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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
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
Carlo Perrone, Andri Rauch, Hansjakob Furrer, Markus Hug, Gilles Wandeler
No abstract text is available yet for this article.
March 13, 2018: AIDS
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
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
Robert Güerri-Fernández, Elisabet Lerma-Chippirraz, Ana Fernandez Marron, Natalia García-Giralt, Judit Villar-García, Jade Soldado, Alicia González-Mena, Ana Guelar, Adolfo Díez-Pérez, Todd T Brown, Hernando Knobel
: 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 naïve HIV patients that were going to start antiretroviral (ART) a single pill treatment with Elvitegravir/cobicistat, Tenofovir (TDF), Emtricitavine (FTC) were included...
February 8, 2018: AIDS
Katherine J Lepik, Benita Yip, Ana Ulloa, Lu Wang, Junine Toy, Linda Akagi, Viviane Dias Lima, Silvia Guillemi, Julio S G Montaner, Rolando Barrios
OBJECTIVES: 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 ≥19 years 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 two years until 31-Dec-2016...
February 8, 2018: AIDS
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...
January 30, 2018: Antiviral Research
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
Isabelle Malet, Francesca A Ambrosio, Frédéric Subra, Béatrice Herrmann, Hervé Leh, Marie-Christine Bouger, Anna Artese, Christine Katlama, Carmine Talarico, Isabella Romeo, Stefano Alcaro, Giosuè Costa, Eric Deprez, Vincent Calvez, Anne-Geneviève Marcelin, Olivier Delelis
Background: Dolutegravir, an integrase strand-transfer inhibitor (STI), shows a high genetic barrier to resistance. Dolutegravir is reported to be effective against viruses resistant to raltegravir and elvitegravir. In this study, we report the case of a patient treated with dolutegravir monotherapy. Failure of dolutegravir treatment was observed concomitant with the appearance of N155H-K211R-E212T mutations in the integrase (IN) gene in addition to the polymorphic K156N mutation that was present at baseline in this patient...
January 24, 2018: Journal of Antimicrobial Chemotherapy
Edwin DeJesus, Bernard Haas, Sorana Segal-Mauer, Moti Ramgopal, Anthony Mills, Nicolas Margot, Ya-Pei Liu, Tariro Makadzange, Scott McCallister
BACKGROUND: We previously demonstrated superior efficacy and safety advantages in HIV-infected, virologically suppressed adults switched to a regimen containing tenofovir alafenamide (TAF) as compared with those remaining on a tenofovir disoproxil fumarate (TDF) regimen through week 48. We now report longer-term data through week 96. METHODS: In this randomized, active-controlled, multicenter, open-label, non-inferiority trial ( number NCT01815736), we randomized virologically suppressed (HIV-1 RNA <50 copies/mL) adults (2:1) to receive a once-daily, single-tablet regimen containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF group) or to continue one of four TDF-containing regimens (TDF group) for 96 weeks...
January 25, 2018: AIDS Research and Human Retroviruses
Takuma Yonemura, Nozomi Okada, Koichi Sagane, Kazuhiro Okamiya, Hideki Ozaki, Toshiaki Iida, Hiroyuki Yamada, Hiroki Yagura
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) is specified in its package insert to be taken with food to obtain sufficient exposure of EVG. It has been reported that a nutritional protein-rich drink shows comparable pharmacokinetics (PK) of EVG to those with a standard breakfast. In this study, the PK profiles of EVG and COBI were evaluated by administration of a single dose of EVG/COBI/FTC/TAF, after ingestion of either a nutritional protein-rich drink, milk, or apple juice...
January 24, 2018: Clinical Pharmacology in Drug Development
Emmanuel Ndashimye, Mariano Avino, Fred Kyeyune, Immaculate Nankya, Richard M Gibson, Eva Nabulime, Art F Y Poon, Cissy Kityo, Peter Mugyenyi, Miguel E Quinones-Mateu, Eric Arts
OBJECTIVES: To screen for drug resistance and possible treatment with Dolutegravir (DTG) in treatment naïve patients and those experiencing virologic failure during first, second, and third line combined antiretroviral therapy (cART) in Uganda. DESIGN: Samples from 417 patients in Uganda were analyzed for predicted drug resistance upon failing a first (N=158), second (N=121), or third line (all 51 involving Raltegravir [RAL]) treatment regimen. METHOD: HIV-1 pol gene was amplified and sequenced from plasma samples...
January 21, 2018: AIDS Research and Human Retroviruses
Charlotte Charpentier, Isabelle Malet, Elisabeth Andre-Garnier, Alexandre Storto, Laurence Bocket, Corinne Amiel, Laurence Morand-Joubert, Camille Tumiotto, Thuy Nguyen, Anne Maillard, Audrey Rodallec, Marie Leoz, Brigitte Montes, Véronique Schneider, Jean-Christophe Plantier, Julia Dina, Coralie Pallier, Audrey Mirand, Catherine Roussel, Anne Signori-Schmuck, Stéphanie Raymond, Vincent Calvez, Constance Delaugerre, Anne-Geneviève Marcelin, Diane Descamps
Objectives: To assess the phenotypic susceptibility of the E157Q polymorphism in HIV-1 integrase (IN) and the virological outcome of patients infected with E157Q-mutated virus initiating an IN inhibitor (INI)-based regimen. Methods: This was a multicentre study assessing IN sequences from INI-naive patients among 17 French HIV clinical centres. E157Q site-directed mutants in pNL4.3 and pCRF02_AG contexts were assessed in a recombinant phenotypic assay. Results: Prevalence of the E157Q polymorphism was 2...
January 12, 2018: Journal of Antimicrobial Chemotherapy
Anthony T Podany, Sara H Bares, Joshua Havens, Ravi Dyavar Shetty, Jennifer O'neill, Sarah Lee, Courtney V Fletcher, Susan Swindells, Kimberly K Scarsi
OBJECTIVES: The aim of the study was to compare the intra-individual plasma and intracellular peripheral blood mononuclear cell (PBMC) pharmacokinetics (PK) of tenofovir (TFV) and its intracellular metabolite, tenofovir-diphosphate (TFV-DP) in patients switched from a fixed dose combination (FDC) tablet of tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC)/ elvitegravir (EVG)/ cobicistat (COBI) to a FDC containing tenofovir alafenamide (TAF)/FTC/EVG/COBI. DESIGN: A single arm, prospective, non-randomized, cross-over, PK study in patients receiving a TDF-containing regimen (TDF 300 mg/ FTC 200 mg/ EVG 150 mg/ COBI 150 mg) switched to a TAF-containing FDC regimen (TAF 10 mg/ FTC 200 mg/ EVG 150 mg/ COBI 150 mg)...
January 13, 2018: AIDS
Sebastiano Leone, Milensu Shanyinde, Alessandro Cozzi Lepri, Fiona C Lampe, Pietro Caramello, Andrea Costantini, Andrea Giacometti, Andrea De Luca, Antonella Cingolani, Francesca Ceccherini Silberstein, Massimo Puoti, Andrea Gori, Antonella d'Arminio Monforte
To evaluate incidence rates of and predictors for any antiretroviral (ART) drug discontinuation by HCV infection status in a large Italian cohort of HIV infected patients. All patients enrolled in ICONA who started combination antiretroviral therapy (cART) containing abacavir or tenofovir or emtricitabine or lamivudine plus efavirenz or rilpivirine or atazanavir/r or darunavir/r (DRV/r) or lopinavir/r or dolutegravir or elvitegravir or raltegravir were included. Multivariate Poisson regression models were used to determine factors independently associated with single ART drug discontinuation...
January 9, 2018: European Journal of Clinical Microbiology & Infectious Diseases
Ujjwal Neogi, Kamlendra Singh, Shambhu G Aralaguppe, Leonard C Rogers, Duncan T Njenda, Stefan G Sarafianos, Bo Hejdeman, Anders Sönnerborg
OBJECTIVE: To determine the antiretroviral activity of the integrase strand transfer inhibitors (INSTIs), raltegravir, elvitegravir, dolutegravir, cabotegravir and bictegravir, against different subtypes as well as primary and acquired drug resistance mutations (DRM) in a patient-cohort infected with diverse subtypes. DESIGN: Biochemical and virological drug sensitivity analysis using patient derived HIV-1 genes and cross-sectional/longitudinal clinical study. METHODS: Assays for inhibition of 3'-end processing (IC50-3P), strand transfer (IC50-ST) and drug sensitivity (DSA) for five INSTIs were done using patient-derived integrase or gag-pol genes from subtypes A1, B, C, 01_AE and 02_AG...
December 12, 2017: AIDS
Andrew Merker, Melissa Badowski, Thomas Chiampas, Sarah E Pérez, Mahesh Patel, Jeremy Young, Ryan Werner
Minimal information is available regarding antiretroviral prescribing patterns and outcomes for HIV patients in correctional systems. This study analyzes single- (STR) and multiple- (MTR) tablet regimen effectiveness in patients receiving HIV telemedicine care through the Illinois Department of Corrections (IDOC). This study involves a retrospective review of HIV-positive adult patients in IDOC on either an STR (efavirenz, rilpivirine, elvitegravir based) or an MTR (emtricitabine/tenofovir with atazanavir/ritonavir, darunavir/ritonavir, or raltegravir)...
January 1, 2017: Journal of Correctional Health Care
Erik De Clercq
Tenofovir (TFV) is the cornerstone of the treatment and prophylaxis of HIV infections. It has been routinely used in its prodrug form TDF (tenofovir disoproxil fumarate) combined with emtricitabine ((-)FTC) and other antiretroviral agents. TDF has now been replaced by TAF (tenofovir alafenamide) which allows better uptake by the lymphoid tissue. In combination with elvitegravir (E), cobicistat (C), emtricitabine (F), TAF can be advocated as an STR (single tablet regimen, Genvoya®) for the treatment of HIV infections...
December 7, 2017: Biochemical Pharmacology
Yuqing Gong, Pallabita Chowdhury, Narasimha M Midde, Mohammad A Rahman, Murali M Yallapu, Santosh Kumar
Purpose: Monocytes serve as sanctuary sites for HIV-1 from which virus is difficult to be eliminated. Therefore, an effective viral suppression in monocytes is critical for effective antiretroviral therapy (ART). This study focuses on a new strategy using nanoformulation to optimize the efficacy of ART drugs in HIV-infected monocytes. Methods: Poly(lactic- co -glycolic acid) (PLGA)-based elvitegravir nanoparticles (PLGA-EVG) were prepared by nano-precipitation technique...
December 2017: Biochemistry and Biophysics Reports
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