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https://www.readbyqxmd.com/read/27922453/safety-and-efficacy-of-the-hiv-1-attachment-inhibitor-prodrug-fostemsavir-in-antiretroviral-experienced-subjects-week-48-analysis-of-ai438011-a-phase-iib-randomized-controlled-trial
#1
Melanie Thompson, Jacob P Lalezari, Richard Kaplan, Yvett Pinedo, Otto A Sussmann Pena, Pedro Cahn, David A Stock, Samit R Joshi, George J Hanna, Max Lataillade
BACKGROUND: Fostemsavir is a prodrug of temsavir, an attachment inhibitor that binds directly to HIV-1 gp120, blocking initial viral attachment and entry into host CD4 cells. Efficacy, safety, and dose-response data of fostemsavir in treatment-experienced, HIV-1-infected subjects, through Week 48, are reported. METHODS: AI438011 is an ongoing Phase IIb, randomized, active-controlled trial (NCT01384734). Subjects were randomized 1:1:1:1:1 into five arms: fostemsavir (400 mg twice daily [BID], 800 mg BID, 600 mg once daily [QD], or 1200 mg QD), and a reference arm (ritonavir-boosted atazanavir [ATV/r] 300/100 mg QD), each with a backbone of raltegravir 400 mg BID + tenofovir disoproxil fumarate 300 mg QD...
December 6, 2016: Antiviral Therapy
https://www.readbyqxmd.com/read/27901085/wide-variation-in-susceptibility-of-transmitted-founder-hiv-1-subtype-c-isolates-to-protease-inhibitors-and-association-with-in-vitro-replication-efficiency
#2
Katherine A Sutherland, Dami A Collier, Daniel T Claiborne, Jessica L Prince, Martin J Deymier, Richard A Goldstein, Eric Hunter, Ravindra K Gupta
The gag gene is highly polymorphic across HIV-1 subtypes and contributes to susceptibility to protease inhibitors (PI), a critical class of antiretrovirals that will be used in up to 2 million individuals as second-line therapy in sub Saharan Africa by 2020. Given subtype C represents around half of all HIV-1 infections globally, we examined PI susceptibility in subtype C viruses from treatment-naïve individuals. PI susceptibility was measured in a single round infection assay of full-length, replication competent MJ4/gag chimeric viruses, encoding the gag gene and 142 nucleotides of pro derived from viruses in 20 patients in the Zambia-Emory HIV Research Project acute infection cohort...
November 30, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27898595/increase-in-international-normalized-ratio-after-switching-from-atazanavir-ritonavir-to-darunavir-cobicistat-in-a-patient-on-warfarin-boosters-are-not-always-equal
#3
Alice L Tseng, Jonathan Luetkehoelter, Sharon L Walmsley
No abstract text is available yet for this article.
January 2, 2017: AIDS
https://www.readbyqxmd.com/read/27828808/managing-chronic-kidney-disease-in-the-older-adults-living-with-hiv
#4
Frank A Post
PURPOSE OF REVIEW: HIV replication and immunodeficiency are important risk factors for chronic kidney disease (CKD). Widespread use of antiretrovirals that may affect kidney function underscores the need for monitoring kidney function, allowing early detection of drug-induced kidney injury and identification of patients who may benefit from antiretroviral therapy switches. RECENT FINDINGS: Several cohorts have reported an increased incidence of CKD with tenofovir [tenofovir disoproxil fumarate (TDF)], atazanavir, and lopinavir, and CKD risk scores have been developed to identify those most at risk of kidney disease progression while receiving these agents...
November 8, 2016: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/27798641/switch-to-ritonavir-boosted-versus-unboosted-atazanavir-plus-raltegravir-dual-drug-therapy-leads-to-similar-efficacy-and-safety-outcomes-in-clinical-practice
#5
Pierre Gantner, Firouze Bani-Sadr, Rodolphe Garraffo, Pierre-Marie Roger, Michèle Treger, Thomas Jovelin, Pascal Pugliese, David Rey
OBJECTIVES: To assess immunovirological response, safety and pharmacokinetic of NRTI-sparing regimen dual therapy of atazanavir (ATV) and raltegravir (RAL) in maintenance strategy. METHODS: A retrospective analysis was conducted on a cohort of HIV-infected adults followed in French centers (Dat'AIDS cohort), comparing the proportions of virological and therapeutic failures between ATV + RAL and ATV/ritonavir + RAL dual therapy regimens. RESULTS: 283 patients were assessed: 185 switched for ATV + RAL and 98 for ATV/ritonavir + RAL dual therapy...
2016: PloS One
https://www.readbyqxmd.com/read/27798211/daclatasvir-30-mg-day-is-the-correct-dose-for-patients-taking-atazanavir-cobicistat
#6
E J Smolders, E P H Colbers, C T M M de Kanter, K Velthoven-Graafland, J P H Drenth, D M Burger
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...
October 20, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27789848/dolutegravir-50%C3%A2-mg-thrice-weekly-plus-atazanavir-400%C3%A2-mg-daily-in-a-long-term-virologically-suppressed-hiv-infected-patient
#7
Massimiliano Lanzafame, Emanuela Lattuada, Stefano Nicolè, Fabio Rigo, Giulia Cucchetto, Ercole Concia, Sandro Vento
Highly active antiretroviral therapy (HAART) has changed the natural course of HIV infection. However, the toxicities associated with long-term use of nucleoside reverse transcriptase inhibitors (NRTIs) have led to the assessment of dual-therapy approaches with less toxicity. Atazanavir and dolutegravir have antiviral potency, tolerability and favourable metabolic profile. In suppressed HIV-infected patients, with NRTIs-related toxicity effects, the association of atazanavir and dolutegravir, favoured by their positive pharmacokinetics interaction, could be used as 'maintenance' antiretroviral therapy...
October 27, 2016: International Journal of STD & AIDS
https://www.readbyqxmd.com/read/27774892/atazanavir-plus-cobicistat-week-48-and-week-144-subgroup-analyses-of-a-phase-3-randomized-double-blind-active-controlled-trial
#8
Joel E Gallant, Graeme Moyle, Juan Berenguer, Peter Shalit, Huyen Cao, Ya-Pei Liu, Joel Myers, Lisa Rosenblatt, Lingfeng Yang, Javier Szwarcberg
OBJECTIVES: Cobicistat (COBI) enhances atazanavir (ATV) pharmacokinetic parameters similarly to ritonavir (RTV) in both healthy volunteers and HIV-infected adults. Primary efficacy and safety outcomes of this Phase 3, international, randomized, double-blind, double-dummy, active-controlled trial in HIV-1-infected treatment-naïve adults (GS-US-216-0114/NCT01108510) demonstrated that ATV+COBI was non-inferior to ATV+RTV, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), at Weeks 48 and 144, with high rates of virologic success for both regimens (85...
October 21, 2016: Current HIV Research
https://www.readbyqxmd.com/read/27749561/long-term-effectiveness-of-unboosted-atazanavir-plus-abacavir-lamivudine-in-subjects-with-virological-suppression-a-prospective-cohort-study
#9
Josep M Llibre, Alessandro Cozzi-Lepri, Court Pedersen, Matti Ristola, Marcelo Losso, Amanda Mocroft, Viktar Mitsura, Karolin Falconer, Fernando Maltez, Marek Beniowski, Vincenzo Vullo, Gamal Hassoun, Elena Kuzovatova, János Szlavik, Anastasiia Kuznetsova, Hans-Jürgen Stellbrink, Claudine Duvivier, Simon Edwards, Kamilla Laut, Roger Paredes
Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant.We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/mL...
October 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27743681/-abacavir-lamivudine-unboosted-atazanavir-in-routine-clinical-practice-twelve-years-experience
#10
M Eulalia Valencia, Luz Martín-Carbonero, Victoria Moreno, José Ignacio Bernardino, M Luisa Montes, Rocío Montejano
OBJECTIVE: To describe the experience using the combination abacavir, lamivudine plus non-boosted atazanavir (ABC/3TC+ATV) in a group of pretreated patients. PATIENTS AND METHODS: We performed a retrospective observational study to describe baseline characteristics and the evolution of patients who had received or were treating with ABC/3TC+ATV, from November 2004 and June 15th 2015, in the clinical setting. RESULTS: Overall, 236 patients were included in the study...
October 13, 2016: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/27741139/efavirenz-versus-boosted-atazanavir-containing-regimens-and-immunologic-virologic-and-clinical-outcomes-a-prospective-study-of-hiv-positive-individuals
#11
Lauren E Cain, Ellen C Caniglia, Andrew Phillips, Ashley Olson, Roberto Muga, Santiago Pérez-Hoyos, Sophie Abgrall, Dominique Costagliola, Rafael Rubio, Inma Jarrín, Heiner Bucher, Jan Fehr, Ard van Sighem, Peter Reiss, François Dabis, Marie-Anne Vandenhende, Roger Logan, James Robins, Jonathan A C Sterne, Amy Justice, Janet Tate, Giota Touloumi, Vasilis Paparizos, Anna Esteve, Jordi Casabona, Rémonie Seng, Laurence Meyer, Sophie Jose, Caroline Sabin, Miguel A Hernán
OBJECTIVE: To compare regimens consisting of either ritonavir-boosted atazanavir or efavirenz and a nucleoside reverse transcriptase inhibitor (NRTI) backbone with respect to clinical, immunologic, and virologic outcomes. DESIGN: Prospective studies of human immunodeficiency virus (HIV)-infected individuals in Europe and the United States included in the HIV-CAUSAL Collaboration. METHODS: HIV-positive, antiretroviral therapy-naive, and acquired immune deficiency syndrome (AIDS)-free individuals were followed from the time they started an atazanavir or efavirenz regimen...
October 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27723524/determination-of-genotoxic-impurity-in-atazanavir-sulphate-drug-substance-by-lc-ms
#12
Geetha Bhavani K, Bala Murali Krishna K, Srinivasu N, Ramachandran D, V V S S Raman N, Hari Babu B
A sensitive LC-MS method was developed for the determination of tert-butyl 2-[4-(pyridine-2-yl) benzyl] hydrazine carboxylate (GTI-A), a genotoxic impurity in Atazanavir sulphate drug substance. The method was validated as per International Council for Harmonization guidelines, for QL, DL, linearity and accuracy. The QL and DL values obtained were 1.1ppm and 0.3ppm respectively. The Correlation coefficient found for the linearity study was 0.999. The % recovery of the added impurity in the range of 96.4-100...
September 26, 2016: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/27721547/incidence-of-atazanavir-associated-adverse-drug-reactions-in-second-line-drugs-treated-south-indian-hiv-1-infected-patients
#13
Dhakshinamoorthy Subashini, Thongadi Ramesh Dinesha, Jayaseelan Boobalan, Lawrence Christopher Samuel, Selvamuthu Poongulali, Ambrose Pradeep, Sunil Suhas Solomon, Suniti Solomon, Pachamuthu Balakrishnan, Shanmugam Saravanan
BACKGROUND: Ritonavir-boosted atazanavir (ATV/r) is the preferred second-line protease inhibitor (PI) option for HIV patients in resource-limited settings; its pattern of adverse drug reactions (ADRs) has not been much reported from India; hence, in this study, we have analyzed the incidence of ATV/r-associated ADRs in Southern Indian HIV-1-infected patients. METHODS: In this prospective study, 111 HIV patients treated with ATV/r were included with at least 2 years follow-up visits for the emergence of hyperbilirubinemia, hypertransaminasemia, and serum creatinine elevation...
September 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/27704731/efficacy-and-safety-of-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-in-asian-subjects-with-human-immunodeficiency-virus-1-infection-a-sub-analysis-of-phase-3-clinical-trials
#14
Jun Yong Choi, Somnuek Sungkanuparph, Thanomsak Anekthananon, Paul Sax, Edwin DeJesus, Howard Edelstein, Mark Nelson, Jennifer DeMorin, Hui C Liu, Raji Swamy, Joonwoo Bahn, Sunjin Hwang, Sang Youn Yang, Christopher Ng, David Piontkowsky
The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) were analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naïve and ART-experienced Asian subjects infected with human immunodeficiency virus (HIV)-1. Studies GS-US-236-102 and GS-US-236-103 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naïve subjects, comparing E/C/F/TDF versus efavirenz (EFV)/F/TDF or ritonavir-boosted atazanavir (ATV+RTV) plus emtricitabine/tenofovir DF (F/TDF), respectively...
September 2016: Infection & Chemotherapy
https://www.readbyqxmd.com/read/27704026/changes-in-insulin-resistance-after-initiation-of-raltegravir-or-protease-inhibitors-with-tenofovir-emtricitabine-aids-clinical-trials-group-a5260s
#15
Sahera Dirajlal-Fargo, Carlee Moser, Todd T Brown, Theodoros Kelesidis, Michael P Dube, James H Stein, Judith Currier, Grace A McComsey
Background.  Antiretroviral therapy (ART) can alter glucose metabolism, but little data exist on the association of raltegravir (RAL) with insulin resistance. Methods.  A5260s was a substudy of A5257, a prospective open-label randomized trial in which human immunodeficiency virus (HIV)-infected treatment-naive participants were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or RAL over 96 weeks. Baseline and changes in insulin resistance as estimated by the homeostatic model assessment of insulin resistance (HOMA-IR) were assessed...
September 2016: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/27699054/opsoclonus-myoclonus-ataxia-syndrome-in-an-hiv-infected-child
#16
Noella Maria Delia Pereira, Ira Shah, Shilpa Kulkarni
Opsoclonus-myoclonus-ataxia (OMA) syndrome typically presents with chaotic eye movements and myoclonus with some patients exhibiting ataxia and behavioural disturbances. The pathogenesis may be inflammatory with an infectious or paraneoplastic trigger. We present a 13-year-old HIV-infected girl who was initially started on highly active antiretroviral therapy (HAART) in March 2013 with a CD4 count of 79 cells/cumm. Initially, the patient did not comply with treatment, resulting in a CD4+ count of 77 cells/mm(3) in November 2015 and prompting a new HAART scheme comprising lamivudine, tenofovir and ritonavir-boosted atazanavir...
October 2016: Oxford Medical Case Reports
https://www.readbyqxmd.com/read/27696440/atazanavir-increases-the-plasma-concentrations-of-1200-mg-raltegravir-dose
#17
Rajesh Krishna, Lilly East, Patrick Larson, Chandni Valiathan, Kathleen Deschamps, Julie Ann Luk, Crystal Bethel-Brown, Helen Manthos, John Brejda, Michael Gartner
Raltegravir is a human immunodeficiency virus (HIV)-1 integrase strand transfer inhibitor currently marketed at a dose of 400 mg twice-daily (b.i.d.). Raltegravir 1200 mg once-daily (q.d.) (investigational q.d. formulation of 2 × 600 mg tablets; q.d. RAL) was found to be generally well tolerated and non-inferior to the marketed 400 mg b.i.d. dose at 48 weeks in a phase 3 trial. Since raltegravir is eliminated mainly by metabolism via a uridine diphosphate glucuronosyltransferase (UGT) 1A1-mediated glucuronidation pathway, co-administration of UGT1A1 inhibitors may increase the plasma levels of q...
December 2016: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/27689417/immunovirological-efficacy-of-once-daily-maraviroc-plus-ritonavir-boosted-atazanavir-after-48-weeks-in-naive-hiv-infected-patients
#18
Ildefonso Pulido, Miguel Genebat, Ana I Alvarez-Rios, Rebeca S De Pablo-Bernal, Mohammed Rafii-El-Idrissi Benhnia, Yolanda M Pacheco, Ezequiel Ruiz-Mateos, Manuel Leal
Toxicities related to the use of nucleoside analogues have increased the interest in developing nucleoside-sparing regimens, mainly combining protease inhibitors with raltegravir. However, data regarding the use of CCR5-antagonists in this setting and in the naive scenario are scarce. The main objective was to analyze the immunovirological efficacy and tolerability of a low-dose, once-daily, maraviroc (MVC)-containing, nucleoside reverse transcriptase inhibitor-sparing dual therapy compared with standard triple therapy after 48 weeks for naive HIV-infected patients in the routine clinical practice setting...
October 2016: Viral Immunology
https://www.readbyqxmd.com/read/27677263/atazanavir-and-cardiovascular-risk-among-human-immunodeficiency-virus-infected-patients-a-systematic-review
#19
Dominic Chow, Cecilia Shikuma, Corey Ritchings, Muxing Guo, Lisa Rosenblatt
INTRODUCTION: Patients with human immunodeficiency virus (HIV) infection have an increased risk of cardiovascular disease (CVD). While viral suppression with antiretroviral therapy decreases CVD risk overall, several studies have suggested that certain antiretrovirals, particularly certain protease inhibitors, may be associated with an increased relative risk of CVD. In AIDS Clinical Trials Group 5260 s, ritonavir-boosted atazanavir (ATV) was associated with slower atherosclerosis progression compared to ritonavir-boosted darunavir and raltegravir, potentially due to hyperbilirubinemia...
September 27, 2016: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/27665573/evaluation-of-concomitant-antiretrovirals-and-cyp2c9-cyp2c19-polymorphisms-on-the-pharmacokinetics-of-etravirine
#20
Bruce Green, Herta Crauwels, Thomas N Kakuda, Simon Vanveggel, Anne Brochot
BACKGROUND: Etravirine is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretrovirals for treatment-experienced HIV patients ≥6 years of age. Etravirine is primarily metabolized by cytochrome P450 (CYP) 2C9, CYP2C19, and CYP3A. This analysis determined the impact of concomitant antiretrovirals and CYP2C9/CYP2C19 phenotype on the pharmacokinetics of etravirine. METHODS: We used 4728 plasma concentrations from 817 adult subjects collected from four clinical studies to develop the population pharmacokinetic model...
September 24, 2016: Clinical Pharmacokinetics
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