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https://www.readbyqxmd.com/read/28076335/infrequent-development-of-drug-resistance-in-hiv-1-infected-treatment-naive-subjects-after-96-weeks-of-treatment-with-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-or-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate
#1
Nicolas Margot, Stephanie Cox, Moupali Das, Scott McCallister, Michael D Miller, Christian Callebaut
BACKGROUND: Tenofovir alafenamide (TAF) is a novel prodrug of the nucleotide RT inhibitor (NtRTI) tenofovir (TFV) that loads lymphocytes with TFV-diphosphate more efficiently than tenofovir disoproxil fumarate (TDF). The single-tablet regimen (STR) composed of elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF) has demonstrated non-inferiority to the STR of E/C/F/TDF in clinical studies, with high proportions of subjects achieving HIV-1 RNA <50 copies/mL at week 48, and maintained through week 96...
January 11, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/27999055/unravelling-the-dynamics-of-selection-of-multiresistant-variants-to-integrase-inhibitors-in-an-hiv-1-infected-child-using-ultra-deep-sequencing
#2
Karl Stefic, Maud Salmona, Marisa Capitao, Marion Splittgerber, Zoha Maakaroun-Vermesse, Marie-Laure Néré, Louis Bernard, Marie-Laure Chaix, Francis Barin, Constance Delaugerre
BACKGROUND: Ultra-deep sequencing (UDS) allows detection of minority resistant variants (MRVs) with a threshold of 1% and could be useful to identify variants harbouring single or multiple drug-resistance mutations (DRMs). OBJECTIVES: We analysed the integrase gene region longitudinally using UDS in an HIV-1-infected child rapidly failing a raltegravir-based regimen. METHODS: Longitudinal plasma samples at baseline and weeks 4, 8, 13, 17 and 39 were obtained, as well as the mother's baseline plasma sample...
December 20, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27999051/pharmacokinetic-interactions-between-cobicistat-boosted-elvitegravir-and-darunavir-in-hiv-infected-patients
#3
Alicia Gutierrez-Valencia, Omar J Benmarzouk-Hidalgo, Silvia Llaves, Tamara Fernandez-Magdaleno, Nuria Espinosa, Pompeyo Viciana, Luis F Lopez-Cortes
OBJECTIVES: To evaluate if there are significant drug-drug interactions between cobicistat-boosted elvitegravir and 800 mg darunavir once daily taken simultaneously, as has been suggested previously. METHODS: The study population consisted of three groups of unselected volunteers taking a regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (150, 150, 200 and 300 mg, respectively) co-formulated in a single tablet plus 800 mg darunavir (group A); only co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate (group B); and cobicistat-boosted darunavir (800 mg darunavir + 150 mg cobicistat) plus two nucleos(t)ide analogues (group C)...
December 20, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27941989/real-world-assessment-of-renal-and-bone-safety-among-patients-with-hiv-infection-exposed-to-tenofovir-disoproxil-fumarate-containing-single-tablet-regimens
#4
Ella T Nkhoma, Lisa Rosenblatt, Joel Myers, Angelina Villasis-Keever, John Coumbis
OBJECTIVES: Tenofovir disoproxil fumarate (TDF)-containing antiretroviral regimens have been associated with an increased incidence of renal and bone adverse outcomes. Here, we estimated the real-world incidence of renal and bone adverse outcomes among patients with HIV infection receiving different TDF-containing single-tablet regimens (STRs). METHODS: This cohort study used US health insurance data spanning the years 2008-2014. We identified HIV-infected patients aged ≥18 years (all HIV patients) and those with ≥6 months of continuous enrollment prior to initiating efavirenz/emtricitabine/TDF (EFV/FTC/TDF), rilpivirine/FTC/TDF (RPV/FTC/TDF) or elvitegravir/cobicistat/FTC/TDF (EVG/COBI/FTC/TDF)...
2016: PloS One
https://www.readbyqxmd.com/read/27907972/-tenofovir-alafenamide-fumarate-a-new-generation-of-tenofovir
#5
Svatava Snopková, Kateřina Havlíčková, Petr Husa
Antiretroviral therapy as a life-long treatment has to meet the criteria of maximum efficiency while maintaining the highest possible level of safety and tolerance. Tenofovir disoproxil fumarate (TDF) is an antiretroviral drug with an excellent effect of virological suppression. However, some patients can over time develop clinically significant nephrotoxicity or bone loss. Tenofovir alafenamide fumarate (TAF) is a novel prodrug of tenofovir (TFV) that is more stable in human plasma and more efficiently penetrates into target cells than TFV...
September 2016: Klinická Mikrobiologie a Infekc̆ní Lékar̆ství
https://www.readbyqxmd.com/read/27894270/evaluation-of-tolerability-with-the-co-formulation-elvitegravir-cobicistat-emtricitabine-and-tenofovir-disoproxil-fumarate-for-post-hiv-exposure-prophylaxis
#6
Nadia Valin, Laurent Fonquernie, Anne Daguenel, Pauline Campa, Theresita Anthony, Marguerite Guiguet, Pierre Marie Girard, Marie Caroline Meyohas
BACKGROUND: The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (Stribild(®)) prescribed as one pill taken once daily for HIV PEP in terms of tolerability and adherence...
November 29, 2016: BMC Infectious Diseases
https://www.readbyqxmd.com/read/27860104/higher-rates-of-neuropsychiatric-adverse-events-leading-to-dolutegravir-discontinuation-in-women-and-older-patients
#7
C Hoffmann, T Welz, M Sabranski, M Kolb, E Wolf, H-J Stellbrink, C Wyen
OBJECTIVES: Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (INSTI), is now among the most frequently used antiretroviral agents. However, recent reports have raised concerns about potential neurotoxicity. METHODS: We performed a retrospective analysis of a cohort of HIV-infected patients who had initiated an INSTI in two large German out-patient clinics between 2007 and 2016. We compared discontinuation rates because of adverse events (AEs) within 2 years of starting treatment with dolutegravir, raltegravir or elvitegravir/cobicistat...
January 2017: HIV Medicine
https://www.readbyqxmd.com/read/27798496/how-recent-findings-on-the-pharmacokinetics-and-pharmacodynamics-of-integrase-inhibitors-can-inform-clinical-use
#8
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...
February 2017: Current Opinion in Infectious Diseases
https://www.readbyqxmd.com/read/27798217/efficacy-of-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-as-treatment-for-primary-or-recent-hiv-infection
#9
Silvia Nozza, Andrea Poli, Marco Ripa, Laura Galli, Stefania Chiappetta, Vincenzo Spagnuolo, Cristina Rovelli, Adriano Lazzarin, Antonella Castagna, Giuseppe Tambussi
No abstract text is available yet for this article.
October 17, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27797606/rilpivirine-emtricitabine-and-tenofovir-alafenamide-single-tablet-combination-for-the-treatment-of-hiv-1-infection-in-selected-patients
#10
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
https://www.readbyqxmd.com/read/27767362/elvitegravir-for-the-treatment-of-hiv
#11
Nathan R Unger, Marylee V Worley, Jamie J Kisgen, Elizabeth M Sherman, Lindsey M Childs-Kean
Current antiretrovirals (ARVs) have demonstrated the ability to prolong the life of an HIV infected individual via suppression of the virus and subsequent restoration of immune function. Despite significant advancement, there remains an opportunity for improvement. One ARV that attempts to fill global HIV therapeutic needs by balancing convenience, safety, and efficacy is elvitegravir (EVG). Areas covered: Using MEDLINE/PubMed, a literature search was conducted for published articles on the safety and efficacy of EVG in the treatment of HIV infection...
October 31, 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27765666/safety-efficacy-and-pharmacokinetics-of-a-single-tablet-regimen-containing-elvitegravir-cobicistat-emtricitabine-and-tenofovir-alafenamide-in-treatment-naive-hiv-infected-adolescents-a-single-arm-open-label-trial
#12
Aditya H Gaur, Hilda Kizito, Wasana Prasitsueubsai, Natella Rakhmanina, Mohammed Rassool, Rana Chakraborty, Jagmohan Batra, Pope Kosalaraksa, Wicharn Luesomboon, Danielle Porter, Yongwu Shao, Michael Myers, Lillian Ting, Devi SenGupta, Erin Quirk, Martin S Rhee
BACKGROUND: The prodrug tenofovir alafenamide is associated with improved renal and bone safety compared with tenofovir disoproxil fumarate. We aimed to assess safety, pharmacokinetics, and efficacy of this single-tablet, fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-infected, treatment-naive adolescents. METHODS: We did a 48 week, single-arm, open-label trial in treatment-naive adolescents with HIV from ten hospital clinics in South Africa, Thailand, Uganda, and the USA...
December 2016: Lancet HIV
https://www.readbyqxmd.com/read/27753684/a-randomized-open-label-trial-to-evaluate-switching-to-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-plus-darunavir-in-treatment-experienced-hiv-1-infected-adults
#13
Gregory D Huhn, Pablo Tebas, Joel Gallant, Timothy Wilkin, Andrew Cheng, Mingjin Yan, Lijie Zhong, Christian Callebaut, Joseph M Custodio, Marshall W Fordyce, Moupali Das, Scott McCallister
BACKGROUND: HIV-infected, treatment-experienced adults with a history of prior resistance and regimen failure can be virologically suppressed but may require multi-tablet regimens associated with lower adherence and potential resistance development. METHODS: We enrolled HIV-infected, virologically suppressed adults with 2- to 3-class drug resistance and at least 2 prior regimen failures into this phase 3, open-label, randomized study. The primary endpoint was the percentage of participants with HIV-1 RNA <50 copies/mL at week 24 (FDA snapshot algorithm)...
October 6, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/27742226/equivalent-decline-in-inflammation-markers-with-tenofovir-disoproxil-fumarate-vs-tenofovir-alafenamide
#14
Nicholas T Funderburg, Grace A McComsey, Manjusha Kulkarni, Tammy Bannerman, Jessica Mantini, Bernadette Thornton, Hui C Liu, Yafeng Zhang, Qinghua Song, Liang Fang, Jason Dinoso, Andrew Cheng, Scott McCallister, Marshall W Fordyce, Moupali Das
BACKGROUND: Initiation of antiretroviral therapy (ART) and subsequent virologic suppression reduces immune activation and systemic inflammation. METHODS: We examined longitudinal changes in biomarkers of monocyte activation (sCD14, sCD163), and systemic (IL-6, hsCRP, sTNFR-I and D-dimer) and vascular (Lp-PLA2) inflammation in a subgroup (N=100 per arm) of participants enrolled in a randomized, placebo-controlled trial comparing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF; TAF) to E/C/F/tenofovir disoproxil fumarate (E/C/F/TDF; TDF) in treatment-naïve adults...
November 2016: EBioMedicine
https://www.readbyqxmd.com/read/27737783/development-of-a-phenotypic-susceptibility-assay-for-hiv-1-integrase-inhibitors
#15
Eva Heger, Alexandra Andrée Theis, Klaus Remmel, Hauke Walter, Alejandro Pironti, Elena Knops, Veronica Di Cristanziano, Björn Jensen, Stefan Esser, Rolf Kaiser, Nadine Lübke
Phenotypic resistance analysis is an indispensable method for determination of HIV-1 resistance and cross-resistance to novel drug compounds. Since integrase inhibitors are essential components of recent antiretroviral combination therapies, phenotypic resistance data, in conjunction with the corresponding genotypes, are needed for improving rules-based and data-driven tools for resistance prediction, such as HIV-Grade and geno2pheno[integrase]. For generation of phenotypic resistance data to recent integrase inhibitors, a recombinant phenotypic integrase susceptibility assay was established...
October 11, 2016: Journal of Virological Methods
https://www.readbyqxmd.com/read/27714978/switching-regimens-in-virologically-suppressed-hiv-1-infected-patients-evidence-base-and-rationale-for-integrase-strand-transfer-inhibitor-insti-containing-regimens
#16
REVIEW
F Raffi, S Esser, G Nunnari, I Pérez-Valero, L Waters
In an era when most individuals with treated HIV infection can expect to live into old age, clinicians should proactively review their patients' current and future treatment needs and challenges. Clinical guidelines acknowledge that, in the setting of virological suppression, treatment switch may yield benefits in terms of tolerability, regimen simplification, adherence, convenience and long-term health considerations, particularly in the context of ageing. In this paper, we review evidence from six key clinical studies on switching virologically suppressed patients to regimens based on integrase strand transfer inhibitors (INSTIs), the antiretroviral class increasingly preferred as initial therapy in clinical guidelines...
October 2016: HIV Medicine
https://www.readbyqxmd.com/read/27704731/efficacy-and-safety-of-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-in-asian-subjects-with-human-immunodeficiency-virus-1-infection-a-sub-analysis-of-phase-3-clinical-trials
#17
Jun Yong Choi, Somnuek Sungkanuparph, Thanomsak Anekthananon, Paul Sax, Edwin DeJesus, Howard Edelstein, Mark Nelson, Jennifer DeMorin, Hui C Liu, Raji Swamy, Joonwoo Bahn, Sunjin Hwang, Sang Youn Yang, Christopher Ng, David Piontkowsky
The efficacy and safety of a single tablet regimen (STR) of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) were analyzed in Phase 3 clinical trials in antiretroviral therapy (ART)-naïve and ART-experienced Asian subjects infected with human immunodeficiency virus (HIV)-1. Studies GS-US-236-102 and GS-US-236-103 were randomized, double-blind, placebo-controlled, 144-week studies conducted in ART-naïve subjects, comparing E/C/F/TDF versus efavirenz (EFV)/F/TDF or ritonavir-boosted atazanavir (ATV+RTV) plus emtricitabine/tenofovir DF (F/TDF), respectively...
September 2016: Infection & Chemotherapy
https://www.readbyqxmd.com/read/27682062/drug-resistant-integrase-mutants-cause-aberrant-hiv-integrations
#18
Janani Varadarajan, Mary Jane McWilliams, Bryan T Mott, Craig J Thomas, Steven J Smith, Stephen H Hughes
BACKGROUND: HIV-1 integrase is the target for three FDA-approved drugs, raltegravir, elvitegravir, and dolutegravir. All three drugs bind at the active site of integrase and block the strand transfer step of integration. We previously showed that sub-optimal doses of the anti-HIV drug raltegravir can cause aberrant HIV integrations that are accompanied by a variety of deletions, duplications, insertions and inversions of the adjacent host sequences. RESULTS: We show here that a second drug, elvitegravir, also causes similar aberrant integrations...
September 29, 2016: Retrovirology
https://www.readbyqxmd.com/read/27673443/brief-report-switching-to-tenofovir-alafenamide-coformulated-with-elvitegravir-cobicistat-and-emtricitabine-in-hiv-infected-adults-with-renal-impairment-96-week-results-from-a-single-arm-multicenter-open-label-phase-3-study
#19
Frank A Post, Pablo Tebas, Amanda Clarke, Laurent Cotte, William R Short, Michael E Abram, Shuping Jiang, Andrew Cheng, Moupali Das, Marshall W Fordyce
Tenofovir disoproxil fumarate is associated with renal and bone toxicity. In a single-arm, open-label study of 242 virologically suppressed, HIV-infected participants with creatinine clearance 30-69 mL/min who switched to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, participants had stable creatinine clearance, significant and durable improvements in proteinuria, albuminuria, and tubular proteinuria (P < 0.001), and significant increases in hip and spine bone mineral density through 96 weeks (P < 0...
February 1, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/27645238/antiviral-activity-of-bictegravir-gs-9883-a-novel-potent-hiv-1-integrase-strand-transfer-inhibitor-with-an-improved-resistance-profile
#20
Manuel Tsiang, Gregg S Jones, Joshua Goldsmith, Andrew Mulato, Derek Hansen, Elaine Kan, Luong Tsai, Rujuta A Bam, George Stepan, Kirsten M Stray, Anita Niedziela-Majka, Stephen R Yant, Helen Yu, George Kukolj, Tomas Cihlar, Scott E Lazerwith, Kirsten L White, Haolun Jin
Bictegravir (BIC; GS-9883), a novel, potent, once-daily, unboosted inhibitor of HIV-1 integrase (IN), specifically targets IN strand transfer activity (50% inhibitory concentration [IC50] of 7.5 ± 0.3 nM) and HIV-1 integration in cells. BIC exhibits potent and selective in vitro antiretroviral activity in both T-cell lines and primary human T lymphocytes, with 50% effective concentrations ranging from 1.5 to 2.4 nM and selectivity indices up to 8,700 relative to cytotoxicity. BIC exhibits synergistic in vitro antiviral effects in pairwise combinations with tenofovir alafenamide, emtricitabine, or darunavir and maintains potent antiviral activity against HIV-1 variants resistant to other classes of antiretrovirals...
December 2016: Antimicrobial Agents and Chemotherapy
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