Search Results - "Ouwerkerk–Mahadevan, Sivi"

Population Pharmacokinetic Analysis of Bedaquiline‐Clarithromycin for Dose Selection Against Pulmonary Nontuberculous Mycobacteria Based on a Phase 1, Randomized, Pharmacokinetic Study by Kurosawa, Ken, Rossenu, Stefaan, Biewenga, Jeike, Ouwerkerk‐Mahadevan, Sivi, Willems, Wouter, Ernault, Etienne, Kambili, Chrispin

“…Based on the in vitro profile of bedaquiline against mycobacterial species, it is being investigated for clinical efficacy against pulmonary nontuberculous…”
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JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐Infected Patients Without Cirrhosis: OMEGA‐1 by Zeuzem, Stefan, Bourgeois, Stefan, Greenbloom, Susan, Buti, Maria, Aghemo, Alessio, Lampertico, Pietro, Janczewska, Ewa, Lim, Seng Gee, Moreno, Christophe, Buggisch, Peter, Tam, Edward, Corbett, Chris, Willems, Wouter, Vijgen, Leen, Fevery, Bart, Ouwerkerk‐Mahadevan, Sivi, Ackaert, Oliver, Beumont, Maria, Kalmeijer, Ronald, Sinha, Rekha, Biermer, Michael

“…The combination of three direct‐acting antiviral agents (AL‐335, odalasvir, and simeprevir: JNJ‐4178 regimen) for 6 or 8 weeks demonstrated good efficacy and…”
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Telaprevir combination therapy in HCV/HIV co‐infected patients (INSIGHT study): sustained virologic response at 12 weeks final analysis by Montes, Marisa, Nelson, Mark, Marie Girard, Pierre, Sasadeusz, Joe, Horban, Andrzej, Grinsztejn, Beatriz, Zakharova, Natalia, Rivero, Antonio, Lathouwers, Erkki, Janssen, Katrien, Ouwerkerk‐Mahadevan, Sivi, Witek, James

“…Introduction We report the SVR12 final analysis of a phase 3 study of telaprevir in combination with peginterferon (P)/ribavirin (R) in HCV‐genotype 1,…”
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Simeprevir With Peginterferon and Ribavirin Leads to High Rates of SVR in Patients With HCV Genotype 1 Who Relapsed After Previous Therapy: A Phase 3 Trial by Forns, Xavier, Lawitz, Eric, Zeuzem, Stefan, Gane, Ed, Bronowicki, Jean Pierre, Andreone, Pietro, Horban, Andrzej, Brown, Ashley, Peeters, Monika, Lenz, Oliver, Ouwerkerk–Mahadevan, Sivi, Scott, Jane, De La Rosa, Guy, Kalmeijer, Ronald, Sinha, Rekha, Beumont–Mauviel, Maria

“…Background & Aims Simeprevir is an oral, once-daily inhibitor of hepatitis c virus (HCV) protease NS3/4A. We investigated the safety and efficacy of simeprevir…”
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Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial by Jacobson, Ira M, Prof, Dore, Gregory J, Prof, Foster, Graham R, Prof, Fried, Michael W, Prof, Radu, Monica, MD, Rafalsky, Vladimir V, Prof, Moroz, Larysa, Prof, Craxi, Antonio, Prof, Peeters, Monika, MSc, Lenz, Oliver, PhD, Ouwerkerk-Mahadevan, Sivi, PhD, De La Rosa, Guy, MD, Kalmeijer, Ronald, MD, Scott, Jane, PhD, Sinha, Rekha, PhD, Beumont-Mauviel, Maria, PhD

“…Summary Background Although the addition of the HCV NS3/4A protease inhibitors boceprevir and telaprevir to pegylated interferon (peginterferon) alfa plus…”
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Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial by Manns, Michael, Prof, Marcellin, Patrick, Prof, Poordad, Fred, Prof, de Araujo, Evaldo Stanislau Affonso, PhD, Buti, Maria, Prof, Horsmans, Yves, Prof, Janczewska, Ewa, MD, Villamil, Federico, Prof, Scott, Jane, PhD, Peeters, Monika, MSc, Lenz, Oliver, PhD, Ouwerkerk-Mahadevan, Sivi, PhD, De La Rosa, Guy, MD, Kalmeijer, Ronald, MD, Sinha, Rekha, PhD, Beumont-Mauviel, Maria, PhD

“…Summary Background Pegylated interferon (peginterferon) alfa 2a or 2b plus ribavirin regimens were the standard of care in patients with hepatitis C virus…”
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Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study by Lawitz, Eric, Prof, Sulkowski, Mark S, Prof, Ghalib, Reem, MD, Rodriguez-Torres, Maribel, MD, Younossi, Zobair M, Prof, Corregidor, Ana, MD, DeJesus, Edwin, MD, Pearlman, Brian, Prof, Rabinovitz, Mordechai, Prof, Gitlin, Norman, MD, Lim, Joseph K, MD, Pockros, Paul J, MD, Scott, John D, MD, Fevery, Bart, MSc, Lambrecht, Tom, MSc, Ouwerkerk-Mahadevan, Sivi, PhD, Callewaert, Katleen, MSc, Symonds, William T, PharmD, Picchio, Gaston, PhD, Lindsay, Karen L, MD, Beumont, Maria, MD, Jacobson, Ira M, Prof

“…Summary Background Interferon-free regimens are needed to treat hepatitis C virus (HCV) infections. We investigated the efficacy of combined simeprevir and…”
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Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial by Reddy, K Rajender, Prof, Zeuzem, Stefan, Prof, Zoulim, Fabien, Prof, Weiland, Ola, Prof, Horban, Andrzej, Prof, Stanciu, Carol, Prof, Villamil, Federico Guillermo, MD, Andreone, Pietro, Prof, George, Jacob, Prof, Dammers, Elisabeth, MSc, Fu, Min, MS, Kurland, Darryl, MD, Lenz, Oliver, PhD, Ouwerkerk-Mahadevan, Sivi, PhD, Verbinnen, Thierry, PhD, Scott, Jane, PhD, Jessner, Wolfgang, MD

“…Summary Background We did a phase 3 study in previous non-responders with chronic hepatitis C virus (HCV) genotype 1 infection and compensated liver disease…”
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Clinical impact of pharmacokinetic interactions between the HCV protease inhibitor simeprevir and frequently used concomitant medications by Marra, Fiona, Höner zu Siederdissen, Christoph, Khoo, Saye, Back, David, Schlag, Michael, Ouwerkerk‐Mahadevan, Sivi, Bicer, Ceyhun, Lonjon‐Domanec, Isabelle, Jessner, Wolfgang, Beumont‐Mauviel, Maria, Kalmeijer, Ronald, Cornberg, Markus

“…Aims Direct‐acting antiviral agents (DAAs) for the treatment of hepatitis C (HCV) can be associated with drug–drug interactions (DDIs) with concomitant…”
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Pharmacokinetics of bound and unbound telaprevir in cirrhotic patients with moderate and severe hepatic impairment by Ouwerkerk-Mahadevan, Sivi, Halabi, Atef, Cieslarová, Blanka, Aerts, Indra, Witek, James, Van Solingen-Ristea, Rodica, Luo, Donghan

“…This study aimed to characterize the pharmacokinetic parameters of telaprevir (TVR) in patients with moderate and severe hepatic impairment, measure the…”
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Simeprevir plus peginterferon/ribavirin for HCV genotype 1-infected treatment-naïve patients in China and South Korea by Wei, Lai, Han, Tao, Yang, Dongliang, Heo, Jeong, Shang, Jia, Cheng, Jun, Chen, Xinyue, Xie, Qing, Kim, Ju-Hyun, Kalmeijer, Ronald, Ouwerkerk-Mahadevan, Sivi, Hoeben, Eva, Lenz, Oliver, Verbinnen, Thierry, Sinha, Rekha, Li, MengChun, Scott, Jane, Peeters, Monika, Witek, James

“…Background and Aim Approximately one‐third of patients with hepatitis C virus (HCV) genotype (GT) 1 infection live in East Asia. This study evaluated the…”
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Efficacy, safety, and pharmacokinetics of simeprevir, daclatasvir, and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation: The Phase II SATURN study by Forns, Xavier, Berenguer, Marina, Herzer, Kerstin, Sterneck, Martina, Donato, Maria Francesca, Andreone, Pietro, Fagiuoli, Stefano, Cieciura, Tomasz, Durlik, Magdalena, Calleja, Jose Luis, Mariño, Zoe, Shukla, Umesh, Verbinnen, Thierry, Lenz, Oliver, Ouwerkerk‐Mahadevan, Sivi, Peeters, Monika, Janssen, Katrien, Kalmeijer, Ronald, Jessner, Wolfgang

“…Background Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced…”
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Efficacy of telaprevir-based therapy in stable liver transplant patients with chronic genotype 1 hepatitis C by Forns, Xavier, Samuel, Didier, Mutimer, David, Fagiuoli, Stefano, Navasa, Miquel, Agarwal, Kosh, Berenguer, Marina, Colombo, Massimo, Herzer, Kerstin, Nevens, Frederik, Daems, Bjorn, Janssen, Katrien, Ouwerkerk-Mahadevan, Sivi, Kimko, Holly, Lathouwers, Erkki, Witek, James, Solingen-Ristea, Rodica Van

“…AbstractBackground and rationale. The REPLACE study (NCT01571583) investigated telaprevir-based triple therapy in patients who have recurrent genotype 1…”
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Drug–Drug Interactions with the NS3/4A Protease Inhibitor Simeprevir by Ouwerkerk-Mahadevan, Sivi, Snoeys, Jan, Peeters, Monika, Beumont-Mauviel, Maria, Simion, Alexandru

“…Simeprevir is an NS3/4A protease inhibitor approved for the treatment of hepatitis C infection, as a component of combination therapy. Simeprevir is…”
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Elucidating the Plasma and Liver Pharmacokinetics of Simeprevir in Special Populations Using Physiologically Based Pharmacokinetic Modelling by Snoeys, Jan, Beumont, Maria, Monshouwer, Mario, Ouwerkerk-Mahadevan, Sivi

“…The disposition of simeprevir (SMV) in humans is characterised by cytochrome P450 3A4 metabolism and hepatic uptake by organic anion transporting polypeptide…”
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Clinical Pharmacokinetics of Ponesimod, a Selective S1P1 Receptor Modulator, in the Treatment of Multiple Sclerosis by Kruger, Terra M., Valenzuela, Belén, Thompson, Charles D., Ouwerkerk-Mahadevan, Sivi, Ruixo, Juan Jose Perez

“…Ponesimod, a selective, rapidly reversible, and orally active, sphingosine-1 phosphate receptor (S1P) modulator, is indicated for the treatment of…”
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SAT-341 Discovery of a pan-genotypic hepatitis E virus replication inhibitor by Zhang, Xin, Klöhn, Mara, Ouwerkerk-Mahadevan, Sivi, Jagst, Michelle, Vereyken, Liesbeth, Verboven, Peter, Todt, Daniel, Jonckers, Tim H.M., Coelmont, Lotte, Fletcher, Helen, Samby, Kirandeep, Koul, Anil, Neyts, Johan, Steinmann, Eike, Kaptein, Suzanne J.F.

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Efficacy and safety of simeprevir with PegIFN/ribavirin in naïve or experienced patients infected with chronic HCV genotype 4 by Moreno, Christophe, Hezode, Christophe, Marcellin, Patrick, Bourgeois, Stefan, Francque, Sven, Samuel, Didier, Zoulim, Fabien, Grange, Jean-Didier, Shukla, Umesh, Lenz, Oliver, Ouwerkerk-Mahadevan, Sivi, Fevery, Bart, Peeters, Monika, Beumont, Maria, Jessner, Wolfgang

“…Background & Aims Simeprevir (SMV) is a once-daily (QD), oral hepatitis C virus (HCV) NS3/4A protease inhibitor approved for treatment of genotype (GT) 1 and…”
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Effect of Ponesimod Exposure on Total Lymphocyte Dynamics in Patients with Multiple Sclerosis by Valenzuela, Belén, Pérez-Ruixo, Juan-José, Leirens, Quentin, Ouwerkerk-Mahadevan, Sivi, Poggesi, Italo

“…Objective The aim of this study was to characterize the relationship between ponesimod plasma concentrations and the temporal evolution of lymphocyte counts in…”
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Population Pharmacokinetic Modeling of JNJ-53718678, a Novel Fusion Inhibitor for the Treatment of Respiratory Syncytial Virus: Results from a Phase I, Double-Blind, Randomized, Placebo-Controlled First-in-Human Study in Healthy Adult Subjects by Huntjens, Dymphy R. H., Ouwerkerk-Mahadevan, Sivi, Brochot, Anne, Rusch, Sarah, Stevens, Marita, Verloes, Rene

“…Background JNJ-53718678 is a potent small-molecule inhibitor of the F-glycoprotein-mediated complex membrane fusion process of the respiratory syncytial virus…”
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