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Rosario Palacios, M Mayorga, C M González-Domenech, C Hidalgo-Tenorio, C Gálvez, L Muñoz-Medina, J de la Torre, A Lozano, M Castaño, M Omar, Jesús Santos
OBJECTIVES: To analyze the efficacy and safety of dolutegravir/rilpivirine (DTG/RPV) in HIV-infected patients who switched from any other antiretroviral therapy (ART). METHODS: Open-label, multicenter study including patients who switched to DTG/RPV between February 2015 and February 2016. Efficacy (HIV RNA <50 copies/mL), adverse events, and metabolic changes at 24 weeks were analyzed. RESULTS: A total of 104 participants were included, who switched for the following reasons: toxicity/intolerance (42...
January 2018: Journal of the International Association of Providers of AIDS Care
Ahizechukwu C Eke, Nahida Chakhtoura, Angela Kashuba, Brookie M Best, Craig Sykes, Jiajia Wang, Alice M Stek, Elizabeth Smith, Samantha Calabrese, Edmund V Capparelli, Mark Mirochnick
BACKGROUND: Concentrations of antiretrovirals (ARVs) in the genital tract play a key role in pre-exposure prophylaxis. This study aims to describe rilpivirine (Edurant) concentrations in the genital tract in pregnant and postpartum women. METHODS: International Maternal Pediatric Adolescent AIDS Clinical Trials Protocol P1026s is an ongoing, prospective study of antiretroviral pharmacokinetics (PK) in HIV infected pregnant women that include a cohort receiving rilpivirine combination regimen...
March 8, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
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
L Ryom, C Boesecke, M Bracchi, J Ambrosioni, A Pozniak, J Arribas, G Behrens, Pgm Mallon, M Puoti, A Rauch, J M Miro, O Kirk, C Marzolini, J D Lundgren, M Battegay
BACKGROUND: The European AIDS Clinical Society (EACS) Guidelines have since 2005 provided multidisciplinary recommendations for the care of HIV-positive persons in geographically diverse areas. GUIDELINE HIGHLIGHTS: Major revisions have been made in all sections of the 2017 Guidelines: antiretroviral treatment (ART), comorbidities, coinfections and opportunistic diseases. Newly added are also a summary of the main changes made, and direct video links to the EACS online course on HIV Management...
March 1, 2018: HIV Medicine
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
Amedeo Ferdinando Capetti, Maria Vittoria Cossu, Gaetana Sterrantino, Giorgio Barbarini, Simona Di Giambenedetto, Giuseppe Vittorio De Socio, GianCarlo Orofino, Antonio Di Biagio, Benedetto M Celesia, Stefano Rusconi, Barbara Argenteri, Giuliano Rizzardini
BACKGROUND: Data from clinical studies confirm the efficacy of switching to dolutegravir (DTG) plus rilpivirine (RPV) in selected patients. OBJECTIVE: The primary objective is to report the 96-week virological suppression in our cohort, assessing the durability of this strategy in complicated situations. The secondary objective is to describe the safety and metabolic profile. METHODS: All patients who had switched to DTG plus RPV between October 1, 2014, and September 30, 2015, were analyzed using a retrospective-prospective design, approved by ethics committees...
February 1, 2018: Annals of Pharmacotherapy
Nadia Galizzi, Laura Galli, Andrea Poli, Nicola Gianotti, Elisabetta Carini, Alba Bigoloni, Giuseppe Tambussi, Silvia Nozza, Adriano Lazzarin, Antonella Castagna, Daniela Mancusi, Roberta Termini
INTRODUCTION: A regimen with rilpivirine (RPV), abacavir (ABC) and lamivudine (3TC) is simple and may allow the sparing of tenofovir and protease inhibitors. However, data on use of this combination as a strategy of switch are limited. Aims of the study were to assess the long-term efficacy and safety of this regimen. METHODS: Retrospective study on HIV-1 infected patients followed at the Infectious Disease Department of the San Raffaele Scientific Institute, HBsAg-negative, HLA B5701-negative, with no documented resistance to RPV, ABC and 3TC, with HIV-RNA<50 copies/mL who started RPV plus ABC/3TC from March 2013 to September 2015...
2018: PloS One
Rosaleen Boswell, Michelle M Foisy, Christine A Hughes
OBJECTIVE: To review available evidence for dolutegravir-based dual therapy as maintenance treatment in HIV-1 infected patients. DATA SOURCES: A literature search was conducted using PubMed, MEDLINE, and Google Scholar to the end of January 2018. Conference abstracts and article bibliographies were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All English-language, randomized, and observational studies were included. DATA SYNTHESIS: In all, 12 studies were identified: 10 were observational, and 2 were randomized trials...
February 1, 2018: Annals of Pharmacotherapy
Ron Zhi-Hui Chiang, Samuel Ken-En Gan, Chinh Tran-To Su
HIV drug resistant mutations that render the current Highly Active Anti-Retroviral Therapy cocktail drugs ineffective are increasingly reported. To study the mechanisms of these mutations in conferring drug resistance, we computationally analyzed fourteen Reverse Transcriptase (RT) structures of HIV-1 on the following parameters: drug-binding pocket volume, allosteric effects caused by the mutations, and structural thermal stability. We constructed structural correlation-based networks of the mutant RT-drug complexes and the analyses support the use of Efavirenz as the first-line drug, given that cross-resistance is least likely to develop from Efavirenz-resistant mutations...
February 5, 2018: Bioscience Reports
Nadège Néant, Florence Gattacceca, Minh Patrick Lê, Yazdan Yazdanpanah, Catherine Dhiver, Sylvie Bregigeon, Saadia Mokhtari, Gilles Peytavin, Catherine Tamalet, Diane Descamps, Bruno Lacarelle, Caroline Solas
PURPOSE: Rilpivirine, prescribed for the treatment of HIV infection, presents an important inter-individual pharmacokinetic variability. We aimed to determine population pharmacokinetic parameters of rilpivirine in adult HIV-infected patients and quantify their inter-individual variability. METHODS: We conducted a multicenter, retrospective, and observational study in patients treated with the once-daily rilpivirine/tenofovir disoproxil fumarate/emtricitabine regimen...
January 26, 2018: European Journal of Clinical Pharmacology
Zhongxia Zhou, Tao Liu, Dongwei Kang, Zhipeng Huo, Gaochan Wu, Dirk Daelemans, Erik De Clercq, Christophe Pannecouque, Peng Zhan, Xinyong Liu
A new series of diarylpyrimidines (DAPYs) were designed, synthesized and evaluated as novel HIV-1 NNRTIs to further explore the chemical space surrounding the "hydrophobic channel" of the NNRTI binding pocket (NNIBP), guided by the comprehensive analysis of X-ray structural biology data of HIV-1 RT/NNRTI complexes and molecular modeling. Encouragingly, most of the synthesized DAPYs were found to be active against the HIV-1 wild-type (WT) strain with EC50 values ranging from 3 nM to 63 nM, and displayed significantly reduced cytotoxicity compared with etravirine (ETV) and rilpivirine (RPV)...
January 19, 2018: Organic & Biomolecular Chemistry
Olayemi Osiyemi, Salih Yasin, Carmen Zorrilla, Ceyhun Bicer, Vera Hillewaert, Kimberley Brown, Herta M Crauwels
INTRODUCTION: Physiologic changes during pregnancy may impact the pharmacokinetics of drugs. In addition, efficacy and safety/tolerability concerns have been identified for some antiretroviral agents. METHODS: Human immunodeficiency virus (HIV)-1-infected pregnant women (18-26 weeks gestation) receiving the non-nucleoside reverse transcriptase inhibitor rilpivirine 25 mg once daily were enrolled in this phase 3b, open-label study examining the impact of pregnancy on the pharmacokinetics of rilpivirine when it is given in combination with other antiretroviral agents...
January 15, 2018: Infectious Diseases and Therapy
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
Ameya R Kirtane, Omar Abouzid, Daniel Minahan, Taylor Bensel, Alison L Hill, Christian Selinger, Anna Bershteyn, Morgan Craig, Shirley S Mo, Hormoz Mazdiyasni, Cody Cleveland, Jaimie Rogner, Young-Ah Lucy Lee, Lucas Booth, Farhad Javid, Sarah J Wu, Tyler Grant, Andrew M Bellinger, Boris Nikolic, Alison Hayward, Lowell Wood, Philip A Eckhoff, Martin A Nowak, Robert Langer, Giovanni Traverso
The efficacy of antiretroviral therapy is significantly compromised by medication non-adherence. Long-acting enteral systems that can ease the burden of daily adherence have not yet been developed. Here we describe an oral dosage form composed of distinct drug-polymer matrices which achieved week-long systemic drug levels of the antiretrovirals dolutegravir, rilpivirine and cabotegravir in a pig. Simulations of viral dynamics and patient adherence patterns indicate that such systems would significantly reduce therapeutic failures and epidemiological modelling suggests that using such an intervention prophylactically could avert hundreds of thousands of new HIV cases...
January 9, 2018: Nature Communications
Josep M Llibre, Chien-Ching Hung, Cynthia Brinson, Francesco Castelli, Pierre-Marie Girard, Lesley P Kahl, Elizabeth A Blair, Kostas Angelis, Brian Wynne, Kati Vandermeulen, Mark Underwood, Kim Smith, Martin Gartland, Michael Aboud
BACKGROUND: Lifelong HIV antiretroviral therapy (ART) has prompted an interest in two-drug regimens to minimise cumulative drug exposure and toxicities. The safety, tolerability, and efficacy of dolutegravir and rilpivirine suggest potential compatibility and effectiveness as a two-drug regimen. We aimed to investigate this two-drug regimen in a phase 3 study. METHODS: We identically designed SWORD-1 and SWORD-2, which were open-label, parallel-group, multicentre, phase 3, randomised, non-inferiority studies in 12 countries evaluating efficacy and safety of once-daily dolutegravir 50 mg plus rilpivirine 25 mg versus current ART regimen (CAR)...
January 5, 2018: Lancet
Deanna Kerrigan, Andrea Mantsios, Miguel Gorgolas, Maria-Luisa Montes, Federico Pulido, Cynthia Brinson, Jerome deVente, Gary J Richmond, Sarah W Beckham, Paige Hammond, David Margolis, Miranda Murray
Challenges with adherence to daily oral antiretroviral therapy (ART) among people living with HIV (PLHIV) have stimulated development of injectable long-acting (LA) regimens. We conducted 39 in-depth interviews with participants and providers in a Phase IIb study (LATTE-2) evaluating an injectable LA regimen in the U.S. and Spain. Interviews exploring participant and provider attitudes and experiences with LA versus oral ART were audiotaped, transcribed and analyzed using thematic content analysis. Participants described the convenience of LA injections versus daily pills and emotional benefits such as minimized potential for HIV disclosure and eliminating the "daily reminder of living with HIV...
2018: PloS One
Amedeo F Capetti, Maria V Cossu, Laura Paladini, Giuliano Rizzardini
The HIV-infected population is aging and comorbidities and polypharmacological regimens are increasing. To reduce toxicity and drug burden researchers are evaluating the efficacy, safety and durability of dual therapies as a switch option in subjects who have achieved stable virologic suppression. Initially effective dual combinations relied on protease inhibitors but when dolutegravir, the first integrase inhibitor to display a high genetic barrier, became commercially available, many physicians began to use it in a variety of dual regimens, generating several observational cohorts...
January 2018: Expert Opinion on Pharmacotherapy
Stéphanie Raymond, Florence Nicot, Coralie Pallier, Pantxika Bellecave, Anne Maillard, Mary Anne Trabaud, Laurence Morand-Joubert, Audrey Rodallec, Corinne Amiel, Thomas Mourez, Laurence Bocket, Agnès Beby-Defaux, Magali Bouvier-Alias, Sidonie Lambert-Niclot, Charlotte Charpentier, Brice Malve, Audrey Mirand, Julia Dina, Hélène Le Guillou-Guillemette, Stéphanie Marque-Juillet, Anne Signori-Schmuck, Francis Barin, Ali Si-Mohamed, Véronique Avettand Fenoel, Catherine Roussel, Vincent Calvez, Karine Saune, Anne Geneviève Marcelin, Christophe Rodriguez, Diane Descamps, Jacques Izopet
Background: Minority resistant variants of HIV-1 could influence the virological response to treatment based on non-nucleoside reverse transcriptase (RT) inhibitors. Data on minority rilpivirine-resistant variants are scarce. This study used next-generation sequencing (NGS) to identify patients harbouring minority resistant variants to nucleos(t)ide and non-nucleoside RT inhibitors and to assess their influence on the virological response (VR). Methods: All the subjects, 541 HIV-1-infected patients being treated at 24 French virology laboratories, started their first line regimen containing rilpivirine between 2012 and 2015...
December 13, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Grace A McComsey, Sergio Lupo, David Parks, Mónica Coronado Poggio, Joseph De Wet, Lesley P Kahl, Kostas Angelis, Brian Wynne, Kati Vandermeulen, Martin Gartland, Michael Cupo, Michael Aboud
OBJECTIVE: Bone mineral density (BMD) loss, a risk factor for osteoporosis, has been attributed to HIV infection and antiretroviral therapy (ART), including regimens containing tenofovir disoproxil fumarate. DESIGN: Study 202094 is an open-label, parallel-group, sub-study of the phase III SWORD-1 and SWORD-2 studies ( identifier, NCT02478632). METHODS: HIV-1-infected adults with HIV-1 RNA less than 50 copies/ml who received ART containing tenofovir disoproxil fumarate for at least 6 months were randomized to receive dolutegravir with rilpivirine or continue current ART regimen...
February 20, 2018: 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
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