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https://www.readbyqxmd.com/read/29029135/small-increase-in-dolutegravir-trough-but-equivalent-total-dolutegravir-exposure-with-simeprevir-in-hiv-hcv-seronegative-volunteers
#1
Christine E MacBrayne, Jose Castillo-Mancilla, James R Burton, Samantha MaWhinney, Charlotte B Wagner, Kestutis Micke, Jordan Fey, Ryan T Huntley, Bayli Larson, Lane R Bushman, Jennifer J Kiser
Background: Dolutegravir, an HIV integrase strand-transfer inhibitor, and simeprevir, an HCV NS3/4A PI, have the potential to interact as dolutegravir is a P-glycoprotein, uridine glucuronosyl transferase 1A1 and cytochrome P450 3A substrate and simeprevir has been shown to mildly inhibit these. Objectives: To compare dolutegravir and simeprevir pharmacokinetics (PK) when given separately versus in combination. Methods: Healthy volunteers received: (i) 150 mg of simeprevir once daily for 7 days; (ii) 50 mg of dolutegravir once daily for 7 days; and (iii) 150 mg of simeprevir once daily plus 50 mg of dolutegravir once daily for 7 days, with randomization to treatment sequence...
October 4, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28992878/peginterferon-alfa-2a-for-the-treatment-of-chronic-hepatitis-c-in-the-era-of-direct-acting-antivirals
#2
REVIEW
Yan Huang, Ming-Hui Li, Min Hou, Yao Xie
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population...
October 15, 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28977040/incidence-of-daa-failure-and-the-clinical-impact-of-retreatment-in-real-life-patients-treated-in-the-advanced-stage-of-liver-disease-interim-evaluations-from-the-piter-network
#3
Loreta A Kondili, Giovanni Battista Gaeta, Maurizia Rossana Brunetto, Alfredo Di Leo, Andrea Iannone, Teresa Antonia Santantonio, Adele Giammario, Giovanni Raimondo, Roberto Filomia, Carmine Coppola, Daniela Caterina Amoruso, Pierluigi Blanc, Barbara Del Pin, Liliana Chemello, Luisa Cavalletto, Filomena Morisco, Laura Donnarumma, Maria Grazia Rumi, Antonio Gasbarrini, Massimo Siciliano, Marco Massari, Romina Corsini, Barbara Coco, Salvatore Madonia, Marco Cannizzaro, Anna Linda Zignego, Monica Monti, Francesco Paolo Russo, Alberto Zanetto, Marcello Persico, Mario Masarone, Erica Villa, Veronica Bernabucci, Gloria Taliani, Elisa Biliotti, Luchino Chessa, Maria Cristina Pasetto, Pietro Andreone, Marzia Margotti, Giuseppina Brancaccio, Donatella Ieluzzi, Guglielmo Borgia, Emanuela Zappulo, Vincenza Calvaruso, Salvatore Petta, Loredana Falzano, Maria Giovanna Quaranta, Liliana Elena Weimer, Stefano Rosato, Stefano Vella, Edoardo Giovanni Giannini
BACKGROUND: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. AIM: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. METHODS: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers...
2017: PloS One
https://www.readbyqxmd.com/read/28971875/pharmacokinetic-interactions-between-simeprevir-and-ledipasvir-in-treatment-na%C3%A3-ve-hepatitis-c-virus-genotype-1-infected-patients-without-cirrhosis-treated-with-a-simeprevir-sofosbuvir-ledipasvir-regimen
#4
Stefan Bourgeois, Yves Horsmans, Frederik Nevens, Hans van Vlierberghe, Christophe Moreno, Maria Beumont, Leen Vijgen, Veerle van Eygen, Donghan Luo, Vera Hillewaert, Pieter Van Remoortere, Jolanda van de Logt, Sivi Ouwerkerk-Mahadevan
Interactions between simeprevir (hepatitis C virus [HCV] NS3/4A protease inhibitor) and ledipasvir (HCV NS5A replication complex inhibitor) were investigated in treatment-naïve HCV genotype 1-infected patients without cirrhosis, treated with simeprevir/sofosbuvir/ledipasvir in a two-panel, Phase 2, open-label study (NCT02421211). Patients had stable background treatment with sofosbuvir (400 mg once daily [QD]). In Panel 1 (N=20), the effect of ledipasvir (90 mg QD) on simeprevir (150 mg QD) was studied. Patients received simeprevir and sofosbuvir from Days 1--14; steady-state pharmacokinetics (PK) of simeprevir were assessed (Day 14)...
October 2, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28922704/direct-acting-antivirals-for-chronic-hepatitis-c
#5
REVIEW
Janus C Jakobsen, Emil Eik Nielsen, Joshua Feinberg, Kiran Kumar Katakam, Kristina Fobian, Goran Hauser, Goran Poropat, Snezana Djurisic, Karl Heinz Weiss, Milica Bjelakovic, Goran Bjelakovic, Sarah Louise Klingenberg, Jian Ping Liu, Dimitrinka Nikolova, Ronald L Koretz, Christian Gluud
BACKGROUND: Millions of people worldwide suffer from hepatitis C, which can lead to severe liver disease, liver cancer, and death. Direct-acting antivirals (DAAs), e.g. sofosbuvir, are relatively new and expensive interventions for chronic hepatitis C, and preliminary results suggest that DAAs may eradicate hepatitis C virus (HCV) from the blood (sustained virological response). Sustained virological response (SVR) is used by investigators and regulatory agencies as a surrogate outcome for morbidity and mortality, based solely on observational evidence...
September 18, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28889051/different-spectrophotometric-methods-applied-for-the-analysis-of-simeprevir-in-the-presence-of-its-oxidative-degradation-product-acomparative-study
#6
Khalid A M Attia, Nasr M El-Abasawi, Ahmed El-Olemy, Ahmed Serag
Five simple spectrophotometric methods were developed for the determination of simeprevir in the presence of its oxidative degradation product namely, ratio difference, mean centering, derivative ratio using the Savitsky-Golay filters, second derivative and continuous wavelet transform. These methods are linear in the range of 2.5-40μg/mL and validated according to the ICH guidelines. The obtained results of accuracy, repeatability and precision were found to be within the acceptable limits. The specificity of the proposed methods was tested using laboratory prepared mixtures and assessed by applying the standard addition technique...
September 5, 2017: Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy
https://www.readbyqxmd.com/read/28884930/retreatment-with-sofosbuvir-ledipasvir-with-or-without-lead-in-interferon-%C3%AE-injections-in-patients-infected-with-genotype-1b-hcv-after-unsuccessful-daclatasvir-asunaprevir-therapy
#7
Hayato Uemura, Yoshihito Uchida, Jun-Ichi Kouyama, Kayoko Naiki, Shinpei Yamaba, Akira Fuchigami, Yoichi Saito, Keisuke Shiokawa, Yohei Fujii, Hiroshi Uchiya, Manabu Nakazawa, Satsuki Ando, Masamitsu Nakao, Daisuke Motoya, Kayoko Sugawara, Mie Inao, Yukinori Imai, Nobuaki Nakayama, Tomoaki Tomiya, Satoshi Mochida
AIMS: To improve the therapeutic efficacy of sofosbuvir/ledipasvir for the retreatment of patients after daclatasvir/asunaprevir, a customized therapy with or without lead-in interferon-β injections was performed according to the types of resistance-associated substitutions (RASs) in the NS5A region of genotype 1b HCV. METHODS: Thirty-three patients failing prior daclatasvir/asunaprevir received sofosbuvir/ledipasvir for 12 weeks. Patients with HCV carrying unfavorable NS5A-RASs and/or those with previous simeprevir administration were given lead-in interferon-β injections twice a day for 2 weeks; sequential changes in the NS5A-RASs during the injection period were evaluated using deep sequencing...
September 8, 2017: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/28881052/asunaprevir-and-daclatasvir-for-recurrent-hepatitis-c-after-liver-transplantation-a-japanese-multicenter-experience
#8
Toru Ikegami, Yoshihide Ueda, Nobuhisa Akamatsu, Kohei Ishiyama, Ryoichi Goto, Akihiko Soyama, Kaori Kuramitsu, Masaki Honda, Masahiro Shinoda, Tomoharu Yoshizumi, Hideaki Okajima, Yuko Kitagawa, Yukihiro Inomata, Yonson Ku, Susumu Eguchi, Akinobu Taketomi, Hideki Ohdan, Norihiro Kokudo, Mitsuo Shimada, Katsuhiko Yanaga, Hiroyuki Furukawa, Shinji Uemoto, Yoshihiko Maehara
The safety and efficacy of an IFN-free regimen using asunaprevir (ASV) and daclatasvir (DCV) for recurrent hepatitis C virus (HCV) infection after liver transplantation (LT) have not been evaluated in Japan. A multicenter study of LT recipients (n = 74) with recurrent HCV genotype 1b infection treated with ASV-DCV for 24 weeks was performed. Medical history was positive for pegylated interferon and ribavirin (Peg-IFN/RBV) in 40 (54.1%) patients, and for simeprevir (SMV) with Peg-IFN/RBV in 12 (16.2%) patients...
September 7, 2017: Clinical Transplantation
https://www.readbyqxmd.com/read/28877086/short-article-retreatment-of-chronic-hepatitis-c-virus-infection-after-unsuccessful-therapy-with-all-oral-direct-acting-antiviral-regimens-a-real-life-experience
#9
Laura Milazzo, Carlo Magni, Fosca Niero, Monica Schiavini, Alessia Lai, Valeria Cento, Francesca Binda, Spinello Antinori, Salvatore Sollima
OBJECTIVE: Few real-life data are available on the retreatment of patients who failed direct-acting antiviral (DAA)-regimens. We reported the outcome of retreatment with approved DAA regimens in a real-life cohort of patients who previously failed an all-oral DAAs combination and we analyzed the association with resistance substitutions (RASs) performed at the time of virological failure. AIM AND METHODS: Next-generation sequencing of the NS3, NS5A, and NS5B regions was performed by Illumina deep sequencing...
November 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28856597/chemical-genetics-based-development-of-small-molecules-targeting-hepatitis-c-virus
#10
REVIEW
Guanghai Jin, Jisu Lee, Kyeong Lee
Hepatitis C virus (HCV) infection is a major worldwide problem that has emerged as one of the most significant diseases affecting humans. There are currently no vaccines or efficient therapies without side effects, despite today's advanced medical technology. Currently, the common therapy for most patients (i.e. genotype 1) is combination of HCV-specific direct-acting antivirals (DAAs). Up to 2011, the standard of care (SOC) was a combination of peg-IFNα with ribavirin (RBV). After approval of NS3/4A protease inhibitor, SOC was peg-IFNα and RBV with either the first-generation DAAs boceprevir or telaprevir...
August 30, 2017: Archives of Pharmacal Research
https://www.readbyqxmd.com/read/28856278/efficacy-of-hcv-treatment-in-poland-at-the-turn-of-the-interferon-era-the-epiter-study
#11
Robert Flisiak, Joanna Pogorzelska, Hanna Berak, Andrzej Horban, Iwona Orłowska, Krzysztof Simon, Ewelina Tuchendler, Grzegorz Madej, Anna Piekarska, Maciej Jabłkowski, Zbigniew Deroń, Włodzimierz Mazur, Marcin Kaczmarczyk, Ewa Janczewska, Arkadiusz Pisula, Jacek Smykał, Krzysztof Nowak, Marek Matukiewicz, Waldemar Halota, Joanna Wernik, Katarzyna Sikorska, Iwona Mozer-Lisewska, Błażej Rozpłochowski, Aleksander Garlicki, Krzysztof Tomasiewicz, Joanna Krzowska-Firych, Barbara Baka-Ćwierz, Wiesław Kryczka, Dorota Zarębska-Michaluk, Iwona Olszok, Anna Boroń-Kaczmarska, Barbara Sobala-Szczygieł, Bronisława Szlauer, Bogumiła Korcz-Ondrzejek, Jerzy Sieklucki, Robert Pleśniak, Agata Ruszała, Barbara Postawa-Kłosińska, Jolanta Citko, Anna Lachowicz-Wawrzyniak, Joanna Musialik, Edyta Jezierska, Witold Dobracki, Beata Dobracka, Jan Hałubiec, Rafał Krygier, Anna Strokowska, Wojciech Chomczyk, Krystyna Witczak-Malinowska
THE AIM OF THE STUDY: Was to analyze the efficacy achieved with regimens available for chronic hepatitis C (CHC) in Poland between 2013 and 2016. MATERIAL AND METHODS: Data were collected from 29 centers and included 6786 patients with available sustained virologic response (SVR) data between 1 January 2013 and 31 March 2016. RESULTS: The sustained virologic response rate for genotypes (G) 1a, 1b, 2, 3 and 4 was 62%, 56%, 92%, 67% and 56% respectively; 71% patients (n = 4832) were treated with pegylated interferon α (Peg-IFNα) and ribavirin (RBV), with SVR rates of 58%, 49%, 92%, 67% and 55% respectively...
December 2016: Clin Exp Hepatol
https://www.readbyqxmd.com/read/28827512/efficacy-and-safety-of-sofosbuvir-based-regimens-for-treatment-in-chronic-hepatitis-c-genotype-1-patients-with-moderately-impaired-renal-function
#12
Hyun Phil Shin, Ji-Ae Park, Blaire Burman, Richard A Kozarek, Asma Siddique
Background/Aims: Treatment of chronic hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD) is essential. The availability of sofosbuvir (SOF) has dramatically improved overall HCV cure rates, however there is insufficient data regarding its use in patients with CKD. We evaluated SOF in patients with hepatitis C genotype 1 (G1) and moderately impaired renal function. Methods: We retrospectively reviewed all patients treated with a SOF-based regimen from December 2013 through September 2015 at Virginia Mason Medical Center...
August 22, 2017: Clinical and Molecular Hepatology
https://www.readbyqxmd.com/read/28809742/treatment-of-chronic-hcv-infection-with-the-new-direct-acting-antivirals-daa-first-report-of-a-real-world-experience-in-southern-brazil
#13
Hugo Cheinquer, Hoel Sette-Jr, Fernando H Wolff, Alexandre de Araujo, Silvia Coelho-Borges, Silvia R P Soares, Mauricio F A Barros
INTRODUCTION AND AIM: There is almost no data regarding the efficacy of direct acting antivirals (DAAs) therapy in Brazil. The aim of this historical cohort study is to describe the sustained virologic response (SVR) rate among real-world compensated chronic hepatitis C patients in three hepatology centers from Southern Brazil. MATERIALS AND METHODS: Patients were included if they had at least 12 weeks follow-up after the end of therapy. Patients that were lost to follow-up or had treatment prematurely interrupted for any reason were considered treatment failure in this intention to treat analysis...
September 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28804248/effect-of-chronic-hepatitis-c-virus-treatment-by-combination-therapy-on-cardiovascular-system
#14
Reda Biomy, Mohamed Abdelshafy, Ahmed Abdelmonem, Hesham Abu-Elenin, George Ghaly
BACKGROUND: The prevalence of hepatitis C virus (HCV) in Egypt is quite high, and the combined oral direct-acting antiviral agents (DAAs) may have impressive results. OBJECTIVE: To assess the cardiovascular effects of DAAs in patients with HCV. METHODS: A total of 170 patients with HCV were divided into 2 groups: first group (100 patients) received triple combination therapy (pegylated interferon alfa, sofosbuvir, and ribavirin, whereas the second group (70 patients) received dual combination therapy (sofosbuvir and simeprevir)...
2017: Clinical Medicine Insights. Cardiology
https://www.readbyqxmd.com/read/28800033/predictors-of-early-discontinuation-of-interferon-free-direct-antiviral-agents-in-patients-with-hepatitis-c-virus-and-advanced-liver-fibrosis-results-of-a-real-life-cohort
#15
Noelle Miotto, Leandro C Mendes, Letícia P Zanaga, Eduardo S L Goncales, Maria S K Lazarini, Marcelo N Pedro, Fernando L Gonçales, Raquel S B Stucchi, Aline G Vigani
AIM: The aim of this study was to determine risk factors for premature treatment discontinuation among patients with hepatitis C and advanced fibrosis with advanced fibrosis treated with interferon (IFN)-free direct antiviral agents (DAA)-based therapy. PATIENTS AND METHODS: We included all patients with chronic hepatitis C virus infection and advanced liver fibrosis in whom treatment was initiated with IFN-free DAA therapy at a university hospital from December 2015 through June 2016...
October 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28799277/the-italian-compassionate-use-of-sofosbuvir-observational-cohort-study-for-the-treatment-of-recurrent-hepatitis-c-clinical-and-virological-outcomes
#16
Paola Carrai, Cristina Morelli, Gabriella Cordone, Antonietta Romano, Mariarosa Tamé, Raffaella Lionetti, Giada Pietrosi, Ilaria Lenci, Guido Piai, Francesco Paolo Russo, Carmine Coppola, Mario Melazzini, Simona Montilla, Luca Pani, Sandra Petraglia, Pierluigi Russo, Maria Paola Trotta, Silvia Martini, Pierluigi Toniutto
Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3-F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child-Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86...
August 11, 2017: Transplant International: Official Journal of the European Society for Organ Transplantation
https://www.readbyqxmd.com/read/28798288/the-real-world-safety-and-efficacy-of-daclatasvir-and-asunaprevir-for-elderly-patients
#17
Shinya Taki, Hideyuki Tamai, Yoshiyuki Ida, Naoki Shingaki, Akira Kawashima, Ryo Shimizu, Kosaku Moribata, Takao Maekita, Mikitaka Iguchi, Jun Kato, Taisei Nakao, Masayuki Kitano
Background/Aims: Although daclatasvir with asunaprevir was approved in Japan for interferon ineligible or intolerant patients, patients aged ≥75 years were excluded in the phase III trial. The present study aimed to evaluate the safety and efficacy of this therapy for elderly patients aged ≥75 years and to clarify whether an extremely high sustained virological response (SVR) rate can be achieved, even in a real-world setting when patients with resistance-associated substitutions (RASs) to nonstructural protein 5A (NS5A) inhibitors or prior simeprevir failure are excluded...
August 14, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28795238/efficacy-and-safety-of-sofosbuvir-based-interferon-free-therapy-the-management-of-rheumatologic-extrahepatic-manifestations-associated-with-chronic-hepatitis-c%C3%A2-virus-infection
#18
A A Shahin, H S Zayed, M Said, S A Amer
BACKGROUND: The use of pegylated interferon alpha (IFN) has been of concern in chronic hepatitis C virus (HCV) patients with rheumatologic extrahepatic manifestations (EHM) due to the immunostimulatory effects of IFN. AIM: To study the efficacy and safety of sofosbuvir-based, IFN-free antiviral therapy in chronic HCV patients with rheumatologic EHM. MATERIAL AND METHODS: Group A included 24 patients with arthropathy (arthralgia or arthritis, n = 15) or vasculitis (n = 9) who received sofosbuvir and ribavirin (n = 17) or sofosbuvir and simeprevir (n = 7)...
August 9, 2017: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/28767462/efficacy-and-safety-of-simeprevir-or-daclatasvir-in-combination-with-sofosbuvir-for-the-treatment-of-hepatitis-c-genotype-4-infection
#19
Mohammed A Babatin, Abdullah S Alghamdi, Ali Albenmousa, Abdulla Alaseeri, Mahdi Aljarodi, Haziz Albiladi, Ashwaq Alsahafi, Mohammed Almugharbal, Hammad S Alothmani, Faisal M Sanai, Khalid I Bzeizi
INTRODUCTION: The combination of sofosbuvir (SOF) with simeprevir (SMV) or daclatasvir (DCV) is very effective in treating hepatitis C virus (HCV) infection, particularly genotype (GT) 1. However, the data on GT4 are very limited. We aimed to determine the efficacy and safety of SOF in combination with either SMV or DCV in GT4-infected patients. PATIENTS AND METHODS: In this real life, prospective, observational study, HCV (GT4) patients (n=96) were evaluated in 2 groups on the basis of the 12-week treatment regimen they received...
August 1, 2017: Journal of Clinical Gastroenterology
https://www.readbyqxmd.com/read/28755246/biocatalytic-asymmetric-synthesis-of-1r-2s-n-boc-vinyl-acca-ethyl-ester-with-a-newly-isolated-sphingomonas-aquatilis
#20
Shaozhou Zhu, Ying Shi, Xinyu Zhang, Guojun Zheng
1-amino cyclopropane-1-carboxylic acid (ACCA) and its derivatives are essential pharmacophoric unit that widely used in drug research and development. Specifically, (1R, 2S)-N-Boc-vinyl-ACCA ethyl ester (vinyl-ACCA) is a key chiral intermediate in the synthesis of highly potent hepatitis C virus (HCV) NS3/4A protease inhibitors such as asunaprevir and simeprevir. Developing strategies for the asymmetric synthesis of vinyl-ACCA is thus extremely high demand. In this study, 378 bacterial strains were isolated from soil samples using N-Boc-vinyl-ACCA ethyl ester as the sole carbon source and were screened for esterase activity...
July 28, 2017: Applied Biochemistry and Biotechnology
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