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202. Comprehensive Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Evaluation of Once-Daily Efavirenz 400 and 600 mg in Treatment-Naïve HIV-Infected Patients at 96 Weeks: Results of the ENCORE1 Study

Author

Dickinson, Laura, Amin, Janaki, Else, Laura, Boffito, Marta, Egan, Deirdre, Owen, Andrew, Khoo, Saye, Back, David, Orrell, Catherine, Clarke, Amanda, Losso, Marcelo, Phanuphak, Praphan, Carey, Dianne, Cooper, David A., Emery, Sean, and Puls, Rebekah

Published
2016
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203. TOWARDS A GLOBAL EIGHT-STATE FIT OF THE ROTATIONAL AND VIBRATIONAL SPECTRA OF HN3

Author

Woods, R., primary, Wood, Samuel, additional, Vávra, Karel, additional, Urban, Stepan, additional, Smith, Houston, additional, Owen, Andrew, additional, Orr, Vanessa, additional, McMahon, Robert, additional, Kisiel, Zbigniew, additional, Kania, Patrik, additional, Esselman, Brian, additional, Billinghurst, Brant, additional, and Amberger, Brent, additional

Published
2022
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204. COMBINED MILLIMETER WAVE AND FTIR SPECTRA OF DN3

Author

Woods, R., primary, Wood, Samuel, additional, Vávra, Karel, additional, Urban, Stepan, additional, Smith, Houston, additional, Owen, Andrew, additional, Orr, Vanessa, additional, McMahon, Robert, additional, Kisiel, Zbigniew, additional, Kania, Patrik, additional, Esselman, Brian, additional, Billinghurst, Brant, additional, and Amberger, Brent, additional

Published
2022
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205. Favipiravir and/or Nitazoxanide: a randomized, double-blind, 2x2 design, placebo-controlled trial of early therapy in COVID-19 (FANTAZE).

Author

Smith, Tania A., primary, Hoyo-Vadillo, Carlos, additional, Agyeman, Akosua, additional, Favari-Perozzi, Liliana, additional, Gastine, Silke, additional, Debhbi, Hakim-Moulay, additional, Villegas-Lara, Beatriz, additional, Mateos, Eduardo, additional, Perez-Gonzalez, Yessica, additional, Navarro-Gualito, Maria D., additional, Cruz-Carvajal, Alejandra S., additional, Cortes-Vazquez, Miguel A., additional, Bekker-Mendez, Carolina, additional, Aguirre-Alvarado, Charmina, additional, Aguirre-Gil, Gisela, additional, Delgado-Pastelin, Lucero, additional, Owen, Andrew, additional, Lowe, David, additional, Standing, Joseph F., additional, and Peña, Jorge Escobedo-de la, additional

Published
2022
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206. Neuroinvasion and Neurotropism by SARS-CoV-2 Variants in the K18-hACE2 Mouse

Author

Seehusen, Frauke, primary, Clark, Jordan J., additional, Sharma, Parul, additional, Bentley, Eleanor G., additional, Kirby, Adam, additional, Subramaniam, Krishanthi, additional, Wunderlin-Giuliani, Sabina, additional, Hughes, Grant L., additional, Patterson, Edward I., additional, Michael, Benedict D., additional, Owen, Andrew, additional, Hiscox, Julian A., additional, Stewart, James P., additional, and Kipar, Anja, additional

Published
2022
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209. Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV-2 Omicron variant (B.1.1.529) in K18-hACE2 mice

Author

Tatham, Lee, Sharp, Joanne, Kijak, Edyta, Herriott, Joanne, Neary, Megan, Box, Helen, Valentijn, Anthony, Cox, Helen, Pertinez, Henry, Curley, Paul, Arshad, Usman, Rajoli, Rajith KR, Rannard, Steve, Stewart, James, and Owen, Andrew

Subjects
Article
Abstract

The Omicron variant (B.1.1.529) of SARS-CoV-2 has placed enormous strain on global healthcare systems since it was first identified by South African researchers in late 2021. Omicron has >50 mutations which mainly occur in the surface spike protein and this has led to rapid assessment of monoclonal antibodies to assess the impact on virus neutralisation. Ronapreve has shown potential application in post-exposure prophylaxis, mild/moderate disease and in seronegative patients with severe COVID19, but several early reports of loss of in vitro neutralisation activity have been documented. Here, the virological efficacy of Ronapreve was assessed in K18-hACE2 mice to provide an in vivo outcome. Ronapreve reduced sub-genomic RNA in lung and nasal turbinate for the Delta variant but not the Omicron variant of SARS-CoV-2 at doses 2-fold higher than those shown to be active against previous variants of the virus. These data add to the growing evidence that the effectiveness of Ronapreve is compromised for the Omicron variant.

Published
2022

210. Remdesivir-ivermectin combination displays synergistic interaction with improved in vitro activity against SARS-CoV-2

Author

Jeffreys, Laura, Pennington, Shaun, Duggan, Jack, Caygill, Claire, Lopeman, Rose, Breen, Alastair, Jinks, Jessica, Ardrey, Alison, Donnellan, Samantha, Patterson, Ian, Hughes, Grant, Hong, David W, O'Neill, Paul M, Aljayyoussi, Ghaith, Owen, Andrew, Ward, Steve, and Biagini, Giancarlo

Subjects
qv_268.5, qv_4, wc_506, wc_505
Abstract

A key element for the prevention and management of COVID-19 is the development of effective therapeutics. Drug combination strategies of repurposed drugs offer several advantages over monotherapies, including the potential to achieve greater efficacy, the potential to increase the therapeutic index of drugs and the potential to reduce the emergence of drug resistance. Here, we report on the in vitro synergistic interaction between two FDA approved drugs, remdesivir and ivermectin resulting in enhanced antiviral activity against SARS-CoV-2. Whilst the in vitro synergistic activity reported here does not support the clinical application of this combination treatment strategy, due to insufficient exposure of ivermectin in vivo, the data do warrant further investigation. Efforts to define the mechanisms underpinning the observed synergistic action, could lead to the development of novel therapeutic treatment strategies.

Published
2022

222. Lack of antiviral activity of probenecid in Vero E6 cells and Syrian golden hamsters: a need for better understanding of inter-lab differences in preclinical assays

Author

Box, Helen, primary, Pennington, Shaun H, additional, Kijak, Edyta, additional, Tatham, Lee, additional, Caygill, Claire H, additional, Lopeman, Rose C, additional, Jeffreys, Laura N, additional, Herriott, Joanne, additional, Sharp, Joanne, additional, Neary, Megan, additional, Valentijn, Anthony, additional, Pertinez, Henry, additional, Curley, Paul, additional, Arshad, Usman, additional, Rajoli, Rajith KR, additional, Rannard, Steve, additional, Stewart, James P., additional, Biagini, Giancarlo A, additional, and Owen, Andrew, additional

Published
2022
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223. Unlike Chloroquine, Mefloquine Inhibits SARS-CoV-2 Infection in Physiologically Relevant Cells

Author

Sacramento, Carolina Q., primary, Fintelman-Rodrigues, Natalia, additional, Dias, Suelen S. G., additional, Temerozo, Jairo R., additional, Da Silva, Aline de Paula D., additional, da Silva, Carine S., additional, Blanco, Camilla, additional, Ferreira, André C., additional, Mattos, Mayara, additional, Soares, Vinicius C., additional, Pereira-Dutra, Filipe, additional, Miranda, Milene Dias, additional, Barreto-Vieira, Debora F., additional, da Silva, Marcos Alexandre N., additional, Santos, Suzana S., additional, Torres, Mateo, additional, Chaves, Otávio Augusto, additional, Rajoli, Rajith K. R., additional, Paccanaro, Alberto, additional, Owen, Andrew, additional, Bou-Habib, Dumith Chequer, additional, Bozza, Patrícia T., additional, and Souza, Thiago Moreno L., additional

Published
2022
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224. Efficacy and safety of nitazoxanide combined with ritonavir-boosted atazanavir for the treatment of mild to moderate COVID-19

Author

Fowotade, Adeola, primary, Bamidele, Folasade, additional, Egbetola, Boluwatife, additional, Fagbamigbe, Adeniyi Francis, additional, Adeagbo, Babatunde Ayodeji, additional, Adefuye, Bolanle Olufunlola, additional, Olagunoye, Ajibola, additional, Ojo, Temitope Olumuyiwa, additional, Adebiyi, Akindele Olupelumi, additional, Olagunju, Omobolanle Ibitayo, additional, Ladipo, Olabode Taiwo, additional, Akinloye, Abdulafeez, additional, Onayade, Adedeji, additional, Bolaji, Oluseye Oladotun, additional, Rannard, Steve, additional, Happi, Christian, additional, Owen, Andrew, additional, and Olagunju, Adeniyi, additional

Published
2022
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225. Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics

Author

Quinn, Tom M., primary, Gaughan, Erin E., additional, Bruce, Annya, additional, Antonelli, Jean, additional, O'Connor, Richard, additional, Li, Feng, additional, McNamara, Sarah, additional, Koch, Oliver, additional, MacKintosh, Claire, additional, Dockrell, David, additional, Walsh, Timothy, additional, Blyth, Kevin G., additional, Church, Colin, additional, Schwarze, Jürgen, additional, Boz, Cecilia, additional, Valanciute, Asta, additional, Burgess, Matthew, additional, Emanuel, Philip, additional, Mills, Bethany, additional, Rinaldi, Giulia, additional, Hardisty, Gareth, additional, Mills, Ross, additional, Findlay, Emily Gwyer, additional, Jabbal, Sunny, additional, Duncan, Andrew, additional, Plant, Sinéad, additional, Marshall, Adam D.L., additional, Young, Irene, additional, Russell, Kay, additional, Scholefield, Emma, additional, Nimmo, Alastair F., additional, Nazarov, Islom B., additional, Churchill, Grant C., additional, McCullagh, James S.O., additional, Ebrahimi, Kourosh H., additional, Ferrett, Colin, additional, Templeton, Kate, additional, Rannard, Steve, additional, Owen, Andrew, additional, Moore, Anne, additional, Finlayson, Keith, additional, Shankar-Hari, Manu, additional, Norrie, John, additional, Parker, Richard A., additional, Akram, Ahsan R., additional, Anthony, Daniel C., additional, Dear, James W., additional, Hirani, Nik, additional, and Dhaliwal, Kevin, additional

Published
2022
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226. Ronapreve (REGN-CoV; casirivimab and imdevimab) reduces the viral burden and alters the pulmonary response to the SARS-CoV 2 Delta variant (B.1.617.2) in K18-hACE2 mice using an experimental design reflective of a treatment use case

Author

Tatham, Lee, primary, Kipar, Anja, additional, Sharp, Joanne, additional, Kijak, Edyta, additional, Herriott, Joanne, additional, Neary, Megan, additional, Box, Helen, additional, Gallardo Toledo, Eduardo, additional, Valentijn, Anthony, additional, Cox, Helen, additional, Pertinez, Henry, additional, Curley, Paul, additional, Arshad, Usman, additional, Rajoli, Rajith KR, additional, Rannard, Steve, additional, Stewart, James, additional, and Owen, Andrew, additional

Published
2022
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227. Linear and branched polymer prodrugs of the water-soluble nucleoside reverse-transcriptase inhibitor emtricitabine as structural materials for long-acting implants

Author

Shakil, Anika, primary, Hern, Faye Yvette, additional, Liu, Chung, additional, Temburnikar, Kartik, additional, Chambon, Pierre, additional, Liptrott, Neill, additional, McDonald, Tom O, additional, Neary, Megan, additional, Owen, Andrew, additional, Freel Meyers, Caren Laura, additional, and Rannard, Steve, additional

Published
2022
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236. SARS-CoV-2 Omicron-B.1.1.529 Variant leads to less severe disease than Pango B and Delta variants strains in a mouse model of severe COVID-19

Author

Bentley, Eleanor G., primary, Kirby, Adam, additional, Sharma, Parul, additional, Kipar, Anja, additional, Mega, Daniele F., additional, Bramwell, Chloe, additional, Penrice-Randal, Rebekah, additional, Prince, Tessa, additional, Brown, Jonathan C., additional, Zhou, Jie, additional, Screaton, Gavin R., additional, Barclay, Wendy S., additional, Owen, Andrew, additional, Hiscox, Julian A., additional, and Stewart, James P., additional

Published
2021
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237. Impact of long-acting therapies on the global HIV epidemic

Author

Chandiwana, Nomathemba C., primary, Serenata, Celicia M., additional, Owen, Andrew, additional, Rannard, Steve, additional, Pérez Casas, Carmen, additional, Scott, Cherise, additional, Hill, Andrew, additional, Clayden, Polly, additional, and Flexner, Charles, additional

Published
2021
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240. Preferences of Persons With or at Risk for Hepatitis C for Long-Acting Treatments

Author

Weld, Ethel D, primary, Astemborski, Jacqueline, additional, Kirk, Gregory D, additional, Sulkowski, Mark S, additional, Katz, Stephanie, additional, Rothman, Richard, additional, Solomon, Sunil S, additional, Matthews, Gail V, additional, Hsieh, Yu Hsiang, additional, Verma, Malvika, additional, Traverso, Giovanni, additional, Swindells, Susan, additional, Owen, Andrew, additional, Feld, Jordan, additional, Flexner, Charles, additional, Mehta, Shruti H, additional, and Thomas, David L, additional

Published
2021
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241. Tako-Tsubo syndrome in an anaesthetised patient undergoing arthroscopic knee surgery

Author

Artukoglu Feyzi, Owen Andrew, and Hemmerling Thomas

Subjects
General anaesthesia, Tako-Tsubo syndrome, broken heart syndrome, myocardial stunning, Anesthesiology, RD78.3-87.3, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

We present a case of stress-induced myocardial stunning, also known as tako-Tsubo syndrome, in an anaesthetised patient undergoing arthroscopic replacement of the cruciate ligament. The patient′s (44 y male, ASA class II) had a history of hypertension with no other known disease. He underwent a femoral nerve block with 20 ml of 0.5% ropivacaine before receiving a balanced general anaesthesia (propofol induction, sevoflurane maintenance, 10 µg/kg sufentanil). Ten min after the beginning of surgery during endoscopic intra-articular manipulation, the patient suffered from bradycardia and hypotension; following the administration of ephedrine and atropine, he developed tachycardia, hypertension and ST segment depression. Subsequently, his systemic blood pressure dropped necessitating inotropic drug support and - later - intraaortic balloon counterpulsation; a TEE revealed no evidence of hypovolemia, anterior and antero-septal hypokinesia with an ejection fraction of 25%. Surgery was finished whilst stabilising the patient haemodynamically. Postoperative cardiac enzymes showed little elevation, an emergency coronary angiogram apical akinesia with typical ballooning and basal hyperkinesias, compatible with Tako-tsubo syndrome. The patient′s postoperative course was uneventful. We theorize that stress caused by sudden surgical pain stimulus (introduction of the endoscope into the articulation), superficial anaesthesia and insufficient analgesia created a stressful event which probably might have caused a catecholamine surge as basis of Tako-tsubo syndrome.

Published
2008

242. Randomised Controlled Trial of Intravenous Nafamostat Mesylate in COVID pneumonitis: Phase 1b/2a Experimental Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics

Author

Quinn, Tom M., primary, Gaughan, Erin E., additional, Bruce, Annya, additional, Antonelli, Jean, additional, O’Connor, Richard, additional, Li, Feng, additional, McNamara, Sarah, additional, Koch, Oliver, additional, MacIntosh, Claire, additional, Dockrell, David, additional, Walsh, Timothy, additional, Blyth, Kevin G., additional, Church, Colin, additional, Schwarze, Jürgen, additional, Boz, Cecilia, additional, Valanciute, Asta, additional, Burgess, Matthew, additional, Emanuel, Philip, additional, Mills, Bethany, additional, Rinaldi, Giulia, additional, Hardisty, Gareth, additional, Mills, Ross, additional, Findlay, Emily, additional, Jabbal, Sunny, additional, Duncan, Andrew, additional, Plant, Sinéad, additional, Marshall, Adam D. L., additional, Young, Irene, additional, Russell, Kay, additional, Scholefield, Emma, additional, Nimmo, Alastair F., additional, Nazarov, Islom B., additional, Churchill, Grant C., additional, McCullagh, James S.O., additional, Ebrahimi, Kourosh H., additional, Ferrett, Colin, additional, Templeton, Kate, additional, Rannard, Steve, additional, Owen, Andrew, additional, Moore, Anne, additional, Finlayson, Keith, additional, Shankar-Hari, Manu, additional, Norrie, John, additional, Parker, Richard A., additional, Akram, Ahsan R., additional, Anthony, Daniel C., additional, Dear, James W., additional, Hirani, Nik, additional, and Dhaliwal, Kevin, additional

Published
2021
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243. Cognitive Aids for the Management of Thoracic Anesthesia Emergencies: Consensus Guidelines on Behalf of a Canadian Thoracic Taskforce.

Author

Cowan, Jayden, primary, Hutton, Meredith, additional, Owen, Andrew, additional, Lam, Darren, additional, Bracco, David, additional, Hurdle, Heather, additional, Lohser, Jens, additional, Hirshberg, Jonah, additional, Cory, Julia, additional, Chow, Lorraine, additional, McDonald, Sarah, additional, and Haber, Julia, additional

Published
2021
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244. Single‐dose immunisation with a multimerised SARS‐CoV‐2 receptor binding domain (RBD) induces an enhanced and protective response in mice

Author

Salzer, Ralf, Clark, Jordan J, Vaysburd, Marina, Chang, Veronica T, Albecka, Anna, Kiss, Leo, Sharma, Parul, Gonzalez Llamazares, Andres, Kipar, Anja, Hiscox, Julian A, Owen, Andrew, Aricescu, A Radu, Stewart, James P, James, Leo C, Löwe, Jan, University of Zurich, James, Leo C, and Löwe, Jan

Subjects
1303 Biochemistry, Biophysics, 10184 Institute of Veterinary Pathology, Cell Biology, Biochemistry, 1307 Cell Biology, 1315 Structural Biology, 1311 Genetics, Structural Biology, 1312 Molecular Biology, Genetics, 570 Life sciences, biology, Molecular Biology, 1304 Biophysics
Published
2021

245. AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Author

Griffiths, Gareth O, FitzGerald, Richard, Jaki, Thomas, Corkhill, Andrea, Reynolds, Helen, Ewings, Sean, Condie, Susannah, Tilt, Emma, Johnson, Lucy, Radford, Mike, Simpson, Catherine, Saunders, Geoffrey, Yeats, Sara, Mozgunov, Pavel, Tansley-Hancock, Olana, Martin, Karen, Downs, Nichola, Eberhart, Izabela, Martin, Jonathan WB, Goncalves, Cristiana, Song, Anna, Fletcher, Tom, Byrne, Kelly, Lalloo, David G, Owen, Andrew, Jacobs, Michael, Walker, Lauren, Lyon, Rebecca, Woods, Christie, Gibney, Jennifer, Chiong, Justin, Chandiwana, Nomathemba, Jacob, Shevin, Lamorde, Mohammed, Orrell, Catherine, Pirmohamed, Munir, Khoo, Saye, AGILE Investigators, Desmond Tutu HIV Centre, Faculty of Health Sciences, Jaki, Thomas [0000-0002-1096-188X], and Apollo - University of Cambridge Repository

Subjects
Medicine (General), medicine.medical_specialty, Population, Psychological intervention, Medicine (miscellaneous), 030204 cardiovascular system & hematology, wc_500, Update, law.invention, Cohort Studies, 03 medical and health sciences, R5-920, 0302 clinical medicine, Randomized controlled trial, law, wc_506, wc_505, medicine, Clinical endpoint, Master protocol, Humans, Pharmacology (medical), Medical physics, 030212 general & internal medicine, education, Pandemics, Protocol (science), Randomised controlled trial, education.field_of_study, business.industry, SARS-CoV-2, COVID-19, wb_102.5, Phase I/II, Bayesian, 3. Good health, Identification (information), Treatment Outcome, business, Platform study, Agile software development, Cohort study
Abstract

Funder: Unitaid, BACKGROUND: There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. METHODS/DESIGN: AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. DISCUSSION: Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. TRIAL REGISTRATION: EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183 19 February 2021 ISRCTN reference: 27106947.

Published
2021
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250. Holistic Review of the Preclinical Landscape for Long-Acting Anti-infective Drugs Using HIV as a Paradigm.

Author

Neary, Megan, Owen, Andrew, and Olagunju, Adeniyi

Subjects
*HIV infections, *DRUG delivery systems, *IN vitro studies, *BIOLOGICAL models, *DRUG efficacy, *SMALL molecules, *CLINICAL drug trials, *ANTI-infective agents, *MONOCLONAL antibodies, *TISSUE engineering, *PHARMACEUTICAL chemistry, *DRUG development
Abstract

Lack of predictive preclinical models is a key contributor to the steep attrition rate in drug development. Successful clinical translation may be higher for new chemical entities or existing approved drugs reformulated for long-acting (LA) administration if preclinical studies designed to identify any new uncertainties are predictive of human exposure and response. In this review, we present an overview of standard preclinical assessments deployed for LA formulations and delivery systems, using human immunodeficiency virus LA therapeutics preclinical development as a paradigm. Key progress in the preclinical development of novel LA antiretrovirals formulations and delivery systems are summarized, including bispecific broadly neutralizing monoclonal antibody and small molecule technologies for codelivery of multiple drugs with disparate solubility properties. There are new opportunities to take advantage of recent developments in tissue engineering and 3-dimensional in vitro modeling to advance preclinical modeling of anti-infective activity, developmental and reproductive toxicity assessment, and to apply quantitative modeling and simulation strategies. These developments are likely to drive the progression of more LA anti-infective drugs and multipurpose technologies into clinical development in the coming years. [ABSTRACT FROM AUTHOR]

Published
2022
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