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Frank Palella, Xiuhong Li, Samir K Gupta, Michelle M Estrella, John P Phair, Joseph B Margolick, Roger Detels, Lawrence Kingsley, Lisa P Jacobson
BACKGROUND: Factors affecting kidney function and proteinuria among HIV+ and HIV- persons need better characterization. METHODS: We evaluated estimated glomerular filtration rate (eGFR, mL/min per 1.73 m) changes, proteinuria prevalence (a urine protein-to-creatinine ratio [UPCr] of ≥0.2 at two consecutive visits) and associated factors among HIV+ and HIV- men. RESULTS: There were 917 HIV+ men receiving HAART, 159 HIV+ men not receiving HAART, and 1305 HIV- men seen from 10/2003 to 9/2014...
March 20, 2018: AIDS
Arkaitz Imaz, Jordi Niubó, Alieu Amara, Saye Khoo, Elena Ferrer, Juan M Tiraboschi, Laura Acerete, Benito Garcia, Antonia Vila, Daniel Podzamczer
This study aimed to assess cerebrospinal fluid (CSF) drug concentrations and viral suppression in HIV-1-infected patients on ritonavir-boosted atazanavir (ATV/r) plus lamivudine (3TC) dual therapy. HIV-1-infected adults with suppressed plasma HIV-1 RNA who switched to ATV/r plus 3TC were studied. Total ATV and 3TC concentrations at the end of the dosing interval (C24h ), using a validated LC-MS/MS method, and HIV-1 RNA were measured in paired CSF and plasma samples 12 weeks after switching. Ten individuals were included...
March 14, 2018: Journal of Neurovirology
Dimitrios Pilalas, Lemonia Skoura, Apostolia Margariti, Fani Chatzopoulou, Dimitrios Chatzidimitriou, Olga Tsachouridou, Pantelis Zebekakis, Simeon Metallidis, Maria Papaioannou
OBJECTIVES: Despite successful virological suppression, HIV transcription frequently persists intracellularly. In this study, we hypothesize that HIV persistent transcription(HIVpt) may affect to a different extent patients on stable efavirenz(EFV) versus atazanavir(ATV)-based regimens. The role of the expression of drug efflux transporters in HIVpt was also investigated. METHODS: We prospectively enrolled 51 virologically suppressed patients on first-line treatment for one year with EFV or ATV combined with emtricitabine and tenofovir and followed them up for one year...
2018: PloS One
Theodoros Kelesidis, Carlee B Moser, Elizabeth Johnston, James H Stein, Michael P Dube, Otto O Yang, Grace A McComsey, Judith S Currier, Todd T Brown
BACKGROUND: The contributions of the Receptor activator of nuclear factor kappa-B ligand (RANKL)/osteoprotegerin (OPG) axis to cardiovascular and bone disease in treated HIV-1 infection is not well-defined. SETTING: Prospective, observational, longitudinal study. METHODS: In a subset analysis of a prospective randomized clinical trial, 234 HIV-1-infected antiretroviral therapy (ART)-naïve participants received tenofovir-emtricitabine plus either atazanavir/ritonavir, darunavir/ritonavir, or raltegravir and achieved plasma HIV-1 RNA <50 copies/ml by week 24 and thereafter...
March 12, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Ovokeroye A Abafe, Jana Späth, Jerker Fick, Stina Jansson, Chris Buckley, Annegret Stark, Bjoern Pietruschka, Bice S Martincigh
South Africa has the largest occurrence of the human immune deficiency virus (HIV) in the world but has also implemented the largest antiretroviral (ARV) treatment programme. It was therefore of interest to determine the presence and concentrations of commonly used antiretroviral drugs (ARVDs) and, also, to determine the capabilities of wastewater treatment plants (WWTPs) for removing ARVDs. To this end, a surrogate standard based LC-MS/MS method was optimized and applied for the detection of thirteen ARVDs used in the treatment and management of HIV/acquired immune deficiency syndrome (HIV/AIDS) in two major and one modular WWTP in the eThekwini Municipality in KwaZulu-Natal, South Africa...
February 20, 2018: Chemosphere
Nico Holmstock, Marlies Oorts, Jan Snoeys, Pieter Annaert
Hepatic drug transporters play a pivotal role in the excretion of drugs from the body, in drug-drug interactions as well as in drug-induced liver toxicity. Hepatocytes cultured in sandwich configuration are an advantageous model to investigate the interactions of drug candidates with apical efflux transporters in a bio-relevant manner. However, the commonly used 'offline' assays (i.e. that rely on measuring intracellular accumulated amounts after cell lysis) are time and resource consuming while data output is often high and variable...
March 9, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
Erik Mogalian, Luisa M Stamm, Anu Osinusi, Diana M Brainard, Gong Shen, Kah Hiing John Ling, Anita Mathias
Background: Combining antiviral regimens in the HCV/HIV coinfected population can be complex as they share overlapping mechanisms for elimination that may result in potential drug interactions. The pharmacokinetics, safety, and tolerability of concomitantly administered sofosbuvir/velpatasvir (SOF/VEL) with multiple commonly prescribed antiretroviral (ARV) regimens were evaluated. Methods: Healthy volunteers were enrolled into two phase 1, open-label, randomized, multiple-dose, cross-over studies...
March 7, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Maria Alvarellos, Chantal Guillemette, Russ B Altman, Teri E Klein
No abstract text is available yet for this article.
March 6, 2018: Pharmacogenetics and Genomics
Elisa Colella, Dario Cattaneo, Laura Galli, Sara Baldelli, Emilio Clementi, Massimo Galli, Adriano Lazzarin, Antonella Castagna, Stefano Rusconi, Vincenzo Spagnuolo
The 96-week results of the Monotherapy Once a Day with Atazanavir/r (MODAt) study [NCT01511809] showed an inferior virological efficacy of atazanavir (ATV)/ritonavir monotherapy versus triple therapy, which was promptly retrieved by the reintroduction of nucleoside/nucleotide inhibitors of reverse transcriptase [N(n)RTIs]. We aimed to identify potential relationships between ATV exposure and clinical outcome in HIV-1 subjects treated with ATV/ritonavir monotherapy [ATV/r 300/100mg] versus ATV/ritonavir triple therapy [ATV/r 300/100mg+2NRTIs]...
March 2, 2018: New Microbiologica
Antonella d'Arminio Monforte, Patrizia Lorenzini, Alessandro Cozzi-Lepri, Cristina Mussini, Antonella Castagna, Franco Baldelli, Massimo Puoti, Francesca Vichi, Adelaide Maddaloni, Sergio Lo Caputo, Nicola Gianotti, Andrea Antinori
Background We aimed to mimic the ACTG 5257 trial, comparing raltegravir (RAL), ritonavir-boosted atazavavir (ATV/r) and ritonavir-boosted darunavir (DRV/r) in the observational setting. Methods All the ICONA patients starting a first cART with 2NRTI + ATV/r, DRV/r or RAL were included. Primary end-point was treatment failure, i.e. virological failure (confirmed HIV-RNA > 200copies/mL > 6 months therapy) or discontinuation for any reason of the third drug. Secondary end-points: virological failure50 (50 copies/mL threshold), and discontinuation of the third drug due to intolerance/toxicity...
March 1, 2018: HIV Clinical Trials
Sally Hodder, Kathleen Squires, Cissy Kityo, Debbie Hagins, Anchalee Avihingsanon, Anna Kido, Shuping Jiang, Rima Kulkarni, Andrew Cheng, Huyen Cao
BACKGROUND: The integrase inhibitor regimen (elvitegravir [EVG]/cobicistat [COBI]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) demonstrated superior efficacy when compared to a protease inhibitor regimen (ritonavir-boosted atazanavir [ATV+RTV] plus FTC/TDF) in 575 treatment-naïve women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing EVG, COBI, FTC, and tenofovir alafenamide TAF (E/C/F/TAF) versus remaining on ATV+RTV and FTC/TDF...
February 21, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Vagish Hemmige, Charlene A Flash, Josephinel Carter, Thomas P Giordano, Teddy Zerai
Newer HIV regimens are typically taken once daily but vary in the number of pills required. Whether the number of pills in a once-daily HIV regimen affects clinical outcomes is unknown. We retrospectively compared adherence, retention in care, and virologic outcomes between patients starting a once daily single-tablet regimen (STR) to patients starting a once-daily multi-tablet regimen (MTR) in a publicly funded clinic in the United States. Outcomes were measured in the year after starting ART and included retention in care, virologic suppression, and medication possession ratio of at least 80%...
February 25, 2018: AIDS Care
JoEllen M McMillan, Denise A Cobb, Zhiyi Lin, Mary G Banoub, Raghubendra S Dagur, Amanda A Branch Woods, Weimin Wang, Edward Makarov, Ted Kocher, Poonam S Joshi, Rolen M Quadros, Donald W Harms, Samuel M Cohen, Howard E Gendelman, Channabasavaiah B Gurumurthy, Santhi Gorantla, Larisa Y Poluektova
Antiretroviral drug (ARV) metabolism is linked largely to hepatic cytochrome P450 (CYP) activity. One ARV drug class known to be metabolized by intestinal and hepatic CYP3A are the protease inhibitors (PI). Plasma drug concentrations in are boosted by CYP3A inhibitors such as cobisistat and ritonavir (RTV). Studies of such drug-drug interactions are limited as the enzyme pathways are human specific. While immune-deficient mice reconstituted with human cells are an excellent model to study ARVs during human immunodeficiency virus type 1 (HIV-1) infection, they cannot reflect human drug metabolism...
February 23, 2018: Journal of Pharmacology and Experimental Therapeutics
Sanjay Pujari, Sunil Gaikwad, Vivek Bele, Kedar Joshi, Digamber Dabhade
BACKGROUND: There is no information on the clinical effectiveness of Maraviroc (MVC) amongst People Living with HIV (PLHIV) in India infected with HIV-1 Subtype C viruses. METHODS: We conducted a retrospective chart review of adult PLHIV on MVC based Antiretroviral (ARV) regimens for at least 6 months. Maraviroc was initiated amongst PLHIV with documented R5 tropic viruses (determined by in-house population sequencing of the V3 loop in triplicate and interpreted using the Geno2Pheno algorithm) in combination with an Optimized Background regimen (designed using genotypic resistance testing and past ARV history)...
January 2018: Journal of the International Association of Providers of AIDS Care
Nicole S Delino, Manabu Aoki, Hironori Hayashi, Shin-Ichiro Hattori, Simon B Chang, Yuki Takamatsu, Cuthbert D Martyr, Debananda Das, Arun K Ghosh, Hiroaki Mitsuya
We identified four novel nonpeptidic human immunodeficiency virus type 1 (HIV-1) protease inhibitors (PIs), GRL-078, -079, -077, and -058, containing an alkylamine at the C5 position of P2-tetrahydropyrano-tetrahydrofuran (Tp-THF) and a P2' -cyclopropyl (Cp)(or isopropyl)-aminobenzothiazole (Abt). Their 50% effective concentrations (EC50 s) were 2.5-30 nM against wild-type HIV-1NL4-3 , 0.3-6.7 nM against HIV-2EHO , and 0.9-90 nM against laboratory-selected-PI-resistant HIV-1 and clinical HIV-1 variants resistant to multiple FDA-approved PIs (HIVMDR )...
February 20, 2018: Antimicrobial Agents and Chemotherapy
Borja Mora-Peris, George Bouliotis, Kulasegaram Ranjababu, Amanda Clarke, Frank A Post, Mark Nelson, Laura Burgess, Juan Tiraboschi, Saye Khoo, Steve Taylor, Deborah Ashby, Alan Winston
BACKGROUND: Maraviroc-intensified antiretroviral therapy (ART) may be associated with cognitive benefits. METHODS: Therapy naïve, cognitively asymptomatic, HIV-positive individuals were randomly allocated on a 1:1 basis to standard ART (Arm1; tenofovir-emtricitabine plus atazanavir/ritonavir) or maraviroc intensified ART (Arm2: abacavir-lamivudine plus darunavir/ritonavir/maraviroc). Over 48 weeks, detailed assessments of cognitive function (CF) tests were undertaken and cerebral metabolites measured using proton magnetic resonance spectroscopy...
February 12, 2018: AIDS
S Dey, S Subhasis Patro, N Suresh Babu, P N Murthy, S K Panda
A stability-indicating reverse phase-high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C18 column Phenomenix (250 mm×4.6 mm, 5 μm) with a mobile phase consisting of 900 mL of HPLC grade methanol and 100 mL of water of HPLC grade. The pH was adjusted to 3.55 with acetic acid. The mobile phase was sonicated for 10 min and filtered through a 0.45 μm membrane filter at a flow rate of 0.5 mL/min...
April 2017: Journal of Pharmaceutical Analysis
Célia Lloret-Linares, Yasmin Rahmoun, Amanda Lopes, Dorothée Chopin, Guy Simoneau, Andrew Green, Brigitte Delhotal, Hélène Sauvageon, Stéphane Mouly, Jean-François Bergmann, Pierre-Olivier Sellier
BACKGROUND: To compare the steady state plasma concentrations (Css) of three antiretroviral drugs in both normal and overweight patients, and to determine the relationship between Css and fat mass (FM) or lean body mass. METHODS: Patients treated for more than 6 months once daily with one of the antiretroviral drugs: efavirenz (EFV) 600mg, atazanavir boosted with ritonavir (ATV-r) 300mg/100mg, or darunavir boosted with ritonavir (DRV-r) 800mg/100mg, combined with two nucleoside analogues, were enrolled prospectively...
November 2, 2017: Thérapie
J R Santos, A Cozzi-Lepri, A Phillips, S De Wit, C Pedersen, P Reiss, A Blaxhult, A Lazzarin, M Sluzhynska, C Orkin, C Duvivier, J Bogner, P Gargalianos-Kakolyris, P Schmid, G Hassoun, I Khromova, M Beniowski, V Hadziosmanovic, D Sedlacek, R Paredes, J D Lundgren
OBJECTIVES: The aim of the study was to evaluate the long-term response to antiretroviral treatment (ART) based on atazanavir/ritonavir (ATZ/r)-, darunavir/ritonavir (DRV/r)-, and lopinavir/ritonavir (LPV/r)-containing regimens. METHODS: Data were analysed for 5678 EuroSIDA-enrolled patients starting a DRV/r-, ATZ/r- or LPV/r-containing regimen between 1 January 2000 and 30 June 2013. Separate analyses were performed for the following subgroups of patients: (1) ART-naïve subjects (8%) at ritonavir-boosted protease inhibitor (PI/r) initiation; (2) ART-experienced individuals (44%) initiating the new PI/r with a viral load (VL) ≤500 HIV-1 RNA copies/mL; and (3) ART-experienced patients (48%) initiating the new PI/r with a VL >500 copies/mL...
February 1, 2018: HIV Medicine
Sebastiano Leone, Milensu Shanyinde, Alessandro Cozzi Lepri, Fiona C Lampe, Pietro Caramello, Andrea Costantini, Andrea Giacometti, Andrea De Luca, Antonella Cingolani, Francesca Ceccherini Silberstein, Massimo Puoti, Andrea Gori, Antonella d'Arminio Monforte
To evaluate incidence rates of and predictors for any antiretroviral (ART) drug discontinuation by HCV infection status in a large Italian cohort of HIV infected patients. All patients enrolled in ICONA who started combination antiretroviral therapy (cART) containing abacavir or tenofovir or emtricitabine or lamivudine plus efavirenz or rilpivirine or atazanavir/r or darunavir/r (DRV/r) or lopinavir/r or dolutegravir or elvitegravir or raltegravir were included. Multivariate Poisson regression models were used to determine factors independently associated with single ART drug discontinuation...
January 9, 2018: European Journal of Clinical Microbiology & Infectious Diseases
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