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Efavirenz

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https://www.readbyqxmd.com/read/28323755/cyp2b6-genotype-directed-dosing-is-required-for-optimal-efavirenz-exposure-in-children-3-to-36-months-with-hiv-infection
#1
Carolyn Bolton Moore, Edmund V Capparelli, Pearl Samson, Mutsa Bwakura-Dangarembizi, Patrick Jean-Philippe, Carol Worrell, Barbara Heckman, Lynette Purdue, Stephen A Spector, Alex Benns, William Borkowsky, Amy Loftis, Elizabeth Hawkins, Carole Wallis, Ellen G Chadwick
OBJECTIVES: To determine safety, efficacy and genotypic-specific dose requirements of EFV in children aged 3 - <36 months of age with HIV infection with or without TB co-infection. DESIGN: IMPAACT P1070 was a 24 week prospective cohort trial of EFV (as open capsules) plus two nucleoside reverse transcriptase inhibitors in children with HIV infection 3- < 36 months without tuberculosis (Cohort 1). METHODS: CYP2B6 G516T genotype was determined and intensive PK's were performed at week 2...
March 18, 2017: AIDS
https://www.readbyqxmd.com/read/28321284/gynaecomastia-in-two-men-on-stable-antiretroviral-therapy-who-commenced-treatment-for-tuberculosis
#2
Jeremy D Kratz, Ahmad Y El-Shazly, Santos G Mambuque, Elpidio Demetria, Peter Veldkamp, Timothy S Anderson
Gynaecomastia is a common clinical presentation that varies from benign presentations in stages of human development to hormonal pathology, mainly due to hepatic dysfunction, malignancy, and adverse pharmacologic effects. We describe the development of significant bilateral gynaecomastia after starting treatment for pulmonary tuberculosis (TB) in two males with WHO stage III Human Immunodeficiency Virus (HIV) infection on stable antiretroviral regimens. Emerging reports suggest that distinct hepatic impairment in efavirenz metabolism modulates oestrogenic activity, which may be potentiated by anti-tuberculosis therapy...
December 2016: Malawi Medical Journal: the Journal of Medical Association of Malawi
https://www.readbyqxmd.com/read/28321215/ifn-%C3%AE-inhibits-drug-resistant-hiv-infection-of-macrophages
#3
Xu Wang, He Wang, Man-Qing Liu, Jie-Liang Li, Run-Hong Zhou, Yu Zhou, Yi-Zhong Wang, Wang Zhou, Wen-Zhe Ho
Type III interferons (IFN-λs) have been demonstrated to inhibit a number of viruses, including HIV. Here, we further examined the anti-HIV effect of IFN-λs in macrophages. We found that IFN-λs synergistically enhanced anti-HIV activity of antiretrovirals [azidothymidine (AZT), efavirenz, indinavir, and enfuvirtide] in infected macrophages. Importantly, IFN-λs could suppress HIV infection of macrophages with the drug-resistant strains, including AZT-resistant virus (A012) and reverse transcriptase inhibitor-resistant virus (TC49)...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28320796/effect-of-alcohol-consumption-and-psychosocial-stressors-on-preterm-and-small-for-gestational-age-births-in-hiv-infected-women-in-south-africa-a-cohort-study
#4
Ayesha Sania, Kirsty Brittain, Tamsin K Phillips, Allison Zerbe, Agnes Ronan, Landon Myer, Elaine J Abrams
OBJECTIVES: Psychosocial stressors such as depression and stress, intimate partner violence (IPV) and alcohol use have been linked to preterm and small-for-gestational-age (SGA) births in general populations. The prevalence of psychosocial stressors and alcohol abuse is high in many HIV-infected (HIV+) populations. Our objective was to evaluate the effects of psychosocial stressors and alcohol abuse on birth outcomes in HIV-infected women. METHODS: Antenatal depression and non-specific psychological distress, periconception IPV and alcohol consumption were measured during the second trimester among HIV+ women initiating antiretroviral treatment with efavirenz + emtricitibine + tenofovir in Cape Town, South Africa...
March 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28296019/health-care-provider-communication-training-in-rural-tanzania-empowers-hiv-infected-patients-on-antiretroviral-therapy-to-discuss-adherence-problems
#5
S Erb, E Letang, T R Glass, A Natamatungiro, D Mnzava, H Mapesi, M Haschke, U Duthaler, B Berger, L Muri, J Bader, C Marzolini, L Elzi, T Klimkait, W Langewitz, M Battegay
OBJECTIVES: Self-reported adherence assessment in HIV-infected patients on antiretroviral therapy (ART) is challenging and may overestimate adherence. The aim of this study was to improve the ability of health care providers to elicit patients' reports of nonadherence using a "patient-centred" approach in a rural sub-Saharan African setting. METHODS: A prospective interventional cohort study of HIV-infected patients on ART for ≥ 6 months attending an HIV clinic in rural Tanzania was carried out...
March 13, 2017: HIV Medicine
https://www.readbyqxmd.com/read/28290974/sepsis-mimicker-in-an-human-immunodeficiency-virus-infected-patient
#6
Mackenzie K Morgan, Joshua D Hartzell, Jason M Blaylock
A 22-year-old human immunodeficiency virus-infected male presented with fever, rash, hypotension, and renal insufficiency 18 days following initiation of therapy with an efavirenz-based antiretroviral regimen. Although rash is a common side effect of efavirenz, severe hypersensitivity reactions are rare. Systemic symptoms can include hepatic toxicity and pneumonitis, and in one instance death. Corticosteroids are the mainstay of treatment.
March 2017: Military Medicine
https://www.readbyqxmd.com/read/28289388/hla-b-57-allele-is-associated-with-concomitant-anti-tuberculosis-and-antiretroviral-drugs-induced-liver-toxicity-in-ethiopians
#7
Zelalem Petros, Junko Kishikawa, Eyasu Makonnen, Getnet Yimer, Abiy Habtewold, Eleni Aklillu
Drug-induced liver injury (DILI) is a known adverse effect of both anti-tuberculosis (anti-TB) and antiretroviral (ARV) drugs. Recent studies highlight the implications of genetic predispositions to DILI. We performed a case-control study to identify Human Leukocyte Antigen-B (HLA-B) variant alleles associated with anti-TB and ARV co-treatment induced liver toxicity in Ethiopian TB and HIV co-infected patients. A total of 495 newly diagnosed TB and HIV co-infected patients were enrolled and received rifampicin based anti-TB and efavirenz based ARV therapy...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28276283/novel-fused-pyrimidine-and-isoquinoline-derivatives-as-potent-hiv-1-nnrtis-a-patent-evaluation-of-wo2016105532a1-wo2016105534a1-and-wo2016105564a1
#8
REVIEW
Dongwei Kang, Zhipeng Huo, Gaochan Wu, Jiabao Xu, Peng Zhan, Xinyong Liu
In the three patent applications, the impact of changing the pyrimidine core of the rilpivirine (RPV) to a variety of alternative fused cores was explored, culminating in the identification of a series of conformationally restricted compounds with comparable potencies against WT and mutant HIV-1 strains with those of efavirenz (EFV) and RPV, and higher security in the Human Ether-a-go-go-Related Gene (hERG) assay. Areas covered: The present review provides a fused pyrimidine and isoquinoline derivatives as potent HIV-1 NNRTIs, and highlights the conformational restriction strategies in the development of NNRTIs...
April 2017: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/28259776/switching-from-efavirenz-emtricitabine-and-tenofovir-disoproxil-fumarate-to-tenofovir-alafenamide-coformulated-with-rilpivirine-and-emtricitabine-in-virally-suppressed-adults-with-hiv-1-infection-a-randomised-double-blind-multicentre-phase-3b-non-inferiority
#9
Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Claudia T Martorell, Joseph de Wet, Hans-Jürgen Stellbrink, Jean-Michel Molina, Frank A Post, Ignacio Pérez Valero, Danielle Porter, YaPei Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide is a prodrug that reduces tenofovir plasma concentrations by 90% compared with tenofovir disoproxil fumarate, thereby decreasing bone and renal risks. The coformulation of rilpivirine, emtricitabine, and tenofovir alafenamide has recently been approved, and we aimed to investigate the efficacy, safety, and tolerability of switching to this regimen compared with remaining on coformulated efavirenz, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, placebo-controlled, non-inferiority trial, HIV-1-infected adults were enrolled at 120 hospitals and outpatient clinics in eight countries in North America and Europe...
March 1, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28258984/application-of-design-space-optimization-strategy-to-the-development-of-lc-methods-for-simultaneous-analysis-of-18-antiretroviral-medicines-and-4-major-excipients-used-in-various-pharmaceutical-formulations
#10
Védaste Habyalimana, Jérémie Kindenge Mbinze, Achille Loconon Yemoa, Christelle Waffo, Tidiane Diallo, Nicodème Kalenda Tshilombo, Justin-Léonard Kadima Ntokamunda, Pierre Lebrun, Philippe Hubert, Roland Djang'eing'a Marini
As one of the world's most significant public health challenges in low- and middle-income countries, HIV/AIDS deserves to be treated with appropriate medicines, however which are not spared from counterfeiting. For that, we developed screening and specific HPLC methods that can analyze 18 antiretroviral medicines (ARV) and 4 major excipients. Design of experiments and design space methodology were initially applied for 15 ARV and the 4 excipients with prediction thanks to Monte Carlo simulations and focusing on rapidity and affordability thus using short column and low cost organic solvent (methanol) in gradient mode with 10mM buffer solutions of ammonium hydrogen carbonate...
February 24, 2017: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/28250252/association-of-il10-il4-ifng-and-ctla4-gene-polymorphisms-with-efavirenz-hypersensitivity-reaction-in-patients-infected-with-human-immunodeficiency-virus
#11
Raphael de Oliveira Rodrigues, Silvia Helena Barem Rabenhorst, Paulo Germano de Carvalho, Greyce Luri Sasahara, Luciana Mabel Ferreira Vasconcelos, Érico Antônio Gomes de Arruda, Silvia Fernandes Ribeiro da Silva, Ilana Farias Ribeiro, E Aparecida Tiemi Nagao-Dias
We evaluated IL-10 -592 C/A, IL-4 -589 C/T, IFN-γ +874 A/T, CTLA-4 +49 A/G gene polymorphisms in efavirenz hypersensitivity reaction. A total of 63 HIV-positive patients under treatment at a public hospital were included in the study, of which 21 presented efavirenz hypersensitivity. Patients who presented efavirenz hypersensitivity reaction showed a higher frequency of the IL-10 -592A allele than the controls (p = 0.028). The allele A was associated with increased risk to efavirenz hypersensitivity (OR = 2...
February 28, 2017: Japanese Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28247479/does-efavirenz-replacement-improve-neurological-function-in-treated-hiv-infection
#12
B Payne, T J Chadwick, A Blamire, K N Anderson, J Parikh, J Qian, A M Hynes, J Wilkinson, D A Price
OBJECTIVES: The contribution of specific antiretroviral drugs to cognitive function in HIV-infected people remains poorly understood. Efavirenz (EFV) may plausibly cause cognitive impairment. The objective of this study was therefore to determine whether chronic EFV therapy is a modifier of neurocognitive and neurometabolic function in the setting of suppressive highly active antiretroviral therapy. METHODS: We performed an open-label phase IV controlled trial. Adult subjects who were stable on suppressive EFV therapy for at least 6 months were switched to ritonavir-boosted lopinavir (LPV/r) with no change in the nucleoside reverse transcriptase inhibitor (NRTI) backbone...
March 1, 2017: HIV Medicine
https://www.readbyqxmd.com/read/28243600/systematic-approach-for-the-formulation-and-optimization-of-solid-lipid-nanoparticles-of-efavirenz-by-high-pressure-homogenization-using-design-of-experiments-for-brain-targeting-and-enhanced-bioavailability
#13
Shweta Gupta, Rajesh Kesarla, Narendra Chotai, Ambikanandan Misra, Abdelwahab Omri
The nonnucleoside reverse transcriptase inhibitors, used for the treatment of HIV infections, are reported to have low bioavailability pertaining to high first-pass metabolism, high protein binding, and enzymatic metabolism. They also show low permeability across blood brain barrier. The CNS is reported to be the most important HIV reservoir site. In the present study, solid lipid nanoparticles of efavirenz were prepared with the objective of providing increased permeability and protection of drug due to biocompatible lipidic content and nanoscale size and thus developing formulation having potential for enhanced bioavailability and brain targeting...
2017: BioMed Research International
https://www.readbyqxmd.com/read/28230617/acute-kidney-injury-after-efavirenz-tenofovir-disoproxil-fumarate-emtricitabine-atripla-overdose
#14
Thomas Havenith, David Burger, Maarten J Visschers, Jolanda Schippers, Astrid O Lashof
We describe a patient with acute renal failure and irreversible kidney damage after an overdose with the fixed dose combination of efavirenz/tenofovir disoproxil fumarate/emtricitabine (Atripla). The acute kidney injury was most probably caused by tenofovir. Efavirenz and emtricitabine seemed relatively safe in overdose. The pharmacokinetics in overdose of all 3 drugs and the effect of hemodialysis on the tenofovir clearance were studied by measuring the plasma concentrations and by the use of clinical pharmacokinetic software...
April 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28225830/ex-vivo-activation-of-cd4-t-cells-from-donors-on-suppressive-art-can-lead-to-sustained-production-of-infectious-hiv-1-from-a-subset-of-infected-cells
#15
John K Bui, Elias K Halvas, Elizabeth Fyne, Michele D Sobolewski, Dianna Koontz, Wei Shao, Brian Luke, Feiyu F Hong, Mary F Kearney, John W Mellors
The fate of HIV-infected cells after reversal of proviral latency is not well characterized. Simonetti, et al. recently showed that CD4+ T-cells containing intact proviruses can clonally expand in vivo and produce low-level infectious viremia. We hypothesized that reversal of HIV latency by activation of CD4+ T-cells can lead to the expansion of a subset of virus-producing cells rather than their elimination. We established an ex vivo cell culture system involving stimulation of CD4+ T-cells from donors on suppressive antiretroviral therapy (ART) with PMA/ionomycin (day 1-7), followed by rest (day 7-21), and then repeat stimulation (day 21-28), always in the presence of high concentrations of raltegravir and efavirenz to effectively block new cycles of viral replication...
February 2017: PLoS Pathogens
https://www.readbyqxmd.com/read/28222098/multicenter-study-of-skin-rashes-and-hepatotoxicity-in-antiretroviral-na%C3%A3-ve-hiv-positive-patients-receiving-non-nucleoside-reverse-transcriptase-inhibitor-plus-nucleoside-reverse-transcriptase-inhibitors-in-taiwan
#16
Pei-Ying Wu, Chien-Yu Cheng, Chun-Eng Liu, Yi-Chien Lee, Chia-Jui Yang, Mao-Song Tsai, Shu-Hsing Cheng, Shih-Ping Lin, De-Yu Lin, Ning-Chi Wang, Yi-Chieh Lee, Hsin-Yun Sun, Hung-Jen Tang, Chien-Ching Hung
OBJECTIVES: Two nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) plus 1 non-NRTI (nNRTI) remain the preferred or alternative combination antiretroviral therapy (cART) for antiretroviral-naive HIV-positive patients in Taiwan. The three most commonly used nNRTIs are nevirapine (NVP), efavirenz (EFV) and rilpivirine (RPV). This study aimed to determine the incidences of hepatotoxicity and skin rashes within 4 weeks of initiation of cART containing 1 nNRTI plus 2 NRTIs. METHODS: Between June, 2012 and November, 2015, all antiretroviral-naive HIV-positive adult patients initiating nNRTI-containing cART at 8 designated hospitals for HIV care were included in this retrospective observational study...
2017: PloS One
https://www.readbyqxmd.com/read/28213595/qualitative-study-of-the-breather-trial-short-cycle-antiretroviral-therapy-is-it-acceptable-to-young-people-living-with-hiv
#17
Sarah Bernays, Sara Paparini, Janet Seeley, Stella Namukwaya Kihika, Diana Gibb, Tim Rhodes
OBJECTIVES: A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8-24) living with HIV with viral load <50 c/mL to examine adaptation, acceptability and experience of SCT to inform intervention development. SETTING: Paediatric HIV clinics in the UK (2), Ireland (1), the USA (1) and Uganda (1)...
February 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28207816/hiv-drug-therapy-duration-a-swedish-real-world-nationwide-cohort-study-on-infcarehiv-2009-2014
#18
Amanda Häggblom, Stefan Lindbäck, Magnus Gisslén, Leo Flamholc, Bo Hejdeman, Andreas Palmborg, Amy Leval, Eva Herweijer, Sverrir Valgardsson, Veronica Svedhem
BACKGROUND: As HIV infection needs a lifelong treatment, studying drug therapy duration and factors influencing treatment durability is crucial. The Swedish database InfCareHIV includes high quality data from more than 99% of all patients diagnosed with HIV infection in Sweden and provides a unique opportunity to examine outcomes in a nationwide real world cohort. METHODS: Adult patients who started a new therapy defined as a new 3rd agent (all antiretrovirals that are not N[t]RTIs) 2009-2014 with more than 100 observations in treatment-naive or treatment-experienced patients were included...
2017: PloS One
https://www.readbyqxmd.com/read/28198788/high-rates-of-baseline-drug-resistance-and-virologic-failure-among-art-na%C3%A3-ve-hiv-infected-children-in-mali
#19
Claudia S Crowell, Almoustapha I Maiga, Mariam Sylla, Babafemi Taiwo, Niaboula Kone, Assaf P Oron, Robert L Murphy, Anne-Geneviève Marcelin, Ban Traore, Djeneba B Fofana, Gilles Peytavin, Ellen G Chadwick
BACKGROUND: Limited data exist on drug resistance and antiretroviral treatment (ART) outcomes in HIV-1 infected children in West Africa. We determined the prevalence of baseline resistance and correlates of virologic failure (VF) in a cohort of ART naïve HIV-1 infected children <10 years of age initiating ART in Mali. METHODS: Reverse transcriptase and protease genes were sequenced at baseline (before ART) and at 6 months. Resistance was defined according to the Stanford HIV Genotypic Resistance database...
February 13, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28194792/semisimultaneous-midazolam-administration-to-evaluate-the-time-course-of-cyp3a-activation-by-a-single-oral-dose-of-efavirenz
#20
Gerd Mikus, Tilman Heinrich, Julia Bödigheimer, Claudia Röder, Anne-Kathrin Matthee, Johanna Weiss, Jürgen Burhenne, Walter E Haefeli
This study aimed to assess whether a single oral dose of the nonnucleoside reverse transcriptase inhibitor efavirenz can alter CYP3A in vivo. In 12 healthy participants individual CYP3A activity was quantified using a semisimultaneous methodology (midazolam orally and 6 hours later intravenously) both alone and during a period of 22 days after a single oral dose of 400 mg efavirenz. Twelve hours after efavirenz administration, midazolam apparent oral clearance was significantly increased by 70%, and midazolam systemic clearance after intravenous administration was significantly increased by 27%...
February 14, 2017: Journal of Clinical Pharmacology
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