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Akademický článek

Simeprevir, daclatasvir, and sofosbuvir for hepatitis C virus‐infected patients: Long‐term follow‐up results from the open‐label, Phase II IMPACT study

Autor: Eric Lawitz, Fred Poordad, Julio A. Gutierrez, Maria Beumont, Greet Beets, Ann Vandevoorde, Pieter Van Remoortere, Donghan Luo, Leen Vijgen, Veerle Van Eygen, Mohamed Gamil

Publikováno v: Health Science Reports, Vol 3, Iss 2, Pp n/a-n/a (2020)

Abstract Background and aims Direct‐acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection have resulted in high rates of sustained virologic response (SVR) following 8 to 24 weeks of treatment. However, difficult‐to‐cure/cirrhoti

Externí odkaz: https://doaj.org/article/61e6a0119abd4699b62cba409899ce21

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Akademický článek

Virology analysis in HCV genotype 1-infected patients treated with the combination of simeprevir and TMC647055/ritonavir, with and without ribavirin, and JNJ-56914845

Autor: Leen Vijgen, Kim Thys, An Vandebosch, Pieter Van Remoortere, René Verloes, Sandra De Meyer

Publikováno v: Virology Journal, Vol 14, Iss 1, Pp 1-10 (2017)

Abstract Background In study TMC647055HPC2001, a 3-direct-acting-antiviral (DAA) regimen combining NS3/4A protease inhibitor simeprevir (SMV), non-nucleoside NS5B inhibitor TMC647055/ritonavir (RTV) and NS5A inhibitor JNJ-56914845 resulted in high su

Externí odkaz: https://doaj.org/article/b8e56cc302c3411a9f7452c4760b97dc

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Akademický článek

Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects.

Autor: Matthew W McClure, Elina Berliba, Tengiz Tsertsvadze, Adrian Streinu-Cercel, Leen Vijgen, Béatrice Astruc, Alain Patat, Christopher Westland, Sushmita Chanda, Qingling Zhang, Thomas N Kakuda, Jennifer Vuong, Nick Khorlin, Leonid Beigelman, Lawrence M Blatt, John Fry

Publikováno v: PLoS ONE, Vol 13, Iss 10, p e0204974 (2018)

BACKGROUND:The nucleotide analog AL-335 is a pangenotypic hepatitis C virus (HCV) nonstructural protein (NS)5B inhibitor being evaluated as treatment for chronic HCV infection. METHODS:This three-part randomized, double-blind study evaluated the safe

Externí odkaz: https://doaj.org/article/734ab2d56f1a434cbd65736ecb72aa86

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JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study

Autor: Yasuhiro Asahina, Toshikazu Nakano, Hiroshi Yatsuhashi, Yosuke Hagiwara, Tetsuo Takehara, Yuhan Huang, Hiroko Shimizu, Leen Vijgen, Yasuhito Tanaka, Masayuki Kurosaki, Naoki Hiramatsu, Akito Nozaki, Kazuaki Chayama, Norio Hayashi, Hiroki Yoshida, Naoya Sakamoto, Michael Biermer

Publikováno v: Journal of Gastroenterology

Background The efficacy, safety, and pharmacokinetics of the combination of three direct-acting antiviral (DAA) agents (adafosbuvir [also known as AL-335], odalasvir, and simeprevir) were investigated in DAA treatment-naïve Japanese patients with ge

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b4a1ec81c4ebbd495a6dd89552d279c3
https://doi.org/10.1007/s00535-020-01672-0

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Simeprevir, daclatasvir, and sofosbuvir for hepatitis C virus‐infected patients: Long‐term follow‐up results from the open‐label, Phase II IMPACT study

Autor: M. Gamil, Ann Vandevoorde, Veerle Van Eygen, Pieter Van Remoortere, Fred Poordad, Donghan Luo, Eric Lawitz, Julio A. Gutierrez, Greet Beets, Leen Vijgen, Maria Beumont

Publikováno v: Health Science Reports
Health Science Reports, Vol 3, Iss 2, Pp n/a-n/a (2020)

Background and aims Direct‐acting antiviral agents (DAAs) for hepatitis C virus (HCV) infection have resulted in high rates of sustained virologic response (SVR) following 8 to 24 weeks of treatment. However, difficult‐to‐cure/cirrhotic patient

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1e49d089dc6ca2fcde1790137a338a00
http://europepmc.org/articles/PMC7136481

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Short‐Duration AL‐335, Odalasvir, With or Without Simeprevir, in Patients With HCV GT1 or 3 Infection Without Cirrhosis

Autor: Matthew W. McClure, Christian Schwabe, Thomas N. Kakuda, Lawrence M. Blatt, John Fry, Edward Gane, Catherine A.M. Stedman, Leen Vijgen, Sushmita Mukherjee Chanda

Publikováno v: Hepatology. 68:2145-2157

This open-label, phase IIa study assessed the safety, pharmacokinetics, and efficacy of direct-acting antiviral agent (DAA) regimens in patients with chronic hepatitis C virus (HCV) infection. Multiple 6-12-week oral regimens of 400-800 mg once daily

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3b4f8a3d32c10bf33870b5752746e84
https://doi.org/10.1002/hep.30126

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Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection

Autor: Sivi Ouwerkerk-Mahadevan, Eric Lawitz, Thomas N. Kakuda, Maria Beumont, Mark S. Sulkowski, O. Khalid, William B. Smith, V. Van Eygen, Leen Vijgen, R. Ghalib, Jordan J. Feld, P. Van Remoortere, M. Gamil, A. Corregidor, Donghan Luo, Franco Felizarta

Publikováno v: Journal of Viral Hepatitis. 25:631-639

The phase 2, open-label ACCORDION (ClinicalTrials.gov: NCT02349048) study investigated the efficacy, safety and pharmacokinetics of a 6- or 8-week regimen of simeprevir, daclatasvir and sofosbuvir in treatment-naïve patients with chronic hepatitis C

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a881120c5a4ddaaaaa27d89fc389794b
https://doi.org/10.1111/jvh.12853

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Discovery of 1-((2R,4aR,6R,7R,7aR)-2-Isopropoxy-2-oxidodihydro-4H,6H-spiro[furo[3,2-d][1,3,2]dioxaphosphinine-7,2′-oxetan]-6-yl)pyrimidine-2,4(1H,3H)-dione (JNJ-54257099), a 3′-5′-Cyclic Phosphate Ester Prodrug of 2′-Deoxy-2′-Spirooxetane Uridine Triphosphate Useful for HCV Inhibition

Autor: Leen Vijgen, Lotke Tambuyzer, Bart Stoops, Sophie Lachau-Durand, Abdellah Tahri, Laurent Leclercq, Tse-I Lin, Jan Snoeys, Kenny Simmen, Jan Martin Berke, Tim H. M. Jonckers, Pierre Jean-Marie Bernard Raboisson

Publikováno v: Journal of Medicinal Chemistry. 59:5790-5798

JNJ-54257099 (9) is a novel cyclic phosphate ester derivative that belongs to the class of 2′-deoxy-2′-spirooxetane uridine nucleotide prodrugs which are known as inhibitors of the HCV NS5B RNA-dependent RNA polymerase (RdRp). In the Huh-7 HCV ge

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::b2f88621605dec048482d1cbd2ed84b9
https://doi.org/10.1021/acs.jmedchem.6b00382

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In Vitro Activity of Simeprevir against Hepatitis C Virus Genotype 1 Clinical Isolates and Its Correlation with NS3 Sequence and Site-Directed Mutants

Autor: Tom Jacobs, Sandra De Meyer, Thierry Verbinnen, Bart Fevery, Oliver Lenz, Leen Vijgen

Publikováno v: Antimicrobial Agents and Chemotherapy. 59:7548-7557

Simeprevir (TMC435) is a once-daily, single-pill, oral hepatitis C virus (HCV) NS3 protease inhibitor approved for the treatment of chronic HCV infection. Phenotypic characterization of baseline isolates and isolates from HCV genotype 1-infected pati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b991ebbe1c300202507b59d711c02957
https://doi.org/10.1128/aac.01444-15

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