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Hiv and pharmacokinetics

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https://www.readbyqxmd.com/read/29351333/simultaneous-quantification-of-four-antiretroviral-drugs-in-breast-milk-samples-from-hiv-positive-women-by-an-ultra-high-performance-liquid-chromatography-tandem-mass-spectrometry-uplc-ms-ms-method
#1
Alicia Ramírez-Ramírez, Elías Sánchez-Serrano, Giselle Loaiza-Flores, Noemí Plazola-Camacho, Rosa Georgina Rodríguez-Delgado, Ricardo Figueroa-Damián, Mauricio Domínguez-Castro, Margarita López-Martínez, Zayra Flores-García, Jessica Hernández-Pineda
The primary strategy to avoid mother-to-child transmission of human immunodeficiency virus (HIV) through breastfeeding is administration of highly active antiretroviral therapy (HAART) to HIV-positive pregnant women. Because significant changes in the pharmacokinetics of antiretroviral (ARV) drugs occur during pregnancy, quantifying HAART and the viral load in breast milk in this population is essential. Here, we developed an analytical assay for the simultaneous quantification of four ARV drugs in breast milk using ultra-performance liquid chromatography coupled to tandem mass spectrometry...
2018: PloS One
https://www.readbyqxmd.com/read/29347858/where-are-we-with-injectables-against-hiv-infection-and-what-are-the-remaining-challenges
#2
Said A Hassounah, Thibault Mesplède
Drug adherence has been a recurring issue in the field of HIV treatment, and low treatment adherence is typically associated with emergence of drug resistance, treatment failure and increased risks of transmission. Injectable antiretroviral drugs offer a unique opportunity to counter this issue for the treatment of HIV-positive individuals. In addition, injectables offer a remarkable opportunity to reduce new HIV infections, if applied in the context of both treatment-as-prevention and pre-exposure prophylaxis...
January 19, 2018: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/29345598/dolutegravir-related-neurological-adverse-events-a-case-report-of-successful-management-with-therapeutic-drug-monitoring
#3
Francois Parant, Patrick Miailhes, Florence Brunel, Marie-Claude Gagnieu
Dolutegravir (DTG), a highly effective second-generation HIV integrase inhibitor with high genetic barrier to resistance, has shown excellent tolerability and safety profiles in clinical trials. However, some patients may experience neurological or psychiatric adverse effects leading to DTG discontinuation. This report describes a case of 29-year-old woman who developed neurological adverse events after starting the DTG-based antiretroviral therapy. Serum DTG concentrations were supra-therapeutic which has required a dosing interval adjustment...
January 16, 2018: Current Drug Safety
https://www.readbyqxmd.com/read/29342239/hplc-estimation-ex-vivo-everted-sac-permeability-and-in-vivo-pharmacokinetic-studies-of-darunavir
#4
Vasanti M Suvarna, Preeti C Sangave
Darunavir ethanolate (DRV) is an efficient protease inhibitor (PI) used in the treatment of human immunodeficiency virus (HIV) type-1 patients. An isocratic reversed-phase HPLC method was developed to monitor concentration of darunavir in in vitro intestinal fluid samples in everted sac absorption model in the presence of bioenhancers, viz., piperine, quercetin, naringenin. The method was validated and successfully applied to everted sac and pharmacokinetic studies in rats. The absorption profiles of DRV and apparent permeability coefficients were determined...
January 12, 2018: Journal of Chromatographic Science
https://www.readbyqxmd.com/read/29335895/pharmacokinetics-antiviral-activity-and-safety-of-rilpivirine-in-pregnant-women-with-hiv-1-infection-results-of-a-phase-3b-multicenter-open-label-study
#5
Olayemi Osiyemi, Salih Yasin, Carmen Zorrilla, Ceyhun Bicer, Vera Hillewaert, Kimberley Brown, Herta M Crauwels
INTRODUCTION: Physiologic changes during pregnancy may impact the pharmacokinetics of drugs. In addition, efficacy and safety/tolerability concerns have been identified for some antiretroviral agents. METHODS: Human immunodeficiency virus (HIV)-1-infected pregnant women (18-26 weeks gestation) receiving the non-nucleoside reverse transcriptase inhibitor rilpivirine 25 mg once daily were enrolled in this phase 3b, open-label study examining the impact of pregnancy on the pharmacokinetics of rilpivirine when it is given in combination with other antiretroviral agents...
January 15, 2018: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/29302757/indinavir-alters-the-pharmacokinetics-of-lamivudine-partially-via-inhibition-of-multidrug-and-toxin-extrusion-protein-1-mate1
#6
Qing Li, Zhi Ye, Peng Zhu, Dong Guo, Hong Yang, Jin Huang, Wei Zhang, James E Polli, Yan Shu
PURPOSE: Lamivudine, a characterized substrate for human multidrug and toxin extrusion protein 1 (hMATE1) in vitro, was commonly used with indinavir as a therapy against human immunodeficiency virus (HIV). We aimed to investigate whether mouse MATE1 is involved in the disposition of lamivudine in vivo, and whether there is any transporter-mediated interaction between indinavir and lamivudine. METHODS: The role of MATE1 in the disposition of lamivudine was determined using Mate1 wild type (+/+) and knockout (-/-) mice...
January 4, 2018: Pharmaceutical Research
https://www.readbyqxmd.com/read/29285948/translation-of-combination-nanodrugs-into-nanomedicines-lessons-learned-and-future-outlook
#7
Qingxin Mu, Jesse Yu, Lisa A McConnachie, John C Kraft, Yu Gao, Gaurav K Gulati, Rodney J Y Ho
The concept of nanomedicine is not new. For instance, some nanocrystals and colloidal drug molecules are marketed that improve pharmacokinetic characteristics of single-agent therapeutics. For the past two decades, the number of research publications on single-agent nanoformulations has grown exponentially. However, formulations advancing to preclinical and clinical evaluations that lead to therapeutic products has been limited. Chronic diseases such as cancer and HIV/AIDS require drug combinations, not single agents, for durable therapeutic responses...
December 29, 2017: Journal of Drug Targeting
https://www.readbyqxmd.com/read/29282567/demonstration-of-direct-nose-to-brain-transport-of-unbound-hiv-1-replication-inhibitor-db213-via-intranasal-administration-by-pharmacokinetic-modeling
#8
Qianwen Wang, Yufeng Zhang, Chun-Ho Wong, H Y Edwin Chan, Zhong Zuo
Intranasal administration could be an attractive alternative route of administration for the delivery of drugs to the central nervous system (CNS). However, there are always doubts about the direct transport of therapeutics from nasal cavity to the CNS since there are only limited studies on the understanding of direct nose-to-brain transport. Therefore, this study aimed to (1) investigate the existence of nose-to-brain transport of intranasally administered HIV-1 replication inhibitor DB213 and (2) assess the direct nose-to-brain transport of unbound HIV-1 replication inhibitor DB213 quantitatively by a pharmacokinetic approach...
December 27, 2017: AAPS Journal
https://www.readbyqxmd.com/read/29279368/from-in-silico-hit-to-long-acting-late-stage-preclinical-candidate-to-combat-hiv-1-infection
#9
Shalley N Kudalkar, Jagadish Beloor, Elias Quijano, Krasimir A Spasov, Won-Gil Lee, José A Cisneros, W Mark Saltzman, Priti Kumar, William L Jorgensen, Karen S Anderson
The HIV-1 pandemic affecting over 37 million people worldwide continues, with nearly one-half of the infected population on highly active antiretroviral therapy (HAART). Major therapeutic challenges remain because of the emergence of drug-resistant HIV-1 strains, limitations because of safety and toxicity with current HIV-1 drugs, and patient compliance for lifelong, daily treatment regimens. Nonnucleoside reverse transcriptase inhibitors (NNRTIs) that target the viral polymerase have been a key component of the current HIV-1 combination drug regimens; however, these issues hamper them...
December 26, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29258331/specimen-processing-impacts-tissue-tenofovir-pk-measurements
#10
Rahul P Bakshi, Jennifer C Breakey, Madhuri Manohar, Bhavna Jois, Edward J Fuchs, Mark A Marzinke
Antiretroviral drug concentrations at sites of HIV exposure are important drivers that influence the development HIV pre-exposure chemoprophylaxis strategies and regimens. We assessed the effect of collection method - in the presence or absence of tissue culture media - on tenofovir (TFV) and tenofovir diphosphate (TFV-DP) concentrations in colonic biopsies. We find significant baseline inter-biopsy variation in TFV (38% CV) and TFV-DP (33% CV) concentrations. Incubation in media leads to a fluid absorption-driven 2-fold increase in tissue weight with a concomitant 75% decrease in weight-adjusted tissue TFV concentrations over 120 min...
December 19, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/29247579/peg-interferon-and-ribavirin-treatment-in-hiv-hcv-co-infected-patients-in-thailand-efficacy-safety-and-pharmacokinetics
#11
E J Smolders, N Thammajaruk, C T M M de Kanter, A Colbers, P Chaiyahong, T Cuprasitrut, S Chittmittraprap, T Apornpong, S Khemnark, P Tangkijvanich, D M Burger, A Avihingsanon
OBJECTIVE: In Thailand, 7.2% of HIV patients are co-infected with hepatitis C virus (HCV) and these patients are treated with peg-interferon + ribavirin (PR) for their HCV-infection. This study evaluates efficacy and safety of PR treatment and pharmacokinetics of ribavirin in this population. METHODS: HIV/HCV co-infected Thai patients were treated with PR for 24 or 48 weeks. R plasma concentrations were measured during treatment. Sustained virological response 24 weeks after end of treatment (SVR24) was used to describe efficacy...
December 16, 2017: Tropical Medicine & International Health: TM & IH
https://www.readbyqxmd.com/read/29247506/suboptimal-anti-tuberculosis-drug-concentrations-and-outcomes-in-small-and-hiv-coinfected-children-in-india-recommendations-for-dose-modifications
#12
Benjamin Guiastrennec, Geetha Ramachandran, Mats O Karlsson, A K Hemanth Kumar, Perumal Kannabiran Bhavani, N Poorana Gangadevi, Soumya Swaminathan, Amita Gupta, Kelly E Dooley, Radojka M Savic
This work aimed to evaluate the once-daily anti-tuberculosis treatment as recommended by the new Indian pediatric guidelines. Isoniazid, rifampin and pyrazinamide concentration-time profiles and treatment outcome were obtained from 161 Indian children with drug-sensitive tuberculosis undergoing thrice-weekly dosing as per previous Indian pediatric guidelines. The exposure-response relationships were established using a population pharmacokinetic-pharmacodynamic approach. Rifampin exposure was identified as the unique predictor of treatment outcome...
December 16, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29243133/symptomatic-cerebrospinal-fluid-hiv-1-escape-with-no-resistance-associated-mutations-following-low-level-plasma-viremia
#13
Mattia Trunfio, Sarah Beth Joseph, Valeria Ghisetti, Alessandra Romito, Caterina Martini, Jessica Cusato, Sabrina Audagnotto, Laura Pesci Kincer, Micol Ferrara, Arianna Sala, Daniele Imperiale, Giovanni Di Perri, Andrea Calcagno
The majority of neurologically symptomatic cerebrospinal fluid HIV-1 escape cases are connected with resistance-associated mutations and potentially explained by low cerebrospinal fluid antiretroviral concentrations. However, there are still significant knowledge gaps regarding the physiopathology and long-term management of neurosymptomatic viral escape. We report a case of Parkinson-like syndrome following cerebrospinal fluid HIV-1 escape in a 40-year-old female patient with an history of persistent low-level plasma viremia under treatment...
December 14, 2017: Journal of Neurovirology
https://www.readbyqxmd.com/read/29237008/pharmacokinetics-of-darunavir-cobicistat-and-etravirine-alone-and-co-administered-in-hiv-infected-patients
#14
José Moltó, Adrian Curran, Cristina Miranda, Elizabeth Challenger, José Ramón Santos, Esteban Ribera, Saye Khoo, Marta Valle, Bonaventura Clotet
Objectives: To determine the effect of etravirine on the pharmacokinetics of darunavir/cobicistat and vice versa. Safety and tolerability of this combination were also evaluated. Methods: Open-label, fixed-sequence trial in two cohorts of HIV-infected patients on therapy with darunavir/cobicistat 800/150 mg once daily (DRV cohort; n = 15) or etravirine 400 mg once daily (ETR cohort; n = 15). Etravirine or darunavir/cobicistat were added on days 1-14 and 1-7 in participants in the DRV or ETR cohort, respectively...
December 11, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29227461/population-pharmacokinetics-of-lopinavir-in-severely-malnourished-hiv-infected-children-and-the-effect-on-treatment-outcomes
#15
Moherndran Archary, Helen Mcllleron, Raziya Bobat, Phillip La Russa, Thobekile Sibaya, Lubbe Wiesner, Stefanie Hennig
BACKGROUND: In developing countries, malnutrition remains a common clinical syndrome at antiretroviral treatment (ART) initiation. Physiological changes due to malnutrition and during nutritional recovery could affect the pharmacokinetics of antiretroviral drugs. METHODS: HIV-infected children admitted with severe acute malnutrition were randomised to early or delayed initiation of lopinavir/ritonavir, abacavir and lamivudine using WHO weight-band dosage charts...
December 8, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29218501/evaluating-safety-reporting-in-paediatric-antibiotic-trials-2000-2016-a-systematic-review-and-meta-analysis
#16
REVIEW
Paola Pansa, Yingfen Hsia, Julia Bielicki, Irja Lutsar, A Sarah Walker, Mike Sharland, Laura Folgori
BACKGROUND: There are very few options to treat multidrug-resistant bacterial infections in children. A major barrier is the duration and complexity of regulatory trials of new antibiotics. Extrapolation of safety data from adult trials could facilitate drug development for children. OBJECTIVE: We performed a systematic review on the safety of antibiotic clinical trials (CTs) in children (0-18 years) to evaluate the overall quality of safety trials conducted in children and to determine if age-specific adverse events (AEs) could be identified for specific antibiotic classes...
December 7, 2017: Drugs
https://www.readbyqxmd.com/read/29214737/efficacy-safety-and-patient-reported-outcomes-of-ledipasvir-sofosbuvir-in-ns3-4a-protease-inhibitor-experienced-individuals-with-hepatitis-c-virus-genotype-1-and-hiv-coinfection-with-and-without-cirrhosis-anrs-hc31-softrih-study
#17
E Rosenthal, C Fougerou-Leurent, A Renault, M P Carrieri, F Marcellin, R Garraffo, E Teicher, H Aumaitre, K Lacombe, F Bailly, E Billaud, S Chevaliez, S Dominguez, M A Valantin, J Reynes, A Naqvi, L Cotte, S Metivier, V Leroy, M Dupon, T Allegre, P De Truchis, V Jeantils, J Chas, D Salmon-Ceron, P Morlat, D Neau, P Perré, L Piroth, S Pol, M Bourlière, G P Pageaux, L Alric, D Zucman, P M Girard, I Poizot-Martin, Y Yazdanpanah, F Raffi, E Le Pabic, C Tual, A Pailhé, I Amri, E Bellissant, J M Molina
OBJECTIVES: Studies evaluating the efficacy and safety of the fixed-dose combination ledipasvir (LDV)/sofosbuvir (SOF) in patients coinfected with HIV-1 and hepatitis C virus (HCV) have mainly included treatment-naïve patients without cirrhosis. We aimed to evaluate the efficacy and safety of this combination in treatment-experienced patients with and without cirrhosis. METHODS: We conducted a multicentre, open-label, double-arm, nonrandomized study in patients coinfected with HIV-1 and HCV genotype 1 with and without cirrhosis, who had good viral suppression on their antiretroviral regimens...
December 7, 2017: HIV Medicine
https://www.readbyqxmd.com/read/29210627/pharmacokinetic-analysis-of-nevirapine-extended-release-400%C3%A2-mg-once-daily-vs-nevirapine-immediate-release-200%C3%A2-mg-twice-daily-formulation-in-treatment-na%C3%A3-ve-patients-with-hiv-1-infection
#18
Chan-Loi Yong, Joseph C Gathe, Gabriele Knecht, Catherine Orrell, Josep Mallolas, Daniel Podzamczer, Benoit Trottier, Wei Zhang, John P Sabo, Richard Vinisko, Murray Drulak, Anne-Marie Quinson
BACKGROUND: VERxVE data showed non-inferior virologic efficacy with extended release nevirapine (NVP-XR) dosed 400 mg once daily (QD) versus immediate release nevirapine (NVP-IR) 200 mg twice daily in a double-blind, non-inferiority study in treatment-naïve HIV-1-positive patients. OBJECTIVE: To study the pharmacokinetics (PK) of the NVP formulations and identify possible associations with demographic factors. METHODS: Patients with viral load ≥1000 copies/mL and CD4+ count > 50- <400 cells/mm3 (males) and >50- <250 cells/mm3 (females) at screening received NVP-IR 200 mg QD during a 14-day lead-in and were then stratified by baseline viral load and randomized to NVP-XR or -IR...
November 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/29208244/role-of-nucleoside-transporters-in-transplacental-pharmacokinetics-of-nucleoside-reverse-transcriptase-inhibitors-zidovudine-and-emtricitabine
#19
S Karbanova, L Cerveny, M Ceckova, Z Ptackova, L Jiraskova, S Greenwood, F Staud
INTRODUCTION: Zidovudine (AZT) and emtricitabine (FTC) are effective and well tolerated antiretroviral drugs, routinely used in the prevention of perinatal HIV transmission. However, precise mechanism(s) involved in their transfer from mother to fetus are not fully elucidated. Since both drugs are nucleoside analogues, we hypothesized that the mechanisms of their transplacental passage might include equilibrative nucleoside transporters, ENT1 and/or ENT2. METHODS: To address this issue, we performed in vitro accumulation assays in the BeWo placental trophoblast cell line, ex vivo uptake studies in fresh villous fragments isolated from human placenta and in situ dually perfused rat term placenta experiments...
December 2017: Placenta
https://www.readbyqxmd.com/read/29206748/pharmacokinetics-and-pharmacodynamics-of-atazanavir-in-hiv-1-infected-children-treated-with-atazanavir-powder-and-ritonavir-combined-analysis-of-the-prince-1-and-2-studies
#20
Heather Sevinsky, Luna Zaru, Reena Wang, Xiaohui Xu, Cheryl Pikora, Todd A Correll, Timothy Eley
BACKGROUND: Two clinical studies (PRINCE-1 and -2) in HIV-1-infected children assessed the safety, efficacy, and pharmacokinetics of dual nucleos(t)ide reverse transcriptase inhibitor (NRTI) background therapy plus once-daily atazanavir powder formulation boosted with ritonavir (ATV+RTV). Here, we present a combined analysis of ATV pharmacokinetics and pharmacodynamics across these studies. METHODS: Intensive 24-hour pharmacokinetic profiles at steady state compared ATV exposures (area under the concentration-time curve in one dosing interval [AUCτ]) in 5 ATV+RTV baseline weight-band dosing categories with historic data in adults receiving ATV+RTV 300/100-mg capsules...
December 4, 2017: Pediatric Infectious Disease Journal
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