15 research outputs found

    Week 48 resistance analyses of the once-daily, single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

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    Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) >= 400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL = 3 thymidine analog-associated mutations (24% not fully susceptible to tenofovir) detected at screening. All achieved VL <50 copies/mL at week 48 or prior discontinuation. D/C/F/TAF has a high genetic barrier to resistance; no darunavir, primary PI, or tenofovir RAMs were observed through 48 weeks in AMBER and EMERALD. Only one postbaseline M184I/V RAM was observed in HIV-1 of an AMBER participant. In EMERALD, baseline archived RAMs to darunavir, emtricitabine, and tenofovir in participants with prior VF did not preclude virologic response

    Food and water security issues in Russia I : Food security in the general population of the Russian Arctic, Siberia and the Far East

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    Background. Problems related to food security in Russian Arctic (dietary imbalance, predominance ofcarbohydrates, shortage of milk products, vegetables and fruits, deficit of vitamins and microelements,chemical, infectious and parasitic food contamination) have been defined in the literature. But no standardprotocol of food security assessment has been used in the majority of studies. Objectives. Our aim was to obtain food security indicators, identified within an Arctic collaboration,for selected regions of the Russian Arctic, Siberia and the Far East, and to compare food safety in theseterritories. Study design and methods. In 18 regions of the Russian Arctic, Siberia and the Far East, the followingindicators of food security were analyzed: food costs, food consumption, and chemical and biological foodcontamination for the period 2000-2011. Results. Food costs in the regions are high, comprising 2343% of household income. Only 4 out of 10 foodgroups (fish products, cereals, sugar, plant oil) are consumed in sufficient amounts. The consumption of milkproducts, eggs, vegetables, potatoes, fruits (and berries) is severely low in a majority of the selected regions.There are high levels of biological contamination of food in many regions. The biological and chemicalcontamination situation is alarming, especially in Chukotka. Only 7 food pollutants are under regularcontrol; among pesticides, only DDT. Evenki AO and Magadan Oblast have reached peak values in foodcontaminants compared with other regions. Mercury in local fish has not been analyzed in the majority of theregions. In 3 regions, no monitoring of DDToccurs. Aflatoxins have not been analyzed in 5 regions. Nitrateshad the highest percentage in excess of the hygienic threshold in all regions. Excesses of other pollutants indifferent regions were episodic and as a rule not high. Conclusion. Improvement of the food supply and food accessibility in the regions of the Russian Arctic,Siberia and the Far East is of utmost importance. Both quantitative and qualitative control of chemical andbiological contaminants in food is insufficient and demands radical enhancement aimed at improving foodsecurity

    The impact of a Nickel-Copper smelter on concentrations of toxic elements in local wild food from the Norwegian, Finnish, and Russian border regions

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    Toxic elements emitted from the Pechenganickel complex on the Kola Peninsula have caused concern about potential effects on local wild food in the border regions between Norway, Finland and Russia. The aim of this study was to assess Ni, Cu, Co, As, Pb, Cd, and Hg concentrations in local wild foods from these border regions. During 2013–2014, we collected samples of different berry, mushroom, fish, and game species from sites at varying distances from the Ni-Cu smelter in all three border regions. Our results indicate that the Ni-Cu smelter is the main source of Ni, Co, and As in local wild foods, whereas the sources of Pb and Cd are more complex. We observed no consistent trends for Cu, one of the main toxic elements emitted by the Ni-Cu smelter; nor did we find any trend for Hg in wild food. Concentrations of all investigated toxic elements were highest in mushrooms, except for Hg, which was highest in fish. EU maximum levels of Pb, Cd, and Hg were exceeded in some samples, but most had levels considered safe for human consumption. No international thresholds exist for the other elements under study

    The impact of a nickel-copper smelter on concentrations of toxic elements in local wild food from the Norwegian, Finnish, and Russian border regions

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    Abstract Toxic elements emitted from the Pechenganickel complex on the Kola Peninsula have caused concern about potential effects on local wild food in the border regions between Norway, Finland and Russia. The aim of this study was to assess Ni, Cu, Co, As, Pb, Cd, and Hg concentrations in local wild foods from these border regions. During 2013–2014, we collected samples of different berry, mushroom, fish, and game species from sites at varying distances from the Ni-Cu smelter in all three border regions. Our results indicate that the Ni-Cu smelter is the main source of Ni, Co, and As in local wild foods, whereas the sources of Pb and Cd are more complex. We observed no consistent trends for Cu, one of the main toxic elements emitted by the Ni-Cu smelter; nor did we find any trend for Hg in wild food. Concentrations of all investigated toxic elements were highest in mushrooms, except for Hg, which was highest in fish. EU maximum levels of Pb, Cd, and Hg were exceeded in some samples, but most had levels considered safe for human consumption. No international thresholds exist for the other elements under study
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