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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
#1
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
#2
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
https://www.readbyqxmd.com/read/28286560/prevalence-of-end-of-treatment-rna-positive-sustained-viral-response-in-hcv-patients-treated-with-sofosbuvir-combination-therapies
#3
Miguel Malespin, Tamara Benyashvili, Susan L Uprichard, Alan S Perelson, Harel Dahari, Scott J Cotler
BACKGROUND: Some chronic hepatitis C virus (HCV), genotype 1 infected patients treated with direct antiviral agents (DAAs) remain viremic at end of treatment (EOT+), yet go on to achieve sustained virological response 12 weeks after completion of therapy (SVR12). The incidence of EOT+/SVR in patients with genotype 1 and other genotypes, as well as whether such patients achieve SVR24 remain in question. The aims of this study were to evaluate the frequency and durability of EOT+/SVR12&24 and other response categories in HCV genotype 1, 2, or 3 infected patients treated with DAA in clinical practice...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28280374/optimizing-choice-of-oral-interferon-free-treatment-for-genotype-1-hepatitis-c-virus-using-testing-for-ns5a-resistance-a-cost-utility-analysis-from-the-perspective-of-the-italian-national-health-service
#4
Kirsten Y Westerhout, Walter Bouwmeester, Inge Duchesne, Marta Pisini, Marjanne A Piena, Francesco Damele, Beatrice Gueron, Maarten Treur, Jonathan Belsey
BACKGROUND: Patients with genotype-1 hepatitis C virus infection who have failed to respond to standard therapy or who relapse following treatment may be considered for an interferon-free regimen incorporating a nonstructural protein 5A (NS5A) inhibitor. Sustained virologic response (SVR) with these regimens is typically >90%, but this is reduced in patients with NS5A resistance. European Association for Study of the Liver guidelines recommend simeprevir + sofosbuvir ± ribavirin (SMV+SOF±R) for re-treating patients failing an NS5A inhibitor-containing regimen...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28274850/direct-acting-antiviral-therapy-restores-immune-tolerance-to-patients-with-hepatitis-c-virus-induced-cryoglobulinemia-vasculitis
#5
Cloé Comarmond, Marlène Garrido, Stanislas Pol, Anne-Claire Desbois, Myrto Costopoulos, Magali Le Garff-Tavernier, Si Nafa Si Ahmed, Laurent Alric, Hélène Fontaine, Bertrand Bellier, Anna Maciejewski, Michelle Rosenzwajg, David Klatzmann, Lucile Musset, Thierry Poynard, Patrice Cacoub, David Saadoun
BACKGROUND & AIMS: Interferon-free direct-acting antiviral (DAA) therapies are effective in patients with hepatitis C virus-induced cryoglobulinemia vasculitis (HCV-CV). We analyzed blood samples from patients with HCV-CV before and after DAA therapy to determine mechanisms of these drugs and their effects on cellular immunity. METHODS: We performed a prospective study of 27 consecutive patients with HCV-CV (median age 59 years) treated with DAA therapy (21 patients received sofosbuvir plus ribavirin for 24 weeks, 4 patients received sofosbuvir plus daclatasvir for 12 weeks, and 2 patients received sofosbuvir plus simeprevir for 12 weeks) in Paris, France...
March 5, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28271521/transformation-of-hepatitis-c-antiviral-treatment-in-a-national-healthcare-system-following-the-introduction-of-direct-antiviral-agents
#6
A M Moon, P K Green, K Berry, G N Ioannou
BACKGROUND: Highly effective direct antiviral agents (DAAs) for hepatitis C virus (HCV) were introduced recently. Their utilisation has been limited by high cost and low access to care. AIM: To describe the effect of DAAs on HCV treatment and cure rates in the United States Veterans Affairs (VA) national healthcare system. METHODS: We identified all HCV antiviral treatment regimens initiated from 1 January 1999 to 31 December 2015 (n = 105 369) in the VA national healthcare system, and determined if they resulted in sustained virological response (SVR)...
March 8, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28270091/implications-of-hepatitis-c-virus-subtype-1a-migration-patterns-for-virus-genetic-sequencing-policies-in-italy
#7
Lize Cuypers, Bram Vrancken, Lavinia Fabeni, Nadia Marascio, Valeria Cento, Velia Chiara Di Maio, Marianna Aragri, Andrea Clemencia Pineda-Peña, Yoeri Schrooten, Kristel Van Laethem, Daniel Balog, Alfredo Focà, Carlo Torti, Frederik Nevens, Carlo Federico Perno, Anne-Mieke Vandamme, Francesca Ceccherini-Silberstein
BACKGROUND: In-depth phylogeographic analysis can reveal migration patterns relevant for public health planning. Here, as a model, we focused on the provenance, in the current Italian HCV subtype 1a epidemic, of the NS3 resistance-associated variant (RAV) Q80K, known to interfere with the action of NS3/4A protease inhibitor simeprevir. HCV1a migration patterns were analysed using Bayesian phylodynamic tools, capitalising on newly generated and publicly available time and geo-referenced NS3 encoding virus genetic sequence data...
March 7, 2017: BMC Evolutionary Biology
https://www.readbyqxmd.com/read/28270038/inf-free-sofosbuvir-based-treatment-of-post-transplant-hepatitis-c-relapse-a-swedish-real-life-experience
#8
Castedal Maria, Segenmark Michael, Cederberg Susanne, Skoglund Catarina, Weiland Ola
BACKGROUND: Relapse of hepatitis C virus (HCV) infection after liver transplantation has been universal, and the fibrosis progression faster than in non-transplanted patients. Interferon (IFN)-free treatment with direct antiviral agents (DAA) has improved the treatment outcome dramatically. We here report on the outcome of IFN-free treatment for HCV relapse after liver transplantation in a real life setting in Sweden. MATERIAL: In total, 93 patients with a mean age of 60 years (range 32-80) with HCV relapse after liver transplantation were given sofosbuvir-based treatment in combination with a protease inhibitor (simeprevir) or a NS5A inhibitor (daclatasvir or ledipasvir) with or without addition of ribavirin (RBV), or sofosbuvir and RBV only...
May 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28261822/systematic-review-interferon-free-regimens-for-patients-with-hcv-related-child-c-cirrhosis
#9
REVIEW
M Guarino, F Morisco, M R Valvano, A M Ippolito, M Librandi, N Andriulli, M Greco, A Amoruso, A Iacobellis, G Niro, N Caporaso, A Andriulli
BACKGROUND: It is unclear whether the efficacy and long-term outcome of treating patients with hepatitis C virus (HCV)-positive cirrhosis with the new protease inhibitors will extend to those with Child C cirrhosis. AIM: To assess the effectiveness of the interferon-free regimens in Child C cirrhotic patients with HCV infection. METHODS: A systematic Medline search was conducted to retrieve studies describing the treatment of Child C patients with direct-acting agents...
March 6, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28261382/efficacy-and-safety-of-telaprevir-and-simeprevir-based-triple-therapies-for-older-patients-with-chronic-hepatitis-c
#10
Satoshi Yamagiwa, Toru Ishikawa, Nobuo Waguri, Soichi Sugitani, Hiroto Wakabayashi, Shogo Ohkoshi, Takashi Tsukishiro, Toru Takahashi, Toshiaki Watanabe, Shuji Terai
AIM: To evaluate and compare the efficacy and safety of telaprevir (TVR)-and simeprevir (SMV)-based triple therapies in elderly patients, specifically patients aged 66 years or older. METHODS: The present study enrolled 112 and 76 Japanese patients with chronic hepatitis C virus genotype 1b infection who were treated with a 12-wk TVR-based or SMV-based triple therapy, respectively, followed by a dual therapy that included pegylated interferon α and ribavirin (RBV) for 12 wk...
February 18, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28228479/unraveling-the-structural-basis-of-grazoprevir-potency-against-clinically-relevant-substitutions-in-hepatitis-c-virus-ns3-4a-protease-from-genotype-1a
#11
Zhuyan Guo, Stuart Black, Yuan Hu, Patricia McMonagle, Paul Ingravallo, Robert Chase, Stephanie Curry, Ernest Asante-Appiah
Grazoprevir is a potent pan-genotype, macrocyclic inhibitor of hepatitis C virus (HCV) NS3/4A protease and was developed for treating chronic HCV infection. In HCV genotype (GT) 1a, grazoprevir maintains potent activity against a majority of NS3 resistance-associated amino acid substitutions including the highly prevalent and naturally-occurring Q80K polymorphism that impacts simeprevir, another NS3/4A protease inhibitor. The basis for an unexpected difference in the clinical impact of some NS3 substitutions was investigated...
February 21, 2017: Journal of Biological Chemistry
https://www.readbyqxmd.com/read/28187751/efficacy-safety-and-pharmacokinetics-of-simeprevir-and-tmc647055-ritonavir-with-or-without-ribavirin-and-jnj-56914845-in-hcv-genotype-1-infection
#12
RANDOMIZED CONTROLLED TRIAL
Stefan Bourgeois, Hans Van Vlierberghe, Christophe Moreno, Hans Orlent, Frederik Nevens, Keikawus Arastéh, Yves Horsmans, Jörn M Schattenberg, Peter Buggisch, Sven Francque, Leen Vijgen, Thomas N Kakuda, Eva Hoeben, Donghan Luo, An Vandebosch, Bert Jacquemyn, Pieter Van Remoortere, René Verloes
BACKGROUND: A Phase 2a, open-label study (NCT01724086) was conducted to assess the efficacy and safety of a once-daily, 2-direct-acting-antiviral-agent (2-DAA) combination of simeprevir + TMC647055/ritonavir ± ribavirin and of the 3-DAA combination of simeprevir + TMC647055/ritonavir + JNJ-56914845 in chronic hepatitis C virus genotype (GT)1-infected treatment-naïve and prior-relapse patients. METHODS: The study comprised four 12-week treatment panels: Panel 1 (n = 10; GT1a) and Panel 2-Arm 1 (n = 12; GT1b): simeprevir 75 mg once daily + TMC647055 450 mg once daily/ritonavir 30 mg once daily + ribavirin 1000-1200 mg/day; Panel 2-Arm 2 (n = 9; GT1b): simeprevir 75 mg + TMC647055 450 mg/ritonavir 30 mg without ribavirin; Panel 3: simeprevir 75 mg + TMC647055 600 mg/ritonavir 50 mg with (Arm 1: GT1a; n = 7) or without (Arm 2: GT1b; n = 8) ribavirin; Panel 4: simeprevir 75 mg + TMC647055 450 mg/ritonavir 30 mg + JNJ-56914845 30 mg once daily (Arm 1: n = 22; GT1a/GT1b) or 60 mg once daily (Arm 2: n = 22; GT1a/GT1b)...
February 10, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/28184378/relapse-of-hcv-genotype-1b-infection-after-sofosbuvir-ledipasvir-treatment-presenting-as-de-novo-cryoglobulinemic-vasculitis
#13
Mohammad Qasim Khan, Alan D Moreno, Nora Joseph, George Kim, Claus J Fimmel
Relapse of hepatitis C virus (HCV) genotype 1 infection after combination therapy with sofosbuvir and ledipasvir is unusual. We report a treatment-naïve, non-cirrhotic patient in whom the relapse of genotype 1b HCV infection was accompanied by de novo cryoglobulinemic vasculitis and glomerulonephritis, requiring hemodialysis for acute renal failure. Sequence analysis revealed several resistance-associated variants in the HCV NS5a gene but not in NS3/4A. The patient's vasculitis was successfully treated with immunosuppression and plasmapheresis, followed by retreatment of HCV with a combination of sofosbuvir, simeprevir, and ribavirin...
2017: ACG Case Reports Journal
https://www.readbyqxmd.com/read/28178397/the-efficacy-and-safety-of-dual-oral-therapy-with-daclatasvir-and-asunaprevir-for-genotype-1b-in-japanese-real-life-settings
#14
Hitomi Sezaki, Fumitaka Suzuki, Tetsuya Hosaka, Norio Akuta, Shunichiro Fujiyama, Yusuke Kawamura, Masahiro Kobayashi, Yoshiyuki Suzuki, Satoshi Saitoh, Yasuji Arase, Kenji Ikeda, Mariko Kobayashi, Hiromitsu Kumada
BACKGROUND & AIMS: It is important to investigate the treatment outcomes in patients excluded from clinical trials (CTR). The aims of this study were to evaluate the efficacy and safety of a 24-week daclatasvir (DCV) and asunaprevir (ASV) therapy for patients with chronic hepatitis C virus (HCV)-1b infection. METHODS: A total of 651 HCV-1b patients started dual oral therapy with DCV and ASV for 24 weeks in Toranomon Hospital, Tokyo. Among them, 276 patients met phase III CTR inclusion criteria...
February 8, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28174263/quantifying-antiviral-activity-optimizes-drug-combinations-against-hepatitis-c-virus-infection
#15
Yoshiki Koizumi, Hirofumi Ohashi, Syo Nakajima, Yasuhito Tanaka, Takaji Wakita, Alan S Perelson, Shingo Iwami, Koichi Watashi
With the introduction of direct-acting antivirals (DAAs), treatment against hepatitis C virus (HCV) has significantly improved. To manage and control this worldwide infectious disease better, the "best" multidrug treatment is demanded based on scientific evidence. However, there is no method available that systematically quantifies and compares the antiviral efficacy and drug-resistance profiles of drug combinations. Based on experimental anti-HCV profiles in a cell culture system, we quantified the instantaneous inhibitory potential (IIP), which is the logarithm of the reduction in viral replication events, for both single drugs and multiple-drug combinations...
February 21, 2017: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/28174003/role-of-simeprevir-plasma-concentrations-in-hcv-treated-patients-with-dermatological-symptoms
#16
Lucio Boglione, Amedeo De Nicolò, Simone Mornese Pinna, Jessica Cusato, Fabio Favata, Alessandra Ariaudo, Chiara Carcieri, Giuseppe Cariti, Giovanni Di Perri, Antonio D'Avolio
BACKGROUND AND AIMS: Up till now the role of simeprevir plasma concentrations has not been described in treated patients affected by chronic hepatitis C and with dermatological side-effects. In this study, we have evaluated a possible relationship between plasma levels and the onset of skin complaints for the first time. METHODS: We report a clinical and pharmacokinetic analysis of 56 patients treated with simeprevir-based therapies. RESULTS: Simeprevir plasma concentrations were significantly related to dermatological side-effects at early time-points (P<0...
January 17, 2017: Digestive and Liver Disease
https://www.readbyqxmd.com/read/28163136/safety-and-effectiveness-of-a-12-week-course-of-sofosbuvir-and-simeprevir%C3%A2-%C3%A2-%C3%A2-ribavirin-in-hcv-infected-patients-with-or-without-hiv-infection-a-multicentre-observational-study
#17
MULTICENTER STUDY
Giuseppe Bruno, Annalisa Saracino, Claudia Fabrizio, Luigia Scudeller, Eugenio Milano, Raffaele Dell'Acqua, Nicoletta Ladisa, Massimo Fasano, Salvatore Minniti, Giovanni Buccoliero, Alessandra Tartaglia, Adele Giammario, Michele Milella, Gioacchino Angarano
The combination of sofosbuvir and simeprevir ± ribavirin (SOF + SMV ± RBV) for hepatitis C virus (HCV) treatment has been associated with high rates of sustained virological response (SVR). Few data are available regarding this regimen in HIV/HCV co-infected patients. This study evaluated the effectiveness and safety of a 12-week course of SOF + SMV ± RBV in a cohort of HCV monoinfected and HIV/HCV co-infected individuals. HCV-infected patients, with or without HIV infection, receiving a 12-week course of SOF + SMV ± RBV in four Italian centres from February to October 2015, were included in this retrospective observational study...
March 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/28135777/simeprevir-and-daclatasvir-for-12-or-24-weeks-in-treatment-na%C3%A3-ve-patients-with-hcv-genotype-1b-and-advanced-liver-disease
#18
Christophe Hézode, Piero L Almasio, Stefan Bourgeois, Peter Buggisch, Ashley Brown, Moises Diago, Yves Horsmans, Lawrence Serfaty, Ferenc Szalay, Giovanni B Gaeta, Ramon Planas, Michael Schlag, Isabelle Lonjon-Domanec, Edmund Omoruyi, Ralph DeMasi, Stefan Zeuzem
We investigated the efficacy and safety of simeprevir (SMV) plus daclatasvir (DCV) in treatment-naïve patients with chronic, genotype (GT) 1b hepatitis C virus (HCV) infection and advanced liver disease, excluding patients with pre-defined NS5A resistance-associated substitutions (RAS) METHODS: This phase II, open-label, single-arm, multicentre study included patients aged ≥18 years with advanced fibrosis or compensated cirrhosis (METAVIR F3/4). Patients with NS5A-Y93H or L31M/V RAS at screening were excluded...
January 30, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28125694/sofosbuvir-in-combination-with-simeprevir-ribavirin-in-genotype-4-hepatitis-c-patients-with-advanced-fibrosis-or-cirrhosis-a-real-world-experience-from-belgium
#19
Delphine Degré, Thomas Sersté, Luc Lasser, Jean Delwaide, Peter Starkel, Wim Laleman, Philippe Langlet, Hendrik Reynaert, Stefan Bourgeois, Thomas Vanwolleghem, Sergio Negrin Dastis, Thierry Gustot, Anja Geerts, Christophe Van Steenkiste, Chantal de Galocsy, Antonia Lepida, Hans Orlent, Christophe Moreno
INTRODUCTION: Hepatitis C virus (HCV) is a major global health issue and successful treatment has been associated with a reduction of risk of all-cause mortality. Advancements have been made in HCV treatment through the use of interferon-free regimens. Most trials have been conducted in HCV genotype (GT) 1 and data for interferon-free regimens in GT4 patients are limited. The aim of this study was to evaluate the safety and efficacy of sofosbuvir plus simeprevir in a real-world cohort of HCV GT4 patients with advanced fibrosis...
2017: PloS One
https://www.readbyqxmd.com/read/28124463/hepatitis-c-treatment-from-response-guided-to-resource-guided-therapy-in-the-transition-era-from-ifn-containing-to-ifn-free-regimens
#20
REVIEW
Ming-Lung Yu
Peginterferon/ribavirin has been the standard-of-care for chronic hepatitis C virus (HCV) infections: 48-week for genotype 1 or 4 (HCV-1/4) and 24-week for HCV-2/3. Response-guided therapy recommended shorter 24-week and 16-week regimens for HCV-1 with lower baseline viral loads (LVL, <400,000-800,000 IU/ml) and rapid virological response (RVR, undetectable HCV RNA at week 4) and HCV-2/3 with RVR, respectively; and extending to 72 and 48 weeks for HCV-1 slower responders and HCV-2 non-RVR patients, respectively, to improve the efficacy...
January 26, 2017: Journal of Gastroenterology and Hepatology
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