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[PMID]: 29311445 [Au] Autor: Somura Y; Kimoto K; Oda M; Okutsu Y; Kato R; Suzuki Y; Siki D; Hirai A; Akiba T; Shinkai T; Sadamasu K [Ad] Endereço: Tokyo Metropolitan Institute of Public Health. [Ti] Título: [Serial Food Poisoning Outbreaks Caused by Norovirus-Contaminated Shredded Dried Laver Seaweed Provided at School Lunch, Tokyo, 2017]. [So] Source: Shokuhin Eiseigaku Zasshi;58(6):260-267, 2017. [Is] ISSN: 1882-1006 [Cp] País de publicação: Japan [La] Idioma: jpn [Ab] Resumo: In February 2017, four food poisoning outbreaks occurred in Tokyo, involving ten schools. Shredded dried laver seaweed processed by a single food manufacturer in December 2016 was provided in common for the school meals that caused all four outbreaks. Of 4,209 persons exposed, 1,193 (28.3%) had symptoms of gastroenteritis. Norovirus (NoV) GII was detected in 207 (78.1%) of 265 cases by real-time RT-PCR. Thirty-one shredded dried laver seaweed samples were examined and seven (22.6%) of them were positive for NoV GII. PCR fragments of NoV ORF1/2 junction region (302 bp) from seven shredded dried laver seaweed samples and 20 clinical samples derived from the four outbreaks were sequenced. All of them displayed complete homology, and the genotype was classified as GII.17. A nearly full-length sequence (7,420 bp) of NoV RNA derived from a case was obtained by next-generation sequencer analysis and phylogenetic analysis indicated that this strain belongs to the same cluster as Hu/GII/JP/2015/GII.P17_GII.17/Kawasaki308. Thus, our investigation elucidated that the causative agent of these four serial food poisoning outbreaks was NoV GII.17 and the infectious source was a single batch of shredded dried laver seaweed. The water activity of the shredded dried laver seaweed was found to be 0.119 to 0.129. It was epidemiologically clarified that NoV does not lose infectivity for about two months even in the dry state. We conclude that a large diffuse outbreak of food poisoning caused by NoV GII.17 contamination of shredded dried laver seaweed had occurred in Tokyo. Our elucidation of the causative agent indicated that the food poisoning outbreaks in multiple areas of Japan, including Tokyo, during January to February 2017 were caused by the same contaminated food. [Mh] Termos MeSH primário: Infecções por Caliciviridae/etiologia Infecções por Caliciviridae/virologia Surtos de Doenças/estatística & dados numéricos Análise de Alimentos Contaminação de Alimentos/análise Doenças Transmitidas por Alimentos/etiologia Doenças Transmitidas por Alimentos/virologia Almoço Norovirus/isolamento & purificação Instituições Acadêmicas/estatística & dados numéricos Alga Marinha/virologia [Mh] Termos MeSH secundário: Infecções por Caliciviridae/epidemiologia Cobicistat Combinação de Medicamentos Emtricitabina Doenças Transmitidas por Alimentos/epidemiologia Norovirus/classificação Norovirus/genética Quinolonas RNA Viral/isolamento & purificação Tenofovir/análogos & derivados Fatores de Tempo Tóquio/epidemiologia [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Drug Combinations); 0 (Quinolones); 0 (RNA, Viral); 0 (genovoya); 99YXE507IL (Tenofovir); G70B4ETF4S (Emtricitabine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1801 [Cu] Atualização por classe: 180123 [Lr] Data última revisão: 180123 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 180110 [St] Status: MEDLINE [do] DOI: 10.3358/shokueishi.58.260

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[PMID]: 28632758 [Au] Autor: Squillace N; Ricci E; Quirino T; Gori A; Bandera A; Carenzi L; De Socio GV; Orofino G; Martinelli C; Madeddu G; Rusconi S; Maggi P; Celesia BM; Cordier L; Vichi F; Calza L; Falasca K; Di Biagio A; Pellicanò GF; Bonfanti P; CISAI Study Group [Ad] Endereço: Infectious Diseases Clinic, Azienda Socio Sanitaria Territoriale di MONZA, San Gerardo Hospital-University of Milano-Bicocca, Monza, Italy. [Ti] Título: Safety and tolerability of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil fumarate in a real life setting: Data from surveillance cohort long-term toxicity antiretrovirals/antivirals (SCOLTA) project. [So] Source: PLoS One;12(6):e0179254, 2017. [Is] ISSN: 1932-6203 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: OBJECTIVES: The study aim was to evaluate the impact on Liver and Kidney toxicity of the single tablet regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) on Antiretroviral Therapy (ART) experienced or naïve patients. METHODS: Patients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3-4 Adverse Events in subjects beginning new antiretroviral drug regimens. In this analysis, patients were evaluated at T0 (baseline), T1 (six months) and at T2 (twelve months). RESULTS: A total of 329 patients were enrolled, and 280 (85.1%) of these had at least one follow-up visit. Median observation time was 11 months (IQR 7.0-15.5). Two hundred and two patients (72.1%) were ART experienced and 78 (27.9%) ART naive. Prevalence of HCV-co-infection was 21.4%. At T1, we observed a significant decline in estimated glomerular filtration rate (eGFR), both in experienced and naive patients (mean change from T0-7.5 ± 12.8 ml/min, -15.5 ± 17.8 ml/min, respectively, p = 0.0005), which was confirmed at T2 (mean change from T0-8.2 ± 15.8 ml/min, -17.6 ± 19.4 ml/min, respectively, p = 0.001). Regarding aspartate aminotransferase (AST) and alanine transaminase (ALT) grade 1-2 modifications, no significant differences were observed between experienced and naïve subjects, but an increased prevalence of abnormal liver function test was observed in patients with chronic HCV infection (p<0.001). CONCLUSIONS: A significant decline in eGFR was observed in patients initiating EVG/COBI/FTC/TDF in the first 6 months, with no significant worsening occurring at 12 months vs. 6 months of therapy. Patients with chronic HCV infection were at higher risk to develop abnormal liver tests. [Mh] Termos MeSH primário: Fármacos Anti-HIV/uso terapêutico Cobicistat/uso terapêutico Emtricitabina/uso terapêutico Infecções por HIV/tratamento farmacológico HIV-1/efeitos dos fármacos Quinolonas/uso terapêutico Tenofovir/uso terapêutico [Mh] Termos MeSH secundário: Adulto Combinação de Medicamentos Feminino Infecções por HIV/virologia Seres Humanos Masculino Dose Máxima Tolerável Meia-Idade Segurança [Pt] Tipo de publicação: JOURNAL ARTICLE; MULTICENTER STUDY; OBSERVATIONAL STUDY [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (Drug Combinations); 0 (JTK 303); 0 (Quinolones); 99YXE507IL (Tenofovir); G70B4ETF4S (Emtricitabine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 170928 [Lr] Data última revisão: 170928 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170621 [St] Status: MEDLINE [do] DOI: 10.1371/journal.pone.0179254

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[PMID]: 28282300 [Au] Autor: Arribas JR; Thompson M; Sax PE; Haas B; McDonald C; Wohl DA; DeJesus E; Clarke AE; Guo S; Wang H; Callebaut C; Plummer A; Cheng A; Das M; McCallister S [Ad] Endereço: *Infectious Diseases Unit, Internal Medicine Service, Hospital Universitario La Paz, Madrid, ES; †AIDS Research Consortium of Atlanta, Atlanta, GA; ‡Division of Infectious Diseases, Brigham and Women's Hospital, Boston, MA; §Internal Medicine, General Hospital Graz-West, Graz, AT; ‖Tarrant County Infectious Disease Associates, Fort Worth, TX; ¶Division of Infectious Diseases, UNC School of Medicine, Chapel Hill, NC; #Orlando Immunology Center, Orlando, FL; **Claude Nicol Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, United Kingdom; and ††Departments of Biometrics, Virology, Clinical Operations, and HIV Clinical Research, Gilead Sciences, Inc., Foster City, CA. [Ti] Título: Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. [So] Source: J Acquir Immune Defic Syndr;75(2):211-218, 2017 Jun 01. [Is] ISSN: 1944-7884 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: In 2 double-blind phase 3 trials, 1733 antiretroviral-naive adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95% confidence interval: 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P < 0.001), with no cases of proximal tubulopathy for TAF vs 4 for TDF. There were greater increases in lipids with TAF vs TDF, with no difference in the total cholesterol to high-density lipoprotein ratio. For initial HIV therapy, E/C/F/TAF is superior to E/C/F/TDF in efficacy and bone and renal safety. [Mh] Termos MeSH primário: Adenina/análogos & derivados Fármacos Anti-HIV/uso terapêutico Cobicistat/uso terapêutico Emtricitabina/uso terapêutico Infecções por HIV/tratamento farmacológico Quinolonas/uso terapêutico Tenofovir/uso terapêutico [Mh] Termos MeSH secundário: Adenina/uso terapêutico Densidade Óssea/efeitos dos fármacos Contagem de Linfócito CD4 Método Duplo-Cego Infecções por HIV/imunologia Seres Humanos Meia-Idade Resultado do Tratamento Estados Unidos [Pt] Tipo de publicação: COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (GS-7340); 0 (JTK 303); 0 (Quinolones); 99YXE507IL (Tenofovir); G70B4ETF4S (Emtricitabine); JAC85A2161 (Adenine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170623 [Lr] Data última revisão: 170623 [Sb] Subgrupo de revista: IM; X [Da] Data de entrada para processamento: 170311 [St] Status: MEDLINE [do] DOI: 10.1097/QAI.0000000000001350

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[PMID]: 28219799 [Au] Autor: Simiele M; Ariaudo A; De Nicolò A; Favata F; Ferrante M; Carcieri C; Bonora S; Di Perri G; De Avolio A [Ad] Endereço: University of Turin, Department of Medical Sciences,(2) Laboratory of Clinical Pharmacology and Pharmacogenetics,(3) Amedeo di Savoia Hospital, CorsoSvizzera 164, 10149, Turin, Italy; "CoQuaLab", Academic Apin-off of University of Turin, Italy. [Ti] Título: UPLC-MS/MS method for the simultaneous quantification of three new antiretroviral drugs, dolutegravir, elvitegravir and rilpivirine, and other thirteen antiretroviral agents plus cobicistat and ritonavir boosters in human plasma. [So] Source: J Pharm Biomed Anal;138:223-230, 2017 May 10. [Is] ISSN: 1873-264X [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Rilpivirine (RPV), dolutegravir (DTG) and elvitegravir (EVG) are the latest antiretroviral drugs approved for treatment of HIV infection. Currently, poor information is currently available concerning their pharmacokinetic and pharmacodynamic properties, thus making the use of therapeutic drug monitoring for these drugs not useful. This lack of information is partially due to the absence of an high-throughput method for their simultaneous quantification together with other antiretroviral drugs. In this work, we describe the development and validation of a new UPLC-MS/MS method to quantify these drugs, together with other fourteen antiretroviral agents, in human plasma. One hundred microliters of plasma samples were added with internal standard (6,7-Dimethyl- 2,3-di(2-pyridyl) quinoxaline), underwent a simple protein precipitation with methanol:acetonitrile (50:50v/v) followed by sample dilution with water. Chromatographic separation was performed on a Acquity UPLC HSS T3 column (150mm x 2.1mm I.D) with a particle size of 1.8µm and compounds were detected with a tandem mass detector, monitoring two ion transitions for each drugs. The mean recovery of RPV, DTG and EVG were 101%, 87% and 112.3% respectively. Accuracy and precision inter/intra-day were below 15% for all drugs, in accordance to Food and Drug Administration guidelines requirements. The UPLC-MS/MS method reported here could be used routinely to monitor plasma concentrations of antiviral drugs, including RPV, DTG and EVG. [Mh] Termos MeSH primário: Antirretrovirais/sangue Antirretrovirais/química Cromatografia Líquida de Alta Pressão/métodos Espectrometria de Massas em Tandem/métodos [Mh] Termos MeSH secundário: Fármacos Anti-HIV/sangue Fármacos Anti-HIV/química Cobicistat/sangue Cobicistat/química Compostos Heterocíclicos com 3 Anéis/sangue Compostos Heterocíclicos com 3 Anéis/química Seres Humanos Limite de Detecção Quinolonas/sangue Quinolonas/química Reprodutibilidade dos Testes Rilpivirina/sangue Rilpivirina/química Ritonavir/sangue Ritonavir/química [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (Anti-Retroviral Agents); 0 (Heterocyclic Compounds, 3-Ring); 0 (JTK 303); 0 (Quinolones); DKO1W9H7M1 (dolutegravir); FI96A8X663 (Rilpivirine); LW2E03M5PG (Cobicistat); O3J8G9O825 (Ritonavir) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170628 [Lr] Data última revisão: 170628 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170222 [St] Status: MEDLINE

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[PMID]: 28186251 [Au] Autor: Perrier M; Charpentier C; Peytavin G; Lê M; Blondel L; Visseaux B; Joly V; Pinto A; Matheron S; Yazdanpanah Y; Descamps D; Landman R [Ad] Endereço: IAME, UMR 1137, Univ. Paris Diderot, Sorbonne Paris Cité, Paris F-75018, France. [Ti] Título: Switch as maintenance to elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate: week 48 results in a clinical cohort. [So] Source: J Antimicrob Chemother;72(6):1745-1751, 2017 Jun 01. [Is] ISSN: 1460-2091 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Objectives: To assess, in a clinical cohort, the efficacy of switching current ART in virologically suppressed patients to elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate as a single-tablet regimen (STR) using the PCR signal of the plasma viral load (pVL) assay and determination of plasma drug concentration ( C 24 ). Patients and methods: This was an observational single-centre study enrolling antiretroviral-treated patients with pVL <50 copies/mL initiating elvitegravir-based STR. PCRneg was defined as an undetected PCR signal. Results: One hundred and fifty-one patients were enrolled. At STR baseline, the median time since first ART and time of virological suppression were 5 years (IQR 3-9) and 24 months (IQR 9-44), respectively. By week (W) 48, 26 (17%) of the patients had discontinued STR due to adverse events. The proportion of patients maintaining pVL <50 copies/mL on treatment was 98%, 96%, 93% and 97% at W12, W24, W36 and W48, respectively. Five patients (3.3%) experienced a virological failure and emergence of resistance was observed in two of them with the selection of M184V and N155H mutations. At baseline, W12, W24, W36 and W48, 70%, 57%, 72%, 61% and 74% of the patients with pVL <20 copies/mL had a PCRneg, respectively. The median elvitegravir plasma C 24 value was 648 ng/mL (IQR 348-989; n = 237), with 84% of elvitegravir C 24 values >45 ng/mL, the protein-adjusted IC 95 . Conclusions: In this clinical cohort of virologically suppressed patients switching to STR, most subjects had adequate elvitegravir C 24 values with a high proportion maintaining virological suppression with no residual viraemia until W48. [Mh] Termos MeSH primário: Cobicistat/uso terapêutico Emtricitabina/uso terapêutico Infecções por HIV/tratamento farmacológico Quinolonas/uso terapêutico Tenofovir/uso terapêutico Carga Viral [Mh] Termos MeSH secundário: Adulto Fármacos Anti-HIV/administração & dosagem Fármacos Anti-HIV/sangue Fármacos Anti-HIV/uso terapêutico Terapia Antirretroviral de Alta Atividade Contagem de Linfócito CD4 Cobicistat/administração & dosagem Cobicistat/sangue Estudos de Coortes Emtricitabina/administração & dosagem Emtricitabina/sangue Feminino Infecções por HIV/sangue HIV-1/efeitos dos fármacos Seres Humanos Quimioterapia de Manutenção Masculino Meia-Idade Reação em Cadeia da Polimerase Quinolonas/administração & dosagem Quinolonas/sangue RNA Viral/sangue Comprimidos Tenofovir/administração & dosagem Tenofovir/sangue Viremia/tratamento farmacológico [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; OBSERVATIONAL STUDY; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (JTK 303); 0 (Quinolones); 0 (RNA, Viral); 0 (Tablets); 99YXE507IL (Tenofovir); G70B4ETF4S (Emtricitabine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1711 [Cu] Atualização por classe: 171107 [Lr] Data última revisão: 171107 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 170211 [St] Status: MEDLINE [do] DOI: 10.1093/jac/dkx018

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[PMID]: 28166190 [Au] Autor: Jongbloed-de Hoon M; Colbers A; Velthoven-Graafland K; Duisenberg-van Essenberg M; Kruijssen M; Abbink E; van Crevel R; Burger D [Ad] Endereço: *Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands; †Department of Pharmacy, Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands; ‡Clinical Research Centre Nijmegen, Radboud University Medical Center, Nijmegen, the Netherlands; and §Department of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands. [Ti] Título: Brief Report: Pharmacokinetics of Crushed Elvitegravir Combination Tablet Given With or Without Enteral Nutrition. [So] Source: J Acquir Immune Defic Syndr;74(5):571-574, 2017 Apr 15. [Is] ISSN: 1944-7884 [Cp] País de publicação: United States [La] Idioma: eng [Ab] Resumo: We investigated whether a fixed-dose combination tablet of elvitegravir, cobicistat, emtricitabine, and tenofovirDF (Stribild) can be crushed and combined with enteral nutrition without influencing pharmacokinetics. This was an open-label, 3-period, single-dose, randomized, crossover trial in 24 healthy volunteers. Subjects received Stribild whole tablet with breakfast (reference), crushed/suspended Stribild + breakfast, crushed/suspended Stribild + enteral nutrition. Crushed/suspended Stribild + enteral nutrition was bioequivalent (90% confidence interval between 80% and 125%) with a whole Stribild tablet. Crushed/suspended Stribild + breakfast showed bioequivalence for the area under the curve (AUC0-32), but not for maximum concentration (Cmax) (considered not clinically relevant). Patients with swallowing difficulties or an enteral feeding tube can use crushed and suspended Stribild tablets. [Mh] Termos MeSH primário: Fármacos Anti-HIV/administração & dosagem Fármacos Anti-HIV/farmacocinética Nutrição Enteral Quinolonas/administração & dosagem Quinolonas/farmacocinética Comprimidos/administração & dosagem Comprimidos/farmacocinética [Mh] Termos MeSH secundário: Adenina/administração & dosagem Adenina/análogos & derivados Adenina/farmacocinética Adulto Cobicistat/administração & dosagem Cobicistat/farmacocinética Estudos Cross-Over Emtricitabina/administração & dosagem Emtricitabina/farmacocinética Feminino Voluntários Saudáveis Seres Humanos Masculino Meia-Idade Ácidos Fosforosos/administração & dosagem Ácidos Fosforosos/farmacocinética Adulto Jovem [Pt] Tipo de publicação: CLINICAL TRIAL, PHASE I; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (9-(2-((bis(pivaloyloxymethoxy)phosphinoyl)methoxy)propyl)adenine); 0 (Anti-HIV Agents); 0 (JTK 303); 0 (Phosphorous Acids); 0 (Quinolones); 0 (Tablets); G70B4ETF4S (Emtricitabine); JAC85A2161 (Adenine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170606 [Lr] Data última revisão: 170606 [Sb] Subgrupo de revista: IM; X [Da] Data de entrada para processamento: 170207 [St] Status: MEDLINE [do] DOI: 10.1097/QAI.0000000000001296

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[PMID]: 27999051 [Au] Autor: Gutierrez-Valencia A; Benmarzouk-Hidalgo OJ; Llaves S; Fernandez-Magdaleno T; Espinosa N; Viciana P; Lopez-Cortes LF [Ti] Título: Pharmacokinetic interactions between cobicistat-boosted elvitegravir and darunavir in HIV-infected patients. [So] Source: J Antimicrob Chemother;72(3):816-819, 2017 Mar 01. [Is] ISSN: 1460-2091 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Objectives: To evaluate if there are significant drug-drug interactions between cobicistat-boosted elvitegravir and 800 mg darunavir once daily taken simultaneously, as has been suggested previously. Methods: The study population consisted of three groups of unselected volunteers taking a regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (150, 150, 200 and 300 mg, respectively) co-formulated in a single tablet plus 800 mg darunavir (group A); only co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (group B); and cobicistat-boosted darunavir (800 mg darunavir + 150 mg cobicistat) plus two nucleos(t)ide analogues (group C). Elvitegravir, cobicistat and darunavir concentrations at the end of the dosing interval ( C 24 ) were quantified using a validated LC with tandem MS method. Results: A total of 170 samples were obtained from 24, 32 and 32 patients in groups A, B and C, respectively. In group A, the elvitegravir C 24 were similar to those in group B (233.67 versus 250.39 ng/mL) ( P = 0.406) and the darunavir C 24 were similar to those in group C (1293.54 versus 1319.34 ng/mL) ( P = 0.908). The cobicistat C 24 were comparable in groups A and B (20.2 versus 20.9 ng/mL) and slightly higher in group C (27.7 ng/mL) ( P = 0.059). Conclusions: The results provide evidence of similar elvitegravir and darunavir C 24 concentrations when these drugs are co-administered as co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate plus 800 mg darunavir or dosed separately. [Mh] Termos MeSH primário: Fármacos Anti-HIV/farmacocinética Cobicistat/administração & dosagem Darunavir/farmacocinética Infecções por HIV/tratamento farmacológico Quinolonas/farmacocinética [Mh] Termos MeSH secundário: Adulto Idoso Idoso de 80 Anos ou mais Fármacos Anti-HIV/administração & dosagem Fármacos Anti-HIV/uso terapêutico Cobicistat/uso terapêutico Darunavir/administração & dosagem Darunavir/uso terapêutico Combinação de Medicamentos Interações Medicamentosas Feminino Infecções por HIV/virologia HIV-1/efeitos dos fármacos Seres Humanos Masculino Meia-Idade Quinolonas/administração & dosagem Quinolonas/uso terapêutico Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (Drug Combinations); 0 (JTK 303); 0 (Quinolones); LW2E03M5PG (Cobicistat); YO603Y8113 (Darunavir) [Em] Mês de entrada: 1710 [Cu] Atualização por classe: 171010 [Lr] Data última revisão: 171010 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161222 [St] Status: MEDLINE [do] DOI: 10.1093/jac/dkw487

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[PMID]: 27798211 [Au] Autor: Smolders EJ; Colbers EP; de Kanter CT; Velthoven-Graafland K; Drenth JP; Burger DM [Ad] Endereço: Department of Pharmacy, Radboud Institute for Health Sciences (RHIS) and Radboud University Medical Center, Nijmegen, The Netherlands elise.smolders@radboudumc.nl. [Ti] Título: Daclatasvir 30 mg/day is the correct dose for patients taking atazanavir/cobicistat. [So] Source: J Antimicrob Chemother;72(2):486-489, 2017 Feb. [Is] ISSN: 1460-2091 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: BACKGROUND: Atazanavir is boosted with the cytochrome P450 (CYP) 3A4 inhibitor ritonavir. When combined with the CYP3A4 substrate daclatasvir, the daclatasvir dosage should be reduced from 60 to 30 mg once daily. Recently, cobicistat was licensed as a CYP3A booster and used with atazanavir. OBJECTIVES: To determine whether the fixed-dose combination of atazanavir/cobicistat has an influence on daclatasvir pharmacokinetics comparable to that of the separate agents atazanavir and ritonavir. METHODS: A prospective, open-label, two-period, randomized, cross-over trial was performed in 16 healthy subjects (NCT02565888). Treatment consisted of 300/100 mg of atazanavir/ritonavir plus 30 mg of daclatasvir once daily (reference) and a second period of 300/150 mg of atazanavir/cobicistat plus 30 mg of daclatasvir once daily (test). A 24 h pharmacokinetic, steady-state curve was recorded for all drugs. Geometric mean ratios (GMRs) with 90% CI were calculated for daclatasvir and atazanavir AUC and C to compare the effect of both treatments (test versus reference). Laboratory safety and adverse events were evaluated throughout the trial. RESULTS: All 16 healthy subjects completed the study. Median (range) age and BMI were 48.5 (21-55) years and 24.5 (19.0-29.2) kg/m , respectively. Pharmacokinetic parameters of ritonavir and cobicistat were comparable to those in the literature. The GMRs (90% CI) of daclatasvir AUC and C (test versus reference) were 101% (92%-111%) and 97% (89%-106%), respectively. Atazanavir GMRs (90% CI) of AUC and C were 82% (75%-79%) and 74% (68%-81%), respectively. No serious adverse events were reported. CONCLUSIONS: Atazanavir/cobicistat and atazanavir/ritonavir had a similar influence on daclatasvir pharmacokinetics in healthy volunteers. Daclatasvir at 30 mg once daily is the correct dose when combined with atazanavir/cobicistat. [Mh] Termos MeSH primário: Fármacos Anti-HIV/uso terapêutico Sulfato de Atazanavir/uso terapêutico Cobicistat/uso terapêutico Infecções por HIV/tratamento farmacológico Imidazóis/administração & dosagem Imidazóis/uso terapêutico [Mh] Termos MeSH secundário: Adulto Fármacos Anti-HIV/efeitos adversos Fármacos Anti-HIV/farmacocinética Sulfato de Atazanavir/farmacocinética Cobicistat/farmacocinética Estudos Cross-Over Inibidores do Citocromo P-450 CYP3A/farmacocinética Inibidores do Citocromo P-450 CYP3A/uso terapêutico Feminino Seres Humanos Imidazóis/farmacocinética Masculino Meia-Idade Estudos Prospectivos Ritonavir/farmacocinética Ritonavir/uso terapêutico Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (BMS-790052); 0 (Cytochrome P-450 CYP3A Inhibitors); 0 (Imidazoles); 4MT4VIE29P (Atazanavir Sulfate); LW2E03M5PG (Cobicistat); O3J8G9O825 (Ritonavir) [Em] Mês de entrada: 1709 [Cu] Atualização por classe: 170907 [Lr] Data última revisão: 170907 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161101 [St] Status: MEDLINE [do] DOI: 10.1093/jac/dkw429

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MEDLINE

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[PMID]: 27190354 [Au] Autor: Milburn J; Jones R; Levy JB [Ad] Endereço: Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, Du Cane Road, London, UK. [Ti] Título: Renal effects of novel antiretroviral drugs. [So] Source: Nephrol Dial Transplant;32(3):434-439, 2017 03 01. [Is] ISSN: 1460-2385 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: Chronic kidney disease (CKD) is a critical comorbidity for patients living with HIV, with an estimated prevalence between 2.4 and 17%. Such patients are increasingly affected by diseases associated with ageing, including cardiovascular disease and CKD, and the prevalence of risk factors such as smoking and dyslipidaemia is increased in this population. Proteinuria is also now recognized as a common finding in individuals living with HIV. While combination antiretroviral (ARV) treatments reduce CKD in the HIV-infected population overall, some ARV drugs have been shown to be nephrotoxic and associated with worsening renal function. Over the last few years, several highly efficacious new ARV agents have been introduced. This brief review will look at the novel agents dolutegravir, raltegravir, elvitegravir, cobicistat, tenofovir alafenamide fumarate and atazanavir, all of which have been licensed relatively recently, and describe issues relevant to renal function, creatinine handling and potential nephrotoxicity. Given the prevalence of CKD, the wide range of possible interactions between HIV, ARV therapy, CKD and its treatments, nephrologists need to be aware of these newer agents and their possible effect on kidneys. [Mh] Termos MeSH primário: Fármacos Anti-HIV/efeitos adversos Infecções por HIV/tratamento farmacológico Insuficiência Renal Crônica/induzido quimicamente [Mh] Termos MeSH secundário: Adenina/efeitos adversos Adenina/análogos & derivados Sulfato de Atazanavir/efeitos adversos Cobicistat/efeitos adversos Creatinina Progressão da Doença Infecções por HIV/complicações Compostos Heterocíclicos com 3 Anéis/efeitos adversos Seres Humanos Proteinúria/induzido quimicamente Proteinúria/complicações Quinolonas/efeitos adversos Raltegravir Potássico/efeitos adversos Insuficiência Renal Crônica/complicações Insuficiência Renal Crônica/metabolismo [Pt] Tipo de publicação: JOURNAL ARTICLE; REVIEW [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (GS-7340); 0 (Heterocyclic Compounds, 3-Ring); 0 (JTK 303); 0 (Quinolones); 43Y000U234 (Raltegravir Potassium); 4MT4VIE29P (Atazanavir Sulfate); AYI8EX34EU (Creatinine); DKO1W9H7M1 (dolutegravir); JAC85A2161 (Adenine); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1710 [Cu] Atualização por classe: 171025 [Lr] Data última revisão: 171025 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 160519 [St] Status: MEDLINE [do] DOI: 10.1093/ndt/gfw064

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[PMID]: 27894270 [Au] Autor: Valin N; Fonquernie L; Daguenel A; Campa P; Anthony T; Guiguet M; Girard PM; Meyohas MC [Ad] Endereço: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France. nadia.valin@aphp.fr. [Ti] Título: Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis. [So] Source: BMC Infect Dis;16(1):718, 2016 Nov 29. [Is] ISSN: 1471-2334 [Cp] País de publicação: England [La] Idioma: eng [Ab] Resumo: BACKGROUND: The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (Stribild ) prescribed as one pill taken once daily for HIV PEP in terms of tolerability and adherence. METHODS: This was a prospective cohort study conducted in one hospital in Paris (April to December 2015. Each participant receiving the PEP treatment (FTC-150 mg/TDF-245 mg/elvitegravir-200 mg/cobicistat 150 mg once daily) at the pharmacy of the hospital were recruited consecutively. A clinical visit was planned at 8 weeks after sexual exposure. Reminders were sent to participants who missed the appointment. A standardized questionnaire was administered to evaluate completeness and tolerability at week 8. RESULTS: Overall, 284 participants (86% men; 80% MSM; median age 30 years) were prescribed Stribild ; 50 stopped after reassessment of risk. Among 234 participants who effectively received PEP, 215 (92%) completed 28 days of PEP with only three who switched from Stribild to another PEP because of side effects. More than 60% of participants reported at least one AE, which were mild to moderate. Fatigue, central neurological and abdominal side effects were the most frequently reported. CONCLUSIONS: Stribild seems to be a good option for HIV PEP due to the easiness of use, the side effects profile and the high completion rate. [Mh] Termos MeSH primário: Fármacos Anti-HIV/efeitos adversos Fármacos Anti-HIV/uso terapêutico Combinação Elvitegravir, Cobicistat, Emtricitabina e Fumarato de Tenofovir Desoproxila/uso terapêutico Infecções por HIV/prevenção & controle Profilaxia Pós-Exposição/métodos [Mh] Termos MeSH secundário: Adolescente Adulto Idoso Fármacos Anti-HIV/administração & dosagem Cobicistat Combinação de Medicamentos Combinação Elvitegravir, Cobicistat, Emtricitabina e Fumarato de Tenofovir Desoproxila/administração & dosagem Combinação Elvitegravir, Cobicistat, Emtricitabina e Fumarato de Tenofovir Desoproxila/efeitos adversos Feminino Infecções por HIV/tratamento farmacológico Homossexualidade Masculina Seres Humanos Masculino Adesão à Medicação Meia-Idade Paris Estudos Prospectivos Comportamento Sexual Adulto Jovem [Pt] Tipo de publicação: JOURNAL ARTICLE [Nm] Nome de substância: 0 (Anti-HIV Agents); 0 (Drug Combinations); 0 (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination); LW2E03M5PG (Cobicistat) [Em] Mês de entrada: 1706 [Cu] Atualização por classe: 170612 [Lr] Data última revisão: 170612 [Sb] Subgrupo de revista: IM [Da] Data de entrada para processamento: 161130 [St] Status: MEDLINE

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