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Amedeo F Capetti, Gaetana Sterrantino, Maria Vittoria Cossu, GianCarlo Orofino, Giorgio Barbarini, Giuseppe V De Socio, Simona Di Giambenedetto, Antonio Di Biagio, Benedetto M Celesia, Barbara Argenteri, Giuliano Rizzardini
INTRODUCTION: Little information is available on the efficacy and safety of the dual combination of ripivirine plus dolutegravir. This work aims at beginning to fill this gap. METHODS: All HIV-1 infected subjects treated with ripivirine plus dolutegravir between October 2014 and September 2015 in eight Italian centres were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. RESULTS: One hundred and thirty-two subjects were followed for a median of 24 months, mean 33 months...
2016: PloS One
Jesús Troya, Pablo Ryan, Esteban Ribera, Daniel Podzamczer, Victor Hontañón, Jose Alberto Terrón, Vicente Boix, Santiago Moreno, Pilar Barrufet, Manuel Castaño, Ana Carrero, María José Galindo, Ignacio Suárez-Lozano, Hernando Knobel, Miguel Raffo, Javier Solís, María Yllescas, Herminia Esteban, Juan González-García, Juan Berenguer, Arkaitz Imaz
OBJECTIVES: Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients. METHODS: We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48...
2016: PloS One
Bilal Nizami, Dominique Sydow, Gerhard Wolber, Bahareh Honarparvar
Regardless of advances in anti-HIV therapy, HIV infection remains an immense challenge due to the rapid onset of mutation instigating drug resistance. Rilpivirine is a second generation di-aryl pyrimidine (DAPY) derivative, known to effectively inhibit wild-type (WT) as well as various mutant HIV-1 reverse transcriptase (RT). In this study, a cumulative 240 ns of molecular dynamic (MD) simulations of WT HIV-1 RT and its corresponding K103N mutated form, complexed with rilpivirine, were performed in solution...
September 9, 2016: Molecular BioSystems
Saran Vardhanabhuti, David Katzenstein, John Bartlett, Nagalingeswaran Kumarasamy, Carole L Wallis
Background.  The mechanism of virologic failure (VF) of lopinavir/ritonavir (LPV/r) monotherapy is not well understood. We assessed sequence changes in human immunodeficiency virus-1 reverse-transcriptase (RT) and protease (PR) regions. Methods.  Human immunodeficiency virus-1 pol sequences from 34 participants who failed second-line LPV/r monotherapy were obtained at study entry (SE) and VF. Sequence changes were evaluated using phylogenetic analysis and hamming distance. Results.  Human immunodeficiency virus-1 sequence change was higher over drug resistance mutation (DRM) sites (median genetic distance, 2...
September 2016: Open Forum Infectious Diseases
Sean E Collins, Philip M Grant, Francois Uwinkindi, Annie Talbot, Eric Seruyange, Deborah Slamowitz, Adeline Mugeni, Eric Remera, Simon Pierre Niyonsenga, Josbert Nyirimigabo, Jean Paul Uwizihiwe, Pierre Dongier, Ribakare Muhayimpundu, Jean-Baptiste Mazarati, Andrew Zolopa, Sabin Nsanzimana
Background.  Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods.  We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors...
September 2016: Open Forum Infectious Diseases
Robert L Glaubius, Urvi M Parikh, Greg Hood, Kerri J Penrose, Eran Bendavid, John W Mellors, Ume L Abbas
Background.  A long-acting injectable formulation of rilpivirine (RPV), under investigation as antiretroviral pre-exposure prophylaxis (PrEP), may facilitate PrEP adherence. In contrast, cross-resistance between RPV and nonnucleoside reverse-transcriptase inhibitors comprising first-line antiretroviral therapy (ART) could promote human immunodeficiency virus (HIV) drug resistance and reduce PrEP's effectiveness. Methods.  We use novel mathematical modeling of different RPV PrEP scale-up strategies in KwaZulu-Natal, South Africa, to investigate their effects on HIV prevention and drug resistance, compared with a reference scenario without PrEP...
September 2016: Open Forum Infectious Diseases
Nirajan Bhusal, Ruengpung Sutthent, Navin Horthongkham, Niracha Athipanyasilp, Wannee Kantakamalakul
BACKGROUND: There have been very few reports of HIV-1 subtypes and drug resistance mutations (DRMs) from Nepal which is geographically located between two high-prevalence HIV-1 infection countries, China and India. The aim of this study was to determine prevalence of acquired and transmitted DRMs and HIV-1 subtypes in Nepal. METHODS: Thirty-five HIV-1 seropositive samples from central region of Nepal were collected in 2011. The subjects were divided into two groups, antiretroviral (ARV) drug naïve group (n=15) and antiretroviral treatment (ART) group (n=20), 90% (18/20) of them received zidovudine, lamivudine and nevirapine (AZT/3TC/NVP) regimen...
October 3, 2016: Current HIV Research
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
K Steegen, M Bronze, M A Papathanasopoulos, G van Zyl, D Goedhals, E Variava, W MacLeod, I Sanne, W S Stevens, S Carmona
BACKGROUND: Routine HIV-1 antiretroviral drug resistance testing for patients failing NNRTI-based regimens is not recommended in resource-limited settings. Therefore, surveys are required to monitor resistance profiles in patients failing ART. METHODS: A cross-sectional survey was conducted amongst patients failing NNRTI-based regimens in the public sector throughout South Africa. Virological failure was defined as two consecutive HIV-1 viral load results >1000 RNA copies/mL...
September 22, 2016: Journal of Antimicrobial Chemotherapy
Ian McGowan, Charlene S Dezzutti, Aaron Siegel, Jarret Engstrom, Alexiy Nikiforov, Kathryn Duffill, Cory Shetler, Nicola Richardson-Harman, Kaleab Abebe, David Back, Laura Else, Deidre Egan, Saye Khoo, James E Egan, Ronald Stall, Peter E Williams, Khaleel K Rehman, Amy Adler, Rhonda M Brand, Beatrice Chen, Sharon Achilles, Ross D Cranston
BACKGROUND: Long-acting injectable antiretroviral agents are being developed for HIV-1 prevention. The MWRI-01 study was done to characterise the safety, acceptability, and pharmacokinetic and pharmacodynamic profile of long-acting rilpivirine. METHODS: We did a phase 1 open-label study at the University of Pittsburgh. We enrolled healthy individuals (aged 18-45 years) who were seronegative for HIV-1. Participants were assigned alternately one intramuscular dose of either 1200 mg or 600 mg long-acting rilpivirine, beginning with the 1200 mg dose...
September 16, 2016: Lancet HIV
Teresa L Parsons, Mark A Marzinke
BACKGROUND: Analytical methodologies for antiretroviral (ARV) quantification are important in determining both systemic and localized drug concentrations. The CCR5-antagonist maraviroc (MVC), the non-nucleoside reverse transcriptase inhibitors (NNRTIs) etravirine (ETV) and rilpivirine (RPV), as well as the integrase strand transfer inhibitor (INSTI) raltegravir (RAL), have all been evaluated using both oral and non-oral dosing regimens, demonstrating a need for dynamic and sensitive bioanalytical tools for drug quantification in plasma and tissue...
November 30, 2016: Journal of Pharmaceutical and Biomedical Analysis
Adrian Curran, Jhon Rojas, Alfonso Cabello, Jesús Troya, Arkaitz Imaz, Pere Domingo, Esteban Martinez, Pablo Ryan, Miguel Górgolas, Daniel Podzamczer, Hernando Knobel, Félix Gutiérrez, Esteban Ribera
OBJECTIVES: To describe the effectiveness and safety of an abacavir/lamivudine + rilpivirine regimen in naive HIV-1-infected patients, as there is a lack of data with this combination. METHODS: This was an observational, retrospective, multicentre study in eight Spanish hospitals. All antiretroviral-naive patients ≥18 years old and starting abacavir/lamivudine + rilpivirine were included. Effectiveness (ITT and on-treatment) and safety (adverse events and laboratory parameters) were assessed during follow-up...
September 2, 2016: Journal of Antimicrobial Chemotherapy
Antonio Di Biagio, Niccolò Riccardi, Lucia Taramasso, Amedeo Capetti, Giovanni Cenderello, Alessio Signori, Paola Vitiello, Michele Guerra, Giuseppe Vittorio de Socio, Giovanni Cassola, Tiziano Quirino, Claudio Viscoli
This study aimed to evaluate the efficacy, tolerability and potential savings of combined antiretroviral therapy (cART) simplification from an unboosted protease inhibitor (PI) regimen with atazanavir or fosamprenavir to a single-tablet regimen (STR) based on rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF) among HIV-1-infected patients with HIV-1 RNA <50 copies/mL. This was a retrospective, multicentre, open-label, 12-week trial. Plasma HIV-1-RNA levels, CD4+ cell counts, cholesterol, triglycerides, bilirubin, glycaemia, creatinine and physical examination were performed at baseline and at scheduled follow-up...
August 17, 2016: International Journal of Antimicrobial Agents
Kateřina Punčochová, Marie Prajzlerová, Josef Beránek, František Štěpánek
Active pharmaceutical ingredients (APIs) with strongly pH-dependent aqueous solubility can face the problem of precipitating from solution when the pH changes from acidic in the stomach to neutral in the intestine. The present work investigates the effect of two polymeric excipients - polyvinylpyrrolidone (PVP) and Soluplus - on the ability to either prevent precipitation, or to control the size distribution of precipitated particles when precipitation cannot be prevented. Two different APIs were compared, Dabigatran etexilate mesylate and Rilpivirine hydrochloride...
August 15, 2016: European Journal of Pharmaceutical Sciences
Pavan Kumar Prathipati, Subhra Mandal, Christopher J Destache
Combination antiretroviral (cARV) treatment is more common in human immunodeficiency virus (HIV) infection. In many instances, treatment regimen includes two or more combination of drugs from six different classes. Some of the antiretroviral combination medications are under study at preclinical and clinical stages. A precise method is required to quantify the drug concentration in biological matrices to study pharmacokinetic behavior and tissue distribution profile in animals and/or humans. We have developed and validated a sensitive and precise liquid chromatography-tandem mass spectrometry method for simultaneous quantification of selected antiretroviral drugs, tenofovir (TNF), emtricitabine (FTC), rilpivirine (RPV), dolutegravir (DTG) and elvitegravir (EVG) in mouse biological matrices...
September 10, 2016: Journal of Pharmaceutical and Biomedical Analysis
A Tostevin, E White, D Dunn, S Croxford, V Delpech, I Williams, D Asboe, A Pozniak, D Churchill, A M Geretti, D Pillay, C Sabin, A Leigh-Brown, E Smit
OBJECTIVES: Transmission of drug-resistant HIV-1 has decreased in the UK since the early 2000s. This analysis reports recent trends and characteristics of transmitted drug resistance (TDR) in the UK from 2010 to 2013. METHODS: Resistance tests conducted in antiretroviral treatment (ART)-naïve individuals between 2010 and 2013 were analysed for the presence of transmitted drug resistance mutations (TDRMs), defined as any mutations from a modified 2009 World Health Organization surveillance list, or a modified 2013 International Antiviral Society-USA list for integrase tests...
August 1, 2016: HIV Medicine
Pierre de Truchis, Minh Patrick Lê, Mamane Daou, Boubacar Madougou, Yacouba Nouhou, Sahada Moussa Saley, Achirou Sani, Eric Adehossi, Elisabeth Rouveix, Mamadou Saidou, Gilles Peytavin, Constance Delaugerre
OBJECTIVES: The objectives of this study were to determine the rate of viral success in HIV-infected patients on first-line ART by the assessment of dried blood spot (DBS) viral load (VL) and to assess the performance of DBS sampling for VL measurement, genotypic resistance and antiretroviral concentration determinations. METHODS: HIV-infected patients treated for >1 year with first-line ART in Niamey, Niger were included. VL based on nucleic acid sequence-based amplification (NASBA) assay (limit of quantification <800 copies/mL) was measured on DBS capillary samples...
July 20, 2016: Journal of Antimicrobial Chemotherapy
Camille Bernaud, Lydie Khatchatourian, Audrey Rodallec, Nolwenn Hall, Philippe Perre, Marine Morrier, Solène Pineau, Thomas Jovelin, Elisabeth André-Garnier, François Raffi, Clotilde Allavena
BACKGROUND: Tenofovir DF/FTC/rilpivirine (TDF/FTC/RPV) is a single tablet regimen considered as safe and efficacious in HIV population as long as food requirements, concomitant PPI administration, and compromised antiviral activity have been carefully reviewed. We evaluated TDF/FTC/RPV in a real-life setting with focus on clinical and virological outcomes. METHODS: OCEAN II is a prospective, two-centre observational study. From September 2012 to December 2013, antiretroviral-naive patients with HIV RNA <100,000 copies/mL or wishing to switch for simplification were considered for TDF/FTC/RPV...
October 2016: Infectious Diseases
Denise Kreutzwiser, Alice Tseng
INTRODUCTION: Significant advances in antiretroviral (ARV) therapy have transformed HIV into a chronic manageable disease. Co-morbidities associated with aging, such as benign prostatic hyperplasia (BPH), are becoming increasingly prevalent in the HIV-infected population. The pharmacological treatment of BPH involves medications mainly metabolized by CYP 450 enzymes, while many ARVs have inducing or inhibiting effects on the CYP 450 system. Consequently, there is potential for significant pharmacokinetic (PK) interactions between these two classes of medications...
October 2016: Expert Opinion on Drug Metabolism & Toxicology
Andrew Mulato, Derek Hansen, Alexander Thielen, Danielle Porter, George Stepan, Kirsten White, Martin Daeumer, Tomas Cihlar, Stephen Yant
Failure of combination antiretroviral (ARV) therapy in HIV-infected patients is often associated with the emergence of drug resistance-associated mutants (RAMs). To facilitate analysis of the barrier to resistance at therapeutically relevant ARV concentrations, we performed fixed-dose in vitro HIV-1 drug resistance selection assays using the immortalized MT-2 T-cell line and primary human CD4+ T cells with a panel of FDA-approved ARVs, each at their respective cell culture equivalent clinical trough concentration (CCE Cmin)...
June 29, 2016: AIDS Research and Human Retroviruses
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