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1. Human Immunodeficiency Virus-1 Viral Load Is Elevated in Individuals With Reverse-Transcriptase Mutation M184V/I During Virological Failure of First-Line Antiretroviral Therapy and Is Associated With Compensatory Mutation L74I

Author

Soo-Yon Rhee, Ravindra K. Gupta, Carlo Federico Perno, John Gregson, Rawlings Datir, Derache A, R S Shafer, Deenan Pillay, Datir, Rawlings [0000-0003-0521-2144], Gupta, Ravindra [0000-0001-9751-1808], and Apollo - University of Cambridge Repository

Subjects
Anti-HIV Agents, viruses, antiretroviral, Context (language use), HIV Infections, Emtricitabine, Virus, Major Articles and Brief Reports, immune system diseases, Drug Resistance, Viral, Immunology and Allergy, Medicine, Humans, AcademicSubjects/MED00860, Treatment Failure, Tenofovir, Randomized Controlled Trials as Topic, drug resistance, business.industry, compensatory mutation, Lamivudine, virus diseases, HIV, DNA-Directed RNA Polymerases, biochemical phenomena, metabolism, and nutrition, Viral Load, Resistance mutation, Virology, Reverse transcriptase, HIV Reverse Transcriptase, CD4 Lymphocyte Count, Regimen, Infectious Diseases, AcademicSubjects/MED00290, Mutation, HIV-1, Reverse Transcriptase Inhibitors, HIV/AIDS, Drug Therapy, Combination, lamivudine, business, Viral load, medicine.drug
Abstract

Background M184V/I cause high-level lamivudine (3TC) and emtricitabine (FTC) resistance and increased tenofovir disoproxil fumarate (TDF) susceptibility. Nonetheless, 3TC and FTC (collectively referred to as XTC) appear to retain modest activity against human immunodeficiency virus-1 with these mutations possibly as a result of reduced replication capacity. In this study, we determined how M184V/I impacts virus load (VL) in patients failing therapy on a TDF/XTC plus nonnucleoside reverse-transcriptase inhibitor (NNRTI)-containing regimen. Methods We compared VL in the absence and presence of M184V/I across studies using random effects meta-analysis. The effect of mutations on virus reverse-transcriptase activity and infectiousness was analyzed in vitro. Results M184I/V was present in 817 (56.5%) of 1445 individuals with virologic failure (VF). Virus load was similar in individuals with or without M184I/V (difference in log10 VL, 0.18; 95% confidence interval, .05–.31). CD4 count was lower both at initiation of antiretroviral therapy and at VF in participants who went on to develop M184V/I. L74I was present in 10.2% of persons with M184V/I but absent in persons without M184V/I (P < .0001). In vitro, L74I compensated for defective replication of M184V-mutated virus. Conclusions Virus loads were similar in persons with and without M184V/I during VF on a TDF/XTC/NNRTI-containing regimen. Therefore, we did not find evidence for a benefit of XTC in the context of first-line failure on this combination., Lamivudine is a cornerstone antiretroviral whose efficacy has been ascribed to high fitness cost of the lamivudine resistance mutation M184V. However, here we demonstrate elevated viral loads in the context of M184V, likely attributable to compensatory mutations such as L74I.

Published
2019

2. Myocardial remodelling after withdrawing therapy for heart failure in patients with recovered dilated cardiomyopathy: insights from TRED-HF

Author

Zohya Khalique, John Gregson, Xiuyu Chen, Richard E. Jones, Dudley J. Pennell, Vassilios S. Vassiliou, A. John Baksi, John G.F. Cleland, Daniel Hammersley, Upasana Tayal, Martin R. Cowie, Ricardo Wage, Ruth Owen, Brian P Halliday, Sanjay K Prasad, Amrit Lota, British Heart Foundation, and Guys & St Thomas NHS Foundation Trust

Subjects
Cardiomyopathy, Dilated, Global longitudinal strain, medicine.medical_specialty, Cardiac & Cardiovascular Systems, medicine.drug_class, Dilated cardiomyopathy, 030204 cardiovascular system & hematology, Ventricular Function, Left, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Extracellular fluid, PROGNOSTIC-SIGNIFICANCE, medicine, Clinical endpoint, Natriuretic peptide, Humans, FIBROSIS, 1102 Cardiorespiratory Medicine and Haematology, Heart Failure, Ejection fraction, Science & Technology, medicine.diagnostic_test, Ventricular Remodeling, business.industry, Magnetic resonance imaging, Stroke Volume, medicine.disease, Confidence interval, DYSFUNCTION, PREVALENCE, DIASTOLIC FUNCTION, Cardiovascular System & Hematology, Heart failure, Cardiology, Cardiovascular System & Cardiology, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine, Extracellular volume
Abstract

Aims: To characterize adverse ventricular remodelling after withdrawing therapy in recovered dilated cardiomyopathy (DCM). Methods and results: TRED-HF was a randomized controlled trial with a follow-on single-arm cross-over phase that examined the safety and feasibility of therapy withdrawal in patients with recovered DCM over 6 months. The primary endpoint was relapse of heart failure defined by (i) a reduction in left ventricular (LV) ejection fraction >10% and to 10% increase in LV end-diastolic volume and to above the normal range, (iii) a twofold rise in N-terminal pro-B-type natriuretic peptide and to >400 ng/L, or (iv) evidence of heart failure. LV mass, LV and right ventricular (RV) global longitudinal strain (GLS) and extracellular volume were measured using cardiovascular magnetic resonance at baseline and follow-up (6 months or relapse) for 48 patients. LV cell and extracellular matrix masses were derived. The effect of withdrawing therapy, stratified by relapse and genotype, was investigated in the randomized and follow-on phases. In the randomized comparison, withdrawing therapy led to an increase in mean LV mass [5.4 g/m 2; 95% confidence interval (CI) 1.3–9.5] and cell mass (4.2 g/m 2; 95% CI 0.5–8.0) and a reduction in LV (3.5; 95% CI 1.6–5.5) and RV (2.4; 95% CI 0.1–4.7) GLS. In a non-randomized comparison of all patients (n = 47) who had therapy withdrawn in either phase, there was an increase in LV mass (6.2 g/m 2; 95% CI 3.6–8.9; P = 0.0001), cell mass (4.0 g/m 2; 95% CI 1.8–6.2; P = 0.0007) and matrix mass (1.7 g/m 2; 95% CI 0.7–2.6; P = 0.001) and a reduction in LV GLS (2.7; 95% CI 1.5–4.0; P = 0.0001). Amongst those who had therapy withdrawn and did not relapse, similar changes were observed (n = 28; LV mass: 5.1 g/m 2, 95% CI 1.5–8.8, P = 0.007; cell mass: 3.7 g/m 2, 95% CI 0.3–7.0, P = 0.03; matrix mass: 1.7 g/m 2, 95% CI 0.4–3.0, P = 0.02; LV GLS: 1.7, 95% CI 0.1–3.2, P = 0.04). Patients with TTN variants (n = 10) who had therapy withdrawn had a greater increase in LV matrix mass (mean effect of TTN: 2.6 g/m 2; 95% CI 0.4–4.8; P = 0.02). Conclusion: In TRED-HF, withdrawing therapy caused rapid remodelling, with early tissue and functional changes, even amongst patients who did not relapse.

Published
2020

3. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

Author

Marco Valgimigli, Takeshi Kimura, Robert W. Yeh, Martin B. Leon, Dominick J. Angiolillo, Roxana Mehran, Mitchell W. Krucoff, Stuart J. Pocock, Yoshiaki Mitsutake, Ernest Spitzer, P. F.Adrian Magee, Andrew Farb, Akihide Konishi, Matthew J. Price, Davide Capodanno, Olivier Varenne, Ute Windhoevel, Roisin Colleran, Philip Urban, C. Michael Gibson, Darren Mylotte, Donald E. Cutlip, Thomas Cuisset, Hyo-Soo Kim, John C. Laschinger, Stefan James, Michael Haude, John Gregson, Marie Claude Morice, John Eikelboom, Norman Stockbridge, Sunil V. Rao, Pedro Eerdmans, Robert A. Byrne, Hôpital de la Tour, Cardiovascular Research Foundation, Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), University of Florida [Gainesville] (UF), University of Catania [Italy], Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital de la Timone [CHU - APHM] (TIMONE), Harvard Medical School [Boston] (HMS), AUTRES, McMaster University [Hamilton, Ontario], U.S. Food and Drug Administration (FDA), London School of Hygiene and Tropical Medicine (LSHTM), Lukaskrankenhaus, Uppsala University, Seoul National University Hospital, Kyoto University, Pharmaceuticals and Medical Devices Agency, Columbia University [New York], National University of Ireland [Galway] (NUI Galway), Scripps Clinic [San Diego, CA, USA], Duke Clinical Research Institute, Duke University Medical Center, Erasmus University Medical Center [Rotterdam] (Erasmus MC), University of Bern, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovascular European Research Center, Beth Israel Deaconess Medical Center [Boston] (BIDMC), Hôpital Privé Jacques Cartier [Massy], The ARC-HBR group was entirely funded by multiple industry sponsors. Sponsors participated as observers in both meetings and were provided a copy of the document before submission. The contributing companies were Abbott Vascular, Alvimedica, Amgen, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Celonova, Chiesi, Cordis, Daiichi Sankyo, Edwards Lifesciences, Janssen, Medinol, Medtronic, Orbusneich, Portola, Sanofi, Sinomed, Sahajanand Medical Technologies, and Terumo.Conflict of interest: Dr Colleran received financial compensation for her contribution to the preparation of this document. In accordance with the ARC charter, none of the other participants received fees or honoraria for their participation in the meetings or their contribution to this document. Dr Urban reports receiving speaker and consulting honoraria as an individual from Biosensors-Europe, Sinomed, and Terumo, participating in paid review activities (Clinical End Point Committee, Data Safety Monitoring Board) for Edward Lifesciences, Terumo, and Abbott Vascular, and serving as a medical codirector at the Cardiovascular European Research Center, a contract research organization based in Massy, France. Dr Mehran reports consultant fees to the institution from Abbott Laboratories and Spectranetics/Philips/Valcano Corp, consulting fees from Boston Scientific, Cardiovascular Systems Inc, Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals Inc, Roivant Sciences Inc, and Sanofi, being the spouse of a consultant for Abiomed and The Medicines Company, research funding to the institution from AstraZeneca, Bayer, Beth Israel Deaconess Hospital, BMS, CSL Behring, Eli Lilly and DSI, Medtronic, Novartis Pharmaceuticals, and Orbus Neich, scientific advisory board fees from PLx Opco Inc, dba PLx Pharma Inc, scientific advisory board fees to the institution from Bristol-Myers Squibb, executive committee fees from Janssen Pharmaceuticals and Osprey Medical, speaker engagements for Abbott Laboratories, equity from Claret Medical and Elixir Medical, and Data Safety Monitoring Board fees to the institution from Atermark Research Partners. Dr Angiolillo reports payments, consulting fees, or honoraria from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PLx Pharma Inc, Pfizer, Sanofi, and The Medicines Company, fees for participation in review activities from CeloNova and St. Jude Medical, institutional grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co, Merck, Novartis, Osprey Medical, and Renal Guard Solutions, and funding from the Scott R. MacKenzie Foundation and the National Institutes of Health/National Center for Advancing Translational Sciences Clinical and Translational Science Award to the University of Florida UL1 TR000064 and National Institutes of Health/National Human Genome Research Institute U01 HG007269. Dr Byrne reports lecture fees from B. Braun Melsungen AG, Biotronik, Boston Scientific, and Micell Technologies and research funding to the institution from Boston Scientific and Celonova Biosciences. Dr Capodanno reports personal fees from Abbott Vascular, Bayer, Daiichi Sankyo, Pfizer, and AstraZeneca. Dr Cutlip reports receiving consultant fees from Celonova Biosciences and academic salary support from the Baim Institute for Clinical Research, an academic research organization in Boston, MA. Dr Eikelboom reports consulting fees and grant support from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Pfizer, Janssen, and Sanofi-Aventis. Dr Gibson reports being chief executive officer of the Baim Institute for Clinical Research, in addition to receiving research grant funding from Angel Medical Corp, Bayer Corp, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson Corp, and Portola Pharmaceuticals, consultant fees from Amarin Pharama, Amgen, Bayer Corp, Boehringer Ingelheim, Boston Clinical Research Institute, Boston Scientific, Cardiovascular Research Foundation, CSL Behring, Chiesi, Duke Clinical Research Institute, Eli Lilly and Company, Gilead Sciences, Inc, Impact Bio LTD, Janssen Pharmaceuticals, Johnson & Johnson Corp, The Medicines Company, MedImmune, Medtelligence, Merck & Co, Inc, Microport, Novo Nordisk, PERT Consortium, Pharma Mar, Portola Pharmaceuticals, Sanofi, Somahlution, Vereseon Corporation, and Web MD, and royalties as a contributor from UpToDate in Cardiovascular Medicine. Dr Gregson reports personal fees from Edwards Lifesciences, MvRX, Amarin Corp, and BioSensors. Dr Haude reports grant support from Biotronik, Orbus Neich, AbboF, Medtronic, and Cardiac Dimensions, speaker’s bureau fees from Biotronik, Orbus Neich, AbboF, Medtronic, Lilly, Philips/ Volcano, and Cardiac Dimensions (Proctor), and consultant fees from Biotronik, Orbus Neich, and AbboF. Dr James reports institutional research grants from AstraZeneca, Bayer, Jansen, The Medicines Company, Abbot Vascular, and Boston Scientific, as well as honoraria from AstraZeneca, Bayer, and Medtronic. Dr Kimura reports consulting fees or honoraria from Abbott Vascular Japan Co, Ltd, Kowa Co, Ltd, Kowa Pharmaceutical Co Ltd, Sanofi K.K., Nippon Boehringer Ingelheim Co, Ltd, and Bristol-Myers Squibb K.K., as well as grant support from Otsuka Pharmaceutical Co, Ltd, Daiichi Sankyo Co, Ltd, Mitsubishi Tanabe Pharma Corp, Takeda Pharmaceutical Co Ltd, and Nippon Boehringer Ingelheim Co, Ltd. Dr Leon reports receiving research grants from Abbott Vascular, Boston Scientific, Medtronic, Biosensors, and SinomedEquity-Medinol. Dr Mylotte reports speaker fees from Biosensors and institutional research grants from Biosensors and Medtronic. Dr Pocock has served on steering committees or data monitoring committees for trials sponsored by AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Idorsia, Janssen, Medtronic, Novartis, Novo Nordisk, and Vifor, and has received grant funding from AstraZeneca and Merck. Dr Price reports receiving consulting honoraria from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, and Abbott Vascular/St Jude Medical, speaker’s bureau/fees from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, Abbott Vascular/St Jude Medical, and ACIST Medical, and institutional research grants from Daiichi-Sankyo. Dr Valgimigli reports grants and personal fees from Abbott, AstraZeneca, and Terumo, personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia, and grants from Medicure. Dr Varenne reports receiving consulting and research grants from Boston Scientific, Abbott Vascular, AstraZeneca, and Servier. Dr Yeh reports consulting and research grants from Abbott Vascular and Boston Scientific, research grants from Abiomed and AstraZeneca, and consulting fees from Biosense Webster, Medtronic, and Teleflex. Dr Krucoff reports receiving consulting and research grants from Abbott Vascular, Biosensors, Boston Scientific, Cook Medical, Medtronic, and OrbusNeich. Dr Morice is the chief executive officer of the Cardiovascular European Research Center, the contract research organization organizing the ARC-HBR initiative. The other authors report no conflicts., Kyoto University [Kyoto], Cardiology, and Prémilleux, Annick

Subjects
Percutaneous, protocole de recherche, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Cardiologie et système cardiovasculaire, 030204 cardiovascular system & hematology, 0302 clinical medicine, maladie coronaire, Cardiac and Cardiovascular Systems, 030212 general & internal medicine, Aged, 80 and over, education.field_of_study, Clinical Trials as Topic, Kardiologi, Frailty, hémorragie, European research, Dual Anti-Platelet Therapy, Anemia, Drug-Eluting Stents, 3. Good health, ddc, Europe, [SDV] Life Sciences [q-bio], Treatment Outcome, Current Opinion, Metals, Stents, clinical trial protocols as topic, Safety, hemorrhage, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Asia, Consensus, Population, Clinical Decision-Making, 610 Medicine & health, Risk Assessment, Medication Adherence, Food and drug administration, 03 medical and health sciences, Physiology (medical), Hypertension, Portal, medicine, Humans, In patient, Acute Coronary Syndrome, Renal Insufficiency, Chronic, Intensive care medicine, education, Aged, business.industry, percutaneous coronary intervention, Percutaneous coronary intervention, Data interpretation, Fibrosis, Thrombocytopenia, United States, Clinical trial, Cardiology and cardiovascular system, business
Abstract

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

Published
2019

4. 4. Socialism and communism

Author

John Gregson

Abstract

This chapter examines the basic features of socialism and communism. Socialism is a complex ideology with numerous variants that are often strongly opposed to each other on one or more central questions or issues. Variants of socialism have converged with other classical ideologies (such as liberalism) in their beliefs and values, yet other variants have remained vehemently opposed to much within liberalism. The chapter first provides a brief historical background on socialism before discussing the key beliefs, values, and assumptions of socialism. In particular, it looks at socialism's critique of industrial capitalism and its vision of the good society, along with its its conception of human nature, community, and freedom. The chapter proceeds by considering some variants of socialism, especially communism and social democracy, as well as the overlap between socialism and other ideologies like liberalism. Finally, it assesses the historical, contemporary, and future impact of socialism.

Published
2017

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