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Telaprevir

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https://www.readbyqxmd.com/read/28261382/efficacy-and-safety-of-telaprevir-and-simeprevir-based-triple-therapies-for-older-patients-with-chronic-hepatitis-c
#1
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/28240597/telaprevir-containing-triple-therapy-in-acute-hcv-coinfection-the-chat-study
#2
Christoph Boesecke, Gurmit K Jagjit Singh, Stefan H-A Scholten, Thomas Lutz, Axel Baumgarten, Stephan M Schneeweiss, Andreas Trein, Michael Rausch, Patrick Ingiliz, Jürgen K Rockstroh, Mark Nelson
BACKGROUND: No published randomised controlled data on the use of direct acting antivirals (DAA) in acute hepatitis C (AHC) coinfection exist. However, with the AHC epidemic ongoing among men who have sex with men (MSM) these are urgently needed. METHODS: The CHAT study is a randomised controlled trial of pegylated interferon + ribavirin (PR) plus telaprevir (TVR) for 12-24 weeks versus PR alone for 24-48 weeks in the response guided treatment of patients with AHC genotype (GT) 1 infection and HIV-1 co-infection in Germany and Great Britain...
February 27, 2017: Antiviral Therapy
https://www.readbyqxmd.com/read/28217253/miliary-tuberculosis-infection-during-hepatitis-c-treatment-with-sofosbuvir-and-ledipasvir-plus-ribavirin
#3
Maria Pilar Ballester-Ferré, Fernando Martínez, Natalia Garcia-Gimeno, Francisco Mora, Miguel A Serra
Chronic hepatitis C virus (HCV) infection is one of the main causes of chronic liver disease worldwide. In the last 5 years, treatment for HCV infection has experienced a marked development. In 2014, the use of ledipasvir/sofosbuvir with or without concomitant weight-based ribavirin was approved with a very significant increase in the sustained virological response. However, new side effects have been associated. We report the first case of an HCV infected patient treated for 12 wk with the combination of sofosbuvir/ledipasvir plus ribavirin who developed a miliary tuberculosis (TB) infection while on therapy...
January 28, 2017: World Journal of Hepatology
https://www.readbyqxmd.com/read/28216512/risk-factors-for-treatment-discontinuation-caused-by-adverse-events-when-using-telaprevir-peginterferon-and-ribavirin-to-treat-chronic-hepatitis-c-a-real-world-retrospective-cohort-study
#4
Kazuki Ide, Yohei Kawasaki, Ryo Iketani, Naohiko Masaki
In this study, a nationwide database was used to identify the risk factors for treatment discontinuation due to adverse events during telaprevir, peginterferon, and ribavirin (T/PR) treatment, and estimate the increase in the occurrence of adverse events when patients have multiple risk factors at the same time. The risk factors were identified using univariate logistic regression analysis, and a Cochran-Armitage trend test was used to analyze the correlation between the number of risk factors and treatment discontinuation due to adverse events...
February 17, 2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28213381/outcomes-of-treatment-with-direct-acting-antivirals-for-infection-with-hepatitis-c-virus-genotypes-1-4-in-an-ambulatory-care-setting
#5
Timothy A Bach, Kathy Zaiken
PURPOSE: Outcomes with direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) genotypes 1-4 were determined. METHODS: A total of 360 patients at 36 clinical sites in Massachusetts with HCV genotypes 1-4 and a prescription for at least one DAA medication between May 2011 and October 2015 were included. The primary investigator completed a retrospective and concurrent chart review, and data were collected through April 2016. RESULTS: A total of 446 patients were assessed for eligibility into the study, with 86 patients excluded...
March 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28183221/sofosbuvir-in-the-treatment-of-early-hcv-infection-in-hiv-infected-men
#6
Ahmed El Sayed, Zachary R Barbati, Samuel S Turner, Andrew L Foster, Tristan Morey, Douglas T Dieterich, Daniel S Fierer
BACKGROUND: There is an international epidemic of hepatitis C virus (HCV) infection among HIV-infected men who have sex with men. We previously showed that adding telaprevir to pegylated interferon (IFN) and ribavirin (RBV) both shortened treatment and increased the cure rate of early HCV in these men. Whether shortening treatment of early HCV using IFN-free regimens would be similarly successful has not yet been demonstrated. METHODS: We performed a pilot study of treatment with sofosbuvir (SOF) + RBV for 12 weeks in early genotype 1 HCV infection in HIV-infected men...
March 2017: HIV Clinical Trials
https://www.readbyqxmd.com/read/28179602/the-safety-profile-of-telaprevir-based-triple-therapy-in-clinical-practice-a-retrospective-cohort-study
#7
Ryo Iketani, Kazuki Ide, Hiroshi Yamada, Yohei Kawasaki, Naohiko Masaki
This study was designed to evaluate the safety profile of adding telaprevir to therapy using pegylated interferon-alfa-2b and ribavirin (PR) using real world patient data obtained from a nationwide Japanese interferon database. This retrospective cohort study compared telaprevir-based triple therapy (T/PR) with PR therapy. The study population comprised patients with genotype 1 chronic hepatitis C represented in the database between December 2009 and August 2015. The primary endpoint was dropout from treatment due to adverse events during the relevant standard treatment duration based on guidelines from the Japan Society of Hepatology...
February 9, 2017: Biological & Pharmaceutical Bulletin
https://www.readbyqxmd.com/read/28174263/quantifying-antiviral-activity-optimizes-drug-combinations-against-hepatitis-c-virus-infection
#8
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/28138248/rapid-virological-response-of-telaprevir-and-boceprevir-in-a-brazilian-cohort-of-hcv-genotype-1-patients-a-multicenter-longitudinal-study
#9
Helena Hl Borba, Astrid Wiens, Laiza M Steimbach, Fernanda S Tonin, Maria LA Pedroso, Cláudia Ap Ivantes, Fernando Fernandez-Llimos, Roberto Pontarolo
BACKGROUND: Chronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil. MATERIALS AND METHODS: A prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28130810/shift-in-disparities-in-hepatitis-c-treatment-from-interferon-to-daa-era-a-population-based-cohort-study
#10
N Z Janjua, N Islam, J Wong, E M Yoshida, A Ramji, H Samji, Z A Butt, M Chong, D Cook, M Alvarez, M Darvishian, M Tyndall, M Krajden
We evaluated the shift in the characteristics of people who received interferon-based hepatitis C virus (HCV) treatments and those who received recently introduced direct-acting antivirals (DAAs) in British Columbia (BC), Canada. The BC Hepatitis Testers Cohort includes 1.5 million individuals tested for HCV or HIV, or reported cases of hepatitis B and active tuberculosis in BC from 1990 to 2013 linked to medical visits, hospitalization, cancer, prescription drugs and mortality data. This analysis included all patients who filled at least one prescription for HCV treatment until 31 July 2015...
January 27, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28127942/prevention-of-allograft-hcv-recurrence-with-peri-transplant-human-monoclonal-antibody-mbl-hcv1-combined-with-a-single-oral-direct-acting-antiviral-a-proof-of-concept-study
#11
H L Smith, R T Chung, P Mantry, W Chapman, M P Curry, T D Schiano, E Boucher, P Cheslock, Y Wang, D C Molrine
Patients with active hepatitis C virus (HCV) infection at transplantation experience rapid allograft infection, increased risk of graft failure and accelerated fibrosis. MBL-HCV1, a neutralizing human monoclonal antibody (mAb) targeting the HCV envelope, was combined with a licensed oral direct-acting antiviral (DAA) to prevent HCV recurrence post-transplant in an open-label exploratory efficacy trial. Eight subjects received MBL-HCV1 beginning on the day of transplant with telaprevir initiated between days 3 and 7 post-transplantation...
March 2017: Journal of Viral Hepatitis
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
#12
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/28118381/clinical-significance-of-two-real-time-pcr-assays-for-chronic-hepatitis-c-patients-receiving-protease-inhibitor-based-therapy
#13
Takako Inoue, Su Su Hmwe, Noritomo Shimada, Keizo Kato, Tatsuya Ide, Takuji Torimura, Takashi Kumada, Hidenori Toyoda, Akihito Tsubota, Koichi Takaguchi, Takaji Wakita, Yasuhito Tanaka
The aim of this study was to determine the efficacy of two hepatitis C virus (HCV) real-time PCR assays, the COBAS AmpliPrep/COBAS TaqMan HCV test (CAP/CTM) and the Abbott RealTime HCV test (ART), for predicting the clinical outcomes of patients infected with HCV who received telaprevir (TVR)-based triple therapy or daclatasvir/asunaprevir (DCV/ASV) dual therapy. The rapid virological response rates in patients receiving TVR-based triple therapy were 92% (23/25) and 40% (10/25) for CAP/CTM and ART, respectively...
2017: PloS One
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
#14
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/28092642/the-number-of-patients-with-chronic-hepatitis-c-in-times-of-new-therapy-options-a-retrospective-observational-study-on-german-health-insurance-funds-data
#15
Stefanie Thönnes, Heiko Friedel, Heike Fröhlich
AIM/OBJECTIVES/BACKGROUND: Chronic hepatitis C (CHC) virus infection is a leading cause of liver-related morbidity and mortality. In Germany, as in many other countries, there is a lack of comprehensive epidemiological data. Routine data from sickness funds can support the estimation of the true prevalence and incidence of CHC. METHODS: In this article, the results of annual and quarterly analyses of prevalence and incidence for the years 2007-2013 are presented using data of several German sickness funds...
January 12, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28011961/genotypic-analysis-of-hcv-1a-by-sequencing-of-the-ns3-proteasic-region-in-simeprevir-therapy-candidates
#16
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)...
December 1, 2016: Le Infezioni in Medicina
https://www.readbyqxmd.com/read/27994911/liver-apparent-diffusion-coefficient-changes-during-telaprevir-based-therapy-for-chronic-hepatitis-c
#17
Nagihan İnan Gürcan, Zakir Sakçı, Sıla Akhan, Elif Sargın Altunok, Aynur Aynıoğlu, Yeşim Gürbüz, Hasan Tahsin Sarisoy, Gür Akansel
BACKGROUND: Diffusion-weighted imaging (DWI) has become an established diagnostic modality for the evaluation of liver parenchymal changes in diseases such as diffuse liver fibrosis. AIMS: To evaluate the parenchymal apparent diffusion coefficient value (ADC) changes using diffusion-weighted imaging (DWI) during telaprevir-based triple therapy. STUDY DESIGN: Diagnostic accuracy study. METHODS: Seventeen patients with chronic hepatitis C virus (HCV) virus and twenty-five normal volunteers were included...
November 2016: Balkan Medical Journal
https://www.readbyqxmd.com/read/27882839/real-world-drug-costs-of-treating-hepatitis-c-genotypes-1-4-with-direct-acting-antivirals-initiating-treatment-at-fibrosis-0-2-and-3-4
#18
Timothy A Bach, Kathy Zaiken
BACKGROUND: Direct-acting antivirals (DAA) for the treatment of hepatitis C virus (HCV) have drastically improved outcomes but are also very costly. For this reason, priority for treatment is often given to patients with a higher fibrosis score at baseline by payers and providers rather than treating all eligible patients. Simulation studies have suggested that waiting to treat patients until fibrosis 3-4 may be more costly and result in worse outcomes; however, real-world implications are unknown...
December 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27882162/evaluation-of-the-health-related-quality-of-life-using-the-36-item-short-form-health-survey-in-patients-with-chronic-hepatitis-c-receiving-pegylated-interferon-ribavirin-telaprevir-triple-treatment
#19
Mitsuyuki Suzuki, Toru Ishikawa, Ai Sakuma, Satoshi Abe, Hiroko Abe, Fujiko Koyama, Tomomi Nakano, Aya Ueki, Hirohito Noguchi, Erina Hasegawa, Shiori Yamagata, Miki Kobayashi, Kazutaka Ohashi, Hiroshi Hirosawa, Takako Fukazawa, Yuka Maruyama, Toshiaki Yoshida
The rate of sustained virologic response (SVR) has increased in patients with chronic hepatitis C (CHC; genotype 1) since triple treatment with pegylated interferon (PEG-IFN), ribavirin (RBV) and telaprevir (TVR) was included in Japanese health insurance. However, side effects such as high-grade anemia and skin disorders means it is important to investigate the extent to which quality of life (QOL) is maintained during treatment. The impact on health-related (HR) QOL, as a result of TVR-based triple treatment was investigated long-term (48 weeks) in 34 patients (18 men, 16 women) following TVR-based triple treatment, using the 36-item short form health survey (SF-36)...
November 2016: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/27861593/neutrophil-and-monocyte-function-in-patients-with-chronic-hepatitis-c-undergoing-antiviral-therapy-with-regimens-containing-protease-inhibitors-with-and-without-interferon
#20
Martina Gambato, Noelia Caro-Pérez, Patricia González, Nuria Cañete, Zoe Mariño, Sabela Lens, Martín Bonacci, Concepció Bartres, José-María Sánchez-Tapias, José A Carrión, Xavier Forns, Manel Juan, Sofía Pérez-Del-Pulgar, María-Carlota Londoño
Real-life data showed an increased incidence of bacterial infections in patients with advanced liver disease receiving a protease inhibitor (PI)-containing antiviral regimen against hepatitis C (HCV). However, the causes of this event are unknown. We hypothesized that PIs might impair innate immune responses through the inhibition of proteases participating in the anti-bacterial functions of neutrophils and monocytes. The aims of the study were to assess phagocytic and oxidative burst capacity in neutrophils and monocytes obtained from patients receiving a PI containing-antiviral regimen, and to determine cytokine secretion after neutrophil stimulation with flagellin...
2016: PloS One
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