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Josep M Llibre, Alessandro Cozzi-Lepri, Court Pedersen, Matti Ristola, Marcelo Losso, Amanda Mocroft, Viktar Mitsura, Karolin Falconer, Fernando Maltez, Marek Beniowski, Vincenzo Vullo, Gamal Hassoun, Elena Kuzovatova, János Szlavik, Anastasiia Kuznetsova, Hans-Jürgen Stellbrink, Claudine Duvivier, Simon Edwards, Kamilla Laut, Roger Paredes
Effectiveness data of an unboosted atazanavir (ATV) with abacavir/lamivudine (ABC/3TC) switch strategy in clinical routine are scant.We evaluated treatment outcomes of ATV + ABC/3TC in pretreated subjects in the EuroSIDA cohort when started with undetectable plasma HIV-1 viral load (pVL), performing a time to loss of virological response (TLOVR <50 copies/mL) and a snapshot analysis at 48, 96, and 144 weeks. Virological failure (VF) was defined as confirmed pVL >50 copies/mL.We included 285 subjects, 67% male, with median baseline CD4 530 cells, and 44 months with pVL ≤50 copies/mL...
October 2016: Medicine (Baltimore)
M Eulalia Valencia, Luz Martín-Carbonero, Victoria Moreno, José Ignacio Bernardino, M Luisa Montes, Rocío Montejano
OBJECTIVE: To describe the experience using the combination abacavir, lamivudine plus non-boosted atazanavir (ABC/3TC+ATV) in a group of pretreated patients. PATIENTS AND METHODS: We performed a retrospective observational study to describe baseline characteristics and the evolution of patients who had received or were treating with ABC/3TC+ATV, from November 2004 and June 15th 2015, in the clinical setting. RESULTS: Overall, 236 patients were included in the study...
October 13, 2016: Enfermedades Infecciosas y Microbiología Clínica
Lauren E Cain, Ellen C Caniglia, Andrew Phillips, Ashley Olson, Roberto Muga, Santiago Pérez-Hoyos, Sophie Abgrall, Dominique Costagliola, Rafael Rubio, Inma Jarrín, Heiner Bucher, Jan Fehr, Ard van Sighem, Peter Reiss, François Dabis, Marie-Anne Vandenhende, Roger Logan, James Robins, Jonathan A C Sterne, Amy Justice, Janet Tate, Giota Touloumi, Vasilis Paparizos, Anna Esteve, Jordi Casabona, Rémonie Seng, Laurence Meyer, Sophie Jose, Caroline Sabin, Miguel A Hernán
OBJECTIVE: To compare regimens consisting of either ritonavir-boosted atazanavir or efavirenz and a nucleoside reverse transcriptase inhibitor (NRTI) backbone with respect to clinical, immunologic, and virologic outcomes. DESIGN: Prospective studies of human immunodeficiency virus (HIV)-infected individuals in Europe and the United States included in the HIV-CAUSAL Collaboration. METHODS: HIV-positive, antiretroviral therapy-naive, and acquired immune deficiency syndrome (AIDS)-free individuals were followed from the time they started an atazanavir or efavirenz regimen...
October 2016: Medicine (Baltimore)
Geetha Bhavani K, Bala Murali Krishna K, Srinivasu N, Ramachandran D, V V S S Raman N, Hari Babu B
A sensitive LC-MS method was developed for the determination of tert-butyl 2-[4-(pyridine-2-yl) benzyl] hydrazine carboxylate (GTI-A), a genotoxic impurity in Atazanavir sulphate drug substance. The method was validated as per International Council for Harmonization guidelines, for QL, DL, linearity and accuracy. The QL and DL values obtained were 1.1ppm and 0.3ppm respectively. The Correlation coefficient found for the linearity study was 0.999. The % recovery of the added impurity in the range of 96.4-100...
September 26, 2016: Journal of Pharmaceutical and Biomedical Analysis
Dhakshinamoorthy Subashini, Thongadi Ramesh Dinesha, Jayaseelan Boobalan, Lawrence Christopher Samuel, Selvamuthu Poongulali, Ambrose Pradeep, Sunil Suhas Solomon, Suniti Solomon, Pachamuthu Balakrishnan, Shanmugam Saravanan
BACKGROUND: Ritonavir-boosted atazanavir (ATV/r) is the preferred second-line protease inhibitor (PI) option for HIV patients in resource-limited settings; its pattern of adverse drug reactions (ADRs) has not been much reported from India; hence, in this study, we have analyzed the incidence of ATV/r-associated ADRs in Southern Indian HIV-1-infected patients. METHODS: In this prospective study, 111 HIV patients treated with ATV/r were included with at least 2 years follow-up visits for the emergence of hyperbilirubinemia, hypertransaminasemia, and serum creatinine elevation...
September 2016: Indian Journal of Pharmacology
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
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
Noella Maria Delia Pereira, Ira Shah, Shilpa Kulkarni
Opsoclonus-myoclonus-ataxia (OMA) syndrome typically presents with chaotic eye movements and myoclonus with some patients exhibiting ataxia and behavioural disturbances. The pathogenesis may be inflammatory with an infectious or paraneoplastic trigger. We present a 13-year-old HIV-infected girl who was initially started on highly active antiretroviral therapy (HAART) in March 2013 with a CD4 count of 79 cells/cumm. Initially, the patient did not comply with treatment, resulting in a CD4+ count of 77 cells/mm(3) in November 2015 and prompting a new HAART scheme comprising lamivudine, tenofovir and ritonavir-boosted atazanavir...
October 2016: Oxford Medical Case Reports
Rajesh Krishna, Lilly East, Patrick Larson, Chandni Valiathan, Kathleen Deschamps, Julie Ann Luk, Crystal Bethel-Brown, Helen Manthos, John Brejda, Michael Gartner
Raltegravir is a human immunodeficiency virus (HIV)-1 integrase strand transfer inhibitor currently marketed at a dose of 400 mg twice-daily (BID). Raltegravir 1200 mg once-daily (QD) [investigational QD formulation of 2 x 600 mg tablets; QD RAL] was found to be generally well tolerated and non-inferior to the marketed 400 mg BID dose at 48 weeks in a Phase 3 trial. Since raltegravir is eliminated mainly by metabolism via a uridine diphosphate glucuronosyltransferase (UGT) 1A1-mediated glucuronidation pathway, coadministration of UGT1A1 inhibitors may increase plasma levels of QD RAL...
September 30, 2016: Biopharmaceutics & Drug Disposition
Ildefonso Pulido, Miguel Genebat, Ana I Alvarez-Rios, Rebeca S De Pablo-Bernal, Mohammed Rafii-El-Idrissi Benhnia, Yolanda M Pacheco, Ezequiel Ruiz-Mateos, Manuel Leal
Toxicities related to the use of nucleoside analogues have increased the interest in developing nucleoside-sparing regimens, mainly combining protease inhibitors with raltegravir. However, data regarding the use of CCR5-antagonists in this setting and in the naive scenario are scarce. The main objective was to analyze the immunovirological efficacy and tolerability of a low-dose, once-daily, maraviroc (MVC)-containing, nucleoside reverse transcriptase inhibitor-sparing dual therapy compared with standard triple therapy after 48 weeks for naive HIV-infected patients in the routine clinical practice setting...
October 2016: Viral Immunology
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
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
David Metsu, Patrick Seraissol, Pierre Delobel, Christel Cinq-Frais, Lise Cuzin, Jacques Izopet, Etienne Chatelut, Peggy Gandia
To date, therapeutic drug monitoring (TDM) is carried out with anti-retrovirals and is usually based on total concentrations (Ct). However, for some patients, TDM does not reflect efficacy or the avoidance of toxicity as is the case for atazanavir (ATV), a HIV protease inhibitor. As the unbound concentration (Cu) is the pharmacological active form, the aim of the study was to evaluate the value of Cu and the unbound fraction (fu, fu = Cu / Ct) for the TDM of ATV. The variability of Cu and the corresponding fu of ATV were explored in 43 patients treated with ATV for an average of 13...
September 24, 2016: Fundamental & Clinical Pharmacology
Alondra Frías, Alex Ortiz, Miriam Soto, Francisco Muñoz, Carolina Chacón
We report a 41-year-old man with HIV and a chronic obstructive pulmonary disease, treated for seven months with Fluticasone/Salmeterol and antiretroviral therapy (Lamivudine, Tenofovir, Atazanavir and Ritonavir). While using these medications, the patients developed a Cushing syndrome in a period of five months. After performing laboratory and imaging tests, it was concluded that the most probable cause of the syndrome was the interaction of inhaled steroids with Ritonavir. After discontinuing these medications the syndrome reverted in a period of 8 months...
July 2016: Revista Médica de Chile
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
Carmina R Fumaz, Aintzane Ayestaran, Nuria Perez-Alvarez, Jose A Muñoz-Moreno, Maria Jose Ferrer, Eugenia Negredo, Bonaventura Clotet
The prevalence and associated factors of erectile dysfunction (ED) in Human Immunodeficiency Virus (HIV)-infected men remain controversial. The authors evaluated ED, clinical, and emotional variables in a group of 501 HIV-infected men in a cross-sectional 4-month observational study. ED was assessed using the International Index of Erectile Function-5 and emotional status using the Hospital Anxiety and Depression (HAD) questionnaire. Median age (interquartile range) was 42 (35, 48) years. Time since HIV diagnosis was 6...
September 19, 2016: American Journal of Men's Health
Lisa Rosenblatt, Amanda M Farr, Ella T Nkhoma, James K Nelson, Corey Ritchings, Stephen S Johnston
BACKGROUND: A previous cohort study indicated that atazanavir (ATV), a protease inhibitor used for HIV treatment, is not associated with an increased risk of cardiovascular (CV) events. The objective of this study was to compare the risk of CV events among antiretroviral-naïve patients initiating ATV-containing versus ATV-free ARV regimens. METHODS: Patients with HIV who newly initiated antiretroviral therapy were selected from MarketScan Commercial and Multi-State Medicaid databases...
September 19, 2016: BMC Infectious Diseases
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)
J A Perez-Molina, R Rubio, A Rivero, J Pasquau, I Suárez-Lozano, M Riera, M Estébanez, R Palacios, J Sanz-Moreno, J Troya, A Mariño, A Antela, J Navarro, H Esteban, S Moreno
OBJECTIVES: We evaluated whether maintenance therapy with atazanavir/ritonavir plus lamivudine (ATV/r + 3TC) was non-inferior to ATV/r plus two nucleosides (ATV/r + 2NUCs) at 96 weeks of follow-up. METHODS: SALT is a multicentre, open-label, non-inferiority clinical trial in HIV-1-infected virologically suppressed patients. Hepatitis B virus surface antigen-negative subjects with no previous treatment failure/resistance mutations and HIV-1-RNA <50 copies/mL for ≥6 months were randomized (1 : 1) to ATV/r + 3TC or ATV/r + 2NUCs...
September 13, 2016: Journal of Antimicrobial Chemotherapy
Silvia A Guillemi, Sean H Ling, Julia S Dahlby, Benita Yip, Wendy Zhang, Mark W Hull, Viviane Dias Lima, Robert S Hogg, Ronald Werb, Julio S Montaner, Marianne Harris
INTRODUCTION: Tenofovir disoproxil fumarate (TDF)-associated renal dysfunction may abate when TDF is replaced with abacavir (ABC). The extent to which the third drug atazanavir contributes to renal dysfunction is unclear. METHODS: A retrospective analysis was conducted on adults who had plasma viral load (pVL)<200 copies/mL for≥six months while receiving TDF/lamivudine (3TC) - or TDF/emtricitabine (FTC)-based antiretroviral therapy (ART), then switched to ABC/3TC while retaining the third drug in the ART regimen...
2016: Journal of the International AIDS Society
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