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https://www.readbyqxmd.com/read/28533924/interferon-free-treatments-in-patients-with-hepatitis-c-genotype-1-4-infections-in-a-real-world-setting
#1
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
#2
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)...
May 17, 2017: Gut and Liver
https://www.readbyqxmd.com/read/28497432/resistance-mechanisms-in-hepatitis-c-virus-implications-for-direct-acting-antiviral-use
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
https://www.readbyqxmd.com/read/28442915/efficacy-and-safety-outcomes-of-sofosbuvir-based-treatment-regimens-for-hepatitis-c-virus-infected-patients-with-or-without-cirrhosis-from-phase-iii-clinical-trials
#9
REVIEW
Young-Mo Yang, Eun Joo Choi
BACKGROUND: With the appearance of oral direct-acting antivirals (DAAs), the field of hepatitis C virus (HCV) treatment has been dramatically changed. This evolution makes possible for all oral treatments to be available for the treatment of HCV-infected patients. The aims of this review were to report the efficacy and safety of sofosbuvir (SOF)-based regimens for the treatment of patients with chronic HCV infection and to provide our clinical perspectives on these regimens. METHODS: A literature search of clinical studies published in PubMed and posted on ClinicalTrials...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28439915/treatment-of-chronic-hepatitis-c-with-direct-acting-antivirals-in-patients-with-%C3%AE-thalassaemia-major-and-advanced-liver-disease
#10
Emmanouil Sinakos, Dimitrios Kountouras, John Koskinas, Kalliopi Zachou, Stylianos Karatapanis, Christos Triantos, Themistoklis Vassiliadis, Ioannis Goulis, Alexandra Kourakli, Efthymia Vlachaki, Barbara Toli, Maria Tampaki, Pinelopi Arvaniti, Georgios Tsiaoussis, Aristea Bellou, Antonis Kattamis, Konstantinos Maragkos, Foteini Petropoulou, George N Dalekos, Evangelos Akriviadis, George V Papatheodoridis
Interferon-based regimens for chronic hepatitis C (CHC) were often deferred in patients with β-thalasaemia major (β-TM) due to poor efficacy and tolerance. Current guidelines recommend direct-acting antivirals (DAAs) for these patients. The aim of this study was to assess the safety and efficacy of DAAs in patients with β-TM and advanced liver disease due to CHC. Patients were recruited from eight liver units in Greece. The stage of liver disease was assessed using transient elastography and/or liver histology...
April 25, 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28425406/curing-chronic-hepatitis-c-a-cost-comparison-of-the-combination-simeprevir-plus-sofosbuvir-vs-protease-inhibitor-based-triple-therapy
#11
Jacob A Langness, David Tabano, Amanda Wieland, Sarah Tise, Lindsay Pratt, Lauren Ayres Harrington, Sonia Lin, Vahram Ghuschcyan, Kavita V Nair, Gregory T Everson
INTRODUCTION: Interferon-free, multi-direct acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection is highly effective and well tolerated, but costly. To gain perspective on the evolving economics of HCV therapy, we compared the cost per cure of a multi-DAA regimen with the prior standard of triple therapy. MATERIAL AND METHODS: Patients infected with HCV genotype 1 who were treated through the University of Colorado Hepatology Clinic between May 2011 and December 2014 comprised the study population...
May 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28416232/experience-in-real-clinical-practice-with-new-direct-acting-antivirals-in-chronic-hepatitis-c
#12
Fernando Manuel Jiménez-Macías, Manuel Cabanillas-Casafranca, Marta Maraver-Zamora, Gema Romero-Herrera, Federico García-García, Antonio Correia-Varela-Almeida, Ana Cabello-Fernández, Manuel Ramos-Lora
INTRODUCTION AND OBJECTIVE: Inclusion of direct-acting antivirals into clinical practice in patients with chronic HCV (CHC) has been a milestone in medicine. PATIENTS AND METHODS: Analytical, prospective study, involving 126 patients with chronic HCV treated with direct-acting antivirals. Efficacy and safety of treatment and factors associated with failure treatment were evaluated. RESULTS: Age 54±10. Male (70%). Cirrhosis (60%). Distribution according to genotypes: G1a (31%), G1b (42%); G3 (14%); G4 (13%)...
April 14, 2017: Medicina Clínica
https://www.readbyqxmd.com/read/28412381/optimal-efficacy-of-interferon-free-hcv-retreatment-after-protease-inhibitors-failure-in-real-life
#13
Valeria Cento, Silvia Barbaliscia, Ilaria Lenci, Tina Ruggiero, Carlo Federico Magni, Stefania Paolucci, Sergio Babudieri, Massimo Siciliano, Caterina Pasquazzi, Alessia Ciancio, Carlo Federico Perno, Francesca Ceccherini-Silberstein
OBJECTIVES: First-generation protease-inhibitors (PIs) had suboptimal efficacy in GT-1 patients with advanced liver disease, and those who failed may need urgent retreatment. Our objective was to analyze the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. METHODS: In this multi-center observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included...
April 12, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/28370880/long-term-outcomes-of-direct-acting-antivirals-in-post-transplant-advanced-hepatitis-c-virus-recurrence-and-fibrosing-cholestatic-hepatitis
#14
R Vukotic, F Conti, S Fagiuoli, M C Morelli, L Pasulo, M Colpani, F G Foschi, S Berardi, P Pianta, M Mangano, M F Donato, F Malinverno, S Monico, M Tamè, G Mazzella, L S Belli, R Viganò, P Carrai, P Burra, F P Russo, I Lenci, P Toniutto, M Merli, L Loiacono, R Iemmolo, A M Degli Antoni, A Romano, A Picciotto, M Rendina, P Andreone
Long-term functional outcomes of sofosbuvir-based antiviral treatment were evaluated in a cohort study involving 16 Italian centres within the international compassionate use programme for post-transplant hepatitis C virus (HCV) recurrence. Seventy-three patients with cirrhosis (n=52) or fibrosing cholestatic hepatitis (FCH, n=21) received 24-week sofosbuvir with ribavirin±pegylated interferon or interferon-free sofosbuvir-based regimen with daclatasvir/simeprevir+ribavirin. The patients were observed for a median time of 103 (82-112) weeks...
March 28, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28369411/sofosbuvir-daclatasvir-simeprevir-plus-ribavirin-in-direct-acting-antiviral-experienced-patients-with-hepatitis-c
#15
Christophe Hézode, Slim Fourati, Stéphane Chevaliez, Giovanna Scoazec, Alexandre Soulier, Anne Varaut, Murielle François, Isaac Ruiz, Françoise Roudot-Thoraval, Ariane Mallat, Jean-Michel Pawlotsky
We assessed the broadly used, off-label combination of sofosbuvir, daclatasvir, simeprevir, and ribavirin in direct-acting antiviral-experienced patients, as recommended in current guidelines despite scarce data. After 24 weeks' treatment, sustained virological response 12 weeks after the end of treatment was achieved in 6 patients (60%). Two cirrhotic patients relapsed and 2 discontinued treatment due to serious adverse events.
June 1, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28322919/evaluation-of-preclinical-antimalarial-drugs-which-can-overcome-direct-acting-antivirals-resistant-hepatitis-c-viruses-using-the-viral-reporter-assay-systems
#16
Youki Ueda, Hiromichi Dansako, Shinya Satoh, Hye-Sook Kim, Yusuke Wataya, Hiroyuki Doi, Masanori Ikeda, Nobuyuki Kato
Persistent hepatitis C virus (HCV) infection causes chronic liver diseases and is a major global health problem. Recently developed treatments with direct-acting antivirals (DAAs) have largely improved the sustained virologic response rate of patients with chronic hepatitis C. However, this approach is still hindered by its great expense and the problem of drug resistance. Using our cell-based HCV assay systems, we reported that the preclinical antimalarial drugs N-89 and N-251 exhibited potent anti-HCV activities...
March 18, 2017: Virus Research
https://www.readbyqxmd.com/read/28321163/optimizing-hepatitis-c-virus-treatment-through-pharmacist-interventions-identification-and-management-of-drug-drug-interactions
#17
Jacob A Langness, Matthew Nguyen, Amanda Wieland, Gregory T Everson, Jennifer J Kiser
AIM: To quantify drug-drug-interactions (DDIs) encountered in patients prescribed hepatitis C virus (HCV) treatment, the interventions made, and the time spent in this process. METHODS: As standard of care, a clinical pharmacist screened for DDIs in patients prescribed direct acting antiviral (DAA) HCV treatment between November 2013 and July 2015 at the University of Colorado Hepatology Clinic. HCV regimens prescribed included ledipasvir/sofosbuvir (LDV/SOF), paritaprevir/ritonavir/ombitasvir/dasabuvir (OBV/PTV/r + DSV), simeprevir/sofosbuvir (SIM/SOF), and sofosbuvir/ribavirin (SOF/RBV)...
March 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28320588/herpes-zoster-reactivation-in-patients-with-chronic-hepatitis-c-under-treatment-with-directly-acting-antiviral-agents-a-case-series
#18
Mohamed El Kassas, Mohamed Naguib Wifi, Reem Mahdy, Shimaa Afify, Enas Hafez, Yasmeen Abd El Latif, Marwa Ezzat, Adel El Tahan, Naglaa Youssef, Gamal Esmat
We report a series of cutaneous Herpes Zoster (HZ) reactivation cases in patients with hepatitis C virus (HCV) infection treated with directly acting antiviral (DAA) agents. Five cases were detected among 2133 treated patients with DAAs at one of the specialized viral hepatitis treatment centers in Egypt. A control group including 2300 age and sex matched HCV patients who were previously treated with pegylated interferon and ribavirin did not show any HZ reactivation reports while on treatment. None of cases had an evidence of immunosuppression or a risk factor for HZ reactivation...
March 2017: Arab Journal of Gastroenterology: the Official Publication of the Pan-Arab Association of Gastroenterology
https://www.readbyqxmd.com/read/28295849/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
#19
Xavier Forns, Marina Berenguer, Kerstin Herzer, Martina Sterneck, Maria Francesca Donato, Pietro Andreone, Stefano Fagiuoli, Tomasz Cieciura, Magdalena Durlik, Jose Luis Calleja, Zoe Mariño, Umesh Shukla, Thierry Verbinnen, Oliver Lenz, Sivi Ouwerkerk-Mahadevan, Monika Peeters, Katrien Janssen, Ronald Kalmeijer, Wolfgang Jessner
BACKGROUND: Recurrent hepatitis C virus (HCV) infection following liver transplantation is associated with accelerated progression to graft failure and reduced patient survival. METHODS: The Phase II, open-label SATURN study (NCT01938625) investigated the combination of simeprevir (SMV), daclatasvir (DCV), and ribavirin (RBV) administered for 24 weeks in 35 patients with recurrent HCV genotype (GT) 1b infection after orthotopic liver transplantation (OLT). RESULTS: High rates of both on-treatment and sustained virologic response 12 weeks after end of treatment (SVR12) were achieved in patients who were either treatment-naïve or had failed post-OLT treatment with peginterferon and RBV...
March 13, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28286567/grazoprevir-elbasvir-combination-therapy-for-hcv-infection
#20
REVIEW
Anaïs Vallet-Pichard, Stanislas Pol
Interferon-free regimens combine different second-wave direct-acting antiviral agents (DAAs), which target the main viral proteins involved in the replication cycle of hepatitis C virus (HCV): NS3/4A protease inhibitors (simeprevir or paritaprevir boosted by ritonavir), NS5B nucleos(t)idic (sofosbuvir) and nonnucleos(t)idic (dasabuvir) polymerase inhibitors, NS5A replication complex inhibitors (daclatasvir, ledipasvir, elbasvir, velpatasvir). Combinations of two or three DAAs, given for 8-24 weeks reach sustained virology response (SVR) rates greater than 90% with good tolerance...
January 2017: Therapeutic Advances in Gastroenterology
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