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https://www.readbyqxmd.com/read/28651301/real-world-single-center-experience-with-sofosbuvir-based-regimens-for-the-treatment-of-chronic-hepatitis-c-genotype-1-patients
#1
Hyun Phil Shin, Blaire Burman, Richard A Kozarek, Amy Zeigler, Chia Wang, Houghton Lee, Troy Zehr, Alicia M Edwards, Asma Siddique
Background/Aims: The approval of sofosbuvir (SOF), a direct-acting antiviral, has revolutionized the treatment of chronic hepatitis C virus (HCV). Methods: We assessed the sustained virological response (SVR) of SOF-based regimens in a real-world single-center setting for the treatment of chronic HCV genotype 1 (G1) patients. This was a retrospective review of chronic HCV G1 adult patients treated with a SOF-based regimen at Virginia Mason Medical Center between December 2013 and August 2015...
June 27, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28645446/cost-effectiveness-analysis-of-two-treatment-strategies-for-chronic-hepatitis-c-before-and-after-access-to-direct-acting-antivirals-in-spain
#2
Juan Turnes, Raquel Domínguez-Hernández, Miguel Ángel Casado
OBJECTIVE: To evaluate the cost-effectiveness of a strategy based on direct-acting antivirals (DAAs) following the marketing of simeprevir and sofosbuvir (post-DAA) versus a pre-direct-acting antiviral strategy (pre-DAA) in patients with chronic hepatitis C, from the perspective of the Spanish National Health System. METHODS: A decision tree combined with a Markov model was used to estimate the direct health costs (€, 2016) and health outcomes (quality-adjusted life years, QALYs) throughout the patient's life, with an annual discount rate of 3%...
June 20, 2017: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/28641865/influence-of-baseline-meld-score-in-the-efficacy-of-treatment-of-hepatitis-c-with-simeprevir-and-sofosbuvir
#3
José María Moreno-Planas, Juan Ramón Larrubia-Marfil, Juan José Sánchez-Ruano, Julia Morillas-Ariño, Roberto Patón-Arenas, Rosa María Sáiz-Chumillas, Emilia Tébar-Romero, Alfredo Lucendo-Villarín, Pilar Gancedo-Bringas, Mario Solera-Muñoz, María Del Mar Vicente-Gutiérrez, Elisa Martínez-Alfaro
INTRODUCTION: There are few published studies on predictors of response to treatment with sofosbuvir and simeprevir in HCV patients. OBJECTIVE: The objective of the study was to analyse possible predictors of response to simeprevir (SMV) and sofosbuvir (SOF) in patients infected with hepatitis C genotypes 1 or 4. PATIENTS AND METHODS: Prospective observational cohort study in 12 hospitals. The primary efficacy endpoint was SVR rate 12 weeks after end of treatment (SVR12)...
June 19, 2017: Enfermedades Infecciosas y Microbiología Clínica
https://www.readbyqxmd.com/read/28637040/a-possible-role-of-therapeutic-drug-monitoring-in-virological-breakthrough-during-simeprevir-and-peg-ifn-treatment-in-hcv-4
#4
Lucio Boglione, Tina Ruggiero, Amedeo De Nicolò, Antonio D'Avolio, Giovanni Di Perri
No abstract text is available yet for this article.
June 22, 2017: Intervirology
https://www.readbyqxmd.com/read/28618285/belgian-experience-with-direct-acting-antivirals-in-people-who-inject-drugs
#5
Rob Bielen, Christophe Moreno, Hans Van Vlierberghe, Stefan Bourgeois, Jean-Pierre Mulkay, Thomas Vanwolleghem, Wim Verlinden, Christian Brixko, Jochen Decaestecker, Chantal De Galocsy, Filip Janssens, Mike Cool, Lode Van Overbeke, Christophe Van Steenkiste, François D'heygere, Wilfried Cools, Frederik Nevens, Geert Robaeys
BACKGROUND AND AIM: Hepatitis C viral infection (HCV) has become a curable disease due to the development of direct acting antivirals (DAA). The WHO has set a target to eliminate HCV completely. Therefore, people who inject drugs (PWID) also need to be treated. In this study, we compared the real-life uptake and outcome of DAA treatment for HCV in PWID and non-PWID. METHODS: We performed a nation-wide, retrospective cohort study in 15 hospitals. All patients who were treated with simeprevir-sofosbuvir, daclatasvir-sofosbuvir, or ombitasvir/paritaprevir ritonavir-dasabuvir between December 2013 and November 2015 were included...
May 30, 2017: Drug and Alcohol Dependence
https://www.readbyqxmd.com/read/28585310/direct-acting-antivirals-for-chronic-hepatitis-c
#6
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) 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). However, it is still questionable if eradication of hepatitis C virus in the blood eliminates hepatitis C in the body, and improves survival and leads to fewer complications...
June 6, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28577353/simeprevir-with-peginterferon-%C3%AE-2a-ribavirin-for-chronic-hepatitis-c-virus-genotype-1-infection-in-treatment-experienced-patients-an-open-label-rollover-study
#7
Edward J Gane, Edwin DeJesus, Ewa Janczewska, Jacob George, Moises Diago, Mariliza Hendrique Da Silva, Henk Reesink, Igor Nikitin, Holger Hinrichsen, Stefan Bourgeois, Peter Ferenci, Umesh Shukla, Ronald Kalmeijer, Oliver Lenz, Bart Fevery, Chris Corbett, Maria Beumont, Wolfgang Jessner
BACKGROUND: This Phase 3, open-label, rollover study (NCT01323244) investigated the efficacy and safety of simeprevir plus peginterferon α-2a (PegIFNα-2a) and ribavirin (RBV) in a well-characterized population of HCV genotype 1 (GT1)-infected treatment-experienced patients. METHODS: Patients who had failed PegIFNα/RBV treatment in the placebo arm of a previous Phase 2/3 simeprevir study (Phase 2/3 group, n = 125), or had been exposed to HCV direct-acting antivirals (simeprevir or other) for up to 14 days in a selected Phase 1 study (Phase 1 group, n = 16), were eligible...
June 2, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28569206/virology-analysis-in-hcv-genotype-1-infected-patients-treated-with-the-combination-of-simeprevir-and-tmc647055-ritonavir-with-and-without-ribavirin-and-jnj-56914845
#8
Leen Vijgen, Kim Thys, An Vandebosch, Pieter Van Remoortere, René Verloes, Sandra De Meyer
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 sustained virologic response 12 weeks after actual end of treatment (SVR12) in chronic hepatitis C virus (HCV) genotype 1-infected patients. SVR12 rates were generally lower in the 2-DAA regimen SMV + TMC647055/RTV with or without ribavirin. The objective of this study was to identify and characterise pre-existing and emerging resistance-associated variants (RAVs) in patients enrolled in study TMC647055HPC2001...
May 31, 2017: Virology Journal
https://www.readbyqxmd.com/read/28566078/-determination-of-drug-resistance-mutations-of-ns3-inhibitors-in-chronic-hepatitis-c-patients-infected-with-genotype-1
#9
Tamer Şanlıdağ, Murat Sayan, Sinem Akçalı, Elmas Kasap, Tahir Buran, Ayşe Arıkan
Direct-acting antiviral agents (DAA) such as NS3 protease inhibitors is the first class of drugs used for chronic hepatitis C (CHC) treatment. NS3 inhibitors (PI) with low genetic barrier have been approved to be used in the CHC genotype 1 infections, and in the treatment of compensated liver disease including cirrhosis together with pegile interferon and ribavirin. Consequently, the development of drug resistance during DAA treatment of CHC is a major problem. NS3 resistant variants can be detected before treatment as they can occurnaturally...
April 2017: Mikrobiyoloji Bülteni
https://www.readbyqxmd.com/read/28560939/a-new-health-technology-assessment-system-for-japan-simulating-the-potential-impact-on-the-price-of-simeprevir
#10
Jörg Mahlich, Isao Kamae, Bruno Rossi
OBJECTIVES: Japanese authorities have announced a plan to introduce a health technology assessment (HTA) system in 2016. This study assessed the potential impact of such a policy on the price of the antivirologic drug simeprevir. METHODS: Taking the antivirologic drug simeprevir as an example, we compared the current Japanese price with hypothetical prices that might result if a U.K. (cost-utility) or German (efficiency frontier) style HTA assessment was in place...
May 31, 2017: International Journal of Technology Assessment in Health Care
https://www.readbyqxmd.com/read/28545127/improvement-of-alt-decay-kinetics-by-all-oral-hcv-treatment-role-of-ns5a-inhibitors-and-differences-with-ifn-based-regimens
#11
Valeria Cento, Thi Huyen Tram Nguyen, Domenico Di Carlo, Elisa Biliotti, Laura Gianserra, Ilaria Lenci, Daniele Di Paolo, Vincenza Calvaruso, Elisabetta Teti, Maddalena Cerrone, Dante Romagnoli, Michela Melis, Elena Danieli, Barbara Menzaghi, Ennio Polilli, Massimo Siciliano, Laura Ambra Nicolini, Antonio Di Biagio, Carlo Federico Magni, Matteo Bolis, Francesco Paolo Antonucci, Velia Chiara Di Maio, Roberta Alfieri, Loredana Sarmati, Paolo Casalino, Sergio Bernardini, Valeria Micheli, Giuliano Rizzardini, Giustino Parruti, Tiziana Quirino, Massimo Puoti, Sergio Babudieri, Antonella D'Arminio Monforte, Massimo Andreoni, Antonio Craxì, Mario Angelico, Caterina Pasquazzi, Gloria Taliani, Jeremie Guedj, Carlo Federico Perno, Francesca Ceccherini-Silberstein
BACKGROUND: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. STUDY DESIGN: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR...
2017: PloS One
https://www.readbyqxmd.com/read/28539815/increase-of-soluble-programmed-cell-death-ligand-1-in-patients-with-chronic-hepatitis-c
#12
Satoshi Yamagiwa, Toru Ishikawa, Nobuo Waguri, Soichi Sugitani, Kenya Kamimura, Atsunori Tsuchiya, Masaaki Takamura, Hirokazu Kawai, Shuji Terai
Objectives: To determine whether the soluble programmed cell death ligand 1 (sPD-L1) levels in patients with chronic hepatitis C (CHC) are associated with the clinical features of the disease and the efficacy of treatment, including interferon (IFN)-α. Methods: We investigated the sPD-L1 levels in the sera of 80 genotype 1b Japanese patients with CHC who underwent 12 weeks of telaprevir (TVR)- or simeprevir (SMV)-based triple therapy followed by 12 weeks of dual therapy with pegylated IFN-α plus ribavirin...
2017: International Journal of Medical Sciences
https://www.readbyqxmd.com/read/28533924/interferon-free-treatments-in-patients-with-hepatitis-c-genotype-1-4-infections-in-a-real-world-setting
#13
Huascar Ramos, Pedro Linares, Ester Badia, Isabel Martín, Judith Gómez, Carolina Almohalla, Francisco Jorquera, Sara Calvo, Isidro García, Pilar Conde, Begoña Álvarez, Guillermo Karpman, Sara Lorenzo, Visitación Gozalo, Mónica Vásquez, Diana Joao, Marina de Benito, Lourdes Ruiz, Felipe Jiménez, Federico Sáez-Royuela, Asociación Castellano Y Leonesa de Hepatología ACyLHE
AIM: To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV). METHODS: We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively)...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28506030/simeprevir-based-triple-therapy-with-reduced-doses-of-pegylated-interferon-%C3%AE-2a-plus-ribavirin-for-interferon-ineligible-patients-with-genotype-1b-hepatitis-c-virus
#14
Hideyuki Tamai, Yoshiyuki Ida, Akira Kawashima, Naoki Shingaki, Ryo Shimizu, Kosaku Moribata, Tetsushi Nasu, Takao Maekita, Mikitaka Iguchi, Jun Kato, Taisei Nakao, Masayuki Kitano
Background/Aims: The present study aimed to evaluate the safety and efficacy of simeprevir-based triple therapy with reduced doses of pegylated interferon (PEG-IFN) and ribavirin for interferon (IFN) ineligible patients, such as elderly and/or cirrhotic patients, and to elucidate the factors contributing to a sustained virologic response (SVR). Methods: One hundred IFN ineligible patients infected with genotype 1b hepatitis C virus (HCV) were treated. Simeprevir (100 mg) was given orally together with reduced doses of PEG-IFN-α 2a (90 μg), and ribavirin (200 mg less than the recommended dose)...
July 15, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28497432/resistance-mechanisms-in-hepatitis-c-virus-implications-for-direct-acting-antiviral-use
#15
Sabrina Bagaglio, Caterina Uberti-Foppa, Giulia Morsica
Multiple direct-acting antiviral (DAA)-based regimens are currently approved that provide one or more interferon-free treatment options for hepatitis C virus (HCV) genotypes (G) 1-6. The choice of a DAA regimen, duration of therapy, and use of ribavirin depends on multiple viral and host factors, including HCV genotype, the detection of resistance-associated amino acid (aa) substitutions (RASs), prior treatment experience, and presence of cirrhosis. In regard to viral factors that may guide the treatment choice, the most important is the infecting genotype because a number of DAAs are genotype-designed...
May 12, 2017: Drugs
https://www.readbyqxmd.com/read/28495568/quantitative-analyses-of-the-influence-of-parameters-governing-rate-determining-process-of-hepatic-elimination-of-drugs-on-the-magnitudes-of-drug-drug-interactions-via-hepatic-oatps-and-cyp3a-using-physiologically-based-pharmacokinetic-models
#16
Takashi Yoshikado, Maeda Kazuya, Hiroyuki Kusuhara, Ken-Ichi Furihata, Yuichi Sugiyama
Physiologically-based pharmacokinetic (PBPK) models were constructed for hepatic organic anion transporting polypeptides (OATPs) and cytochrome P450 3A (CYP3A) substrates (bosentan, repaglinide, clarithromycin, and simeprevir), a CYP3A probe substrate (midazolam), and selective inhibitors for OATPs (rifampicin) and CYP3A (itraconazole), though the role of OATPs in the hepatic uptake of clarithromycin is unclear. The pharmacokinetic data were obtained from our previous clinical drug-drug interaction (DDI) study...
May 8, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28484975/a-clinical-cassette-dosing-study-for-evaluating-the-contribution-of-hepatic-oatps-and-cyp3a-to-drug-drug-interactions
#17
Takashi Yoshikado, Kazuya Maeda, Sawako Furihata, Hanano Terashima, Takeshi Nakayama, Keiko Ishigame, Kazunobu Tsunemoto, Hiroyuki Kusuhara, Ken-Ichi Furihata, Yuichi Sugiyama
PURPOSE: To demonstrate the relative importance of organic anion-transporting polypeptides (OATPs) and cytochrome P450 3A (CYP3A) in the hepatic elimination of substrate drugs. METHODS: A cocktail of subtherapeutic doses of bosentan, repaglinide, clarithromycin, darunavir, simeprevir, and midazolam (CYP3A probe) was administered orally to eight healthy volunteers. Rifampicin (OATP inhibitor; 600 mg, p.o.) and itraconazole (CYP3A inhibitor; 200 mg, i.v.) were coadministered with the cocktail in the second and third phases, respectively...
May 8, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28481460/high-efficacy-of-sofosbuvir-plus-simeprevir-in-a-large-cohort-of-spanish-cirrhotic-patients-infected-with-genotypes-1-and-4
#18
Zoe Mariño, Juan Manuel Pascasio-Acevedo, Adolfo Gallego, Moisés Diago, Carme Baliellas, Rosa Morillas, Martín Prieto, José María Moreno, Gloria Sánchez-Antolín, Mercedes Vergara, Montserrat Forné, Inmaculada Fernández, Maria Ángeles Castro, Sonia Pascual, Alexandra Gómez, Lluis Castells, Jose Luis Montero, Javier Crespo, Jose Luis Calleja, Javier García-Samaniego, Jose Antonio Carrión, Ana Del Carmen Arencibia, Alejandro Blasco, Carmen López-Núñez, Juan José Sánchez-Ruano, Francisco Gea-Rodríguez, Álvaro Giráldez, Joaquín Cabezas, Vanessa Hontangas, Xavier Torras, Jose Castellote, Manuel Romero-Gómez, Juan Turnes, Tomás de Artaza, Isidoro Narváez, Valentín Cuervas-Mons, Xavier Forns
BACKGROUND AND AIMS: Hepatitis C (HCV) therapy with Sofosbuvir(SOF)/ Simeprevir(SMV) in clinical trials and real-world clinical practice, showed high rates of sustained virological response (SVR) in non-cirrhotic genotype(GT)-1 and 4 patients. These results were slightly lower in cirrhotic patients. We investigated real-life effectiveness and safety of SOF/SMV with or without ribavirin(RBV) in a large cohort of cirrhotic patients. METHODS: This collaborative multicentre study included data from 968 patients with cirrhosis infected with HCV-GT1 or 4, treated with SOF/SMV±RBV in 30 centres across Spain between January-2014 and December-2015...
May 8, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28480251/real-world-effectiveness-of-simeprevir-containing-regimens-among-patients-with-chronic-hepatitis-c-virus-the-sonet-study
#19
Imtiaz Alam, Kimberley Brown, Cynthia Donovan, Jamie Forlenza, Kris Lauwers, Mitchell A Mah'moud, Richard Manch, Smruti R Mohanty, Avinash Prabhakar, Robert Reindollar, Ralph DeMasi, Jihad Slim, Neeta Tandon, Shirley Villadiego, Susanna Naggie
BACKGROUND: The Simeprevir ObservatioNal Effectiveness across practice seTtings (SONET) study evaluated the real-world effectiveness of simeprevir-based treatment for hepatitis C virus (HCV) infection. METHODS: The SONET study was a phase 4, prospective, observational, United States-based study enrolling patients ≥18 years of age with chronic genotype 1 HCV infection. The primary endpoint was the proportion of patients who achieved sustained virologic response 12 weeks after the end of treatment (SVR12), defined as HCV ribonucleic acid undetectable ≥12 weeks after the end of all HCV treatments...
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/28467359/long-term-follow-up-of-resistance-associated-substitutions-in-hepatitis-c-virus-in-patients-in-which-direct-acting-antiviral-based-therapy-failed
#20
Kanako Yoshida, Hoang Hai, Akihiro Tamori, Yuga Teranishi, Ritsuzo Kozuka, Hiroyuki Motoyama, Etsushi Kawamura, Atsushi Hagihara, Sawako Uchida-Kobayashi, Hiroyasu Morikawa, Masaru Enomoto, Yoshiki Murakami, Norifumi Kawada
We evaluated the transition of dominant resistance-associated substitutions (RASs) in hepatitis C virus during long-term follow-up after the failure of DAAs (direct acting antivirals)-based therapy. RASs in non-structure (NS)3/4A, NS5A, NS5B, and deletions in NS5A from 20 patients who failed simeprevir/pegylated-interferon/ribavirin (SMV/PEG-IFN/RBV) and 25 patients who failed daclatasvir/asunaprevir (DCV/ASV) treatment were examined by direct sequencing. With respect to SMV/PEG-IFN/RBV treatment, RAS was detected at D168 in NS3/4A but not detected in NS5A and NS5B at treatment failure in 16 of 20 patients...
May 3, 2017: International Journal of Molecular Sciences
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