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2. The IL-6 hypothesis in COVID-19: A phase 2, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of free IL-6 sequestration by the monoclonal antibody sirukumab in severe and critical COVID-19

Author

Gottlieb, Robert L., Clement, Meredith, Cook, Paul, Deveikis, Audra, Foong, Kap Sum, Robinson, Philip, Slim, Jihad, Spak, Cedric W., Buelens, Annemie, Callewaert, Katleen, De Meyer, Sandra, Mo, Wai Ling, Verbrugge, Inge, Van Wesenbeeck, Liesbeth, Zhuang, Yanli, Chien, Jason W., Opsomer, Magda, and Van Landuyt, Erika

Published
2024
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3. Blocking NS3–NS4B interaction inhibits dengue virus in non-human primates

Author

Goethals, Olivia, Kaptein, Suzanne J. F., Kesteleyn, Bart, Bonfanti, Jean-François, Van Wesenbeeck, Liesbeth, Bardiot, Dorothée, Verschoor, Ernst J., Verstrepen, Babs E., Fagrouch, Zahra, Putnak, J. Robert, Kiemel, Dominik, Ackaert, Oliver, Straetemans, Roel, Lachau-Durand, Sophie, Geluykens, Peggy, Crabbe, Marjolein, Thys, Kim, Stoops, Bart, Lenz, Oliver, Tambuyzer, Lotke, De Meyer, Sandra, Dallmeier, Kai, McCracken, Michael K., Gromowski, Gregory D., Rutvisuttinunt, Wiriya, Jarman, Richard G., Karasavvas, Nicos, Touret, Franck, Querat, Gilles, de Lamballerie, Xavier, Chatel-Chaix, Laurent, Milligan, Gregg N., Beasley, David W. C., Bourne, Nigel, Barrett, Alan D. T., Marchand, Arnaud, Jonckers, Tim H. M., Raboisson, Pierre, Simmen, Kenny, Chaltin, Patrick, Bartenschlager, Ralf, Bogers, Willy M., Neyts, Johan, and Van Loock, Marnix

Published
2023
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8. Association of post-treatment virologic relapse and biochemical flares with HBV serum biomarkers in long-term virologically suppressed HBeAg-negative patients stopping NA treatment: Exploratory analyses from the control arm of the REEF-2 study

Author

van Bömmel, Florian, primary, Verbinnen, Thierry, additional, Agarwal, Kosh, additional, Vanwolleghem, Thomas, additional, Lampertico, Pietro, additional, Buti, Maria, additional, Janczewska, Ewa, additional, Bourliere, Marc, additional, Jerzorwski, John, additional, Kakuda, Thomas, additional, De Meyer, Sandra, additional, Bakala, Adam, additional, Lenz, Oliver, additional, and Biermer, Michael, additional

Published
2023
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11. Therapeutic vaccine JNJ-0535 induces a strong HBV-specific T-cell response in healthy adults and a modest response in chronic HBV-infected patients

Author

De Creus, An, primary, Slaets, Leen, additional, Fevery, Bart, additional, Van Gulck, Ellen, additional, Zhou, Linghua, additional, Van De Parre, Tim, additional, Van Den Broeke, Celine, additional, Dimitrova, Dessislava, additional, Lonjon-Domanec, Isabelle, additional, Bluem, Jr, David, additional, Van Remoortere, Pieter, additional, Bourgeois, Stefan, additional, Kennedy, Patrick, additional, and De Meyer, Sandra, additional

Published
2022
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14. Development and optimization of a high-throughput screening assay for in vitro anti-SARS-CoV-2 activity: Evaluation of 5676 Phase 1 Passed Structures

Author

Chiu, Winston, Verschueren, Lore, Eynde, Christel van der, Buyck, Christophe, De Meyer, Sandra, Jochmans, Dirk, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Leyssen, Pieter, Neyts, Johan, Loock, Marnix van, Damme, Ellen van, Chiu, Winston, Verschueren, Lore, Eynde, Christel van der, Buyck, Christophe, De Meyer, Sandra, Jochmans, Dirk, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Leyssen, Pieter, Neyts, Johan, Loock, Marnix van, and Damme, Ellen van

Abstract

Although vaccines are currently used to control the coronavirus disease 2019 (COVID-19) pandemic, treatment options are urgently needed for those who cannot be vaccinated and for future outbreaks involving new severe acute respiratory syndrome coronavirus virus 2 (SARS-CoV-2) strains or coronaviruses not covered by current vaccines. Thus far, few existing antivirals are known to be effective against SARS-CoV-2 and clinically successful against COVID-19. As part of an immediate response to the COVID-19 pandemic, a high-throughput, high content imaging–based SARS-CoV-2 infection assay was developed in VeroE6 African green monkey kidney epithelial cells expressing a stable enhanced green fluorescent protein (VeroE6-eGFP cells) and was used to screen a library of 5676 compounds that passed Phase 1 clinical trials. Eight drugs (nelfinavir, RG-12915, itraconazole, chloroquine, hydroxychloroquine, sematilide, remdesivir, and doxorubicin) were identified as inhibitors of in vitro anti–SARS-CoV-2 activity in VeroE6-eGFP and/or Caco-2 cell lines. However, apart from remdesivir, toxicity and pharmacokinetic data did not support further clinical development of these compounds for COVID-19 treatment.

Published
2022

15. Development and optimisation of a high-throughput screening assay for in vitro antiSARS-CoV-2 activity: evaluation of 5676 phase 1 passed structures

Author

Chiu, Winston, Verschueren, Lore, Eynde, Christel van der, Buyck, Christophe, De Meyer, Sandra, Jochmans, Dirk, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Leyssen, Pieter, Neyts, Johan, Loock, Marnix van, Damme, Ellen van, Chiu, Winston, Verschueren, Lore, Eynde, Christel van der, Buyck, Christophe, De Meyer, Sandra, Jochmans, Dirk, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Leyssen, Pieter, Neyts, Johan, Loock, Marnix van, and Damme, Ellen van

Abstract

Although vaccines are currently used to control the coronavirus disease 2019 (COVID-19) pandemic, treatment options are urgently needed for those who cannot be vaccinated and for future outbreaks involving new severe acute respiratory syndrome coronavirus virus 2 (SARS-CoV-2) strains or coronaviruses not covered by current vaccines. Thus far, few existing antivirals are known to be effective against SARS-CoV-2 and clinically successful against COVID-19. As part of an immediate response to the COVID-19 pandemic, a high-throughput, high content imaging–based SARS-CoV-2 infection assay was developed in VeroE6-eGFP cells and was used to screen a library of 5676 compounds that passed phase 1 clinical trials. Eight candidates (nelfinavir, RG-12915, itraconazole, chloroquine, hydroxychloroquine, sematilide, remdesivir, and doxorubicin) with in vitro anti–SARS-CoV-2 activity in VeroE6-eGFP and/or Caco-2 cell lines were identified. However, apart from remdesivir, toxicity and pharmacokinetic data did not support further clinical development of these compounds for COVID-19 treatment.

Published
2022

16. Development and optimization of a high‐throughput screening assay for in vitro anti‐SARS‐CoV‐2 activity: Evaluation of 5676 Phase 1 Passed Structures

Author

Chiu, Winston, primary, Verschueren, Lore, additional, Van den Eynde, Christel , additional, Buyck, Christophe, additional, De Meyer, Sandra, additional, Jochmans, Dirk, additional, Bojkova, Denisa, additional, Ciesek, Sandra, additional, Cinatl, Jindrich, additional, De Jonghe, Steven, additional, Leyssen, Pieter, additional, Neyts, Johan, additional, Van Loock, Marnix, additional, and Van Damme, Ellen, additional

Published
2022
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21. In vitro activity of itraconazole against SARS-CoV-2

Author

Damme, Ellen van, De Meyer, Sandra, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Jochmans, Dirk, Leyssen, Pieter, Buyck, Christophe, Neyts, Johan, Loock, Marnix van, Damme, Ellen van, De Meyer, Sandra, Bojkova, Denisa, Ciesek, Sandra, Cinatl, Jindrich, De Jonghe, Steven, Jochmans, Dirk, Leyssen, Pieter, Buyck, Christophe, Neyts, Johan, and Loock, Marnix van

Abstract

Although vaccination campaigns are currently being rolled out to prevent coronavirus disease (COVID-19), antivirals will remain an important adjunct to vaccination. Antivirals against coronaviruses do not exist, hence global drug repurposing efforts have been carried out to identify agents that may provide clinical benefit to patients with COVID-19. Itraconazole, an antifungal agent, has been reported to have activity against animal coronaviruses. Using cell-based phenotypic assays, the in vitro antiviral activity of itraconazole and 17-OH itraconazole was assessed against clinical isolates from a German and Belgian patient infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Itraconazole demonstrated antiviral activity in human Caco-2 cells (EC50 = 2.3 µM; 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay). Similarly, its primary metabolite, 17-OH itraconazole, showed inhibition of SARS-CoV-2 activity (EC50 = 3.6 µM). Remdesivir inhibited viral replication with an EC50 = 0.4 µM. Itraconazole and 17-OH itraconazole resulted in a viral yield reduction in vitro of approximately 2-log10 and approximately 1-log10, as measured in both Caco-2 cells and VeroE6-eGFP cells, respectively. The viral yield reduction brought about by remdesivir or GS-441524 (parent nucleoside of the antiviral prodrug remdesivir; positive control) was more pronounced, with an approximately 3-log10 drop and >4-log10 drop in Caco-2 cells and VeroE6-eGFP cells, respectively. Itraconazole and 17-OH itraconazole exert in vitro low micromolar activity against SARS-CoV-2. Despite the in vitro antiviral activity, itraconazole did not result in a beneficial effect in hospitalized COVID-19 patients in a clinical study (EudraCT Number: 2020-001243-15).

Published
2021

22. In vitro activity of itraconazole against SARS‐CoV‐2

Author

Van Damme, Ellen, primary, De Meyer, Sandra, additional, Bojkova, Denisa, additional, Ciesek, Sandra, additional, Cinatl, Jindrich, additional, De Jonghe, Steven, additional, Jochmans, Dirk, additional, Leyssen, Pieter, additional, Buyck, Christophe, additional, Neyts, Johan, additional, and Van Loock, Marnix, additional

Published
2021
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23. SAT-154 - Association of post-treatment virologic relapse and biochemical flares with HBV serum biomarkers in long-term virologically suppressed HBeAg-negative patients stopping NA treatment: Exploratory analyses from the control arm of the REEF-2 study

Author

van Bömmel, Florian, Verbinnen, Thierry, Agarwal, Kosh, Vanwolleghem, Thomas, Lampertico, Pietro, Buti, Maria, Janczewska, Ewa, Bourliere, Marc, Jerzorwski, John, Kakuda, Thomas, De Meyer, Sandra, Bakala, Adam, Lenz, Oliver, and Biermer, Michael

Published
2023
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24. Week 96 resistance analyses of the once‐daily, single‐tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in adults living with HIV‐1 from the phase 3 randomized AMBER and EMERALD trials

Author

Lathouwers, Erkki, primary, Weinsteiger, Shirley, additional, Baugh, Bryan, additional, Ghys, Anne, additional, Jezorwski, John, additional, Mohsine, El Ghazi, additional, Van Landuyt, Erika, additional, and De Meyer, Sandra, additional

Published
2021
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30. Telaprevir for Retreatment of HCV Infection

Author

Zeuzem, Stefan, Andreone, Pietro, Pol, Stanislas, Lawitz, Eric, Diago, Moises, Roberts, Stuart, Focaccia, Roberto, Younossi, Zobair, Foster, Graham R., Horban, Andrzej, Ferenci, Peter, Nevens, Frederik, Müllhaupt, Beat, Pockros, Paul, Terg, Ruben, Shouval, Daniel, van Hoek, Bart, Weiland, Ola, Van Heeswijk, Rolf, De Meyer, Sandra, Luo, Don, Boogaerts, Griet, Polo, Ramon, Picchio, Gaston, and Beumont, Maria

Published
2011

31. In Vitro Activity of Itraconazole Against SARS-CoV-2

Author

Van Damme, Ellen, primary, De Meyer, Sandra, additional, Bojkova, Denisa, additional, Ciesek, Sandra, additional, Cinatl, Jindrich, additional, De Jonghe, Steven, additional, Jochmans, Dirk, additional, Leyssen, Pieter, additional, Buyck, Christophe, additional, Neyts, Johan, additional, and Van Loock, Marnix, additional

Published
2020
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39. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials

Author

Lathouwers, Erkki, Wong, Eric Y, Brown, Kimberley, Baugh, Bryan, Ghys, Anne, Jezorwski, John, Mohsine, El Ghazi, Van Landuyt, Erika, Opsomer, Magda, De Meyer, Sandra, De Wit, S, Florence, E, Vandekerckhove, L, Vandercam, B, Brunetta, J, Klein, M, Murphy, D, Rachlis, A, Walmsley, S, Ajana, F, Cotte, L, Girard, P-M, Katlama, C, Molina, J-M, Poizot-Martin, I, Raffi, F, Rey, D, Reynes, J, Teicher, E, Yazdanpanah, Y, Arasteh, K, Bickel, M, Bogner, J, Esser, S, Faetkenheuer, G, Jessen, H, Kern, W, Rockstroh, J, Spinner, C, Stellbrink, H-J, Stoehr, A, Antinori, A, Castelli, F, Chirianni, A, De Luca, A, Di Biagio, A, Galli, M, Lazzarin, A, Maggiolo, F, Maserati, R, Mussini, C, Garlicki, A, Gasiorowski, J, Halota, W, Horban, A, Parczewski, M, Piekarska, A, Belonosova, E, Chernova, O, Dushkina, N, Kulagin, V, Ryamova, E, Shuldyakov, A, Sizova, N, Tsybakova, O, Voronin, E, Yakovlev, A, Antela, A, Arribas, JR, Berenguer, J, Casado, J, Estrada, V, Galindo, MJ, Garcia Del Toro, M, Gatell, JM, Gorgolas, M, Gutierrez, F, Gutierrez, MDM, Negredo, E, Pineda, JA, Podzamczer, D, Portilla Sogorb, J, Rivero, A, Rubio, R, Viciana, P, De Los Santos, I, Clarke, A, Gazzard, BG, Johnson, MA, Orkin, C, Reeves, I, Waters, L, Benson, P, Bhatti, L, Bredeek, F, Crofoot, G, Cunningham, D, DeJesus, E, Eron, J, Felizarta, F, Franco, R, Gallant, J, Hagins, D, Henry, K, Jayaweera, D, Lucasti, C, Martorell, C, McDonald, C, McGowan, J, Mills, A, Morales-Ramirez, J, Prelutsky, D, Ramgopal, M, Rashbaum, B, Ruane, P, Slim, J, Wilkin, A, deVente, J, Moutschen, M, Van Wijngaerden, E, Vekerckhove, L, Vercam, B, Conway, B, Shafran, S, Janssen Pharmaceutica [Beerse], Janssen Pharmaceutical Research and Development Titusville, AMBER and EMERALD Study Groups: S De Wit, E Florence, L Vandekerckhove, B Vandercam, J Brunetta, M Klein, D Murphy, A Rachlis, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, K Arastéh, M Bickel, J Bogner, S Esser, G Faetkenheuer, H Jessen, W Kern, J Rockstroh, C Spinner, H-J Stellbrink, A Stoehr, A Antinori, F Castelli, A Chirianni, A De Luca, A Di Biagio, M Galli, A Lazzarin, F Maggiolo, R Maserati, C Mussini, A Garlicki, J Gasiorowski, W Halota, A Horban, M Parczewski, A Piekarska, E Belonosova, O Chernova, N Dushkina, V Kulagin, E Ryamova, A Shuldyakov, N Sizova, O Tsybakova, E Voronin, A Yakovlev, A Antela, J R Arribas, J Berenguer, J Casado, V Estrada, M J Galindo, M Garcia Del Toro, J M Gatell, M Gorgolas, F Gutierrez, Mdm Gutierrez, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, A Rivero, R Rubio, P Viciana, I De Los Santos, A Clarke, B G Gazzard, M A Johnson, C Orkin, I Reeves, L Waters, P Benson, L Bhatti, F Bredeek, G Crofoot, D Cunningham, E DeJesus, J Eron, F Felizarta, R Franco, J Gallant, D Hagins, K Henry, D Jayaweera, C Lucasti, C Martorell, C McDonald, J McGowan, A Mills, J Morales-Ramirez, D Prelutsky, M Ramgopal, B Rashbaum, P Ruane, J Slim, A Wilkin, J deVente, S De Wit, E Florence, M Moutschen, E Van Wijngaerden, L Vandekerckhove, B Vandercam, J Brunetta, B Conway, M Klein, D Murphy, A Rachlis, S Shafran, S Walmsley, F Ajana, L Cotte, P-M Girard, C Katlama, J-M Molina, I Poizot-Martin, F Raffi, D Rey, J Reynes, E Teicher, Y Yazdanpanah, J Gasiorowski, W Halota, A Horban, A Piekarska, A Witor, J R Arribas, I Perez-Valero, J Berenguer, J Casado, J M Gatell, F Gutierrez, M J Galindo, Mdm Gutierrez, J A Iribarren, H Knobel, E Negredo, J A Pineda, D Podzamczer, J Portilla Sogorb, F Pulido, C Ricart, A Rivero, I Santos Gil, A Blaxhult, L Flamholc, M Gisslèn, A Thalme, J Fehr, A Rauch, M Stoeckle, A Clarke, B G Gazzard, M A Johnson, C Orkin, F Post, A Ustianowski, L Waters, J Bailey, P Benson, L Bhatti, I Brar, U F Bredeek, C Brinson, G Crofoot, D Cunningham, E DeJesus, C Dietz, R Dretler, J Eron, F Felizarta, C Fichtenbaum, J Gallant, J Gathe, D Hagins, S Henn, K W Henry, G Huhn, M Jain, C Lucasti, C Martorell, C McDonald, A Mills, J Morales-Ramirez, K Mounzer, R Nahass, H Olivet, O Osiyemi, D Prelutsky, M Ramgopal, B Rashbaum, G Richmond, P Ruane, A Scarsella, A Scribner, P Shalit, D Shamblaw, J Slim, K Tashima, G Voskuhl, D Ward, A Wilkin, J de Vente, and Malbec, Odile

Subjects
0301 basic medicine, [SDV]Life Sciences [q-bio], efficacy, Human immunodeficiency virus (HIV), HIV Infections, darunavir, medicine.disease_cause, VIRALLY SUPPRESSED ADULTS, PLUS LAMIVUDINE, DOUBLE-BLIND, 0302 clinical medicine, INFECTION, Medicine and Health Sciences, Emtricitabine, 030212 general & internal medicine, Darunavir, Emtricitabine tenofovir alafenamide, Alanine, Cobicistat, Single tablet regimen, virus diseases, Viral Load, OPEN-LABEL, 3. Good health, [SDV] Life Sciences [q-bio], Drug Combinations, Infectious Diseases, NON-INFERIORITY, INITIAL TREATMENT, Reverse Transcriptase Inhibitors, Life Sciences & Biomedicine, Tablets, medicine.drug, Adult, TENOFOVIR DISOPROXIL FUMARATE, Anti-HIV Agents, Darunavir/Cobicistat, Immunology, archived RAMs, Tenofovir alafenamide, Drug Administration Schedule, single-tablet regimen, resistance, 03 medical and health sciences, deep sequencing, Virology, Drug Resistance, Viral, medicine, darunavir/cobicistat/emtricitabine/TAF, Humans, Clinical Trials/Clinical Studies, Tenofovir, emtricitabine, DRUG-RESISTANCE, Science & Technology, TREATMENT-NAIVE PATIENTS, business.industry, Adenine, cobicistat, 030104 developmental biology, TAF, HIV-1, business
Abstract

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg is being investigated in two Phase III trials, AMBER (NCT02431247; treatment-naive adults) and EMERALD (NCT02269917; treatment-experienced, virologically suppressed adults). Week 48 AMBER and EMERALD resistance analyses are presented. Postbaseline samples for genotyping/phenotyping were analyzed from protocol-defined virologic failures (PDVFs) with viral load (VL) ≥400 copies/mL at failure/later time points. Post hoc analyses were deep sequencing in AMBER, and HIV-1 proviral DNA from baseline samples (VL

Published
2019

43. Pooled resistance analyses of darunavir once-daily regimens and formulations across 10 clinical studies of treatmentnaïve and treatment-experienced patients with human immunodeficiency virus-1 infection.

Author

Lathouwers, Erkki, Seyedkazemi, Sareh, Donghan Luo, Brown, Kimberley, De Meyer, Sandra, and Wong, Eric Y.

Subjects
REVERSE transcriptase inhibitors, PROTEASE inhibitors
Abstract

Background: The efficacy and high barrier to resistance of darunavir have been demonstrated across diverse populations with HIV-1 infection. Objective: To evaluate post-baseline resistance among patients in studies of once-daily (QD) darunavir-based regimens and formulations. Methods: The analysis included treatment-naïve and virologically failing or suppressed patients from 10 phase 2/3 studies (48-192 weeks in duration) of boosted darunavir 800 mg QD-based regimens. Three were phase 3 studies of the QD darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg single-tablet regimen. Post-baseline resistance was evaluated upon protocol-defined virologic failure (PDVF). Resistance-associated mutations (RAMs) were identified using International Antiviral Society-USA mutation lists. Phenotypic analyses varied across studies. Results: Overall, 250 of 3635 patients in the analysis met PDVF criteria; 205 had post-baseline genotypes/phenotypes. In total, four (0.1%) patients developed (or had identified) ≥1 darunavir and/or primary protease inhibitor (PI) RAM; only one (<0.1%) patient (with prior lopinavir virologic failure) lost darunavir phenotypic susceptibility. Among 3317 patients using nucleos(t)ide reverse transcriptase inhibitors (N[t]RTIs; mostly emtricitabine and tenofovir), 13 (0.4%) had ≥1 N(t)RTI RAM (10 with M184I/V). Among patients receiving D/C/F/TAF (n = 1949), none had post-baseline darunavir, primary PI, or tenofovir RAMs; only two (0.1%) patients developed an emtricitabine RAM, M184V/I. Conclusions: Across a large, diverse population using darunavir 800 mg QD-based regimens and formulations, resistance development remains rare. After clinical trials that span >10 years, loss of phenotypic susceptibility to darunavir was only observed once in a PI-experienced patient and has never been observed in treatment-naïve patients, treatment-experienced PI-naïve patients, or treatment-experienced virologically suppressed patients. [ABSTRACT FROM AUTHOR]

Published
2020
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48. Pre-existence and Persistence of Resistant Minority Hepatitis C Virus Variants in Genotype 1-Infected Patients Treated With Simeprevir/Peginterferon/Ribavirin

Author

Fevery, Bart, primary, Thys, Kim, additional, Van Eygen, Veerle, additional, Verbinnen, Thierry, additional, Van Rossem, Elizabeth, additional, Buelens, Annemie, additional, Aerssens, Jeroen, additional, Witek, James, additional, Picchio, Gaston, additional, De Meyer, Sandra, additional, and Lenz, Oliver, additional

Published
2016
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