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Simeprevir

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https://www.readbyqxmd.com/read/29906601/sofosbuvir-in-combination-with-daclatasvir-or-simeprevir-for-12-weeks-in-non-cirrhotic-subjects-chronically-infected-with-hepatitis-c-virus-genotype-1-a-randomized-clinical-trial
#1
Henrique Pott Junior, Guilherme Bricks, Giuliano Grandi, Jorge Figueiredo Senise, Adauto Castelo Filho
OBJECTIVES: This study aimed to investigate the efficacy and safety of sofosbuvir plus daclatasvir (SOF+DCV) or simeprevir (SOF+SMV) in a randomized, open-label, non-inferiority trial of patients infected with hepatitis c virus (HCV) genotype 1, who were previously unresponsive to pegylated interferon and ribavirin or were treatment-naïve. METHODS: Patients were randomly assigned to receive SOF (400 mg once daily) plus DCV (60 mg once daily) or SMV (150 mg once daily) for 12 weeks...
June 12, 2018: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29843679/direct-acting-antiviral-treatment-in-real-world-patients-with-hepatitis-c-not-associated-with-psychiatric-side-effects-a-prospective-observational-study
#2
Isak Sundberg, Anders Lannergård, Mia Ramklint, Janet L Cunningham
BACKGROUND: Treatment of Hepatitis C virus (HCV) infection has evolved from interferon (IFN)-based treatments to direct-acting antivirals (DAAs). Patients with HCV have an elevated psychiatric morbidity (including substance abuse) and patients with such comorbidity have often been excluded from treatment with IFN. To date, little is known about psychiatric adverse effects of DAA-based regimens. We therefore aimed to study the psychiatric side effects of new IFN-free treatment for HCV (including depressive symptoms and sleep) in real world patients also including those with a history of psychiatric diagnosis, substance abuse or drug dependence...
May 29, 2018: BMC Psychiatry
https://www.readbyqxmd.com/read/29771105/direct-acting-antiviral-agents-in-patients-with-hepatitis-c-genotype-1-4-infections-in-a-tertiary-hospital
#3
J C Del Rio-Valencia, R Asensi-Diez, L Villalobos-Torres, I Muñoz Castillo
OBJECTIVE: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease. Six different genotypes (GT) of HCV (genotypes 1-6) have been identified. The genotype is clinically relevant since the majority of current direct antiviral agents (DAA´s) do not have pangenotypic efficacy. The purpose of this study was to describe the clinical characteristics of real world patients and evaluate the effectiveness of different treatment regimens. METHODS: Retrospective and observational study carried out in a third level hospital...
May 16, 2018: Revista Española de Quimioterapia: Publicación Oficial de la Sociedad Española de Quimioterapia
https://www.readbyqxmd.com/read/29752891/effectiveness-and-tolerability-of-direct-acting-antivirals-for-chronic-hepatitis-c-patients-in-a-southern-state-of-brazil
#4
Vinicius Lins Ferreira, Helena Hiemisch Lobo Borba, Astrid Wiens, Maria Lucia Alves Pedroso, Vanessa Ferreira de Camargo Radunz, Cláudia Alexandra Pontes Ivantes, Aline Satie Oba Kuniyoshi, Roberto Pontarolo
BACKGROUND: This study aimed to evaluate the clinical effectiveness in terms of sustained virological response (SVR) and tolerability of available second generation direct-acting antivirals (DAAs) in Brazilian patients. METHODS: This was a retrospective observational study conducted in six centers in Southern Brazil. The sample comprised adult patients who were chronically infected with hepatitis C virus (HCV), regardless of virus genotype, fibrosis stage, or prior treatment...
May 9, 2018: Brazilian Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29740528/treatment-with-sofosbuvir-and-daclatasvir-with-or-without-ribavirin-improves-patient-reported-outcomes-in-hepatitis-c
#5
Lucas Pereira Jorge de Medeiros, Mario Barreto Correa Lima, Marcia Maria Amêndola Pires, Alessandra Mendonça Almeida Maciel, Renata Barboza Vianna Medeiros, Mariana Dermínio Donadel, Isabela Martins Becattini Pereira, Fábio Marchon Leão, Luiz Eduardo Amorim Correa Lima Pires, Helio Rzetelna, Carlos Eduardo Brandão-Mello
Objectives: To evaluate the impact of 3 treatment regimens upon health-related quality of life and work productivity using patient-reported outcomes (PROs) in chronic hepatitis C infected patients: sofosbuvir (SOF) + daclatasvir (DCV); SOF + DCV + ribavirin (RBV); SOF + simeprevir (SMV). Methods: 4 questionnaires were used to evaluate PROs before, during and after treatment: Short Form-36 (SF-36), Chronic Liver Disease Questionnaire (CLDQ) - hepatitis C virus (HCV), Work Productivity and Activity Index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)...
April 2018: Osong Public Health and Research Perspectives
https://www.readbyqxmd.com/read/29736243/pharmacokinetics-safety-and-tolerability-of-the-2-and-3-direct-acting-antiviral-combination-of-al-335-odalasvir-and-simeprevir-in-healthy-subjects
#6
Thomas N Kakuda, Matthew W McClure, Christopher Westland, Jennifer Vuong, Marie-Claude Homery, Gwendoline Poizat, Laure Viguerie, Caroline Denot, Alain Patat, Qingling Zhang, James Hui, David Apelian, David B Smith, Sushmita M Chanda, John Fry
This Phase I, open-label, two-group, fixed-sequence study evaluated the pharmacokinetics and safety of AL-335, odalasvir, and simeprevir in healthy subjects. Group 1 (n   =   16) received AL-335 800 mg once daily (QD) (days 1-3, 11-13, and 21-23), simeprevir 150 mg QD (days 4-23), and odalasvir 150 mg (day 14) followed by 50 mg QD (days 15-23). Group 2 (n   =   16) received the same AL-335 regimen as in Group 1 plus odalasvir 150 mg (day 4) followed by 50 mg QD (days 5-23) and simeprevir 150 mg QD (days 14-23)...
June 2018: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/29735803/the-observed-effect-of-gastric-bypass-surgery-on-direct-acting-antiviral-treatment-a-case-report
#7
Elise J Smolders, Sophie B Willemse, Omar El-Sherif, Saye Khoo, David M Burger
Chronic hepatitis C virus (HCV) infection can be cured with treatment using direct-acting antivirals (DAAs). Although these drugs have been widely studied, information about certain special populations is missing. In this case report we describe a treatment-experienced patient with chronic HCV infection genotype 1b, treated with 150 mg/day simeprevir, 400 mg/day sofosbuvir, and 1,000 mg/ day ribavirin for 24 weeks, after a Roux-and-Y gastric bypass. At steady-state a pharmacokinetic curve was recorded of sofosbuvir, GS-331007, and simeprevir...
April 9, 2018: Annals of Hepatology
https://www.readbyqxmd.com/read/29727383/hepatitis-c-virus-treatment-by-direct-acting-antivirals-in-successfully-treated-hepatocellular-carcinoma-and-possible-mutual-impact
#8
Mohamed Hassany, Aisha Elsharkawy, Amr Maged, Mai Mehrez, Noha Asem, Ahmed Gomaa, Zeinab Mostafa, Bahaa Abbas, Mohamad Soliman, Gamal Esmat
BACKGROUND AND AIMS: Treatment of hepatitis C virus (HCV) after successfully treated hepatocellular carcinoma (HCC) becomes possible with the introduction of direct-acting antivirals because of their favorable efficacy, safety, and short period of treatment. Few data are available on the results of treatment using different direct-acting antiviral regimens in successfully treated HCC and a lot of debate about its role in tumor recurrence. METHODS: Sixty-two HCV-related HCC patients were enrolled in the study after successfully treated HCC; the studied population included either Child-Pugh 'A' or 'B7'...
May 1, 2018: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29722439/high-efficacy-of-direct-acting-anti-viral-agents-in-hepatitis-c-virus-infected-cirrhotic-patients-with-successfully-treated-hepatocellular-carcinoma
#9
M Persico, A Aglitti, A Aghemo, M Rendina, A Lleo, A Ciancio, V Di Marco, P Lampertico, M R Brunetto, M Zuin, P Andreone, E Villa, G Troshina, V Calvaruso, E Degasperi, B Coco, A Giorgini, F Conti, A Di Leo, L Marzi, V Boccaccio, S Bollani, P Maisonneuve, S Bruno
BACKGROUND: The efficacy of direct-acting anti-viral (DAA) therapy in patients with a history of hepatocellular carcinoma (HCC) is unknown. AIM: We prospectively evaluated whether previously treated HCC affects DAA efficacy in a large real-life cohort of cirrhotic patients. METHODS: From January to December 2015 all consecutive HCV mono-infected patients with cirrhosis and/or history of HCC attending 10 Italian tertiary liver centres were enrolled...
May 3, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29702515/integrated-care-for-the-use-of-direct-acting-antivirals-in-patients-with-chronic-hepatitis-c-and-substance-use-disorder
#10
Jean-Baptiste Trabut, Camille Barrault, Hélène Charlot, Damien Carmona, Anne Bourdel, Mustapha Benslimane, Murielle François, Willy Kini-Matondo, Richard Causse, Françoise Roudot-Thoraval, Christophe Hézode
OBJECTIVES: Since little is currently known about predictors of response to direct-acting antiviral agents (DAAs) in people who inject drugs, we undertook an analysis of patients attending a hepatitis clinic with addiction services (outpatient clinics and inpatient services) to examine the outcomes associated with the treatment of difficult-to-manage patients with substance use. Our experience was based on integrated care. METHOD: A retrospective analysis was undertaken of 50 patients with hepatitis C virus (HCV) and a history of addiction who received treatment with DAAs, according to European guidelines...
April 26, 2018: Journal of Addiction Medicine
https://www.readbyqxmd.com/read/29695614/the-drug-drug-interaction-potential-of-antiviral-agents-for-the-treatment-of-chronic-hepatitis-c-infection
#11
Kimberly L Garrison, Polina German, Erik Mogalian, Anita Mathias
Several safe and highly-effective directly-acting antiviral drugs for chronic hepatitis C virus (HCV) have been developed and greatly increase the number of treatment options available to successfully treat HCV infection. However, as treatment regimens contain at least two drugs (e.g., sofosbuvir with daclatasvir, simeprevir, ledipasvir, or velpatasvir; elbasvir and grazoprevir) and up to five drugs (ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin), the potential for drug-drug interactions (DDI) becomes an important consideration for HCV-infected individuals with comorbidities that require concomitant medications, such as HIV/HCV co-infection or immunosuppression following liver transplantation...
April 25, 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29681166/direct-acting-antivirals-to-prevent-vertical-transmission-of-viral-hepatitis-c-when-is-the-optimal-time-to-treat
#12
Leigh Cervino, Lauren M Hynicka
OBJECTIVE: To describe the most current evidence for the use of direct-acting antivirals (DAAs) to treat hepatitis C along the pregnancy-pediatric continuum in the United States. DATA SOURCES: The MEDLINE/PubMed databases were searched (January 1995 to February 2018) for articles in English using the terms: hepatitis C, vertical transmission, pregnancy, pediatrics, ribavirin, interferon, direct acting antivirals, daclatasvir, dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, simeprevir, sofosbuvir, and velpatasvir...
April 1, 2018: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/29661883/unexpected-replication-boost-by-simeprevir-for-simeprevir-resistant-variants-in-genotype-1a-hepatitis-c-virus
#13
Kazuhisa Murai, Tetsuro Shimakami, Christoph Welsch, Takayoshi Shirasaki, Fanwei Liu, Juria Kitabayashi, Shiho Tanaka, Masaya Funaki, Hitoshi Omura, Tomoki Nishikawa, Ariunaa Suminyadorj, Masao Honda, Shuichi Kaneko
Simeprevir is a novel NS3/4A protease inhibitor (PI) of hepatitis C virus (HCV). The baseline polymorphism NS3-Q80K is frequently observed in genotype (gt) 1a HCV and often associated with treatment failure in simeprevir-containing regimens. We aimed to elucidate mechanisms of treatment failure due to NS3-Q80K. We included a Q80R mutation in our study and generated a series of Huh-7.5 cells, each of which harbored either wild-type gt 1a H77S.3 or one of the variants, Q80K or Q80R. The cells were cultured with increasing concentrations of simeprevir, and NS3 domain sequences were determined...
April 16, 2018: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29582685/-real-life-experience-with-direct-acting-antiviral-agents-for-hepatitis-c-virus-in-end-stage-renal-disease
#14
Rebeca García-Agudo, Sami Aoufi-Rabih, Mercedes Salgueira-Lazo, Carmen González-Corvillo, Fabrizio Fabrizi
BACKGROUND AND AIMS: The advent of direct-acting antiviral agents promises to change the management of hepatitis C in patients with end-stage renal disease, a patient group where the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' group of patients with end-stage renal disease. METHODS: We performed a single-arm, multi-centre study in a cohort (n=30) of patients with advanced chronic kidney disease (mostly on dialysis) who underwent antiviral therapy with direct-acting antiviral agents...
March 1, 2018: International Journal of Artificial Organs
https://www.readbyqxmd.com/read/29579872/therapy-with-direct-acting-antiviral-agents-for-hepatitis-c-in-liver-transplant-recipients
#15
F Nogueras López, A López Garrido, E J Ortega Suazo, F Vadillo Calles, F Valverde López, M D Espinosa Aguilar
BACKGROUND: Recurrent infection with the hepatitis C virus (HCV) after liver transplantation (LT) is associated with decreased graft and patient survival. Direct-acting antiviral (DAA) therapies have changed the landscape of HCV due to their excellent safety profile and cure rates. Our aim was to evaluate the efficacy and tolerability of antiviral therapy in recurrent HCV after LT with DAA therapy. METHODS: Our retrospective analysis included 46 LT recipients with HCV recurrence...
March 2018: Transplantation Proceedings
https://www.readbyqxmd.com/read/29572811/teledermatologist-expert-skin-advice-a-unique-model-of-care-for-managing-skin-disorders-and-adverse-drug-reactions-in-hepatitis-c-patients
#16
Samuel Charlston, Gregory Siller
OBJECTIVES: To conduct an audit of teledermatologist expert skin advice, a store and forward tele-dermatological service, to determine its effectiveness and user satisfaction in managing cutaneous adverse drug reactions in patients with hepatitis C, and to demonstrate a unique collaborative model of care for patients receiving specialised drug therapy. METHODS: A retrospective analysis of data on teledermatologist expert skin advice referrals from January 2014 to December 2015 was performed...
March 23, 2018: Australasian Journal of Dermatology
https://www.readbyqxmd.com/read/29572333/risk-of-clinically-relevant-pharmacokinetic-based-drug-drug-interactions-with-drugs-approved-by-the-u-s-food-and-drug-administration-between-2013-and-2016
#17
Jingjing Yu, Zhu Zhou, Jessica Tay-Sontheimer, René H Levy, Isabelle Ragueneau-Majlessi
A total of 103 drugs (including 14 combination drugs) were approved by the U.S. Food and Drug Administration from 2013 to 2016. Pharmacokinetic-based drug interaction profiles were analyzed using the University of Washington Drug Interaction Database, and the clinical relevance of these observations was characterized based on information from new drug application reviews. CYP3A was involved in approximately two-thirds of all drug-drug interactions (DDIs). Transporters (alone or with enzymes) participated in about half of all interactions, but most of these were weak-to-moderate interactions...
June 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29569736/safety-and-efficacy-of-ledipasvir-sofosbuvir-with-or-without-ribavirin-in-hepatitis-c-genotype-1-patients-including-those-with-decompensated-cirrhosis-who-failed-prior-treatment-with-simeprevir-sofosbuvir
#18
A A Modi, H E Nazario, G R Gonzales, S A Gonzalez
BACKGROUND: Combination therapy of simeprevir (SIM)/sofosbuvir (SOF) is an approved treatment for hepatitis C genotype (gen) 1 with overall SVR12 rate of 85%-95%. The single tablet fixed-dose combination of ledipasvir (LDV)/SOF is also approved for gen 1 with sustained virologic response at 12 weeks (SVR12) rates ≥95%. No data are available on the efficacy of retreatment with LDV/SOF in patients who failed initial treatment with SIM/SOF. AIM: To evaluate the efficacy of retreatment with LDV/SOF ± ribavirin (RBV) in gen 1 patients who had previously failed treatment with SIM/SOF...
May 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29549787/identification-of-nucleotides-in-the-5-utr-and-amino-acids-substitutions-that-are-essential-for-the-infectivity-of-5-utr-ns5a-recombinant-of-hepatitis-c-virus-genotype-1b-strain-con1
#19
Jinqian Li, Shengjun Feng, Xi Liu, Mingzhe Guo, Mingxiao Chen, Yiyi Chen, Liang Rong, Jinyu Xia, Yuanping Zhou, Jin Zhong, Yi-Ping Li
Genotype 1b strain Con1 represents an important reference in the study of hepatitis C virus (HCV). Here, we aimed to develop an advanced infectious Con1 recombinant. We found that previously identified mutations A1226G/F1464L/A1672S/Q1773H permitted culture adaption of Con1 Core-NS5A (C-5A) recombinant containing 5'UTR and NS5B-3'UTR from JFH1 (genotype 2a), thus acquired additional mutations L725H/F886L/D2415G. C-5A containing all seven mutations (C-5A_7m) replicated efficiently in Huh7.5 and Huh7.5.1 cells and had an increased infectivity in SEC14L2-expressing Huh7...
May 2018: Virology
https://www.readbyqxmd.com/read/29504152/the-adverse-effects-of-interferon-free-regimens-in-149-816-chronic-hepatitis-c-treated-egyptian-patients
#20
D Attia, K El Saeed, W Elakel, T El Baz, A Omar, A Yosry, M H Elsayed, M Said, M El Raziky, M Anees, W Doss, Y El Shazly, H Wedemeyer, G Esmat
BACKGROUND: Interferon-free regimens are associated with high sustained virological response; however, associated adverse effects have yet to be fully reported. AIM: To evaluate the adverse effects associated with the different direct-acting antiviral drug (DAA) regimens in Egyptian patients. METHODS: This multicenter retrospective study included all adverse effects during and after treatment with DAA regimens of 149 816 chronic hepatitis C treated Egyptian patients...
May 2018: Alimentary Pharmacology & Therapeutics
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