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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
#1
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
#2
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
#3
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: 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
#4
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 7, 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
#5
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
#6
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...
February 2, 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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28102520/us-fda-perspective-on-elbasvir-grazoprevir-treatment-for-patients-with-chronic-hepatitis-c-virus-genotype-1-or-4-infection
#10
Sarita D Boyd, LaRee Tracy, Takashi E Komatsu, Patrick R Harrington, Prabha Viswanathan, Jeff Murray, Adam Sherwat
Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall, the US Food and Drug Administration (FDA) encountered challenging regulatory issues due to the limitations of clinical trial data in certain subpopulations. In GT1a-infected subjects, baseline NS5A resistance-associated polymorphisms emerged as the strongest baseline characteristic associated with diminished SVR12 rates following 12 weeks of elbasvir/grazoprevir treatment...
January 19, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28088870/fatal-relapse-of-myelodysplastic-syndrome-in-a-patient-with-hiv-hepatitis-c-coinfection-treated-with-simeprevir-sofosbuvir
#11
Efemena Michael Diejomaoh, Joseph Clayton Gathe, Carl Craig Mayberry, John Benjamin Clemmons, Bernie Miguel, Alan Glombicki, Benjamin Daquioag
Registrational studies and observational cohorts clearly suggest sustained virologic response (SVR) rates in HIV-/hepatitis C-coinfected patients are similar to monoinfected patients when utilizing interferon-free regimens, and this can be accomplished with agents that are well tolerated with minimal adverse events. These randomized trials that led to the approval of several of our new direct-acting antiviral agents, however, specifically excluded patients who had significant comorbidities and none to our knowledge accepted patients with a history of cancer...
January 1, 2017: Journal of the International Association of Providers of AIDS Care
https://www.readbyqxmd.com/read/28072888/clinical-and-virological-predictors-of-sustained-response-with-an-interferon-based-simeprevir-regimen-for-patients-with-chronic-genotype-1-hepatitis-c-virus-infection
#12
Gianpiero D'Offizi, Calogero Cammà, Chiara Taibi, Michael Schlag, Karin Weber, Maria Palma, Ralph DeMasi, Katrien Janssen, James Witek, Raffaella Lionetti
Simeprevir plus peg-interferon/ribavirin (PR) is approved to treat chronic hepatitis C (HCV) genotype 1 (GT1) and GT4 infection. This study aimed to assess baseline and on-treatment the factors predictive of sustained virologic response 12-weeks post-treatment (SVR12) in patients receiving 12 weeks of simeprevir plus PR followed by 12 or 36 weeks of PR. Data from participants in four studies (QUEST-1, QUEST-2, ATTAIN and PROMISE) were pooled to examine the efficacy and safety of simeprevir+PR in HCV GT1 patients...
January 2017: New Microbiologica
https://www.readbyqxmd.com/read/28070200/the-risk-of-hepatocellular-carcinoma-after-directly-acting-antivirals-for-hepatitis-c-virus-treatment-in-liver-transplanted-patients-is-it-real
#13
Alessio Strazzulla, Rosa Maria Rita Iemmolo, Ennio Carbone, Maria Concetta Postorino, Maria Mazzitelli, Mario De Santis, Fabrizio Di Benedetto, Costanza Maria Cristiani, Chiara Costa, Vincenzo Pisani, Carlo Torti
INTRODUCTION: Since directly acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) were introduced, conflicting data emerged about the risk of hepatocellular carcinoma (HCC) after interferon (IFN)-free treatments. We present a case of recurrent, extra-hepatic HCC in a liver-transplanted patient soon after successful treatment with DAAs, along with a short review of literature. CASE PRESENTATION: In 2010, a 53-year old man, affected by chronic HCV (genotype 1) infection and decompensated cirrhosis, underwent liver resection for HCC and subsequently received orthotopic liver transplantation...
November 2016: Hepatitis Monthly
https://www.readbyqxmd.com/read/28070175/a-special-meeting-review-edition-advances-in-the-treatment-of-hepatitis-c-virus-infection-from-the-2016-easl-meeting-the-annual-meeting-of-the-european-association-for-the-study-of-the-liver-%C3%A2-april-13-17-2016-%C3%A2-barcelona-spainspecial-reporting-on-%C3%A2-six-weeks
#14
https://www.readbyqxmd.com/read/28060441/successful-treatment-of-donor-derived-hepatitis-c-infection-in-a-lung-transplant-recipient
#15
Nicole Theodoropoulos, Bryan A Whitson, Stanley I Martin, Stephanie Pouch, Amy Pope-Harman
Data are limited regarding the use of direct-acting antivirals for treatment of hepatitis C infection post lung transplant, especially in a donor-derived infection. We present a case of a lung transplant recipient with donor-derived hepatitis C that was successfully treated with a 12-week regimen of simeprevir and sofosbuvir. This case reiterates the importance of screening recipients of increased-risk donor organs for disease transmission and the value of early therapy. This article is protected by copyright...
January 6, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28056030/efficacy-of-a-12-week-simeprevir-plus-peginterferon-ribavirin-pr-regimen-in-treatment-na%C3%A3-ve-patients-with-hepatitis-c-virus-hcv-genotype-4-gt4-infection-and-mild-to-moderate-fibrosis-displaying-early-on-treatment-virologic-response
#16
Tarik Asselah, Christophe Moreno, Christoph Sarrazin, Michael Gschwantler, Graham R Foster, Antonio Craxí, Peter Buggisch, Faisal Sanai, Ceyhun Bicer, Oliver Lenz, Gino Van Dooren, Catherine Nalpas, Isabelle Lonjon-Domanec, Michael Schlag, Maria Buti
BACKGROUND: HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12...
2017: PloS One
https://www.readbyqxmd.com/read/28052633/hepatitis-c-efficacy-and-safety-in-real-life
#17
REVIEW
Robert Flisiak, Joanna Pogorzelska, Marta Flisiak-Jackiewicz
Interferon-free combinations were registered in 2014 and 2015 for the treatment of chronic HCV infection. As a result, real-world experience has been gathered in the last year and this paper presents data available in September 2016. Real-world studies on the efficacy of the ledipasvir/sofosbuvir (LDV/SOF)±ribavirin (RBV) regimen showed a sustained virologic response (SVR) rate of between 91% and 98%. The SVR rate in the 13858 patients included in this paper was 94%, and 92% in the 3506 patients with cirrhosis...
January 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28050236/hepatitis-c-eradication-with-sofosbuvir-leads-to-significant-metabolic-changes
#18
Amilcar L Morales, Zachary Junga, Manish B Singla, Maria Sjogren, Dawn Torres
AIM: To assess the effect of sofosbuvir (SOF) based regimens on glycemic and lipid control. METHODS: This is a retrospective analysis of hepatitis C virus (HCV)-infected patients treated and cured with a SOF regimen [SOF/ribavirin/interferon, SOF/simeprevir, or SOF/ledipasvir (LDV) ± ribavirin] from January 2014 to March 2015. Patients with hemoglobin A1C (HbA1C) and lipid panels within six months before and six months after therapy were identified and included in our study...
December 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/28040549/increased-peripheral-cd4-regulatory-t-cells-persist-after-successful-direct-acting-antiviral-treatment-of-chronic-hepatitis-c
#19
Bettina Langhans, Hans Dieter Nischalke, Benjamin Krämer, Annekristin Hausen, Leona Dold, Peer van Heteren, Robert Hüneburg, Jacob Nattermann, Christian P Strassburg, Ulrich Spengler
INTRODUCTION: CD4(+) regulatory T cells (Tregs) expand during chronic hepatitis C virus (HCV) infection, inhibit antiviral immunity and promote fibrosis. Directly acting antivirals (DAA) have revolutionized HCV therapy. However, it is unclear if Tregs are normalized after DAA-induced HCV elimination. METHODS: We analyzed Tregs before (=baseline), at end of therapy (EOT), 12 and 24 weeks (SVR12, SVR24) and long-term (51±14 weeks) after EOT in 26 genotype-1-infected patients successfully treated with sofosbuvir (SOF) plus IFN/ribavirin (n=12) and IFN-free DAA regimens (SOF plus daclatasvir or simeprevir; n=14)...
December 28, 2016: Journal of Hepatology
https://www.readbyqxmd.com/read/28025084/a-profiling-study-of-a-newly-developed-hcvcc-strain-pr63cc-s-sensitivity-to-direct-acting-antivirals
#20
Wanyin Tao, Tianyu Gan, Jie Lu, Jin Zhong
The development of direct-acting antivirals (DAAs) has significantly improved hepatitis C virus (HCV) treatment. However, drug resistance remains a potential concern in the real-world DAA-based therapies. We previously developed a novel full-length genotype 2a HCVcc clone PR63cc directly from clinical isolates. Here in this study, we compared the sensitivity of PR63cc and JFH1 to 12 different DAAs most of which are either already in clinical use or in the late clinical development phase. For NS5B inhibitors, PR63cc and JFH1 displayed comparable sensitivity to nucleoside/nucleotide analogues sofosbuvir and 2'-C-methyladenosine, while PR63cc was 4-fold more sensitive than JFH1 to nesbuvir, a non-nucleoside inhibitor...
December 23, 2016: Antiviral Research
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