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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
#1
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
#2
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
#3
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 9, 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
#4
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
#5
https://www.readbyqxmd.com/read/28060441/successful-treatment-of-donor-derived-hepatitis-c-infection-in-a-lung-transplant-recipient
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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
https://www.readbyqxmd.com/read/28018873/restrictions-for-reimbursement-of-direct-acting-antiviral-treatment-for-hepatitis-c-virus-infection-in-canada-a-descriptive-study
#12
Alison D Marshall, Sahar Saeed, Lisa Barrett, Curtis L Cooper, Carla Treloar, Julie Bruneau, Jordan J Feld, Lesley Gallagher, Marina B Klein, Mel Krajden, Naglaa H Shoukry, Lynn E Taylor, Jason Grebely
BACKGROUND: In Canada, interferon-free, direct-acting antiviral hepatitis C virus (HCV) regimens are costly. This presents challenges for universal drug coverage of the estimated 220 000 people with chronic HCV infection nationwide. The study objective was to appraise criteria for reimbursement of 4 HCV direct-acting antivirals in Canada. METHODS: We reviewed the reimbursement criteria for simeprevir, sofosbuvir, ledipasvir-sofosbuvir and paritaprevir-ritonavir-ombitasvir plus dasabuvir in the 10 provinces and 3 territories...
October 2016: CMAJ Open
https://www.readbyqxmd.com/read/28011961/genotypic-analysis-of-hcv-1a-by-sequencing-of-the-ns3-proteasic-region-in-simeprevir-therapy-candidates
#13
Alfonso Liberti, Adriana Raddi, Nunzia Cuomo
Each phase of the HCV replication cycle can represent a therapy target. In fact, SIMEPREVIR (SMV) acts as NS3/4A protease inhibitor (PI); its efficacy is, however, reduced in HCV1a patients characterized by NS3Q80K polymorphism. The aim of this work was to design a genotypic analysis of NS3 protease in order to characterize viral quasispecies in HCV 1a patients before starting the SMV therapy. In all, 38 peripheral blood-EDTA samples were collected from patients infected with HCV 1a (RNA > 10,000 cp/ml)...
1, 2016: Le Infezioni in Medicina
https://www.readbyqxmd.com/read/28002876/outcomes-of-treatment-with-daclatasvir-and-asunaprevir-for-recurrent-hepatitis-c-after-liver-transplantation
#14
Masaki Honda, Yasuhiko Sugawara, Takehisa Watanabe, Masakuni Tateyama, Motohiko Tanaka, Koushi Uchida, Seiichi Kawabata, Daiki Yoshii, Kouhei Miura, Kaori Isono, Shintaro Hayashida, Yuki Ohya, Hidekazu Yamamoto, Yutaka Sasaki, Yukihiro Inomata
AIM: The development of direct - acting oral agents has dramatically changed the treatment strategy of hepatitis C virus (HCV) infection. Here we aimed to reveal the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) for recurrent HCV genotype 1 infection after liver transplantation (LT). METHODS: A retrospective study was conducted on 9 patients [5 men; 4 had failed peg-interferon/ribavirin, 2 had failed simeprevir/peg-interferon/ribavirin, 1 had the resistance-associated variant (RAV) Y93H in the NS5A region, 1 underwent maintenance dialysis ] who underwent a 24 -week DCV/ASV treatment regimen for recurrent HCV genotype 1 infection...
December 21, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27999010/pharmacokinetics-of-dolutegravir-and-rilpivirine-in-combination-with-simeprevir-and-sofosbuvir-in-hiv-hepatitis-c-virus-coinfected-patients-with-liver-cirrhosis
#15
Marco Merli, Laura Galli, Letizia Marinaro, Alessandra Ariaudo, Emanuela Messina, Caterina Uberti-Foppa, Antonella Castagna, Antonio D'Avolio, Adriano Lazzarin, Stefano Bonora, Hamid Hasson
OBJECTIVES: To evaluate the plasma trough concentrations (Ctrough) of dolutegravir and rilpivirine used in combination with simeprevir and sofosbuvir in HIV/hepatitis C virus (HCV)-coinfected patients with liver cirrhosis. Virological efficacy and safety of both ART and anti-HCV therapy were assessed. PATIENTS AND METHODS: A prospective observational study in HIV/HCV-coinfected patients with liver cirrhosis on ART with dolutegravir plus rilpivirine and treated with simeprevir plus sofosbuvir (±ribavirin) was conducted...
December 20, 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/27970818/psychometric-validation-of-four-patient-reported-outcome-instruments-in-a-diverse-sample-of-adults-with-chronic-hepatitis-c-virus-infection-treated-with-simeprevir-and-sofosbuvir
#16
A Trigg, H Kitchen, T Willgoss, K F Ho, R F Pierson, J Scott
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27943605/efficacy-and-safety-of-direct-acting-antivirals-based-antiviral-therapies-for-hepatitis-c-virus-patients-with-stage-4-5-chronic-kidney-disease-a-meta-analysis
#17
Tao Li, Yundong Qu, Ying Guo, Yan Wang, Lei Wang
BACKGROUND & AIMS: The aim of this study was to assess the efficacy and safety of direct-acting antivirals (DAA)-based antiviral therapies for HCV patients with stage 4-5 chronic kidney disease. METHODS: We conducted a systematic literature search in PubMed, EMBASE, Web of Science, and CENTRAL on the Cochrane Library without time and language limitations. The search strategy used was "(End stage renal disease OR chronic kidney failure OR severe renal impairment OR chronic kidney disease OR dialysis) AND (sofosbuvir OR simeprevir OR grazoprevir OR elbasvir OR ombitasvir OR paritaprevir OR ritonavir OR dasabuvir OR daclatasvir OR asuparevir OR direct-acting antiviral OR DAA)"...
December 10, 2016: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/27943523/safety-and-efficacy-of-daclatasvir-and-asunaprevir-in-hepatitis-c-virus-infected-patients-with-renal-impairment
#18
Goki Suda, Atsushi Nagasaka, Yoshiya Yamamoto, Ken Furuya, Kenichi Kumagai, Mineo Kudo, Katsumi Terashita, Tomoe Kobayashi, Izumi Tsunematsu, Junichi Yoshida, Takashi Meguro, Megumi Kimura, Jun Ito, Machiko Umemura, Takaaki Izumi, Seiji Tsunematsu, Fumiyuki Sato, Yoko Tsukuda, Masato Nakai, Takuya Sho, Mitsuteru Natsuizaka, Kenichi Morikawa, Koji Ogawa, Naoya Sakamoto
BACKGROUND AND AIM: Hepatitis C virus infection is a risk factor for end-stage renal disease, renal graft failure, and hemodialysis patient mortality. However, the efficacy of direct-acting antiviral therapy for hepatitis C virus-infected patients with renal impairment is unclear. Additionally, the promising NS5B-inhibitor sofosbuvir has not been recommended for patients with severe renal impairment. In this prospective, multicenter study, we evaluated the efficacy and safety of daclatasvir and asunaprevir combination therapy, with a focus on patients with renal impairment...
December 12, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
https://www.readbyqxmd.com/read/27932134/efficacy-and-safety-of-therapy-with-simeprevir-and-sofosbuvir-in-liver-transplant-recipients-infected-by-hepatitis-c-virus-genotype-4-cohort-spanish-society-of-liver-transplantation-cohort
#19
G Sanchez Antolin, M Testillano, J M Pascasio, I Narvaez Rodriguez, M Prieto, A Otero, J I Herrero, M Londoño, I Fernandez Vazquez, L Castells
BACKGROUND: Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of 2nd-generation direct-acting antivirals (DAAs), and more data are needed to help guide treatment decisions. We still have even fewer data concerning liver transplant patients. Simeprevir (SIM) and sofosbuvir (SOF) combination is useful to treat this genotype. The aim of this study was to know the efficacy and safety of the combination SIM + SOF ± ribavirin (RBV) in a group of liver transplant patients with HCV genotype 4 infection in Spain in real life...
November 2016: Transplantation Proceedings
https://www.readbyqxmd.com/read/27932113/hepatitis-c-treatment-with-direct-acting-antivirals-in-kidney-transplant-preliminary-results-from-a-multicenter-study
#20
M A Gentil, C González-Corvillo, M Perelló, S Zarraga, C Jiménez-Martín, L R Lauzurica, A Alonso, A Franco, D Hernández-Marrero, A Sánchez-Fructuoso
Hepatitis C (HC) is a very relevant negative prognosis factor for graft and transplant recipient survival. New direct-acting antivirals (DAAs) allow us to solve this problem in an effective way. It is crucial to understand their real impact in our daily practice. We analyzed treatment results with DAA, free of interferon, in kidney transplant recipients (KTRs) from 15 Spanish hospitals (Grupo Español de Actualización en Trasplante), regarding effectiveness, tolerance, and impact on immunosuppression, renal function-proteinuria, and diabetes...
November 2016: Transplantation Proceedings
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