Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin

Background & Aims: Some individuals with hepatitis C virus infection treated with direct-acting antivirals require ribavirin to maximize sustained virological response rates. We describe the clinical management of ribavirin dosing in hepatitis C virus-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Methods: We performed a post hoc analysis of patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 or 24 weeks in six phase 3 trials. Multivariate stepwise logistic regression models assessed predictors associated with ribavirin dose adjustments and with developing anaemia. Results: Of 1548 patients, 100 (6.5%) modified ribavirin dose due to haemoglobin declines, of which 99% achieved sustained virological response at 12 weeks post-treatment. Median time to first ribavirin dose reduction was 37 days. Low baseline haemoglobin was significantly associated with an increased risk of requiring ribavirin dose modification (odds ratio: 0.618 [0.518, 0.738]; P < .001) and developing anaemia (odds ratio: 0.379 [0.243, 0.593]; P < .001). Conclusions: Ribavirin dose reductions were infrequent, occurred early in treatment, and did not impact sustained virological response at 12 weeks post-treatment. Patients with low baseline haemoglobin should be monitored for on-treatment anaemia

Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis – A pooled analysis

AbstractBackground & aimsChronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit–risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis.MethodsTwelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment. The number and percentage of patients with treatment-emergent adverse events (TEAEs), serious TEAEs, and TEAEs consistent with hepatic decompensation were reported.ResultsIn 1066 patients with Child-Pugh A cirrhosis, rates of serious TEAEs and TEAEs leading to study drug discontinuation were 5.3% (95% CI: 4.1–6.8) and 2.2% (95% CI: 1.4–3.2), respectively. Thirteen patients (1.2%; 95% CI: 0.7–2.1) had a TEAE that was consistent with hepatic decompensation. The most frequent TEAEs consistent with hepatic decompensation were ascites (n=8), esophageal variceal hemorrhage (n=4), and hepatic encephalopathy (n=2).ConclusionsThis pooled analysis in 1066 HCV-infected patients with Child-Pugh A cirrhosis confirms the safety of OBV/PTV/r ± DSV ± RBV in this population. These results support the use of OBV/PTV/r ± DSV ± RBV in this high-priority population.Lay summaryThis pooled safety analysis in 1066 HCV-infected patients with compensated cirrhosis, receiving treatment with ombitasvir, paritaprevir, and ritonavir with or without dasabuvir, with or without ribavirin, shows that the rate of hepatic decompensation events was comparable to rates from historical reports for untreated patients

Óleo essencial de Eucalyptus staigeriana no controle de podridões fúngicas no período pós-colheita e na análise sensorial de uvas

The objective of this work was evaluate the effect of Eucalyptus staigeriana essential oil on Colletotrichum gloeosporioides and Greeneria uvicola mycelial growth and conidia germination on grapes, as well as its potential for the control of postharvest rot diseases and its effect on the organoleptic properties of grapes. The essential oil (EO) showed in vitro antifungal activity against both pathogens, with fungicidal effect on mycelial growth and on conidia germination at the concentrations of 1.0 and 0.5 μL mL-1, respectively. The EO volatile compounds had a fungistatic effect on the mycelial growth of C. gloeosporioides and a fungicidal effect on G. uvicola. At postharvest, the EO reduced the incidence of ripe rot up to 75% and 86% in the preventive and curative treatments, respectively, and the incidence of bitter rot up to 54% in the curative treatment. Since the EO does not affect significantly grape sensory properties, it does not affect the consumption intention of grapes treated with the EO. The EO of E. staigeriana is efficient in the in vitro control of both pathogens; moreover, it is also efficient in the control of the incidence of postharvest fungal rot diseases, mainly in the curative treatment.O objetivo deste trabalho foi avaliar o efeito do óleo essencial de Eucalyptus staigeriana sobre o crescimento micelial e a germinação de conídios de Colletotrichum gloeosporioides e Greeneria uvicola em uvas, assim como o seu potencial para o controle de podridões no período pós-colheita e o seu efeito nas propriedades organolépticas das uvas. O óleo essencial (OE) apresentou atividade antifúngica in vitro contra ambos os patógenos, com efeito fungicida sobre o crescimento micelial e sobre a germinação de conídios, nas concentrações de 1,0 e 0,5 μL mL-1, respectivamente. Os compostos voláteis do OE exibiram efeito fungistático sobre o crescimento micelial de C. gloeosporioides e efeito fungicida sobre G. uvicola. Na pós-colheita, o OE reduziu a incidência da podridão-madura em até 75 e 86%, nos tratamentos preventivos e curativos, respectivamente, e a incidência da podridão-amarga em até 54% no tratamento curativo. Como o OE não influencia significativamente as propriedades sensoriais das uvas, não afeta a intenção de consumo para uvas tratadas com o OE. O OE de E. staigeriana é eficiente para o controle in vitro de ambos os patógenos; além disso, também é eficiente no controle da incidência de podridões fúngicas no período pós-colheita, principalmente no tratamento curativo

Um estudo sobre instituições legais e sua relação com a economia sob a ótica de abordagens institucionalistas

Existe muita controvérsia a respeito das causas e consequências do desenvolvimento econômico. A escola institucionalista surgida no início do século XX trouxe um conceito rico de instituição e uma teoria mais abrangente com aspectos sociológicos, psicológicos e evolucionistas. A Nova Economia Institucionalista, seguiu a partir deste caminho e deu uma interpretação mais metodológica ao considerar a diminuição da incerteza ocasionada pela instituição como forma de possibilitar maior eficiência para a economia. A presente monografia visa, a partir destas abordagens institucionalistas, analisar alguns aspectos do sistema legal, como o ambiente regulatório, os direitos de propriedade, a morosidade do judiciário e a aderência do direito na sociedade ligando estes, com base em dados empíricos, à possíveis efeitos na economia.There is a lot of controversy regarding economic development and its causes and consequences. The Institutionalist school risen from the beginning of the 20th century came up with a rich concept of institutions and a broad theory with sociologic, psychologic and evolutionary aspects. The New Institutional Economics, picked up from this track and came up with a more methodological perspective by considering the diminish of uncertainty generated by institutions as a path to allow more efficient economies. This work proposes, form this institutionalists perspectives, to analyze some issues of the legal system, as regulatory quality, property rights, efficiency of decision-making process and the rule of law in societies linking these issues to possible effects in economy, based with empirical data

Pharmacoeconomics applied to chronic hepatitis C

Life expectancy has increased over the last century as it had never been before. This is the result of a combination of many favorable variables such as level of education, improved socio-economic environment and development of medicine. However, new improvements demand heavy investment. Thus, the incorporation of medical technology became a health and economic issue. The pharmacoeconomic knowledge field is being developed to help in the analysis of medical costs and patient needs. The applies to hepatitic C, a common and chronic worldwide disease. In this article, the authors describe the rational behind this type of health economic analysis and review a hepatitis C model. Overall, in a non-Brazilian scenario, it was demonstrated that peginterferon alfa-2a (40KD) is cost effective in the treatment of HCV disease

Estudo da influência dos elementos climáticos em sistemas de baixo custo para monitoramento da qualidade do ar

The atmospheric pollution alerts to the need to promote thedevelopment of air quality monitoring systems. Equipment withlow implementation cost and energy consumption are highlightedfor highly scalable applications. The datasets generated by thesensors feed machine learning algorithms for the weatherconditions analysis in urban centers. However, sensor technologyused in these systems tends to be less accurate than complexequipment, resulting in a strong correlation between the collecteddata and the climatic elements variation. This paper studies theinfluence of temperature and relative humidity in low cost airquality monitoring systems. This knowledge can generate newapproaches to the monitored metrics conditioning and increasethe robustness of the low cost systems