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https://www.readbyqxmd.com/read/28259777/switching-from-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-study
#1
Chloe Orkin, Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Bernard Vandercam, Joseph de Wet, Jürgen Rockstroh, Adriano Lazzarin, Bart Rijnders, Daniel Podzamczer, Anders Thalme, Marcel Stoeckle, Danielle Porter, Hui C Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide, a tenofovir prodrug, results in 90% lower tenofovir plasma concentrations than does tenofovir disproxil fumarate, thereby minimising bone and renal risks. We investigated the efficacy, safety, and tolerability of switching to a single-tablet regimen containing rilpivirine, emtricitabine, and tenofovir alafenamide compared with remaining on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-1-infected adults were screened and enrolled at 119 hospitals in 11 countries in North America and Europe...
March 1, 2017: Lancet HIV
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
#2
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/28182625/viability-of-primary-osteoblasts-after-treatment-with-tenofovir-alafenamide-lack-of-cytotoxicity-at-clinically-relevant-drug-concentrations
#3
Christian Callebaut, Yang Liu, Darius Babusis, Adrian Ray, Michael Miller, Kathryn Kitrinos
Tenofovir alafenamide (TAF) is a phosphonoamidate prodrug of the nucleotide HIV reverse transcriptase inhibitor tenofovir (TFV). TAF is approved for the treatment of HIV-1 infection as part of the single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and TAF. When dosed once-daily, TAF results in approximately 90% lower levels of plasma TFV and a 4-fold increase in intracellular TFV-diphosphate (TFV-DP) in PBMCs compared with the TFV prodrug tenofovir disoproxil fumarate (TDF). Several antiretrovirals, including TDF, have been associated with bone mineral density decreases in patients; the effect of clinically relevant TAF concentrations on primary osteoblast viability was therefore assessed in vitro...
2017: PloS One
https://www.readbyqxmd.com/read/28168828/relative-bioavailability-of-a-dolutegravir-dispersible-tablet-and-the-effects-of-low-and-high-mineral-content-water-on-the-tablet-in-healthy-adults
#4
Ann M Buchanan, Michael Holton, Ian Conn, Mark Davies, Mike Choukour, Brian R Wynne
Dolutegravir (DTG) is approved in the United States to treat HIV-1-infected patients weighing ≥30 kg. A dispersible DTG tablet formulation was recently developed for pediatric patients. This study compares the pharmacokinetics (PK) of the dispersible tablet with that of a previously evaluated granule formulation. In this randomized, open-label, crossover study, 15 healthy adults received single oral doses of DTG 20 mg every 7 days across 5 treatment arms: granules consumed immediately after mixture with purified water, dispersible DTG consumed immediately after reconstitution in low-mineral-content (LMC) or high-mineral-content (HMC) water, and dispersible DTG consumed 30 minutes after dispersal in LMC or HMC water...
February 7, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28152047/effectiveness-and-tolerance-of-single-tablet-versus-once-daily-multiple-tablet-regimens-as-first-line-antiretroviral-therapy-results-from-a-large-french-multicenter-cohort-study
#5
Laurent Cotte, Tristan Ferry, Pascal Pugliese, Marc-Antoine Valantin, Clotilde Allavena, André Cabié, Isabelle Poizot-Martin, David Rey, Claudine Duvivier, Antoine Cheret, Pierre Dellamonica, Pierre Pradat, Jean-Jacques Parienti
OBJECTIVES: Pill burden during antiretroviral treatment (ART) is associated with worse adherence and impaired virological suppression. We compared the effectiveness, tolerance, and persistence on treatment of single tablet regimens (STRs) with non-STR once-daily regimens in patients receiving first-line ART. METHODS: Retrospective analysis of naïve HIV-1 infected patients prospectively enrolled in the French Dat'AIDS cohort and initiating first-line ART with STRs or once-daily non-STRs from 2004 to 2013...
2017: PloS One
https://www.readbyqxmd.com/read/28147708/tolerability-of-central-nervous-system-symptoms-among-hiv-1-infected-efavirenz-users-analysis-of-patient-electronic-medical-record-data
#6
Lisa Rosenblatt, Michael S Broder, Tanya G K Bentley, Eunice Chang, Sheila R Reddy, Elya Papoyan, Joel Myers
Efavirenz (EFV) is a non-nucleoside reverse transcriptase inhibitor indicated for treatment of HIV-1 infection. Despite concern over EFV tolerability in clinical trials and practice, particularly related to central nervous system (CNS) adverse events, some observational studies have shown high rates of EFV continuation at one year and low rates of CNS-related EFV substitution. The objective of this study was to further examine the real-world rate of CNS-related EFV discontinuation in antiretroviral therapy naïve HIV-1 patients...
February 1, 2017: AIDS Care
https://www.readbyqxmd.com/read/28143756/real-world-persistence-with-antiretroviral-therapy-for-hiv-in-the-united-kingdom-a-multicentre-retrospective-cohort-study
#7
Joseph M Lewis, Colette Smith, Adele Torkington, Craig Davies, Shazaad Ahmad, Andrew Tomkins, Jonathan Shaw, Margaret Kingston, Ghadeer Muqbill, Philip Hay, Larissa Mulka, Deborah Williams, Laura Waters, Nataliya Brima, Neal Marshall, Margaret Johnson, Mas Chaponda, Mark Nelson
OBJECTIVES: Persistence with an antiretroviral therapy (ART) regimen for HIV can be defined as the length of time a patient remains on therapy before stopping or switching. We aimed to describe ART persistence in treatment naïve patients starting therapy in the United Kingdom, and to describe differential persistence by treatment regimen. METHODS: We performed a retrospective cohort study at eight UK centres of ART-naïve adults commencing ART between 2012 and 2015...
April 2017: Journal of Infection
https://www.readbyqxmd.com/read/28135199/pre-exposure-prophylaxis-prep-as-an-additional-tool-for-hiv-prevention-among-men-who-have-sex-with-men-in-belgium-the-be-prep-ared-study-protocol
#8
Irith De Baetselier, Thijs Reyniers, Christiana Nöstlinger, Kristien Wouters, Katrien Fransen, Tania Crucitti, Chris Kenyon, Jozefien Buyze, Céline Schurmans, Marie Laga, Bea Vuylsteke
BACKGROUND: Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. OBJECTIVE: With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium...
January 30, 2017: JMIR Research Protocols
https://www.readbyqxmd.com/read/28117606/tenofovir-alafenamide-emtricitabine-elvitegravir-and-cobicistat-combination-therapy-for-the-treatment-of-hiv
#9
Arkaitz Imaz, Daniel Podzamczer
Tenofovir alafenamide (TAF) is a novel prodrug of the nucleotide analogue reverse-transcriptase inhibitor, tenofovir. TAF has been co-formulated with emtricitabine (FTC), elvitegravir (EVG) and the EVG metabolic enhancer, cobicistat (COBI) as a single-tablet regimen being the first TAF-containing antiretroviral combination available. Areas covered: This article summarizes the available information on the pharmacology of the novel compound TAF and overviews TAF/FTC/EVG/COBI use for HIV-1 infected patients, with specific focus on clinical efficacy and safety data...
January 24, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28087863/hiv-update-which-single-tablet-regimens-and-when
#10
REVIEW
Jeffrey T Kirchner
With the approval of single-tablet regimens that contain 3 or 4 drugs, many patients take just one pill a day. So what are the options and what's on the horizon?
November 2016: Journal of Family Practice
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
#11
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/28028855/odds-of-viral-suppression-by-single-tablet-regimens-multiple-tablet-regimens-and-adherence-level-in-hiv-aids-patients-receiving-antiretroviral-therapy
#12
S Scott Sutton, Joseph Magagnoli, James W Hardin
STUDY OBJECTIVE: To evaluate the odds of achieving viral suppression in human immunodeficiency virus (HIV) patients using antiretroviral therapy as a single-tablet regimen (STR) or multiple-tablet regimen (MTR). DESIGN: Retrospective cohort study. DATA SOURCES: South Carolina Medicaid medical and pharmacy paid claims data were obtained from the South Carolina Revenue and Fiscal Affairs Office; laboratory data were obtained from the South Carolina Department of Health and Environmental Control...
February 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/27999051/pharmacokinetic-interactions-between-cobicistat-boosted-elvitegravir-and-darunavir-in-hiv-infected-patients
#13
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/27999048/pre-existent-nrti-and-nnrti-resistance-impacts-on-maintenance-of-virological-suppression-in-hiv-1-infected-patients-who-switch-to-a-tenofovir-emtricitabine-rilpivirine-single-tablet-regimen
#14
D Armenia, D Di Carlo, A Calcagno, G Vendemiati, F Forbici, A Bertoli, G Berno, S Carta, F Continenza, V Fedele, R Bellagamba, S Cicalini, A Ammassari, R Libertone, M Zaccarelli, V Ghisetti, M Andreoni, F Ceccherini-Silberstein, S Bonora, G Di Perri, A Antinori, C F Perno, M M Santoro
OBJECTIVES: To evaluate the maintenance of virological suppression (VS) in antiretroviral-treated HIV-1-suppressed patients switching to a tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) single-tablet regimen, by considering pre-existent resistance (pRes). METHODS: pRes was evaluated according to resistance on all previous plasma genotypic resistance tests. Probability and predictors of virological rebound (VR) were evaluated. RESULTS: Three hundred and nine patients were analysed; 5...
December 20, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27942608/formulation-development-and-optimization-of-lamivudine-300-mg-and-tenofovir-disoproxil-fumarate-tdf-300-mg-fdc-tablets-by-d-optimal-mixture-design
#15
Prosper Tibalinda, Joseph Sempombe, Raphael Shedafa, Nelson Masota, Dickson Pius, Mary Temu, Eliangiringa Kaale
The usage of fixed dose combination (FDC) tablets of Lamivudine and Tenofovir Disoproxil Fumarate (TDF) is increasing due to increased incidences of HIV/Hepatitis B and HIV/TB co-infections. This is likely to increase the financial crisis due to limited resources for funding procurement of ready-made products from the pharmaceuticals manufacturing leading countries. Therefore, production of local oral tablets containing Lamivudine and TDF FDC is inevitable. Lamivudine 300 mg/TDF 300 mg tablets were developed and optimized by D-optimal mixture design and produced by direct compression technique...
December 2016: Heliyon
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
#16
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/27905999/factors-associated-with-hiv-viral-load-blips-and-the-relationship-between-self-reported-adherence-and-efavirenz-blood-levels-on-blip-occurrence-a-case-control-study
#17
Aaron Farmer, Xun Wang, Anuradha Ganesan, Robert G Deiss, Brian K Agan, Thomas A O'Bryan, Kevin Akers, Jason F Okulicz
BACKGROUND: The uncertain etiology of HIV viral load (VL) blips may lead to increased use of clinical resources. We evaluated the association of self-reported adherence (SRA) and antiretroviral (ART) drug levels on blip occurrence in US Military HIV Natural History Study (NHS) participants who initiated the single-tablet regimen efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). METHODS: ART-naïve NHS participants started on EFV/FTC/TDF between 2006 and 2013 who achieved VL suppression (<50 copies/mL) within 12 months and had available SRA and stored plasma samples were included...
March 22, 2016: AIDS Research and Therapy
https://www.readbyqxmd.com/read/27904105/evaluation-of-the-lipid-concentrations-after-switching-from-antiretroviral-drug-tenofovir-disoproxil-fumarate-emtricitabine-to-abacavir-sulfate-lamivudine-in-virologically-suppressed-human-immunodeficiency-virus-infected-patients
#18
Hirotaka Arae, Masao Tateyama, Hideta Nakamura, Daisuke Tasato, Kaoru Kami, Kyoko Miyagi, Saori Maeda, Hitoshi Uehara, Makiko Moromi, Katsunori Nakamura, Jiro Fujita
Objective Recently, tenofovir disoproxil fumatate (TDF)-related side effects, such as renal nephrotoxicity and reduction of bone mineral density, have been reported. Consequently, increased switching from fixed-dose tablet TDF and emtricitabine (TDF/FTC) to abacavir and lamivudine (ABC/3TC) has occurred. Interestingly, while TDF has a lipid-lowering property, one of the ABC-related side effects is hyperlipidemia. Therefore, such switching could cause lipid elevation. To evaluate the change in lipid levels associated with switching from TDF/FTC to ABC/3TC in virologically-suppressed human immunodeficiency virus (HIV)-infected patients...
2016: Internal Medicine
https://www.readbyqxmd.com/read/27898736/long-term-antiretroviral-treatment-adherence-in-hiv-infected-adolescents-and-adults-in-uganda-a-qualitative-study
#19
Seth C Inzaule, Raph L Hamers, Cissy Kityo, Tobias F Rinke de Wit, Maria Roura
BACKGROUND: Long-term success of HIV antiretroviral therapy requires near-perfect adherence, maintained throughout one's lifetime. However, perceptions towards ART and patterns of adherence may change during the life course. We assessed challenges to long-term adherence in adolescents and adults in three regional HIV treatment centers in Uganda. METHODS: We conducted 24 in-depth interviews and 2 focus group discussions with a total of 33 health-care providers and expert clients (HIV patients on long-term ART who assist with adherence support of fellow patients)...
2016: PloS One
https://www.readbyqxmd.com/read/27895236/a-review-of-single-tablet-regimens-for-the-treatment-of-hiv-1-infection
#20
REVIEW
Jamielynn C Sebaaly, Denise Kelley
OBJECTIVE: To review the pharmacokinetics, safety, drug-drug interactions, and advantages and disadvantages of currently available single-tablet regimens (STRs) for HIV-1 infection. DATA SOURCES: A search using PubMed was conducted (up to September 2016) using the following keywords: single tablet regimen AND HIV Additionally, a PubMed search was conducted for each individual STR using the generic names of the agents. Articles were evaluated for content, and additional references were identified from a review of literature citations...
November 27, 2016: Annals of Pharmacotherapy
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