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Dolutegravir

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https://www.readbyqxmd.com/read/29029135/small-increase-in-dolutegravir-trough-but-equivalent-total-dolutegravir-exposure-with-simeprevir-in-hiv-hcv-seronegative-volunteers
#1
Christine E MacBrayne, Jose Castillo-Mancilla, James R Burton, Samantha MaWhinney, Charlotte B Wagner, Kestutis Micke, Jordan Fey, Ryan T Huntley, Bayli Larson, Lane R Bushman, Jennifer J Kiser
Background: Dolutegravir, an HIV integrase strand-transfer inhibitor, and simeprevir, an HCV NS3/4A PI, have the potential to interact as dolutegravir is a P-glycoprotein, uridine glucuronosyl transferase 1A1 and cytochrome P450 3A substrate and simeprevir has been shown to mildly inhibit these. Objectives: To compare dolutegravir and simeprevir pharmacokinetics (PK) when given separately versus in combination. Methods: Healthy volunteers received: (i) 150 mg of simeprevir once daily for 7 days; (ii) 50 mg of dolutegravir once daily for 7 days; and (iii) 150 mg of simeprevir once daily plus 50 mg of dolutegravir once daily for 7 days, with randomization to treatment sequence...
October 4, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29019353/hot-news-ready-for-hiv-dual-therapy-new-data-from-international-hiv-aids-society-2017
#2
George A Yendewa, Robert A Salata
The introduction of combination antiretroviral therapy (ART) in the 1990s has fundamentally transformed the landscape of HIV medicine, greatly improved disease morbidity and mortality, and reduced transmission rates across all demographic groups. Central to this success was the idea that to achieve best disease outcomes and minimize the development of drug resistance, at least three antiretroviral agents should be used for HIV treatment. This therapeutic strategy is a core tenet of HIV medicine, backed by incontrovertible scientific evidence, and made easy to deploy by the high compliance levels with once-daily coformulations, which have generally been well tolerated...
October 11, 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28969531/kidney-transplant-in-a-human-immunodeficiency-virus-positive-patient-case-report-of-drug-interactions
#3
Mümtaz Yılmaz, Deniz Gökengin, Osman Bozbıyık, Cüneyt Hoşcoşkun, Ayşe Uyan, Hüseyin Töz
End-stage renal disease in the human immunodeficiency virus-positive population is increasing. Kidney transplant is the optimal therapy for this population rather than dialysis modalities if some criteria are met. These include undetectable plasma human immunodeficiency virus RNA, CD4 cell count over 200 cells/μL, and the absence of any AIDS-defining illness. Here, we describe the first living-donor kidney transplant in a human immunodeficiency virus-positive recipient in Turkey. The patient, a 52-year-old male diagnosed as human immunodeficiency virus positive, was on antiretroviral therapy, which consisted of 400 mg twice daily darunavir, 100 mg/day ritonavir, and 50 mg/day dolutegravir...
September 30, 2017: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/28968669/human-immunodeficiency-virus-type-1-drug-resistance-mutations-update
#4
Robert W Shafer
As treatment options coalesce around a smaller number of antiretroviral drugs (ARVs), data are emerging on the drug resistance mutations (DRMs) selected by the most widely used ARVs and on the impact of these DRMs on ARV susceptibility and virological response to first- and later-line treatment regimens. Recent studies have described the DRMs that emerge in patients receiving tenofovir prodrugs, the nonnucleoside reverse transcriptase inhibitors efavirenz and rilpivirine, ritonavir-boosted lopinavir, and the integrase inhibitors raltegravir and elvitegravir...
September 15, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28964268/a-dual-regimen-of-ritonavir-darunavir-plus-dolutegravir-for-rescue-or-simplification-of-rescue-therapy-48%C3%A2-weeks-observational-data
#5
Amedeo F Capetti, Maria Vittoria Cossu, Giancarlo Orofino, Gaetana Sterrantino, Giovanni Cenderello, Giuseppe V De Socio, Anna Maria Cattelan, Alessandro Soria, Stefano Rusconi, Niccolò Riccardi, Gian Maria Baldin, Fosca P Niero, Giorgio Barbarini, Giuliano Rizzardini
BACKGROUND: Dolutegravir (DTG) plus darunavir/ritonavir (DRV/r) is a simple combination of drugs that has the best genetic barrier to HIV-1 resistance and may be fit for salvage therapy. METHODS: All HIV-1-infected subjects treated with DTG plus DRV/r between March 2014 and September 2015 in eight Italian centres were included in the analysis. The main metabolic data, efficacy parameters and safety data routinely collected were provided. This observational study is aimed to assess the efficacy of such approach...
September 30, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28961682/effect-of-cobicistat-on-tenofovir-disoproxil-fumarate-tdf-what-is-true-for-taf-may-also-be-true-for-tdf
#6
Dario Cattaneo, Davide Minisci, Sara Baldelli, Cristina Mazzali, Andrea Giacomelli, Laura Milazzo, Paola Meraviglia, Chiara Resnati, Giuliano Rizzardini, Emilio Clementi, Massimo Galli, Cristina Gervasoni
BACKGROUND: The dose of tenofovir alafenamide (TAF) is reduced from 25 to 10 mg daily when given with boosting agents. However, such dose reduction has never been adopted for tenofovir disoproxil fumarate (TDF). In this study we aim to quantify the effect of cobicistat both on tenofovir concentrations and TDF durability in real life setting. METHODS: HIV-positive patients receiving TDF-containing antiretroviral therapies with at least one assessment of tenofovir plasma trough concentrations were included in the study...
September 25, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28956664/investigational-hiv-integrase-inhibitors-in-phase-i-and-phase-ii-clinical-trials
#7
Yingshan Han, Thibault Mesplède, Mark A Wainberg
To date, three HIV integrase strand transfer inhibitors (INSTIs), i.e. raltegravir, elvitegravir and dolutegravir, have been approved for clinical use. Recent research has focused on new integrase inhibitors including those targeting non-catalytic sites of HIV integrase. Areas covered: This paper reviews two investigational INSTIs in phase I and II clinical trials, bictegravir (BIC) and cabotegravir (CAB), as well as an investigational noncatalytic integrase inhibitor (NCINI) termed BI 224436. Expert opinion: Data from phase I and II clinical trials demonstrate that CAB has good efficacy and is well-tolerated...
November 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28951475/mutations-located-outside-the-integrase-gene-can-confer-resistance-to-hiv-1-integrase-strand-transfer-inhibitors
#8
Isabelle Malet, Frédéric Subra, Charlotte Charpentier, Gilles Collin, Diane Descamps, Vincent Calvez, Anne-Geneviève Marcelin, Olivier Delelis
Resistance to the integrase strand transfer inhibitors raltegravir and elvitegravir is often due to well-identified mutations in the integrase gene. However, the situation is less clear for patients who fail dolutegravir treatment. Furthermore, most in vitro experiments to select resistance to dolutegravir have resulted in few mutations of the integrase gene. We performed an in vitro dolutegravir resistance selection experiment by using a breakthrough method. First, MT4 cells were infected with human immunodeficiency virus type 1 (HIV-1) Lai...
September 26, 2017: MBio
https://www.readbyqxmd.com/read/28948180/safety-and-efficacy-of-ombitasvir-paritaprevir-with-ritonavir-%C3%A2-dasabuvir-with-or-without-ribavirin-in-patients-with-human-immunodeficiency-virus-1-and-hepatitis-c-virus-genotype-1-or-genotype-4-coinfection-turquoise-i-part-2
#9
Jürgen K Rockstroh, Chloe Orkin, Rolando M Viani, David Wyles, Anne F Luetkemeyer, Adriano Lazzarin, Ruth Soto-Malave, Mark R Nelson, Sanjay R Bhagani, Hartwig H F Klinker, Giuliano Rizzardini, Pierre-Marie Girard, Cristina Tural, Nancy S Shulman, Niloufar Mobashery, Yiran B Hu, Linda M Fredrick, Tami Pilot-Matias, Roger Trinh, Edward Gane
BACKGROUND: Ombitasvir, paritaprevir with ritonavir, and dasabuvir (OBV/PTV/r ± DSV) ±ribavirin (RBV) are approved to treat hepatitis C virus (HCV) genotype 1 and 4 infection. Here, we investigate the safety and efficacy of OBV/PTV/r + DSV ±RBV for HCV genotype 1, and OBV/PTV/r + RBV for HCV genotype 4, in human immunodeficiency virus (HIV)-1 coinfected patients with or without compensated cirrhosis. METHODS: TURQUOISE-I, Part 2 is a phase 3 multicenter study...
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28944075/efficacy-of-switching-to-dolutegravir-plus-rilpivirine-the-small-tablet-regimen-in-patients-with-dysphagia-two-case-reports
#10
Takefumi Suzuki, Nobuko Hara, Morichika Osa, Kazuhisa Misawa, Kazuo Imai, Yuji Fujikura, Takuya Maeda, Wataru Sonehara, Akihiko Kawana
BACKGROUND: The advent of well-tolerated and effective anti-retroviral drugs against human immunodeficiency virus-1 (HIV-1) infection has been a major step forward that has achieved long-term survival in recent years. The number of HIV-1 infected patients who experience difficulty in swallowing tablets is expected to increase as the HIV-infected population advances in age or develops comorbidities or treatment sequelae affecting the central nervous system. CASE PRESENTATION: Here, we describe two HIV-1-infected patients who experienced progressive dysphagia leading to inability to swallow the antiretroviral tablets included in the standard regimen...
2017: Journal of Pharmaceutical Health Care and Sciences
https://www.readbyqxmd.com/read/28923862/antiviral-activity-of-bictegravir-and-cabotegravir-against-integrase-inhibitor-resistant-sivmac239-and-hiv-1
#11
Said A Hassounah, Ahmad Alikhani, Maureen Oliveira, Simrat Bharaj, Ruxandra-Ilinca Ibanescu, Nathan Osman, Hong-Tao Xu, Bluma G Brenner, Thibault Mesplède, Mark A Wainberg
Animal models are essential to study novel antiretroviral drugs, resistance-associated mutations (RAMs), and treatment strategies. Bictegravir (BIC) is a novel potent integrase (IN) strand transfer inhibitor (INSTI) that has shown promising results against HIV-1 infection in vitro and in vivo and against clinical isolates with resistance against INSTIs. BIC has a higher genetic barrier to the development of resistance than two clinically approved INSTIs termed raltegravir and elvitegravir. Another clinically approved INSTI, dolutegravir (DTG) also possesses a high genetic barrier to resistance while a fourth compound termed cabotegravir (CAB) is currently in late phases of clinical development...
September 18, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28915895/impact-of-ugt1a1-gene-polymorphisms-on-plasma-dolutegravir-trough-concentrations-and-neuropsychiatric-adverse-events-in-japanese-individuals-infected-with-hiv-1
#12
Hiroki Yagura, Dai Watanabe, Hiroyuki Kushida, Kosuke Tomishima, Hiroaki Togami, Atsushi Hirano, Masaaki Takahashi, Kazuyuki Hirota, Motoko Ikuma, Daisuke Kasai, Yasuharu Nishida, Munehiro Yoshino, Kunio Yamazaki, Tomoko Uehira, Takuma Shirasaka
BACKGROUND: Dolutegravir (DTG) is metabolized mainly by uridine diphosphate (UDP)-glucuronosyltransferase 1A1 (UGT1A1), and partly by cytochrome P450 3A (CYP3A). Therefore, we focused on UGT1A1 gene polymorphisms (*6 and *28) in Japanese individuals infected with human immunodeficiency virus (HIV)-1 to examine the relationship between their plasma trough concentration of DTG and gene polymorphisms. Recently, neuropsychiatric adverse events (NP-AEs) after the use of DTG have become a concern, so the association between UGT1A1 gene polymorphisms and selected NP-AEs was also investigated...
September 16, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28906282/dolutegravir-and-metformin-a-case-of-hyperlactatemia
#13
Mark Naccarato, Deborah Yoong, Ignatius W Fong
No abstract text is available yet for this article.
September 24, 2017: AIDS
https://www.readbyqxmd.com/read/28904329/latest-advances-in-the-efficacy-tolerability-and-monotherapy-of-integrase-inhibitors
#14
Qi Tang, Hongzhou Lu
More than 30 drugs for antiretroviral therapy (ART), including integrase inhibitors (INIs), have been approved by the U.S. Food and Drug Administration (FDA) as of 2017. Integrase is the third essential enzyme in the cycle of human immunodeficiency virus (HIV) replication. INIs can effectively inhibit the replication of HIV and HIV is less prone to develop resistance to INIs clinically. Previous studies based on 7 phase III clinic trials indicate that INIs have satisfactory efficacy and tolerability in patients infected with HIV...
2017: Bioscience Trends
https://www.readbyqxmd.com/read/28901945/correction-dolutegravir-abacavir-lamivudine-versus-current-art-in-virally-suppressed-patients-striiving-a-48-week-randomized-non-inferiority-open-label-phase-iiib-study
#15
Benoît Trottier, Jordan E Lake, Ken Logue, Cynthia Brinson, Lizette Santiago, Clare Brennan, Justin A Koteff, Brian Wynne, Judy Hopking, Catherine Granier, Michael Aboud
No abstract text is available yet for this article.
September 13, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28901212/a-retrospective-clinical-audit-of-general-practices-in-australia-to-determine-the-motivation-for-switch-to-dolutegravir-abacavir-lamivudine-and-clinical-outcomes
#16
Pedro E Ferrer, Mark Bloch, Norman Roth, Robert Finlayson, David Baker, Ken Koh, David Orth, Rimgaile Urbaityte, Dannae Brown, Fraser Drummond
The most common reasons for switching HIV-1 therapy in patients with virologic suppression are treatment regimen simplification and resolving tolerability issues. Single-pill regimens that include an integrase inhibitor are recommended options. A retrospective clinical audit was performed to determine the motivations for switching to dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC) at high HIV-caseload general practice clinics in Australia. The most common reasons for switching from a prior suppressive therapy to DTG/ABC/3TC were simplification of regimen, resolving toxicity/intolerance and patient preference (73%, 13% and 12%, respectively)...
January 1, 2017: International Journal of STD & AIDS
https://www.readbyqxmd.com/read/28884279/primary-hiv-infection-clinical-presentation-testing-and-treatment
#17
REVIEW
Aurélia Henn, Clara Flateau, Sébastien Gallien
PURPOSE OF REVIEW: The purpose of this review was to provide current data on clinical presentation, diagnosis, and treatment of primary HIV infection (PHI). RECENT FINDINGS: In 65 to 95% of cases, PHI causes acute retroviral syndrome presenting with unspecific flu-like symptoms. Symptomatic PHI was associated with a faster clinical and immunological progression of HIV infection. Point-of-care tests remain less sensitive than fourth-generation immunoassays (IA) in PHI, especially after tenofovir-based prophylaxis use...
September 7, 2017: Current Infectious Disease Reports
https://www.readbyqxmd.com/read/28867499/coformulated-bictegravir-emtricitabine-and-tenofovir-alafenamide-versus-dolutegravir-with-emtricitabine-and-tenofovir-alafenamide-for-initial-treatment-of-hiv-1-infection-gs-us-380-1490-a-randomised-double-blind-multicentre-phase-3-non-inferiority-trial
#18
Paul E Sax, Anton Pozniak, M Luisa Montes, Ellen Koenig, Edwin DeJesus, Hans-Jürgen Stellbrink, Andrea Antinori, Kimberly Workowski, Jihad Slim, Jacques Reynes, Will Garner, Joseph Custodio, Kirsten White, Devi SenGupta, Andrew Cheng, Erin Quirk
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) coadministered with two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) are recommended as first-line treatment for HIV, and coformulated fixed-dose combinations are preferred to facilitate adherence. We report 48-week results from a study comparing initial HIV-1 treatment with bictegravir-a novel INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug interactions-coformulated with the NRTI combination emtricitabine and tenofovir alafenamide as a fixed-dose combination to dolutegravir administered with coformulated emtricitabine and tenofovir alafenamide...
August 31, 2017: Lancet
https://www.readbyqxmd.com/read/28867497/bictegravir-emtricitabine-and-tenofovir-alafenamide-versus-dolutegravir-abacavir-and-lamivudine-for-initial-treatment-of-hiv-1-infection-gs-us-380-1489-a-double-blind-multicentre-phase-3-randomised-controlled-non-inferiority-trial
#19
Joel Gallant, Adriano Lazzarin, Anthony Mills, Chloe Orkin, Daniel Podzamczer, Pablo Tebas, Pierre-Marie Girard, Indira Brar, Eric S Daar, David Wohl, Jürgen Rockstroh, Xuelian Wei, Joseph Custodio, Kirsten White, Hal Martin, Andrew Cheng, Erin Quirk
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug-drug interactions. We aimed to assess the efficacy and safety of bictegravir coformulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination versus coformulated dolutegravir, abacavir, and lamivudine...
August 31, 2017: Lancet
https://www.readbyqxmd.com/read/28861811/differential-effects-of-antiretroviral-drugs-on-neurons-in-vitro-roles-for-oxidative-stress-and-integrated-stress-response
#20
Anna L Stern, Rebecca N Lee, Nina Panvelker, Jiean Li, Jenna Harowitz, Kelly L Jordan-Sciutto, Cagla Akay-Espinoza
Mounting evidence suggests that antiretroviral drugs may contribute to the persistence of HIV-associated neurocognitive disorders (HAND), which impact 30%-50% of HIV-infected patients in the post-antiretroviral era. We previously reported that two first generation HIV protease inhibitors, ritonavir and saquinavir, induced oxidative stress, with subsequent neuronal death in vitro, which was reversed by augmentation of the endogenous antioxidant response by monomethyl fumarate. We herein determined whether two newer-generation PIs, darunavir and lopinavir, were deleterious to neurons in vitro...
August 31, 2017: Journal of Neuroimmune Pharmacology: the Official Journal of the Society on NeuroImmune Pharmacology
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