6 results on '"Peter Shalit MD and Associates"'
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2. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1
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Douglas Cunningham, D. Ward, Mamta K. Jain, Faiza Ajana, Magda Opsomer, Anita Rachlis, Sharon Walmsley, Frank A. Post, Anders Blaxhult, Amanda Clarke, M. J. Galindo, Marcel Stoeckle, P.-M. Girardy, Karam Mounzer, David Shamblaw, U. F. Bredeek, L. Bhatti, J. J. Eron, Andrew Ustianowski, Mar Gutierrez, John Jezorwski, Javier O Morales-Ramirez, Antonio Rivero, M.A. Johnson, Gatell Jm, Erika Van Landuyt, Stéphane De Wit, A. Wilkin, Laurent Cotte, Cheryl McDonald, D. Murphy, Cynthia Brinson, Romana Petrovic, Olayemi Osiyemi, J. de Vente, I. Poizot-Martin, Juan Berenguer, Robin Dretler, J. Bailey, B. Rashbaum, Moti Ramgopal, A. Scribner, Yazdan Yazdanpanah, Eric Florence, A. Piekarska, Brian Gazzard, Chloe Orkin, W. Halota, Gary Richmond, Jacques Reynes, C. Ricart, C. Lucasti, Ignacio Pérez-Valero, Jason Brunetta, S. Shafran, Daniel Podzamczer, Franco Antonio Felizarta, Claudia Martorell, F. Post, Peter Ruane, Edwin DeJesus, J. Portilla Sogorb, C. Orkin, K. Tashima, Federico Pulido, Bernard Vandercam, F. Pulido, José L. Casado, Christine Katlama, Kimberley Brown, J Gasiorowski, A. Witor, Joseph J. Eron, Brian Conway, Andri Rauch, Jose R. Arribas, Michel Moutschen, H. Olivet, A. Scarsella, Leo Flamholc, A. Horban, D. Cunningham, Ronald Nahass, Félix Gutiérrez, G. Huhn, W.K. Henry, A. Thalme, S De Wit, Jan Fehr, Debbie Hagins, José Antonio Iribarren, J.-M. Molina, S. Henn, F Raffi, Juan A. Pineda, Marina B. Klein, Eugenia Negredo, Hernando Knobel, J. Slim, P. Benson, L. Waters, E. Teicher, Linos Vandekerckhove, Craig A. Dietz, Magnus Gisslén, Joel E. Gallant, J. Gathe, P. Shalit, D. Prelutsky, G. Voskuhl, D. Rey, E. Van Wijngaerden, Anthony Mills, Erkki Lathouwers, Carl J. Fichtenbaum, I. Brar, Gordon Crofoot, Veerle Hufkens, I. Santos Gil, University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC), Queen Mary University of London (QMUL), Pueblo Family Physicians, Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), King's College Hospital (KCH), Université libre de Bruxelles (ULB), Janssen Pharmaceutica [Beerse], Janssen Research & Development, Institute of Tropical Medicine [Antwerp] (ITM), Department of Infectious and Parasitic Diseases (University Liege), Université de Liège, Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Living Hope Foundation, Ghent University Hospital, Cliniques Universitaires Saint-Luc [Bruxelles], Maple Leaf Clinic, Vancouver Infectious Diseases Centre, McGill University = Université McGill [Montréal, Canada], University of Toronto, Sunnybrook Health Sciences Centre, University of Alberta, University Health Network, Services des maladies infectieuses [Tourcoing], Centre Hospitalier de Tourcoing, Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL), Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de maladies infectieuses et tropicales [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université de Paris (UP), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Strasbourg, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Maladies Infectieuses et Tropicales [CHU Bicêtre], AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Wrocław [Poland] (UWr), Faculty of Medicine [Bydgoszcz, Poland], Nicolaus Copernicus University [Toruń], Medical University of Warsaw - Poland, Medical University of Łódź (MUL), Regional Hospital [Chorzow, Poland], La Paz Hospital, IdiPAZ, Hospital General Universitario 'Gregorio Marañón' [Madrid], Hospital Universitario Ramón y Cajal [Madrid], Universidad de Alcalá - University of Alcalá (UAH), Infectious Diseases Service, AIDS Research Group, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Hospital Clínic, University of Barcelona, Barcelona, Spain., Hospital Universitario de Elche, Hospital Universitario de Valencia, Hospital de la Santa Creu i Sant Pau, Donostia Hospital Universitario San Sebastian, IMIM-Hospital del Mar, Generalitat de Catalunya, LLuita contra la Sida Fdn-HIV Unit, Germans Trias i Pujol University Hospital- Universitat Autònoma de Barcelona, Hospital Universitario de Valme, Hospital Universitari de Bellvitge, Universitat de València (UV), Hospital Universitario Reina Sofía, Hospital La Princesa, Madrid, Karolinska Institutet, Södersjukhuset, Skane University Hospital [Malmo], Lund University [Lund], University of Gothenburg (GU), Karolinska University Hospital [Stockholm], University hospital of Zurich [Zurich], Bern University Hospital [Berne] (Inselspital), University Hospital Basel [Basel], Royal Sussex County Hospital, Chelsea and Westminster Hospital, North Manchester General Hospital, University College of London [London] (UCL), Johns Hopkins University School of Medicine [Baltimore], Be Well, AIDS healthcare foundation [California], Henry Ford Hospital, Metropolis Medical, Central Texas Clinical Research, The Crofoot Research Center, Orlando Immunology Center, Kansas City Free Health Clinic, University of Cincinnati (UC), University of Minnesota System, University of Texas Southwestern Medical Center, South Jersey Infectious Disease, Infectious Disease, Tarrant County Infectious Disease Associates, Southern California Men’s Medical Group, Clinical Research Puerto Rico Inc, Philadelphia FIGHT, ID care, Community Research Initiative of New England, Triple O Research Institute PA, Washington University School of Medicine in St. Louis, Washington University in Saint Louis (WUSTL), Midway Immunology Center, Capital Medical Associates, Broward General Medical Center, Ruane Clinical Research Group, Pacific Oaks Medical Group, DCOL Center for Clinical Research, Peter Shalit MD and Associates, La Playa Medical Group, Seton Hall University, Warren Alpert Medical School of Brown University, AIDS Arms, Inc, Dupont Circle Physicians Group, Wake Forest School of Medicine [Winston-Salem], Wake Forest Baptist Medical Center, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Hospital Universitario Donostia [San Sebastian, Spain] (HUD), Universitat Autònoma de Barcelona (UAB), Hospital Universitario de La Princesa, HAL AMU, Administrateur, UCL - SSS/IREC/SLUC - Pôle St.-Luc, and UCL - (SLuc) Service de médecine interne générale
- Subjects
Male ,DOLUTEGRAVIR ,Sustained Virologic Response ,HIV Infections ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Medicine and Health Sciences ,Emtricitabine ,030212 general & internal medicine ,Pharmacology & Pharmacy ,Darunavir ,0303 health sciences ,Alanine ,Drug Substitution ,Cobicistat ,Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination ,Lamivudine ,Antiretrovirals ,Middle Aged ,Viral Load ,OPEN-LABEL ,3. Good health ,WEIGHT-GAIN ,Drug Combinations ,Treatment Outcome ,Dolutegravir ,NON-INFERIORITY ,Female ,Safety ,Viral load ,Life Sciences & Biomedicine ,medicine.drug ,Tablets ,Adult ,medicine.medical_specialty ,Efficacy ,Anti-HIV Agents ,RITONAVIR ,TENOFOVIR ALAFENAMIDE ,LAMIVUDINE ,Tenofovir alafenamide ,Single-tablet regimen ,03 medical and health sciences ,Internal medicine ,Virology ,medicine ,VIH (Virus) ,Humans ,Switch study ,Protease Inhibitors ,Tenofovir ,Aged ,Pharmacology ,Science & Technology ,030306 microbiology ,business.industry ,HIV (Viruses) ,Adenine ,Darunavir/cobicistat/emtricitabine/TAF ,Antiretroviral agents ,COBICISTAT ,MAINTENANCE ,chemistry ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,HIV-1 ,Ritonavir ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,RESISTANCE - Abstract
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL
- Published
- 2019
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3. HIV rebound in HIV controllers is associated with a specific fecal microbiome profile.
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Cai Y, Podlaha O, Deeks SG, Brinson C, Ramgopal MN, DeJesus E, Mills A, Shalit P, Abdel-Mohsen M, Zhang L, de Vries CR, Vendrame E, SenGupta D, and Wallin JJ
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- Humans, Male, Female, Adult, Middle Aged, Retrospective Studies, Viral Load drug effects, Toll-Like Receptor 7 immunology, HIV-1 immunology, Pteridines, HIV Infections immunology, HIV Infections microbiology, HIV Infections drug therapy, Feces microbiology, Gastrointestinal Microbiome drug effects, Gastrointestinal Microbiome immunology, Dysbiosis microbiology, Dysbiosis immunology
- Abstract
HIV infection is associated with gut dysbiosis, and microbiome variability may affect HIV control when antiretroviral therapy (ART) is stopped. The TLR7 agonist, vesatolimod, was previously associated with a modest delay in viral rebound following analytical treatment interruption in HIV controllers (HCs). Using a retrospective analysis of fecal samples from HCs treated with vesatolimod or placebo (NCT03060447), people with chronic HIV (CH; NCT02858401) or without HIV (PWOH), we examined fecal microbiome profile in HCs before/after treatment, and in CH and PWOH. Microbiome diversity and abundance were compared between groups to investigate the association between specific phyla/species, immune biomarkers, and viral outcomes during treatment interruption. Although there were no significant differences in gut microbiome diversity between people with and without HIV, HCs, and CH shared common features that distinguished them from PWOH. there was a trend toward greater microbiome diversity among HCs. Treatment with vesatolimod reduced dysbiosis in HCs. Firmicutes positively correlated with T-cell activation, while Bacteroidetes and Euryarchaeota inversely correlated with TLR7-mediated immune activation. Specific types of fecal microbiome abundance (e.g. Alistipes putredinis) positively correlated with HIV rebound. In conclusion, variability in the composition of the fecal microbiome is associated with markers of immune activation following vesatolimod treatment and ART interruption., (© 2024 Wiley‐VCH GmbH.)
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- 2024
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4. The TLR7 agonist vesatolimod induced a modest delay in viral rebound in HIV controllers after cessation of antiretroviral therapy.
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SenGupta D, Brinson C, DeJesus E, Mills A, Shalit P, Guo S, Cai Y, Wallin JJ, Zhang L, Humeniuk R, Begley R, Geleziunas R, Mellors J, Wrin T, Jones N, Milush J, Ferre AL, Shacklett BL, Laird GM, Moldt B, Vendrame E, Brainard DM, Ramgopal M, and Deeks SG
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- Animals, Anti-Retroviral Agents therapeutic use, Humans, Pteridines, Toll-Like Receptor 7, Viral Load, HIV Infections drug therapy, Simian Acquired Immunodeficiency Syndrome drug therapy, Simian Immunodeficiency Virus
- Abstract
Toll-like receptor 7 (TLR7) agonists, in combination with other therapies, can induce sustained control of simian-human immunodeficiency virus (SHIV) or simian immunodeficiency virus (SIV) in nonhuman primates. Here, we report the results of a randomized, double-blind, placebo-controlled phase 1b clinical trial of an oral TLR7 agonist, vesatolimod, in HIV-1-infected controllers on antiretroviral therapy (ART). We randomized participants 2:1 to receive vesatolimod ( n = 17) or placebo ( n = 8) once every other week for a total of 10 doses while continuing on ART. ART was then interrupted, and the time to viral rebound was analyzed using the Kaplan-Meier method. Vesatolimod was associated with induction of immune cell activation, decreases in intact proviral DNA during ART, and a modest increase in time to rebound after ART was interrupted. The delayed viral rebound was predicted by the lower intact proviral DNA at the end of vesatolimod treatment (13 days after the final dose). Inferred pathway analysis suggested increased dendritic cell and natural killer cell cross-talk and an increase in cytotoxicity potential after vesatolimod dosing. Larger clinical studies will be necessary to assess the efficacy of vesatolimod-based combination therapies aimed at long-term control of HIV infection., (Copyright © 2021 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.)
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- 2021
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5. Loneliness among older adults living with HIV: the "older old" may be less lonely than the "younger old".
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Mazonson P, Berko J, Loo T, Kane M, Zolopa A, Spinelli F, Karris M, and Shalit P
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- Aged, Aged, 80 and over, Emotions, Female, HIV Infections psychology, Humans, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Surveys and Questionnaires, Aging psychology, HIV Infections complications, Loneliness, Quality of Life psychology, Social Isolation psychology
- Abstract
Loneliness is common among older (age 50+) people living with HIV (PLWH). However, little is known about the prevalence of loneliness across subgroups of older PLWH, and the factors that impact loneliness. An online questionnaire was used to collect data from 998 older PLWH. Of those, 61% were 50-59 years old and 39% were 60 or older. The majority were male (89%), gay (77%), and white (69%). Fifty-one percent of participants were classified as lonely. The prevalence of loneliness was lower in the older age group, 46.2% vs. 53.8% ( Χ
2 = 0.02). Covariates associated with loneliness included being younger, being single, having at least a four-year college degree, living alone, screening positive for depression, using recreational drugs, smoking tobacco, having a lower quality of life, and not feeling close to friends. Logistic regression analysis showed that the "younger old" were at 26% greater risk of loneliness, after controlling for the effects of these covariates (RR 1.26, 95% CI: 1.06-1.45). Reasons why the "older old" were less lonely may include lower rates of depression and lower likelihood of feeling distant from friends. Understanding factors that protect the "older old" against loneliness may provide guidance for future interventions.p = 0.02). Covariates associated with loneliness included being younger, being single, having at least a four-year college degree, living alone, screening positive for depression, using recreational drugs, smoking tobacco, having a lower quality of life, and not feeling close to friends. Logistic regression analysis showed that the "younger old" were at 26% greater risk of loneliness, after controlling for the effects of these covariates (RR 1.26, 95% CI: 1.06-1.45). Reasons why the "older old" were less lonely may include lower rates of depression and lower likelihood of feeling distant from friends. Understanding factors that protect the "older old" against loneliness may provide guidance for future interventions.- Published
- 2021
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6. Implementation of a community pharmacy-based pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care.
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Tung EL, Thomas A, Eichner A, and Shalit P
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- Administration, Oral, Adolescent, Adult, Aged, Drug Therapy, Combination, Emtricitabine administration & dosage, Female, Humans, Male, Middle Aged, Tenofovir administration & dosage, Washington, Anti-HIV Agents administration & dosage, Community Pharmacy Services, HIV Infections prevention & control, Pre-Exposure Prophylaxis, Sexually Transmitted Diseases, Viral prevention & control
- Abstract
Background National guidelines for the provision of HIV pre-exposure prophylaxis (PrEP) to reduce a person's risk of acquiring HIV were made available in 2014. We created a pharmacist-managed HIV PrEP clinic in a community pharmacy setting at Kelley-Ross Pharmacy in Seattle, WA, USA., Methods: The clinic operates under a collaborative drug therapy agreement based on these guidelines. This allows pharmacists to initiate and manage tenofovir disoproxil fumarate/emtricitabine under the supervision of a physician medical director., Results: Between March 2015 and February 2018, 714 patients were evaluated and 695 (97.3%) initiated PrEP. Five hundred and thirteen (74%) patients began medication the same day as their initial appointment. Of the prescriptions filled in our pharmacy, 90% of patients had a mean proportion of days covered (PDC) greater than 80%, and 98% had a zero-dollar patient responsibility per month, including uninsured individuals. 19% of patients were lost to follow up, with an effective drop-out rate of 25%. Two hundred and seven diagnoses of sexually transmissible infections were made. There were no HIV seroconversions in the service., Conclusion: The pharmacist-managed PrEP clinic proved to be a successful alternative model of PrEP care, with high initiation rates and low drop-out and lost-to-follow-up rates. This may benefit individuals who do not access PrEP in traditional health care settings or where PrEP access is scarce. Financial sustainability of the model was dependent on the ability of pharmacists in the clinic to bill insurance plans for their services in accordance with Washington State legislative changes requiring commercial insurances to recognise pharmacists as providers.
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- 2018
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