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Hiv and pharmacokinetics

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https://www.readbyqxmd.com/read/27895236/a-review-of-single-tablet-regimens-for-the-treatment-of-hiv-1-infection
#1
REVIEW
Jamielynn C Sebaaly, Denise Kelley
OBJECTIVE: To review the pharmacokinetics, safety, drug-drug interactions, and advantages and disadvantages of currently available single-tablet regimens (STRs) for HIV-1 infection. DATA SOURCES: A search using PubMed was conducted (up to September 2016) using the following keywords: single tablet regimen AND HIV Additionally, a PubMed search was conducted for each individual STR using the generic names of the agents. Articles were evaluated for content, and additional references were identified from a review of literature citations...
November 27, 2016: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/27895016/are-prophylactic-and-therapeutic-target-concentrations-different-the-case-of-lopinavir-ritonavir-or-lamivudine-administered-to-infants-for-the-prevention-of-mother-to-child-hiv-1-transmission-during-breastfeeding
#2
Frantz Foissac, Jörn Blume, Jean-Marc Tréluyer, Thorkild Tylleskär, Chipepo Kankasa, Nicolas Meda, James K Tumwine, Mandisa Singata-Madliki, Kim Harper, Silvia M Illamola, Naïm Bouazza, Nicolas Nagot, Philippe Van de Perre, Stéphane Blanche, Déborah Hirt
The ANRS 12174 trial assessed the efficacy and tolerance of LPV/r versus 3TC prophylaxis administered to breastfed infants, whose HIV-infected mothers were not on ART. In this sub-study, we assessed LPV/r and 3TC pharmacokinetics to evaluate the percentage of infants with therapeutic plasma concentrations and to discuss these data in the context of a prophylactic treatment. Infants from the South African trial site underwent blood sampling for pharmacokinetic study at week 6, 26 and 38 of life. We applied a Bayesian approach to derive the 3TC and LPV pharmacokinetic parameters based on previously published pharmacokinetic models for HIV-infected children...
November 28, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27891651/developing-a-bayesian-adaptive-design-for-a-phase-i-clinical-trial-a-case-study-for-a-novel-hiv-treatment
#3
Alexina J Mason, Juan Gonzalez-Maffe, Killian Quinn, Nicki Doyle, Ken Legg, Peter Norsworthy, Roy Trevelion, Alan Winston, Deborah Ashby
The design of phase I studies is often challenging, because of limited evidence to inform study protocols. Adaptive designs are now well established in cancer but much less so in other clinical areas. A phase I study to assess the safety, pharmacokinetic profile and antiretroviral efficacy of C34-PEG4 -Chol, a novel peptide fusion inhibitor for the treatment of HIV infection, has been set up with Medical Research Council funding. During the study workup, Bayesian adaptive designs based on the continual reassessment method were compared with a more standard rule-based design, with the aim of choosing a design that would maximise the scientific information gained from the study...
November 27, 2016: Statistics in Medicine
https://www.readbyqxmd.com/read/27888453/evaluation-of-nucleoside-reverse-transcriptase-inhibitor-dosing-during-continuous-veno-venous-hemofiltration
#4
Milena M McLaughlin, Inela Masic, Lana Gerzenshtein
Background Unpredictable drug concentrations may lead to suboptimal exposure to nucleoside reverse transcriptase inhibitors (NRTIs) due to inadequate doses administered during continuous veno-venous hemofiltration (CVVH), which in turn may lead to decreased antiretroviral efficacy and possibly further HIV disease progression. Objective To compare administered doses of NRTIs to calculated doses of NRTIs to evaluate if patients were expected to have a favorable pharmacokinetic exposure profile while receiving CVVH...
November 25, 2016: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/27872071/results-of-a-doravirine-atorvastatin-drug-drug-interaction-study
#5
Sauzanne Khalilieh, Ka Lai Yee, Rosa I Sanchez, Ilias Triantafyllou, Li Fan, Noha Maklad, Heather Jordan, Maureen Martell, Marian Iwamoto
Doravirine is a novel, highly potent, once-daily non-nucleoside reverse transcriptase inhibitor in development for HIV-1 infection treatment. In vitro and clinical data suggest doravirine is unlikely to cause significant drug-drug interactions via major drug metabolizing enzymes or transporters. As a common HIV-1 infection comorbidity, hypercholesterolemia is often treated with statins, including the commonly prescribed atorvastatin. Atorvastatin is subject to drug-drug interactions with CYP3A4 inhibitors. Increased exposure due to CYP3A4 inhibition may lead to serious adverse events (AEs), including rhabdomyolysis...
November 21, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27872069/an-evaluation-of-doravirine-pharmacokinetics-when-switching-from-efavirenz-to-doravirine-in-healthy-subjects
#6
Ka Lai Yee, Rosa I Sanchez, Patrice Auger, Rachael Liu, Li Fan, Ilias Triantafyllou, Ming-Tain Lai, Mike Di Spirito, Marian Iwamoto, Sauzanne G Khalilieh
Doravirine is a novel, potent, human immunodeficiency virus-1 (HIV-1) non-nucleoside reverse transcriptase inhibitor (NNRTI) demonstrating a high genetic barrier to resistance and is well tolerated in studies to date. Doravirine is a candidate for patients switching from less-tolerated NNRTIs, such as efavirenz. While doravirine is a CYP3A4 substrate, efavirenz induces CYP3A4; therefore, the pharmacokinetics of both drugs following switching from efavirenz to doravirine were assessed.This was a 3-period, fixed-sequence, open-label study...
November 21, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27863194/pomalidomide-for-symptomatic-kaposi-s-sarcoma-in-people-with-and-without-hiv-infection-a-phase-i-ii-study
#7
Mark N Polizzotto, Thomas S Uldrick, Kathleen M Wyvill, Karen Aleman, Cody J Peer, Margaret Bevans, Irini Sereti, Frank Maldarelli, Denise Whitby, Vickie Marshall, Priscila H Goncalves, Vikram Khetani, William D Figg, Seth M Steinberg, Jerome B Zeldis, Robert Yarchoan
Purpose Kaposi's sarcoma (KS) is a multicentric tumor caused by Kaposi's sarcoma-associated herpesvirus. Unmet needs include therapies that are oral, anthracycline sparing, and deliverable in resource-limited settings. We evaluated pomalidomide, an oral immune modulatory agent, in patients with symptomatic KS. Methods The primary objectives were to assess tolerability, pharmacokinetics, and activity. Initial dosage level was 5 mg once per day for 21 days per 28-day cycle, with a de-escalated level of 3 mg if not tolerable, and aspirin 81 mg once per day thromboprophylaxis...
December 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27863179/population-pharmacokinetics-of-bedaquiline-and-metabolite-m2-in-patients-with-drug-resistant-tuberculosis-the-effect-of-time-varying-weight-and-albumin
#8
E M Svensson, A-G Dosne, M O Karlsson
Albumin concentration and body weight are altered in patients with multidrug-resistant tuberculosis (MDR-TB) and change during the long treatment period, potentially affecting drug disposition. We here describe the pharmacokinetics (PKs) of the novel anti-TB drug bedaquiline and its metabolite M2 in 335 patients with MDR-TB receiving 24 weeks of bedaquiline on top of a longer individualized background regimen. Semiphysiological models were developed to characterize the changes in weight and albumin over time...
November 8, 2016: CPT: Pharmacometrics & Systems Pharmacology
https://www.readbyqxmd.com/read/27858268/misreporting-of-product-adherence-in-the-mtn-003-voice-trial-for-hiv-prevention-in-africa-participants-explanations-for-dishonesty
#9
Elizabeth T Montgomery, B Mensch, P Musara, M Hartmann, K Woeber, J Etima, A van der Straten
Consistent over-reporting of product use limits researchers' ability to accurately measure adherence and estimate product efficacy in HIV prevention trials. While lying is a universal characteristic of the human condition, growing evidence of a stark discrepancy between self-reported product use and biologic or pharmacokinetic evidence demands examination of the reasons research participants frequently misrepresent product use in order to mitigate this challenge in future research. This study (VOICE-D) was an ancillary post-trial study of the vaginal and oral interventions to control the epidemic (VOICE) phase IIb trial (MTN 003)...
November 17, 2016: AIDS and Behavior
https://www.readbyqxmd.com/read/27855070/pharmacokinetics-of-the-first-line-antituberculosis-drugs-in-ghanaian-children-with-tuberculosis-with-and-without-hiv-coinfection
#10
Sampson Antwi, Hongmei Yang, Anthony Enimil, Anima M Sarfo, Fizza S Gillani, Daniel Ansong, Albert Dompreh, Antoinette Orstin, Theresa Opoku, Dennis Bosumtwe, Lubbe Wiesner, Jennifer Norman, Charles A Peloquin, Awewura Kwara
Although human immunodefiency virus (HIV) coinfection is the most important risk factor for poor antituberculosis (anti-TB) treatment response, its effect on the pharmacokinetics of the first-line drugs in children is understudied. This study examined the pharmacokinetics of the four first-line anti-TB drugs in children with tuberculosis (TB) with and without HIV coinfection. Ghanaian children with TB on isoniazid, rifampin, pyrazinamide and ethambutol for at least 4 weeks had blood samples collected at pre-dose, 1, 2, 4, and 8-hours post-dose...
November 14, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27843352/profile-of-once-daily-darunavir-cobicistat-fixed-dose-combination-for-the-treatment-of-hiv-aids
#11
REVIEW
Jordi Navarro, Adrian Curran
Efficacy is the main objective of antiretroviral treatment and adherence is one of the cornerstones to achieve it. For this reason, treatment simplification is of key importance with regard to antiretroviral regimens. Rezolsta® (darunavir/cobicistat) is the first fixed-dose combination containing a protease inhibitor approved for HIV treatment. This coformulation includes darunavir, a protease inhibitor that has shown its efficacy and safety in naïve and treatment-experienced patients, and cobicistat, the new pharmacokinetic enhancer that is expected to replace ritonavir...
2016: HIV/AIDS: Research and Palliative Care
https://www.readbyqxmd.com/read/27832147/model-linking-plasma-and-intracellular-tenofovir-emtricitabine-with-deoxynucleoside-triphosphates
#12
Xinhui Chen, Sharon M Seifert, Jose R Castillo-Mancilla, Lane R Bushman, Jia-Hua Zheng, Jennifer J Kiser, Samantha MaWhinney, Peter L Anderson
The coformulation of the nucleos(t)ide analogs (NA) tenofovir (TFV) disoproxil fumarate (TDF) and emtricitabine (FTC) is approved for HIV-infection treatment and prevention. Plasma TFV and FTC undergo complicated hybrid processes to form, accumulate, and retain as their active intracellular anabolites: TFV-diphosphate (TFV-DP) and FTC-triphosphate (FTC-TP). Such complexities manifest in nonlinear intracellular pharmacokinetics (PK). In target cells, TFV-DP/FTC-TP compete with endogenous deoxynucleoside triphosphates (dNTP) at the active site of HIV reverse transcriptase, underscoring the importance of analog:dNTP ratios for antiviral efficacy...
2016: PloS One
https://www.readbyqxmd.com/read/27809557/comparison-of-dapivirine-vaginal-gel-and-film-formulation-pharmacokinetics-and-pharmacodynamics-fame-02b
#13
Jennifer A Robinson, Mark A Marzinke, Rahul P Bakshi, Edward J Fuchs, Christine Radebaugh, Wutyi S Aung, Hans Spiegel, Jenell S Coleman, Lisa C Rohan, Craig W Hendrix
Objective While pre-exposure prophylaxis with oral tenofovir/emtricitabine reduces HIV acquisition rates, poor adherence to and acceptability of vaginal gels and the potential for evolving drug resistance has led to development of vaginal film formulations and other antiretroviral drugs, respectively, including the non-nucleoside reverse transcriptase inhibitor dapivirine. Study Design In this two-arm, cross-over study of a novel fast-dissolving dapivirine film and a previously studied semisolid dapivirine gel, 10 healthy women received a single 1...
November 3, 2016: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/27799217/population-pharmacokinetics-and-pharmacogenetics-analysis-of-rilpivirine-in-hiv-1-infected-individuals
#14
Manel Aouri, Catalina Barcelo, Monia Guidi, Margalida Rotger, Matthias Cavassini, Cédric Hizrel, Thierry Buclin, Laurent A Decosterd, Chantal Csajka
BACKGROUND: Rilpivirine (RPV), the latest non nucleoside reverse transcriptase inhibitor active against HIV-1, is prescribed in a standard dosage of 25 mg once a day in combination with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The aim of this observational study was to characterize RPV pharmacokinetic profile, to quantify interpatient variability and to identify potential factors that could influence drug exposure. METHODS: RPV concentrations data were collected from HIV patients as part of routine therapeutic drug monitoring performed in our centre...
October 31, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27799204/population-pharmacokinetic-modeling-to-estimate-the-contribution-of-genetic-and-non-genetic-factors-of-efavirenz-disposition
#15
Jason D Robarge, Ingrid F Metzger, Jessica Lu, Nancy Thong, Todd C Skaar, Zeruesenay Desta, Robert R Bies
Efavirenz pharmacokinetics is characterized by large between-subject variability, which determines both therapeutic response and adverse effects. Some of the variability in efavirenz pharmacokinetics has been attributed to genetic variability in cytochrome P450 genes that alter efavirenz metabolism, such as CYP2B6 and CYP2A6 While the effects of additional patient factors have been studied, such as sex, weight, and body mass index, the extent to which they contribute to variability in efavirenz exposure is inconsistently reported...
October 31, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27799203/food-effect-on-pharmacokinetic-parameters-of-abx464-administered-orally-a-randomized-trial-in-healthy-male-subjects
#16
Didier Scherrer, Regine Rouzier, Marine Cardona, P Noel Barrett, Jean-Marc Steens, Paul Gineste, Robert L Murphy, Jamal Tazi, Hartmut J Ehrlich
ABX464 is an antiviral which provides a novel approach to the reduction and control of HIV infection. Investigation of food influence is an important criterion to optimize for treatment. An open-label, food-effect, randomized study was carried out which included 2 groups of 24 subjects each to assess the bioavailability and safety of single (Group 1) and repeated (Group 2) oral doses of ABX464 (50mg) in fed or fasted conditions.Cmax and AUC0-∞ of ABX464 were demonstrated to increase with food after a single dose of ABX464 (219% and 188%, respectively)...
October 31, 2016: Antimicrobial Agents and Chemotherapy
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
#17
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/27798550/bone-age-and-mineral-density-assessments-using-plain-roentgenograms-in-tenofovir-exposed-infants-in-malawi-and-brazil-enrolled-in-hiv-prevention-trials-network-hptn-057
#18
Luiz Eduardo Osorio, Maria Ines Boechat, Mark Mirochnick, Newton Kumwenda, Regis Kreitchmann, Lynda Emel, Jorge Pinto, Esau Joao, Breno Santos, Molly Swenson, Kathleen George, Paul Sato, Lynne Mofenson, Karin Nielsen-Saines
BACKGROUND: Tenofovir disoproxil fumarate (TDF) use during pregnancy has been increasing and studies linking bone toxicity with exposure to TDF have raised concern for its use in infants. METHODS: Hand/wrist and spine radiographs were obtained at 3 days and 12 weeks of age in infants born to HIV-infected pregnant women enrolled in the HIV Prevention Trials Network (HPTN) 057 pharmacokinetic study of TDF conducted in Malawi and Brazil assigned to three TDF dosing cohorts...
October 27, 2016: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27798496/how-recent-findings-on-the-pharmacokinetics-and-pharmacodynamics-of-integrase-inhibitors-can-inform-clinical-use
#19
Emilie Elliot, Mimie Chirwa, Marta Boffito
PURPOSE OF REVIEW: This review of recent published literature and data presented at scientific meetings on integrase stand transfer inhibitors (InSTIs) examines how these findings may impact on their future clinical use. RECENT FINDINGS: Elvitegravir (EVG), raltegravir (RAL) and dolutegravir (DTG) are InSTIs recommended as first-line options for treatment naive patients by the European AIDS Clinical Society, British HIV Association, International AIDS Society-USA and DHHS...
October 27, 2016: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/27797606/rilpivirine-emtricitabine-and-tenofovir-alafenamide-single-tablet-combination-for-the-treatment-of-hiv-1-infection-in-selected-patients
#20
Onyema Ogbuagu
Co-formulated rilpivirine, emtricitabine and tenofovir alafenamide (RPV/F/TAF) is the 6(th) single-tablet combination antiretroviral medication approved within the past decade for the treatment of HIV-1 infection. It was approved based on positive bioequivalence studies with already approved drugs with its component compounds, RPV and the single tablet regimen- elvitegravir, cobicistat, F/TAF. Areas covered: This article reviews the chemical, pharmacodynamic and pharmacokinetic properties, key drug interactions, and the efficacy, safety, tolerability and optimal clinical uses of the medication and/or its components in different patient populations...
October 31, 2016: Expert Review of Anti-infective Therapy
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