.5 months (range, 5.8-24.5) compared to 4.6 months (range, 3.6-6.5) for patients with central nervous system (CNS) relapse (p = 0.35). In conclusion, isolated systemic relapses exist but are infrequent. Early EC relapse suggests the presence of systemic disease undetectable by conventional evaluation at initial diagnosis. Patient follow-up must be prolonged because systemic relapse can occur as late as 10 years after initial diagnosis. Whether EC relapses of PCNSL have a better prognosis than CNS relapses needs to be assessed in a larger cohort. Copyright © 2010 John Wiley & Sons, Ltd.