Full Text Journal Articles by
Author Eric A Hughes

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Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines-Selecting Compounds for Clinical Evaluation in Coronavirus Disease 2019 Clinical Trials.

Timothy G Buchman, Ruxandra Draghia-Akli, Stacey J Adam, Neil R Aggarwal, Joshua P Fessel, Elizabeth S Higgs, Joseph P Menetski, Sarah W Read, Eric A Hughes, ,

Given the urgent need for coronavirus disease 2019 therapeutics, early in the pandemic the Accelerating Coronavirus Disease 2019 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for candidate treatments of coronavirus disease 2019. These treatments included antivirals, immune modulators, severe acute ... Read more >>

Crit Care Med (Critical care medicine)
[2021, 49(11):1963-1973]

Cited: 0 times

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Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): Designing Master Protocols for Evaluation of Candidate COVID-19 Therapeutics.

Lisa LaVange, Stacey J Adam, Judith S Currier, Elizabeth S Higgs, Lora A Reineck, Eric A Hughes, Sarah W Read, ,

Working in an unprecedented time frame, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership developed and launched 9 master protocols between 14 April 2020 and 31 May 2021 to allow for the coordinated and efficient evaluation of multiple investigational therapeutic agents for COVID-19. The ACTIV master protocols were ... Read more >>

Ann Intern Med (Annals of internal medicine)
[2021, 174(9):1293-1300]

Cited: 2 times

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Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study).

Mark S Sulkowski, Steve Flamm, Zeid Kayali, Eric J Lawitz, Paul Kwo, Fiona McPhee, Anne Torbeyns, Eric A Hughes, Eugene S Swenson, Philip D Yin, Misti Linaberry,

<h4>Background & aims</h4>The phase 2, FOURward study (NCT02175966) investigated short-duration therapy (4/6 weeks) with four direct-acting antivirals (DAAs) with distinct mechanisms of action in patients infected with hepatitis C virus (HCV) genotype-1.<h4>Methods</h4>Non-cirrhotic patients were randomized 1:1 to DCV-TRIO (fixed-dose daclatasvir 30 mg, asunaprevir 200 mg and beclabuvir 75 mg) twice-daily + sofosbuvir 400 mg once-daily for 4 ... Read more >>

Liver Int (Liver international : official journal of the International Association for the Study of the Liver)
[2017, 37(6):836-842]

Cited: 15 times

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Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.

Fred Poordad, Eugene R Schiff, John M Vierling, Charles Landis, Robert J Fontana, Rong Yang, Fiona McPhee, Eric A Hughes, Stephanie Noviello, Eugene S Swenson,

<h4>Unlabelled</h4>Chronic hepatitis C virus (HCV) infection with advanced cirrhosis or post-liver transplantation recurrence represents a high unmet medical need with no approved therapies effective across all HCV genotypes. The open-label ALLY-1 study assessed the safety and efficacy of a 60-mg once-daily dosage of daclatasvir (pan-genotypic NS5A inhibitor) in combination with ... Read more >>

Hepatology (Hepatology (Baltimore, Md.))
[2016, 63(5):1493-1505]

Cited: 207 times

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Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection.

Stefan Zeuzem, Christophe Hézode, Jean-Pierre Bronowicki, Veronique Loustaud-Ratti, Francisco Gea, Maria Buti, Antonio Olveira, Tivadar Banyai, M Tarek Al-Assi, Joerg Petersen, Dominique Thabut, Adrian Gadano, Ronald Pruitt, Mihály Makara, Marc Bourlière, Stanislas Pol, Maria Beumont-Mauviel, Sivi Ouwerkerk-Mahadevan, Gaston Picchio, Marc Bifano, Fiona McPhee, Navdeep Boparai, Kin Cheung, Eric A Hughes, Stephanie Noviello, ,

<h4>Background & aims</h4>We evaluated the combination of daclatasvir (pan-genotypic NS5A inhibitor) and simeprevir (NS3/4A protease inhibitor), with or without ribavirin, in hepatitis C virus genotype 1-infected patients.<h4>Methods</h4>This phase II, open-label study enrolled treatment-naive patients or prior null responders with genotype 1b (n=147) or 1a (n=21) infection. Genotype 1b-infected patients were ... Read more >>

J Hepatol (Journal of hepatology)
[2016, 64(2):292-300]

Cited: 25 times

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Dynamics of HCV genotype 4 resistance-associated variants during virologic escape with pIFN/RBV+daclatasvir: a case study using ultra deep pyrosequencing.

Barbara Bartolini, Raffaella Lionetti, Emanuela Giombini, Catia Sias, Chiara Taibi, Marzia Montalbano, Gianpiero D'Offizi, Fiona McPhee, Eric A Hughes, Nannan Zhou, Giuseppe Ippolito, Anna Rosa Garbuglia, Maria R Capobianchi,

<h4>Background</h4>Daclatasvir (DCV) is an approved NS5A inhibitor with potent anti-HCV activity and broad genotype coverage. DCV resistance-associated variants (RAVs) have been described for patients infected with genotype (GT) 1, but increased GT4 prevalence in European countries as a result of immigration has boosted interest in this genotype.<h4>Objectives</h4>Establishment of NS5A variability ... Read more >>

J Clin Virol (Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology)
[2015, 66:38-43]

Cited: 8 times

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Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection.

Gregory J Dore, Eric Lawitz, Christophe Hézode, Stephen D Shafran, Alnoor Ramji, Harvey A Tatum, Gloria Taliani, Albert Tran, Maurizia R Brunetto, Serena Zaltron, Simone I Strasser, Nina Weis, Wayne Ghesquiere, Samuel S Lee, Dominique Larrey, Stanislas Pol, Hugh Harley, Jacob George, Scott K Fung, Victor de Lédinghen, Peggy Hagens, Fiona McPhee, Dennis Hernandez, David Cohen, Elizabeth Cooney, Stephanie Noviello, Eric A Hughes,

<h4>Background & aims</h4>Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus (HCV) genotype 2 or 3 infection produces a sustained virologic response (SVR) in 70%-80% of patients. We performed a randomized, double-blind, phase 2b study to assess whether adding daclatasvir, a nonstructural protein 5A (NS5A) inhibitor ... Read more >>

Gastroenterology (Gastroenterology)
[2015, 148(2):355-366.e1]

Cited: 31 times

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Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis.

Andrew J Muir, Fred Poordad, Jacob Lalezari, Gregory Everson, Gregory J Dore, Robert Herring, Aasim Sheikh, Paul Kwo, Christophe Hézode, Paul J Pockros, Albert Tran, Joseph Yozviak, Nancy Reau, Alnoor Ramji, Katherine Stuart, Alexander J Thompson, John Vierling, Bradley Freilich, James Cooper, Wayne Ghesquiere, Rong Yang, Fiona McPhee, Eric A Hughes, E Scott Swenson, Philip D Yin,

<h4>Importance</h4>Effective and well-tolerated, interferon-free regimens are needed for treatment of patients with chronic hepatitis C virus (HCV) infection and cirrhosis.<h4>Objective</h4>All-oral therapy with daclatasvir (nonstructural protein 5A [NS5A] inhibitor), asunaprevir (NS3 protease inhibitor), and beclabuvir (nonnucleoside NS5B inhibitor), with or without ribavirin, was evaluated in patients with HCV genotype 1 infection ... Read more >>

JAMA (JAMA)
[2015, 313(17):1736-1744]

Cited: 79 times

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Daclatasvir combined with peginterferon alfa-2a and ribavirin in Japanese patients infected with hepatitis C genotype 1.

Namiki Izumi, Osamu Yokosuka, Norifumi Kawada, Yukio Osaki, Kazuhide Yamamoto, Michio Sata, Hiroki Ishikawa, Tomoko Ueki, Wenhua Hu, Fiona McPhee, Eric A Hughes, Hiromitsu Kumada,

<h4>Background</h4>New direct-acting antiviral agents are currently being developed to treat chronic HCV. The efficacy and safety of daclatasvir combined with peginterferon alfa-2a (alfa-2a) and ribavirin were assessed in a randomized, double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection.<h4>Methods</h4>Japanese patients who were treatment-naive (n=25) or prior null ... Read more >>

Antivir Ther (Antiviral therapy)
[2014, 19(5):501-510]

Cited: 21 times

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Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study.

Christophe Hézode, Gideon M Hirschfield, Wayne Ghesquiere, William Sievert, Maribel Rodriguez-Torres, Stephen D Shafran, Paul J Thuluvath, Harvey A Tatum, Imam Waked, Gamal Esmat, Eric J Lawitz, Vinod K Rustgi, Stanislas Pol, Nina Weis, Paul J Pockros, Marc Bourlière, Lawrence Serfaty, John M Vierling, Michael W Fried, Ola Weiland, Maurizia R Brunetto, Gregory T Everson, Stefan Zeuzem, Paul Y Kwo, Mark Sulkowski, Norbert Bräu, Dennis Hernandez, Fiona McPhee, Megan Wind-Rotolo, Zhaohui Liu, Stephanie Noviello, Eric A Hughes, Philip D Yin, Steven Schnittman,

<h4>Objective</h4>To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin.<h4>Design</h4>In this Phase 2b double-blind, placebo-controlled study, treatment-naive adults with HCV genotype 1 (N=365) or 4 (N=30) infection were randomly assigned (2:2:1) to daclatasvir 20 mg or 60 mg, or placebo once daily plus weekly ... Read more >>

Gut (Gut)
[2015, 64(6):948-956]

Cited: 62 times

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Virological escape in HCV genotype-1-infected patients receiving daclatasvir plus ribavirin and peginterferon alfa-2a or alfa-2b.

Fiona McPhee, Dennis Hernandez, Nannan Zhou, Fei Yu, Joseph Ueland, Aaron Monikowski, Kazuaki Chayama, Joji Toyota, Namiki Izumi, Osamu Yokosuka, Norifumi Kawada, Yukio Osaki, Eric A Hughes, Hideaki Watanabe, Hiroki Ishikawa, Hiromitsu Kumada,

<h4>Background</h4>Daclatasvir (DCV; BMS-790052) is a picomolar inhibitor of HCV non-structural protein 5A (NS5A) and has demonstrated efficacy in patients chronically infected with HCV.<h4>Methods</h4>In the double-blind, randomized studies AI444021 and AI444022, 71 Japanese patients chronically infected with HCV genotype 1 (predominantly genotype 1b) received DCV (10 mg or 60 mg) plus ... Read more >>

Antivir Ther (Antiviral therapy)
[2014, 19(5):479-490]

Cited: 29 times

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A randomized trial of daclatasvir with peginterferon alfa-2b and ribavirin for HCV genotype 1 infection.

Fumitaka Suzuki, Joji Toyota, Kenji Ikeda, Kazuaki Chayama, Satoshi Mochida, Norio Hayashi, Hiroki Ishikawa, Hidetaka Miyagoshi, Wenhua Hu, Fiona McPhee, Eric A Hughes, Hiromitsu Kumada,

<h4>Background</h4>Daclatasvir-containing regimens have the potential to address limitations of current regimens combining peginterferon alfa and ribavirin with first-generation protease inhibitors for treatment of chronic HCV genotype 1 infection.<h4>Methods</h4>In this randomized, double-blind study, 27 Japanese treatment-naive patients received once-daily daclatasvir 10 mg or 60 mg or placebo, each combined with peginterferon ... Read more >>

Antivir Ther (Antiviral therapy)
[2014, 19(5):491-499]

Cited: 25 times

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Single-dose pharmacokinetics of boceprevir in subjects with impaired hepatic or renal function.

Michelle Treitel, Thomas Marbury, Richard A Preston, Ilias Triantafyllou, William Feely, Edward O'Mara, Claudia Kasserra, Samir Gupta, Eric A Hughes,

<h4>Background and objective</h4>Boceprevir is a novel inhibitor of the hepatitis C virus NS3 protease and was recently approved for the treatment of patients with chronic hepatitis C infection. The objective of this study was to evaluate the impact of impaired hepatic or renal function on boceprevir pharmacokinetics and safety/tolerability.<h4>Methods</h4>We conducted ... Read more >>

Clin Pharmacokinet (Clinical pharmacokinetics)
[2012, 51(9):619-628]

Cited: 18 times

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Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial.

Stanislas Pol, Reem H Ghalib, Vinod K Rustgi, Claudia Martorell, Greg T Everson, Harvey A Tatum, Christophe Hézode, Joseph K Lim, Jean-Pierre Bronowicki, Gary A Abrams, Norbert Bräu, David W Morris, Paul J Thuluvath, Robert W Reindollar, Philip D Yin, Ulysses Diva, Robert Hindes, Fiona McPhee, Dennis Hernandez, Megan Wind-Rotolo, Eric A Hughes, Steven Schnittman,

<h4>Background</h4>Several direct-acting antivirals for chronic hepatitis C virus (HCV) infection are available, but they are limited by tolerability and dosing schedules. Once-daily daclatasvir, a potent NS5A replication complex inhibitor, was generally well tolerated in phase 1 studies. We assessed daclatasvir in combination with pegylated interferon (peginterferon) and ribavirin for chronic ... Read more >>

Lancet Infect Dis (The Lancet. Infectious diseases)
[2012, 12(9):671-677]

Cited: 98 times

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Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, darunavir, and lopinavir.

Ellen G J Hulskotte, Hwa-Ping Feng, Fengjuan Xuan, Marga G J A van Zutven, Michelle A Treitel, Eric A Hughes, Edward O'Mara, Stephen P Youngberg, John A Wagner, Joan R Butterton,

<h4>Background</h4>Boceprevir represents a new treatment option for hepatitis C (HCV)-infected patients, including those with HCV/human immunodeficiency virus coinfection; however, little is known about pharmacokinetic interactions between boceprevir and antiretroviral drugs.<h4>Methods</h4>A randomized, open-label study to assess the pharmacokinetic interactions between boceprevir and ritonavir-boosted protease inhibitors (PI/r) was conducted in 39 healthy ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2013, 56(5):718-726]

Cited: 39 times

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Recommendations for standardized nomenclature and definitions of viral response in trials of hepatitis C virus investigational agents.

Heiner Wedemeyer, Donald M Jensen, Eliot Godofsky, Nina Mani, Jean-Michel Pawlotsky, Veronica Miller, ,

Outdated virological response terms used at key trial timepoints in clinical trials with first-generation direct-acting antivirals plus pegylated interferon and ribavirin have failed to keep pace with hepatitis C virus (HCV) drug development. A more intuitive and flexible nomenclature capable of adapting to continuing advances in HCV drug development is ... Read more >>

Hepatology (Hepatology (Baltimore, Md.))
[2012, 56(6):2398-2403]

Cited: 25 times

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Case report of successful peginterferon, ribavirin, and daclatasvir therapy for recurrent cholestatic hepatitis C after liver retransplantation.

Robert J Fontana, Eric A Hughes, Henry Appelman, Robert Hindes, Dessislava Dimitrova, Marc Bifano,

A recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) can lead to accelerated allograft injury and fibrosis. The aim of this article is to report the first ever use of daclatasvir (DCV; also known as BMS-790052), a potent orally administered nonstructural 5A replication complex inhibitor, in combination with ... Read more >>

Liver Transpl (Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society)
[2012, 18(9):1053-1059]

Cited: 47 times

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Antiviral activity of narlaprevir combined with ritonavir and pegylated interferon in chronic hepatitis C patients.

Joep de Bruijne, Jilling F Bergmann, Henk W Reesink, Christine J Weegink, Richard Molenkamp, Janke Schinkel, Xiao Tong, Jing Li, Michelle A Treitel, Eric A Hughes, Jan Jaap van Lier, Andre A van Vliet, Harry L A Janssen, Robert J de Knegt,

<h4>Unlabelled</h4>Narlaprevir (SCH 900518) is a potent inhibitor of the hepatitis C virus (HCV) nonstructural protein 3 serine protease that is primarily metabolized by the cytochrome P450-3A4 system. In order to explore the use of ritonavir-based pharmacokinetic enhancement of an HCV protease inhibitor, this study investigated the safety, tolerability, pharmacokinetics, and ... Read more >>

Hepatology (Hepatology (Baltimore, Md.))
[2010, 52(5):1590-1599]

Cited: 16 times

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Immune response to Salmonella: location, location, location?

Eric A Hughes, Jorge E Galán,

Successful immunity against Salmonella infections is dependent on the generation of CD4(+) T helper cells and to a lesser extent on antibody production and CD8(+) T cells. The cells within the lymphatic tissue of the gut are likely to be central for the orchestration of a proper and rapid response. ... Read more >>

Immunity (Immunity)
[2002, 16(3):325-328]

Cited: 29 times

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