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https://www.readbyqxmd.com/read/28333303/efficacy-of-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-as-treatment-for-primary-or-recent-hiv-infection-authors-response
#1
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.
March 14, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28329393/virological-outcomes-of-second-line-protease-inhibitor-based-treatment-for-human-immunodeficiency-virus-type-1-in-a-high-prevalence-rural-south-african-setting-a-competing-risks-prospective-cohort-analysis
#2
Dami Collier, Collins Iwuji, Anne Derache, Tulio de Oliveira, Nonhlanhla Okesola, Alexandra Calmy, Francois Dabis, Deenan Pillay, Ravindra K Gupta
Background.: Second-line antiretroviral therapy (ART) based on ritonavir-boosted protease inhibitors (bPIs) represents the only available option after first-line failure for the majority of individuals living with human immunodeficiency virus (HIV) worldwide. Maximizing their effectiveness is imperative. Methods.: This cohort study was nested within the French National Agency for AIDS and Viral Hepatitis Research (ANRS) 12249 Treatment as Prevention (TasP) cluster-randomized trial in rural KwaZulu-Natal, South Africa...
March 13, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28329343/commonly-transmitted-hiv-1-drug-resistance-mutations-in-reverse-transcriptase-and-protease-in-antiretroviral-treatment-na%C3%A3-ve-patients-do-not-affect-response-to-tenofovir-disoproxil-fumarate-or-tenofovir-alafenamide-containing-regimens
#3
Nicolas A Margot, Pamela Wong, Rima Kulkarni, Kirsten White, Danielle Porter, Michael E Abram, Christian Callebaut, Michael D Miller
Background.: The presence of transmitted drug-resistance mutations (TDRM) in antiretroviral (ARV) treatment-naïve patients can adversely affect the outcome of ARV therapy. Methods.: Resistance testing was conducted in 6704 ARV-naïve subjects predominantly from the U.S. and Europe in 9 Gilead clinical studies from 2000 to 2013. Results.: The presence of TDRM increased during this period (5.2% to 11.4%), primarily driven by non-nucleoside RT inhibitor resistance mutations (NNRTI; 0...
January 30, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28328548/characterization-of-hiv-seroconverters-in-a-tdf-ftc-prep-study-hptn-067-adapt
#4
Mariya V Sivay, Maoji Li, Estelle Piwowar-Manning, Yinfeng Zhang, Sarah E Hudelson, Mark A Marzinke, Rivet K Amico, Andrew Redd, Craig W Hendrix, Peter L Anderson, Kevin Bokoch, Linda Gail-Bekker, Frits van Griensven, Sharon Mannheimer, James P Hughes, Robert Grant, Susan H Eshleman
BACKGROUND: HPTN 067/ADAPT evaluated tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) pre-exposure prophylaxis (PrEP) in women (South Africa) and men who have sex with men (Thailand, US). Participants received once-weekly directly observed TDF/FTC (DOT), and were then randomized to daily, time-driven, or event-driven PrEP. This report describes characterization of 12 HIV seroconversion events in this trial. METHODS: HIV rapid testing was performed at study sites...
March 22, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28322067/the-future-of-pre-exposure-prophylaxis-prep-for-human-immunodeficiency-virus-hiv-infection
#5
Ayşe Elif Özdener, Tae Eun Park, Julie Kalabalik, Rachna Gupta
People at high risk for HIV acquisition should be offered pre-exposure prophylaxis (PrEP). Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) is currently the only medication recommended for pre-exposure prophylaxis (PrEP) by the Centers for Disease Control and Prevention (CDC) in people at high risk for HIV transmission. This article will review medications currently under investigation and the future landscape of PrEP therapy. Areas covered: This article will review clinical trials that have investigated nontraditional regimens of TDF/FTC, antiretroviral agents from different drug classes such as integrase strand transfer inhibitors (INSTI), nucleoside reverse transcriptase inhibitors (NRTI), and non-nucleoside reverse transcriptase inhibitors (NNRTI) as potential PrEP therapies...
March 21, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28316253/predominance-of-hepatitis-b-virus-genotype-a-among-treated-hiv-infected-patients-experiencing-high-hbv-drug-resistance-in-nairobi-kenya
#6
Sepha Nyatichi Mabeya, Caroline Wangari Ngugi, Raphael W Lihana, Samoel Ashimosi Khamadi, Anthony Kebira Nyamache
HBV/HIV coinfections are becoming common with information on HBV genetic diversity and drug resistance still remaining elusive. To evaluate the HBV genetic diversity and drug resistance associated mutations among drug experienced HIV patients, the genetic analysis of the partial HBV-pol-reverse trancriptase gene was successfully sequenced from 13 samples. Analysis of the sequences showed that all (13) the sequences belonged to genotype A. Nucleos(t)ide drug resistance mutations were found in six (6) patients...
March 19, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/28303753/efficacy-and-safety-of-emtricitabine-tenofovir-alafenamide-ftc-taf-vs-emtricitabine-tenofovir-disoproxil-fumarate-ftc-tdf-as-a-backbone-for-treatment-of-hiv-1-infection-in-virologically-suppressed-adults-subgroup-analysis-by-third-agent-of-a-randomized-double
#7
Frank A Post, Yazdan Yazdanpanah, Gabriel Schembri, Adriano Lazzarin, Jacques Reynes, Franco Maggiolo, Mingjin Yan, Michael E Abram, Cecilia Tran-Muchowski, Andrew Cheng, Martin S Rhee
BACKGROUND: FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety. OBJECTIVE: To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third agent). METHODS: We conducted a 48-week subgroup analysis based on third agent from a randomized, double blind study in virologically suppressed adults on a FTC/TDF-containing regimen who switched to FTC/TAF vs...
March 17, 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28301425/dolutegravir-with-tenofovir-disoproxil-fumarate-emtricitabine-as-hiv-post-exposure-prophylaxis-in-gay-and-bisexual-men
#8
John Mcallister, Janet M Towns, Anna Mcnulty, Anna B Pierce, Rosalind Foster, Robyn Richardson, Andrew Carr
OBJECTIVES: Completion rates for HIV post-exposure prophylaxis (PEP) are often low. We investigated the adherence and safety of dolutegravir (DTG 50 mg daily) with tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF-FTC) as 3-drug PEP in gay and bisexual men (GBM). DESIGN: Open-label, single-arm study at 3 sexual health clinics and 2 emergency departments in Australia. METHODS: One hundred HIV-uninfected GBM requiring PEP received DTG plus TDF-FTC for 28 days...
March 15, 2017: AIDS
https://www.readbyqxmd.com/read/28282300/a-randomized-double-blind-comparison-of-tenofovir-alafenamide-taf-vs-tenofovir-disoproxil-fumarate-tdf-each-coformulated-with-elvitegravir-cobicistat-and-emtricitabine-e-c-f-for-initial-hiv-1-treatment-week-144-results
#9
José R Arribas, Melanie Thompson, Paul E Sax, Bernhard Haas, Cheryl McDonald, David A Wohl, Edwin DeJesus, Amanda E Clarke, Susan Guo, Hui Wang, Christian Callebaut, Andrew Plummer, Andrew Cheng, Moupali Das, Scott McCallister
In two double-blind Phase 3 trials, 1733 antiretroviral-naïve adults were randomized to tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 144 weeks, TAF was superior to TDF in virologic efficacy, with 84.2% vs. 80.0% having HIV-1 RNA <50 copies/mL (difference 4.2%; 95%CI 0.6% to 7.8%). TAF had less impact than TDF on bone mineral density and renal biomarkers. No participants on TAF had renal-related discontinuations vs 12 on TDF (P<0...
March 9, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28272164/long-term-96-week-efficacy-and-safety-after-switching-from-tenofovir-disoproxil-fumarate-tdf-to-tenofovir-alafenamide-taf-in-hiv-infected-virologically-suppressed-adults
#10
Francois Raffi, Chloe Orkin, Amanda Clarke, Laurence Slama, Joel Gallant, Eric Daar, Keith Henry, Jorge Santana-Bagur, David K Stein, Nicholaos Bellos, Anthony Scarsella, Mingjin Yan, Michael E Abram, Andrew Cheng, Martin S Rhee
In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n=333) vs. remain on tenofovir disoproxil fumarate (TDF; n=330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA <50 copies/mL (adjusted difference -0.5%; 95%CI [-5.3%, 4.4%]). Proteinuria, albuminuria, proximal renal tubular function, and bone mineral density improved after switching to TAF- from TDF-containing regimens...
March 6, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28263457/ombitasvir-paritaprevir-ritonavir-and-dasabuvir-drug-interactions-with-antiretroviral-agents-and-drugs-forsubstance-abuse
#11
Jennifer R King, Rajeev M Menon
AbbVie's 3 direct-acting antiviral (3D) regimen containing ombitasvir, paritaprevir, ritonavir, and dasabuvir with and without ribavirin is approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Safe and efficacious antiviral regimens resulting in minimal to no drug-drug interactions (DDIs) with antiretrovirals are needed to ensure that patients coinfected with HCV and the human immunodeficiency virus (HIV) achieve 12-week sustained virologic response rates similar to HCV-monoinfected patients...
March 2017: Clinical Pharmacology in Drug Development
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
#12
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
#13
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
#14
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/28253024/differences-in-cumulative-exposure-and-adherence-to-tenofovir-in-the-voice-iprex-ole-and-prep-demo-studies-as-determined-via-hair-concentrations
#15
Catherine A Koss, Peter Bacchetti, Sharon L Hillier, Edward Livant, Howard Horng, Nyaradzo Mgodi, Brenda G Mirembe, Kailazarid Gomez Feliciano, Stephanie Horn, Albert Y Liu, David V Glidden, Robert M Grant, Leslie Z Benet, Alexander Louie, Ariane van der Straten, Z Mike Chirenje, Jeanne M Marrazzo, Monica Gandhi
Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) prevented HIV acquisition among men and women in several trials and is broadly recommended. In the VOICE and FEM-PrEP trials, however, TDF/FTC-based PrEP did not prevent HIV acquisition among women in eastern and southern Africa. Tenofovir was detected in plasma, reflecting exposure and adherence in recent days, in fewer than one-third of participants. Drug concentrations in hair, which represent cumulative exposure and adherence over weeks to months, have never previously been examined among women on PrEP...
March 2, 2017: AIDS Research and Human Retroviruses
https://www.readbyqxmd.com/read/28230617/acute-kidney-injury-after-efavirenz-tenofovir-disoproxil-fumarate-emtricitabine-atripla-overdose
#16
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/28225438/levels-of-intracellular-phosphorylated-tenofovir-and-emtricitabine-correlate-with-natural-substrate-concentrations-in-peripheral-blood-mononuclear-cells-of-persons-prescribed-daily-oral-truvadatm-for-hiv-pre-exposure-prophylaxis
#17
Richard E Haaland, Angela Holder, Chou-Pong Pau, Alison Swaims-Kohlmeier, Carolyn Dawson, Dawn K Smith, Tebogo M Segolodi, Michael C Thigpen, Lynn A Paxton, Teresa L Parsons, Craig W Hendrix, Clyde E Hart
No abstract text is available yet for this article.
February 14, 2017: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/28219610/bictegravir-versus-dolutegravir-each-with-emtricitabine-and-tenofovir-alafenamide-for-initial-treatment-of-hiv-1-infection-a-randomised-double-blind-phase-2-trial
#18
Paul E Sax, Edwin DeJesus, Gordon Crofoot, Douglas Ward, Paul Benson, Robin Dretler, Anthony Mills, Cynthia Brinson, Julie Peloquin, Xuelian Wei, Kirsten White, Andrew Cheng, Hal Martin, Erin Quirk
BACKGROUND: All recent treatment guidelines recommend integrase strand transfer inhibitors (INSTIs) as components of initial HIV therapy. Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity in a 10 day monotherapy study and has a high in-vitro resistance barrier. On the basis of these results, we did a phase 2 trial comparing bictegravir with dolutegravir. METHODS: In this randomised, double-blind, phase 2 trial, we recruited previously untreated adults (aged ≥18 years) with HIV-1 infections from 22 outpatient centres in the USA...
February 14, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28208119/hiv-prevention-opportunities-and-challenges
#19
Jeanne M Marrazzo
Preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)-based regimens has been shown to be effective in preventing acquisition of HIV infection, with protective efficacy being dependent on adherence to treatment. Data from the PROUD (Preexposure Option for Reducing HIV in the UK) and IPERGAY (Action to Prevent Risk Exposure By and For Gay Men) studies, the later of which employed event-driven PrEP, showed a high rate of protective efficacy of PrEP with TDF and emtricitabine among men who have sex with men...
December 2017: Topics in Antiviral Medicine
https://www.readbyqxmd.com/read/28186251/switch-as-maintenance-to-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-week-48-results-in-a-clinical-cohort
#20
Marine Perrier, Charlotte Charpentier, Gilles Peytavin, Minh Lê, Louis Blondel, Benoit Visseaux, Véronique Joly, Adriana Pinto, Sophie Matheron, Yazdan Yazdanpanah, Diane Descamps, Roland Landman
No abstract text is available yet for this article.
February 10, 2017: Journal of Antimicrobial Chemotherapy
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