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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
Alan Winston, Wolfgang Stöhr, Andrea Antinori, Helene Amieva, Philippe Perré, Stephane De Wit, Jacques Reynes, Mark Gompels, Antonella d'Arminio Monforte, Jose-Maria Gatell, Jesper Grarup, Anton Pozniak, Abdel Babiker, François Raffi, Laura Richert
BACKGROUND: Improvements in cognitive function are described after initiation of combination antiretroviral therapy (cART), with sparse data on differences between cART strategies. METHODS: We assessed changes in cognition, over 96 weeks, in therapy naïve HIV-positive adults randomised to darunavir/ritonavir (800/100mg once daily) with either raltegravir (400mg twice daily, Arm1) or tenofovir/emtricitabine (245/200mg once daily, Arm2). Seven cognitive tests were administered at baseline and week 96...
October 3, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Carmela E Corallo, Louise Grannell, Huyen Tran
A 62-year-old man was admitted to hospital for elective revision of a left total hip arthroplasty. His history was significant for human immunodeficiency virus (HIV) infection for which he was taking the following antiretroviral agents (ARVs): etravirine, ritonavir, darunavir, raltegravir and tenofovir/emtricitabine. Rivaroxaban 10 mg daily was commenced on the second postoperative day for venous thromboembolism (VTE) prophylaxis. Approximately 24 h later, the patient developed hypotension and anaemia, accompanied by thigh swelling due to bleeding at the surgical site...
December 2015: Drug Saf Case Rep
Motoko Ikuma, Dai Watanabe, Hiroki Yagura, Misa Ashida, Masaaki Takahashi, Masaaki Shibata, Tadafumi Asaoka, Munehiro Yoshino, Tomoko Uehira, Wataru Sugiura, Takuma Shirasaka
An elderly woman with human immunodeficiency virus-1 infection developed short bowel syndrome as a result of extensive intestinal resection. Considering the possibility of poor absorption of antiretroviral drugs (ARVs), therapeutic drug monitoring (TDM) was performed. A single-dose test of 6 ARVs (darunavir, ritonavir, lopinavir, etravirine, maraviroc, and raltegravir) did not provide information on the appropriate ARV, and repeated TDM under continuous antiretroviral therapy resulted in viral suppression below 50 copies/mL, which was considered to be treatment success...
2016: Internal Medicine
Sahera Dirajlal-Fargo, Carlee Moser, Todd T Brown, Theodoros Kelesidis, Michael P Dube, James H Stein, Judith Currier, Grace A McComsey
Background.  Antiretroviral therapy (ART) can alter glucose metabolism, but little data exist on the association of raltegravir (RAL) with insulin resistance. Methods.  A5260s was a substudy of A5257, a prospective open-label randomized trial in which human immunodeficiency virus (HIV)-infected treatment-naive participants were randomized to tenofovir-emtricitabine (TDF/FTC) plus atazanavir-ritonavir (ATV/r), darunavir-ritonavir (DRV/r), or RAL over 96 weeks. Baseline and changes in insulin resistance as estimated by the homeostatic model assessment of insulin resistance (HOMA-IR) were assessed...
September 2016: Open Forum Infectious Diseases
Jagruti Desai, Hetal Thakkar
The present investigation aimed to study the effect of particle size of solid lipid nanoparticles (SLNs) on oral bioavailability of Darunavir. High pressure homogenization technique was used to prepare SLNs. Three different sized SLNs loaded with Darunavir were developed with mean particle sizes of around 100 nm, 200 nm and 500 nm respectively. The in-vivo pharmacokinetics in rats showed a significant increase in oral bioavailability of Darunavir from all the three formulations in comparison to plain drug suspension and reference tablet...
October 5, 2016: Journal of Microencapsulation
Juan Carlos Domínguez-Hermosillo, José Antonio Mata-Marin, Norma Estela Herrera-González, Marcelino Chávez-García, Gloria Huerta-García, Nohemí Nuñez-Rodríguez, José Gerardo García-Gámez, Anai Jiménez-Romero, Jesús Enrique Gaytán-Martínez
INTRODUCTION: Although both tipranavir (TPV) and darunavir (DRV) represent important options for the management of patients with multi-protease inhibitor (PI)-resistant human immunodeficiency virus (HIV), currently there are no studies comparing the effectiveness and safety of these two drugs in the Mexican population. The aim of this study was to compare the effectiveness of TPV versus DRV as a salvage therapy in HIV-1 treatment-experienced patients. METHODOLOGY: This was a comparative, prospective, cohort study...
September 30, 2016: Journal of Infection in Developing Countries
Dominic Chow, Cecilia Shikuma, Corey Ritchings, Muxing Guo, Lisa Rosenblatt
INTRODUCTION: Patients with human immunodeficiency virus (HIV) infection have an increased risk of cardiovascular disease (CVD). While viral suppression with antiretroviral therapy decreases CVD risk overall, several studies have suggested that certain antiretrovirals, particularly certain protease inhibitors, may be associated with an increased relative risk of CVD. In AIDS Clinical Trials Group 5260 s, ritonavir-boosted atazanavir (ATV) was associated with slower atherosclerosis progression compared to ritonavir-boosted darunavir and raltegravir, potentially due to hyperbilirubinemia...
September 27, 2016: Infectious Diseases and Therapy
Pasquale Pagliano, Tiziana Ascione, Maria Aurora Carleo, Giovanni Boccia, Francesco De Caro, Fabio Tortora
Incidence of brain infections in Human Immunodeficiency Virus (HIV) positive patients is reduced after the availability of current high active antiretroviral therapy (HAART). Herpes Simplex Virus type 2 (HSV-2) is an infrequent cause of encephalitis in HIV patients despite it is frequently involved in sexual transmitted infections. Here, we report a case of HSV-2 encephalitis occurring in a patient without full suppression of HIV replication within the brain. A 38 year-old HIV infected man was admitted to our department because of recurrent generalized seizure and fever during the previous 24 hours...
September 1, 2016: Le Infezioni in Medicina
Bruce Green, Herta Crauwels, Thomas N Kakuda, Simon Vanveggel, Anne Brochot
BACKGROUND: Etravirine is a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretrovirals for treatment-experienced HIV patients ≥6 years of age. Etravirine is primarily metabolized by cytochrome P450 (CYP) 2C9, CYP2C19, and CYP3A. This analysis determined the impact of concomitant antiretrovirals and CYP2C9/CYP2C19 phenotype on the pharmacokinetics of etravirine. METHODS: We used 4728 plasma concentrations from 817 adult subjects collected from four clinical studies to develop the population pharmacokinetic model...
September 24, 2016: Clinical Pharmacokinetics
Amedeo F Capetti, Giancarlo Orofino, Gaetana Sterrantino, Maria V Cossu, Giovanni Cenderello, Anna M Cattelan, Giuseppe V De Socio, Stefano Rusconi, Niccolò Riccardi, Gian M Baldin, Serena Cima, Fosca P Niero, Giuliano Rizzardini, Lolita Sasset
BACKGROUND: Dolutegravir plus darunavir provide high genetic barrier to HIV-1 resistance and fit for simple salvage regimens. METHODS: All HIV-1 infected subjects treated with dolutegravir plus boosted darunavir dual therapy between March 2011 and September 2015 were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. RESULTS: We enrolled 113 subjects. After week 24 one was lost at follow-up, one dropped out for grade 2 elevation of liver enzimes, one died from illicit drug abuse and one from cancer-related sepsis...
September 23, 2016: Antiviral Therapy
Theodoros Kelesidis, Thuy Tien T Tran, Todd T Brown, Carlee Moser, Heather J Ribaudo, Michael P Dube, Otto O Yang, Grace A McComsey, James H Stein, Judith S Currier
BACKGROUND: The role of oxidized lipoproteins (high-density [HDLox] and low-density [LDLox]) and total lipoprotein particle (Lp) number and size in HIV-related cardiovascular disease (CVD) is unclear. The goal of this study was to evaluate changes of these biomarkers and their associations with rate of carotid intima media thickness progression over 3 years (ΔCIMT) in chronic HIV infection. METHODS: Prospective study of 234 HIV-infected antiretroviral treatment naïve participants without CVD who were randomized to receive tenofovir-emtricitabine plus atazanavir/ritonavir, darunavir/ ritonavir, or raltegravir (RAL) and achieved plasma HIV-1 RNA <50 copies/ml by week 24 and thereafter...
September 23, 2016: Antiviral Therapy
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 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 (IC50 = 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 EC50 values ranging from 1.5 to 2.4 nM and selectivity indices up to 8800 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...
September 19, 2016: Antimicrobial Agents and Chemotherapy
Paul de Boissieu, Moustapha Dramé, François Raffi, André Cabie, Isabelle Poizot-Martin, Laurent Cotte, Rodolphe Garraffo, Pierre Delobel, Thomas Huleux, David Rey, Firouzé Bani-Sadr
Data on the long-term efficacy and safety of abacavir/lamivudine (ABC/3TC) and nevirapine (NVP) are scarce. This combination has the advantage of simplifying treatment and improving long-term tolerance. The aim of this study was to compare the rate of any discontinuation of antiretroviral (ARV) regimen because of virologic failure (VF), and/or adverse drug reaction (ADR) among patients receiving stable ARV regimens for at least 6 months.ABC/3TC/NVP was compared to ABC/3TC with either ritonavir-boosted darunavir (DRV/r) or ritonavir-boosted atazanavir (ATV/r), unboosted ATV, or tenofovir/emtricitabine (TDF/FTC) with either one of the following: ATV/r, unboosted ATV, DRV/r, efavirenz (EFV), or NVP, in the French prospective multicenter Dat'AIDS cohort...
September 2016: Medicine (Baltimore)
Masayuki Amano, Pedro Miguel Salcedo-Gómez, Rui Zhao, Ravikiran S Yedidi, Debananda Das, Haydar Bulut, Nicole S Delino, Sheri Venkata Reddy, Arun K Ghosh, Hiroaki Mitsuya
We here report that GRL-10413, a novel non-peptidic HIV-1 protease inhibitor (PI) containing a modified P1 moiety and a sulfonamide isostere, is highly active against laboratory HIV-1 strains and primary clinical isolates (EC50: 0.00035 - 0.0018 μM) with minimal cytotoxicity (CC50: 35.7 μM). GRL-10413 blocked the infectivity and replication of HIV-1NL4-3 variants selected by up to 5 μM concentrations of atazanavir, lopinavir, or amprenavir (EC50: 0.0021 - 0.0023 μM). GRL-10413 also maintained its strong antiviral activity against multi-drug-resistant clinical HIV-1 variants isolated from patients, who no longer responded to various antiviral regimens after long-term antiretroviral therapy...
September 12, 2016: Antimicrobial Agents and Chemotherapy
Dario Cattaneo, Sara Baldelli, Davide Minisci, Paola Meraviglia, Emilio Clementi, Massimo Galli, Cristina Gervasoni
Stribild should be administered under fed conditions to optimize drugs exposure. Here we assessed to what extent this advice is applied in the real life scenario by therapeutic drug monitoring in 75 HIV-infected patients given Stribild-based antiretroviral therapy. Fifty-three percent of our patients took Stribild at lunch/supper time, 23% in the morning with breakfast, and 24% middle in the morning or late in the evening. Twelve out of the 75 patients had unquantifiable elvitegravir concentrations, whereas in the remaining the levels were largely distributed...
October 15, 2016: International Journal of Pharmaceutics
Philip Lackey, Anthony Mills, Felix Carpio, Ricky Hsu, Edwin DeJesus, Gerald Pierone, Cassidy Henegar, Jennifer Fusco, Gregory Fusco, Mike Wohlfeiler
BACKGROUND AND OBJECTIVES: The standard of care for HIV treatment is a three-drug regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) and either a non-nucleoside reverse transcriptase inhibitor, a protease inhibitor (PI) or an integrase strand transfer inhibitor. Darunavir boosted with ritonavir (DRV/r) is the only preferred PI in the US Department of Health and Human Services (DHHS) HIV treatment guidelines for antiretroviral-naïve patients, recommended in combination with tenofovir/emtricitabine for antiretroviral-naïve patients...
September 1, 2016: Clinical Drug Investigation
Natalia Stella-Ascariz, Rocío Montejano, Laura Pintado-Berninches, Susana Monge, José I Bernardino, Ignacio Pérez-Valero, Ma Luisa Montes, Jesús Mingorance, Rosario Perona, José R Arribas
In vitro, tenofovir and abacavir induced a significant dose-dependent inhibition of telomerase activity at therapeutic concentrations in PBMCs of healthy subjects. Median inhibition of telomerase activity by tenofovir at 0.5µM and 1µM was 29% (Interquartile range (IQR) 29%-34%, p=0.042) and 28% (IQR 28%-41%, p=0.042), respectively. Abacavir inhibition was 12% (IQR 9%-13%, p=0.043) at 3µM and 14% (IQR 10%-29%, p=0.043) at 10µM. Tenofovir and abacavir did not change human telomerase reverse transcriptase (hTERT) levels or mRNA levels of other telomerase complex genes...
August 20, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Nicola Gianotti, Laura Galli, Renato Maserati, Laura Sighinolfi, Diego Ripamonti, Loredana Palvarini, Sergio Lo Caputo, Emanuele Focà, Benedetto Maurizio Celesia, Franco Baldelli, Gaetana Sterrantino, Adriano Lazzarin
In a multicentre, open-label, clinical trial, 43 patients virologically suppressed while receiving a standard triple antiretroviral therapy were randomized (1:1:1) to switch to monotherapy with darunavir/ritonavir (DRV/r-MT arm), monotherapy with lopinavir/ritonavir (LPV/r-MT arm) or to continue on the ongoing regimen (cART arm). The proportion (95% CI) of patients with virological success (Snapshot analysis) at week 48 was 73% (48%-90%) in the DRV/r-MT arm, 69% (42%-88%) in the LPV/r-MT arm and 87% (61%-98%) in the cART arm...
August 23, 2016: New Microbiologica
Alessandra Latini, Massimiliano Fabbiani, Vanni Borghi, Gaetana Sterrantino, Alberto Giannetti, Patrizia Lorenzini, Laura Loiacono, Adriana Ammassari, Rita Bellagamba, Manuela Colafigli, Gabriella D'Ettorre, Simona Di Giambenedetto, Andrea Antinori, Mauro Zaccarelli
BACKGROUND: Aim of the study was to assess predictors of discontinuation/toxicity of boosted PI-based (PI/r) dual therapy (DT). METHODS: Observational, retrospective switch study in patients successfully treated with triple drugs regimen. Patients switched to PI/r based DT [darunavir (DRV/r), lopinavir (LPV/r) or atazanavir (ATV/r)] plus a second drug: [raltegravir (RAL), maraviroc (MVC) etravirine (ETR), lamivudine (3TC) or tenofovir (TDF)] between 2009 and 2014 were included...
2016: BMC Infectious Diseases
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