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https://www.readbyqxmd.com/read/29746268/bictegravir
#1
Vincenzo Spagnuolo, Antonella Castagna, Adriano Lazzarin
PURPOSE OF REVIEW: In this review, we will highlight and discuss the recent efficacy and safety data of bictegravir (BIC), a novel second-generation integrase strand transfer inhibitor (INSTI) that has been recently approved, in coformulation with emtricitabine and tenofovir alafenamide (B/F/TAF), for the treatment of HIV-1 infection in antiretroviral naïve subjects and in those with suppressed viremia. RECENT FINDINGS: Preclinical data showed that BIC has a genetic barrier that is higher than that of raltegravir and elvitegravir but is similar to that of dolutegravir (DTG), with retained activity in vitro against isolates containing substitutions associated with resistance against other INSTIs...
May 4, 2018: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29726595/development-and-validation-of-an-hplc-uv-method-for-quantification-of-elvitegravir-and-others-new-antiretrovirals-dolutegravir-and-rilpivirine-in-the-plasma-of-hiv-positive-patients
#2
Massimo Tempestilli, Adriana Ammassari, Antonio D'Avolio, Stefania Cicalini, Anna Loredana Gallo, Simone Fazio, Andrea Antinori, Leopoldo P Pucillo
Therapeutic drug monitoring may be crucial in selected clinical conditions for the management of HIV infection. In the last years, new antiretrovirals have been introduced and in particular elvitegravir (EVG) is now recommended for first-line and in simplification treatment as well as dolutegravir (DTG) and rilpivirine (RPV). The aim of this study was to develop and validate a High Performance Liquid Chromatography-Ultra Violet (HPLC-UV) method for determining EVG and others newest antiretrovirals DTG and RPV in human plasma...
May 4, 2018: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29709783/development-and-validation-of-an-lc-ms-ms-assay-for-tenofovir-and-tenofovir-alafenamide-in-human-plasma-and-cerebrospinal-fluid
#3
Andrew J Ocque, Colleen E Hagler, Gene D Morse, Scott L Letendre, Qing Ma
A liquid chromatography with triple quadrupole mass spectrometry method was developed and validated for the determination of tenofovir and tenofovir alafenamide concentrations in human plasma and cerebrospinal fluid. Tenofovir and tenofovir alafenamide were extracted from matrix by solid phase extraction. The dried extraction eluents were dissolved in water for LC-MS/MS analysis. Separation was achieved with a Phenomenex Synergi 4 μm Polar-RP 80A column (50 × 2 mm) with a gradient elution of 0.1% formic acid in water and acetonitrile...
April 23, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29700852/lc-ms-ms-method-for-the-simultaneous-determination-of-tenofovir-emtricitabine-elvitegravir-and-rilpivirine-in-dried-blood-spots
#4
Pavan Kumar Prathipati, Subhra Mandal, Christopher J Destache
A simple, short, and rugged LC-MS/MS method for the simultaneous determination of tenofovir, emtricitabine, elvitegravir and rilpivirine was developed and validated. Dried blood spots were prepared with 25 μL of spiked whole blood. A 3 mm punch was extracted with methanol containing labeled internal standards. Ten microliter was injected into LC-MS/MS using isocratic mobile phase composed of 0.1% formic acid in water and 0.1% formic acid in acetonitrile (45: 55 v/v) at a flow rate of 0.25 mL/min. The method was validated in the range of 10 to 2000 ng/mL for all four analytes...
April 26, 2018: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/29672676/a-trial-of-a-single-tablet-regimen-of-elvitegravir-cobicistat-emtricitabine-and-tenofovir-disoproxil-fumarate-for-the-initial-treatment-of-hiv-2-infection-in-a-resource-limited-setting-48-week-results-from-senegal-west-africa
#5
Selly Ba, Dana N Raugi, Robert A Smith, Fatima Sall, Khadim Faye, Stephen E Hawes, Papa Salif Sow, Moussa Seydi, Geoffrey S Gottlieb
Background: There is an urgent need for safe and effective ART for HIV-2 infection. We undertook the first clinical trial of a single-tablet-regimen containing elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate (E/C/F/TDF) to assess its effectiveness in HIV-2-infected individuals in Senegal, West Africa. Methods: HIV-2-infected, ART-naïve adults with WHO stage 3-4 disease or CD4 counts below 750 cells/mm3 were eligible for this 48 week, open-label trial...
April 17, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29661866/reciprocal-effects-of-antiretroviral-drugs-used-to-treat-hiv-infection-on-the-fibroblast-growth-factor-21-%C3%AE-klotho-system
#6
Ricardo Moure, Pere Domingo, Joan Villarroya, Laura Gasa, José M Gallego-Escuredo, Tania Quesada-López, Samantha Morón-Ros, Alberto F Maroto, Gracia M Mateo, Joan C Domingo, Francesc Villarroya, Marta Giralt
Following antiretroviral therapy, HIV-infected patients show increased circulating levels of the antidiabetic hormone fibroblast growth factor-21 (FGF21). In contrast, expression of the FGF21-obligatory co-receptor β-Klotho (KLB) is reduced in target tissues. This situation is comparable to the FGF21 resistance status observed in obesity and type-2 diabetes. Here, we performed the first systematic study of the effects of distinct members of different antiretroviral drug classes on the FGF21/KLB system in human hepatic, adipose, and skeletal muscle cells...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29649076/pharmacokinetics-of-tenofovir-alafenamide-when-co-administered-with-other-hiv-antiretrovirals
#7
Rebecca Begley, Moupali Das, Lijie Zhong, John Ling, Brian P Kearney, Joseph M Custodio
BACKGROUND: Tenofovir alafenamide (TAF), a prodrug of the nucleotide analogue tenofovir (TFV), is an antiretroviral (ARV) agent approved either as a complete regimen (elvitegravir/cobicistat/emtricitabine (F)/tenofovir alafenamide (TAF), rilpivirine/F/TAF, bictegravir/F/TAF), or for use with other ARVs (F/TAF), for treatment of HIV. TAF is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters. Disposition of TAF may be altered by co-medications that can inhibit or induce P-gp or BCRP transporters...
April 10, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29644537/drug-drug-interaction-profile-of-the-fixed-dose-combination-tablet-regimen-ledipasvir-sofosbuvir
#8
REVIEW
Polina German, Anita Mathias, Diana M Brainard, Brian P Kearney
Ledipasvir/sofosbuvir (Harvoni® ), a fixed-dose combination tablet of an NS5A inhibitor ledipasvir and an NS5B polymerase inhibitor sofosbuvir, is approved for the treatment of chronic hepatitis C virus infection. Ledipasvir/sofosbuvir exhibits a favorable drug-drug interaction profile and can be administered with various medications that may be used by hepatitis C virus-infected patients, including patients with comorbidities, such as co-infection with human immunodeficiency virus or immunosuppression following liver transplantation...
April 11, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29628511/dolutegravir-neuropsychiatric-adverse-events-specific-drug-effect-or-class-effect
#9
Jean Cyr Yombi
Integrase strand transfer inhibitors (INSTIs) are a newer class of antiretroviral treatment for HIV-infected patient. INSTIs currently available for use are raltegravir, elvitegravir, dolutegravir (DTG), and bictegravir. Clinical studies using INSTIs have demonstrated an 80-90% efficiency in treating HIV-positive antiretroviral therapy - naive patients. They are recommended by internatioal guidelines as the preferred agents for the first-line regimen. INSTIs have also been demonstrated as safe and tolerable...
January 2018: AIDS Reviews
https://www.readbyqxmd.com/read/29627709/rare-emergence-of-drug-resistance-in-hiv-1-treatment-na%C3%A3-ve-patients-receiving-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-for-144-weeks
#10
Nicolas Margot, Stephanie Cox, Moupali Das, Scott McCallister, Michael D Miller, Christian Callebaut
BACKGROUND: The single tablet regimen (STR) composed of elvitegravir (E), cobicistat (C), emtricitabine (F), and tenofovir alafenamide (TAF) (E/C/F/TAF) was compared to the STR composed of E, C, F, and tenofovir disoproxil fumarate (TDF) (E/C/F/TDF) in 2 phase 3 studies in 1733 HIV-1 infected treatment-naïve adults. Superior efficacy of E/C/F/TAF compared to E/C/F/TDF was demonstrated at Week 144 with 84% treatment success compared to 80%, respectively, along with significantly better outcomes of bone and renal safety...
April 2, 2018: Journal of Clinical Virology: the Official Publication of the Pan American Society for Clinical Virology
https://www.readbyqxmd.com/read/29623097/renal-effects-of-non-tenofovir-antiretroviral-therapy-in-patients-living-with-hiv
#11
REVIEW
Milena M McLaughlin, Aimee J Guerrero, Andrew Merker
A review of literature published regarding non-tenofovir antiretroviral agents causing renal adverse effects was conducted. The literature involving renal adverse effects and antiretroviral therapy is most robust with protease inhibitors, specifically atazanavir and indinavir, and includes reports of crystalluria, leukocyturia, nephritis, nephrolithiasis, nephropathy and urolithiasis. Several case reports describe potential nephropathy (including Fanconi syndrome) secondary to administration of abacavir, didanosine, lamivudine and stavudine...
2018: Drugs in Context
https://www.readbyqxmd.com/read/29549274/analyses-of-hiv-1-integrase-sequences-prior-to-south-african-national-hiv-treatment-program-and-available-of-integrase-inhibitors-in-cape-town-south-africa
#12
Dominik Brado, Adetayo Emmanuel Obasa, George Mondinde Ikomey, Ruben Cloete, Kamalendra Singh, Susan Engelbrecht, Ujjwal Neogi, Graeme Brendon Jacobs
HIV-Integrase (IN) has proven to be a viable target for highly specific HIV-1 therapy. We aimed to characterize the HIV-1 IN gene in a South African context and identify resistance-associated mutations (RAMs) against available first and second generation Integrase strand-transfer inhibitors (InSTIs). We performed genetic analyses on 91 treatment-naïve HIV-1 infected patients, as well as 314 treatment-naive South African HIV-1 IN-sequences, downloaded from Los Alamos HIV Sequence Database. Genotypic analyses revealed the absence of major RAMs in the cohort collected before the broad availability of combination antiretroviral therapy (cART) and INSTI in South Africa, however, occurred at a rate of 2...
March 16, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29522076/drug-drug-interactions-studies-between-hcv-antivirals-sofosbuvir-velpatasvir-and-boosted-and-unboosted-hiv-antiretroviral-regimens-in-healthy-volunteers
#13
Erik Mogalian, Luisa M Stamm, Anu Osinusi, Diana M Brainard, Gong Shen, Kah Hiing John Ling, Anita Mathias
Background: Combining antiviral regimens in the HCV/HIV coinfected population can be complex as they share overlapping mechanisms for elimination that may result in potential drug interactions. The pharmacokinetics, safety, and tolerability of concomitantly administered sofosbuvir/velpatasvir (SOF/VEL) with multiple commonly prescribed antiretroviral (ARV) regimens were evaluated. Methods: Healthy volunteers were enrolled into two phase 1, open-label, randomized, multiple-dose, cross-over studies...
March 7, 2018: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29494427/fewer-pills-do-not-mean-fewer-drug-drug-interactions-severe-rhabdomyolysis-on-elvitegravir-cobicistat-and-statin-treatment
#14
Carlo Perrone, Andri Rauch, Hansjakob Furrer, Markus Hug, Gilles Wandeler
No abstract text is available yet for this article.
March 13, 2018: AIDS
https://www.readbyqxmd.com/read/29492905/tenofovir-associated-bone-adverse-outcomes-among-a-us-national-historical-cohort-of-hiv-infected-veterans-risk-modification-by-concomitant-antiretrovirals
#15
Joanne LaFleur, Adam P Bress, Joel Myers, Lisa Rosenblatt, Jacob Crook, Kristin Knippenberg, Roger Bedimo, Pablo Tebas, Heather Nyman, Stephen Esker
INTRODUCTION: Tenofovir disoproxil fumarate (TDF) has been associated with greater incidences of bone complications, which might be modified by some concomitantly administered antiretrovirals, possibly by their effect on tenofovir concentrations. We compared bone adverse outcomes among treatment-naïve HIV-infected US veterans initiating efavirenz (EFV)-containing TDF/emtricitabine (FTC) regimens versus those initiating non-EFV-containing TDF/FTC regimens. METHODS: Using national Veterans Health Administration clinical and administrative data sets, we identified a cohort of treatment-naïve HIV-infected veterans without bone disease who initiated therapy with TDF/FTC plus EFV, rilpivirine, elvitegravir/cobicistat, or ritonavir-boosted protease inhibitors in 2003-2015...
February 28, 2018: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/29481486/efficacy-and-safety-of-switching-to-coformulated-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-e-c-f-taf-in-virologically-suppressed-women
#16
Sally Hodder, Kathleen Squires, Cissy Kityo, Debbie Hagins, Anchalee Avihingsanon, Anna Kido, Shuping Jiang, Rima Kulkarni, Andrew Cheng, Huyen Cao
BACKGROUND: The integrase inhibitor regimen (elvitegravir [EVG]/cobicistat [COBI]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) demonstrated superior efficacy when compared to a protease inhibitor regimen (ritonavir-boosted atazanavir [ATV+RTV] plus FTC/TDF) in 575 treatment-naïve women at week 48. We investigated the efficacy, safety, and tolerability of switching to a TAF-based, single-tablet regimen containing EVG, COBI, FTC, and tenofovir alafenamide TAF (E/C/F/TAF) versus remaining on ATV+RTV and FTC/TDF...
February 21, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29424785/bone-density-microarchitecture-and-tissue-quality-after-1-year-of-treatment-with-tenofovir-disoproxil-fumarate
#17
Robert Güerri-Fernández, Elisabet Lerma-Chippirraz, Ana Fernandez Marron, Natalia García-Giralt, Judit Villar-García, Jade Soldado-Folgado, Alicia González-Mena, Marta Trenchs-Rodríguez, Ana Guelar, Adolfo Díez-Pérez, Todd T Brown, Hernando Knobel
OBJECIVE: Bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) is used to assess bone health in HIV patients. DXA measures the amount of mineral, but not other key aspects of bone strength such as bone microarchitecture or bone quality. Trabecular bone score (TBS) and in-vivo microindentation directly measure trabecular microarchitecture and bone tissue quality, respectively. The aim of this study is to measure bone strength properties using these techniques. RESULTS: Forty naive HIV patients who were going to start antiretroviral therapy (ART), a single pill treatment with elvitegravir/cobicistat, tenofovir disoproxil fumarate (TDF), emtricitavine (FTC) were included...
April 24, 2018: AIDS
https://www.readbyqxmd.com/read/29424784/adverse-drug-reactions-to-integrase-strand-transfer-inhibitors
#18
Katherine J Lepik, Benita Yip, Ana C Ulloa, Lu Wang, Junine Toy, Linda Akagi, Viviane Dias Lima, Silvia Guillemi, Julio S G Montaner, Rolando Barrios
OBJECTIVES: To describe and compare integrase strand transfer inhibitor (INSTI) adverse drug reactions (ADRs) for raltegravir, elvitegravir-cobicistat, and dolutegravir. DESIGN: Population-based, retrospective cohort. METHODS: Antiretroviral-experienced and naive persons at least 19 years old were included if they received their first prescription for raltegravir, elvitegravir-cobicistat, or dolutegravir in British Columbia, Canada, in 2012-2014, and were followed for 2 years until 31 December 2016...
April 24, 2018: AIDS
https://www.readbyqxmd.com/read/29410019/novel-secondary-mutations-c56s-and-g149a-confer-resistance-to-hiv-1-integrase-strand-transfer-inhibitors
#19
Tomokazu Yoshinaga, Takahiro Seki, Shigeru Miki, Tadashi Miyamoto, Akemi Suyama-Kagitani, Shinobu Kawauchi-Miki, Masanori Kobayashi, Akihiko Sato, Eugene Stewart, Mark Underwood, Tamio Fujiwara
Cabotegravir (CAB, S/GSK1265744) is an investigational second-generation integrase strand transfer inhibitor (INSTI) with a chemical structure similar to dolutegravir. CAB is under development as a long-acting injectable formulation for treatment of HIV-1 infection and for pre-exposure prophylaxis. We conducted an in vitro passage study of raltegravir- or elvitegravir-resistant signature mutants in the presence of CAB to characterize the resistance profile of this drug. During passage with Q148H virus, G140S arose by day 14, followed by G149A and C56S...
April 2018: Antiviral Research
https://www.readbyqxmd.com/read/29385867/combination-therapy-with-tenofovir-disoproxil-fumarate-emtricitabine-elvitegravir-cobicistat-plus-darunavir-once-daily-in-antiretroviral-naive-and-treatment-experienced-patients-a-retrospective-review
#20
Mark J Naccarato, Deborah M Yoong, Ignatius W Fong, Kevin A Gough, Marian A Ostrowski, Darrell H S Tan
BACKGROUND: Patients with drug-resistant HIV often require complex antiretroviral regimens. However, combining fixed-dose combination tablets such as tenofovir-disoproxil-fumarate, emtricitabine, and cobicistat-boosted elvitegravir (TDF/FTC/EVG/cobi) with darunavir (DRV) can provide a simple, once-daily (QD), 2-tablet regimen for patients with drug-resistant HIV. Primary objective was to determine the percentage of patients with HIV-1 RNA <40 copies/mL at 48 weeks. METHODS: We performed a retrospective chart review of patients initiated on TDF/FTC/EVG/cobi plus DRV...
January 2018: Journal of the International Association of Providers of AIDS Care
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