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Helena H Borba, Astrid Wiens, Laiza M Steimbach, Cassio M Perlin, Fernanda S Tonin, Maria L A Pedroso, Fernando Fernandez-Llimos, Roberto Pontarolo
PURPOSE: This study aimed to compare the efficacy among direct-acting antiviral agents (first and second-generation direct-acting antiviral agents (DAAs)) with placebo and with standard dual therapy (pegylated interferon + ribavirin (Peg-IFN + RBV)) in terms of rapid virologic response (RVR) and sustained virologic response (SVR) in chronic hepatitis C genotype 1 treatment. METHODS: We performed a systematic review of randomized controlled trials (RCTs) in MEDLINE, International Pharmaceutical Abstracts, Cochrane Library, SCIELO, and Scopus and conducted a network meta-analysis to compare the efficacy of boceprevir (BOC), daclatasvir (DCV), grazoprevir, simeprevir (SMV) and telaprevir (TVR), in treatment-naive and treatment-experienced patients...
October 19, 2016: European Journal of Clinical Pharmacology
Robert Flisiak, Mitchell Shiffman, Juan Arenas, Hugo Cheinquer, Igor Nikitin, Yuping Dong, Khurram Rana, Subasree Srinivasan
BACKGROUND: A randomized, double-blind, multinational, phase 3 study was conducted comparing the efficacy and safety of peginterferon lambda-1a (Lambda)/ribavirin (RBV)/telaprevir (TVR) vs. peginterferon alfa-2a (Alfa)/RBV/TVR in patients with chronic hepatitis C virus (HCV) genotype-1 (GT-1) infection. METHODS: Patients (treatment-naïve or relapsers on prior Alfa/RBV treatment) were randomly assigned in a 2:1 ratio to receive Lambda/RBV/TVR or Alfa/RBV/TVR. Total duration of treatment was either 24 or 48 weeks (response-guided treatment), with TVR administered for the first 12 weeks...
2016: PloS One
Perica Davitkov, Apoorva Krishna Chandar, Amy Hirsch, Anita Compan, Marina G Silveira, Donald D Anthony, Suzanne Smith, Clare Gideon, Robert A Bonomo, Yngve Falck-Ytter
BACKGROUND: Clinicians often face dilemmas with decisions related to formulary choices when two similar drugs are simultaneously available in the market. We studied the comparative safety, effectiveness, and treatment costs of the two first generation direct-acting antiviral agents (DAA), boceprevir and telaprevir as uncertainty existed regarding the drug of choice between these two seemingly equally Hepatitis-C treatment options. METHODS: We randomly assigned 50 patients in an open-label, pragmatic randomized controlled trial (RCT) at a VA Medical Center to either boceprevir or telaprevir in combination with peginterferon and ribavirin, stratified by the presence of cirrhosis and prior treatment experience...
2016: PloS One
Zobair M Younossi, Haesuk Park, Douglas Dieterich, Sammy Saab, Aijaz Ahmed, Stuart C Gordon
BACKGROUND: New direct-acting antiviral (DAA) therapy has dramatically increased cure rates for patients infected with hepatitis C virus (HCV), but has also substantially raised treatment costs. AIM: The aim of this analysis was to evaluate the therapeutic benefit and net costs (i.e. efficiency frontier) and the quality-adjusted cost of care associated with the evolution of treatment regimens for patients with HCV genotype 1 in the United States. DESIGN: A decision-analytic Markov model...
October 2016: Medicine (Baltimore)
Laura I Mosquera-Giraldo, Carlos H Borca, Xiangtao Meng, Kevin J Edgar, Lyudmila V Slipchenko, Lynne S Taylor
Polymers play a key role in stabilizing amorphous drug formulations, a recent strategy employed to improve solubility and bioavailability of drugs delivered orally. However, the molecular mechanism of stabilization is unclear, therefore, the rational design of new crystallization-inhibiting excipients remains a substantial challenge. This article presents a combined experimental and computational approach to elucidate the molecular features that improve the effectiveness of cellulose polymers as solution crystallization inhibitors, a crucial first step toward their rational design...
October 7, 2016: Biomacromolecules
Linh Thuy Nguyen, Emma Gray, Aisling O'Leary, Michael Carr, Cillian F De Gascun
Direct-acting antiviral (DAA) therapies have revolutionised the treatment of hepatitis C virus (HCV). The financial cost of DAAs however is significant, and first generation protease inhibitors (PIs) also require frequent monitoring of viral RNA levels to guide treatment. In this context, we examined the relevance of HCV antigen testing to evaluate the potential role in monitoring virological response to HCV antiviral treatment with the PI-based triple therapies, telaprevir (TVR) and boceprevir (BOC). Chronic HCV-infected individuals (n = 152) enrolled in the Irish Hepatitis C Outcomes Research Network (ICORN) study were prospectively analysed for baseline markers and the early viral kinetics associated with SVR...
2016: PloS One
Steffen Zopf, Lara Rösch, Peter C Konturek, Ruediger S Goertz, Markus F Neurath, Deike Strobel
BACKGROUND Non-invasive procedures such as acoustic radiation force impulse imaging (ARFI) shear-wave elastography are currently used for the assessment of liver fibrosis. In the course of chronic hepatitis C, significant liver fibrosis or cirrhosis develops in approximately 25% of patients, which is a negative predictor of antiviral treatment response. Cirrhosis can be prevented by successful virus elimination. In this prospective study, a pretreatment ARFI cutoff value of 1.5 m/s was evaluated in relation to sustained virological response to anti-HCV therapy...
2016: Medical Science Monitor: International Medical Journal of Experimental and Clinical Research
Jagpreet Chhatwal, Tianhua He, Chin Hur, Maria A Lopez-Olivo
BACKGROUND & AIMS: Direct-acting antivirals (DAAs) are effective in treatment of hepatitis C virus (HCV) genotype 1 infection, but their cost and value have been debated. We performed a systematic review of published cost-effectiveness analyses of DAAs, synthesized their results with updated drug prices, and calculated the maximum price at which DAA therapy for HCV genotype 1 infection is cost effective (increased quality-adjusted life-years [QALYs]) and increased cost that the society is willing to pay) and cost saving (increased QALYs and decreased costs)...
September 17, 2016: Clinical Gastroenterology and Hepatology
Benjamin Maasoumy, Johannes Vermehren
On-treatment hepatitis C virus (HCV) RNA has been used to predict response to interferon (IFN)-based therapy. The concept of response-guided treatment (RGT) was established to determine optimal treatment duration and to early identify patients not responding to futile therapies. RGT helped to improve sustained virologic response (SVR) rates and lower the rates of adverse effects. RGT was of particular importance for telaprevir- and boceprevir-based triple therapies. RGT strategies are dependent on highly sensitive and reproducible HCV RNA quantification...
October 2016: Journal of Hepatology
Preston W Chadwick, Warren R Heymann
No abstract text is available yet for this article.
August 2016: Cutis; Cutaneous Medicine for the Practitioner
Nadia Marascio, Grazia Pavia, Alessio Strazzulla, Tim Dierckx, Lize Cuypers, Bram Vrancken, Giorgio Settimo Barreca, Teresa Mirante, Donatella Malanga, Duarte Mendes Oliveira, Anne-Mieke Vandamme, Carlo Torti, Maria Carla Liberto, Alfredo Focà, The Sinergie-Umg Study Group
Naturally occurring resistance-associated substitutions (RASs) can negatively impact the response to direct-acting antivirals (DAAs) agents-based therapies for hepatitis C virus (HCV) infection. Herein, we set out to characterize the RASs in the HCV1b genome from serum samples of DAA-naïve patients in the context of the SINERGIE (South Italian Network for Rational Guidelines and International Epidemiology, 2014) project. We deep-sequenced the NS3/4A protease region of the viral population using the Ion Torrent Personal Genome Machine, and patient-specific majority rule consensus sequence summaries were constructed with a combination of freely available next generation sequencing data analysis software...
2016: International Journal of Molecular Sciences
A Igarashi, W Tang, I Guerra, L Marié, S Cure, M Lopresti
OBJECTIVE: Hepatitis C is the result of a ribonucleic acid (RNA) virus (hepatitis C virus; HCV). The Japan Society of Hepatology (JSH) estimated that 1.5-2 million people in Japan carry HCV. Six major HCV genotypes (GT) and a large number of subtypes have been described in the literature. In Japan, around 70% to 80% of people are infected with HCV genotype 1b. The progress of the disease primarily affects the liver and may lead to liver cirrhosis, hepatocellular carcinoma (HCC) and death...
September 9, 2016: Current Medical Research and Opinion
A Igarashi, W Tang, S Cure, I Guerra, L Marié, M Lopresti, K Tsutani
OBJECTIVE: Across Japan, around 2 million people are infected with hepatitis C virus (HCV) with long-term complications such as cirrhosis, hepatocellular carcinoma (HCC) and liver transplant (LT). Current treatment options have several limitations due to side effects, interferon intolerability and ineligibility, long treatment durations and low sustained virological responses (SVR) rates, especially for the most severe patients. Sofosbuvir (SOF) is the first nucleotide analog NS5B polymerase inhibitor with pan-genotypic activity...
September 8, 2016: Current Medical Research and Opinion
Naoki Morishita, Naoki Hiramatsu, Tsugiko Oze, Ayako Urabe, Yuki Tahata, Ryoko Yamada, Takayuki Yakushijin, Atsushi Hosui, Sadaharu Iio, Akira Yamada, Hideki Hagiwara, Eiji Mita, Yukinori Yamada, Toshifumi Ito, Masami Inada, Kazuhiro Katayama, Iwao Yabuuchi, Yasuharu Imai, Hayato Hikita, Ryotaro Sakamori, Yuichi Yoshida, Tomohide Tatsumi, Norio Hayashi, Tetsuo Takehara
AIM: Simeprevir (SMV)-based triple therapy is an effective retreatment option following failure of telaprevir (TVR)-based triple therapy. However, it is unclear whether the persistence of resistance-associated variants (RAVs) induced by TVR-based therapy may reduce the treatment effect of SMV-based therapy. METHODS: The factors associated with the treatment effect, including RAVs in the NS3 region, were examined in 21 patients with genotype 1b HCV infection who were treated with SMV-based therapy after failure of TVR-based therapy...
September 4, 2016: Hepatology Research: the Official Journal of the Japan Society of Hepatology
Luciana Santos Pessoa, Luãnna Liebscher Vidal, Emmerson C B da Costa, Celina Monteiro Abreu, Rodrigo Delvecchio da Cunha, Ana Luiza Chaves Valadão, André Felipe Dos Santos, Amilcar Tanuri
Approximately 185 million people worldwide are chronically infected with hepatitis C virus (HCV). The first-wave of approved NS3 protease inhibitors (PIs) were Telaprevir and Boceprevir, which are currently discontinued. Simeprevir is a second-wave PI incorporated into the Brazilian hepatitis C treatment protocol. Drug resistance plays a key role in patients' treatment regimen. Here, we developed a simple phenotypic assay to evaluate the impact of resistance mutations in HCV NS3 protease to PIs, using a protein expression vector containing wild type NS3 protease domain and NS4A co-factor...
July 2016: Genetics and Molecular Biology
Cleo Study Group, Antonio Ascione, Luigi Elio Adinolfi, Pietro Amoroso, Angelo Andriulli, Orlando Armignacco, Tiziana Ascione, Sergio Babudieri, Giorgio Barbarini, Michele Brogna, Francesco Cesario, Vincenzo Citro, Ernesto Claar, Raffaele Cozzolongo, Giuseppe D'Adamo, Emilio D'Amico, Pellegrino Dattolo, Massimo De Luca, Vincenzo De Maria, Massimo De Siena, Giuseppe De Vita, Antonio Di Giacomo, Rosanna De Marco, Giorgio De Stefano, Giulio De Stefano, Sebastiano Di Salvo, Raffaele Di Sarno, Nunzia Farella, Laura Felicioni, Basilio Fimiani, Luca Fontanella, Giuseppe Foti, Caterina Furlan, Francesca Giancotti, Giancarlo Giolitto, Tiziana Gravina, Barbara Guerrera, Roberto Gulminetti, Angelo Iacobellis, Michele Imparato, Angelo Iodice, Vincenzo Iovinella, Antonio Izzi, Alfonso Liberti, Pietro Leo, Gennaro Lettieri, Ileana Luppino, Aldo Marrone, Ettore Mazzoni, Vincenzo Messina, Roberto Monarca, Vincenzo Narciso, Lorenzo Nosotti, Adriano Maria Pellicelli, Alessandro Perrella, Guido Piai, Antonio Picardi, Paola Pierri, Grazia Pietromatera, Francesco Resta, Luca Rinaldi, Mario Romano, Angelo Rossini, Maurizio Russello, Grazia Russo, Rodolfo Sacco, Vincenzo Sangiovanni, Antonio Schiano, Antonio Sciambra, Gaetano Scifo, Filomena Simeone, Annarita Sullo, Pierluigi Tarquini, Paolo Tundo, Alfredo Vallone
AIM: To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1...
August 8, 2016: World Journal of Hepatology
Heather J McElroy, Stuart K Roberts, Alex J Thompson, Peter W Angus, Sarah Jane McKenna, Emma Warren, Sharon Musgrave
OBJECTIVE: To evaluate medical resource utilization (MRU) and associated costs among Australian patients with genotype 1 chronic hepatitis C (GT1 CHC), including both untreated patients and those receiving treatment with first-generation protease inhibitor-based regimens (telaprevir, boceprevir with pegylated interferon and ribavirin). METHODS: Medical records were reviewed for a stratified random sample of GT1 CHC patients first attending two liver clinics between 2011 and 2013 (principal population; PP), supplemented by all GT1 CHC patients attending one transplant clinic in the same period (transplant population; TP)...
August 23, 2016: Journal of Medical Economics
Yoko Yamagiwa, Mai Asano, Youhei Kawasaki, Masaaki Korenaga, Kazumoto Murata, Tatsuya Kanto, Masashi Mizokami, Naohiko Masaki
AIM: Telaprevir (TVR) remarkably improves the efficacy of interferon treatment for chronic hepatitis C. Interleukin-28B (IL28B) genotype and interferon-gamma-inducible protein-10 (IP-10) level predict virologic response to peg-interferon (Peg-IFN)/ribavirin (RBV) therapy. We aimed to investigate the usefulness of pretreatment serum IP-10 levels and IL28B genotyping in predicting sustained virologic response (SVR) to TVR-based triple therapy. METHODS: In this multi-center study, patients infected with hepatitis C virus genotype 1 with high viral load (⩾5...
December 2016: Cytokine
Masahiro Kobayashi, Fumitaka Suzuki, Shunichiro Fujiyama, Yusuke Kawamura, Hitomi Sezaki, Tetsuya Hosaka, Norio Akuta, Yoshiyuki Suzuki, Satoshi Saitoh, Yasuji Arase, Kenji Ikeda, Hiromitsu Kumada
The aim of this study was to assess the rate of development of hepatocellular carcinoma (HCC) in patients who achieved sustained virologic response (SVR) by direct anti-viral agents (DAA). We retrospectively evaluated patients who achieved SVR by oral DAA interferon-free regimens (n = 77) [daclatasvir/asunaprevir (n = 67), ombitasvir/paritaprevir/ritonavir (n = 9), and telaprevir (n = 1)] and by pegylated-interferon plus ribavirin (Peg-IFN/RBV, n = 528). In all patients, the background was chronic hepatitis or cirrhosis caused by HCV genotype 1b...
August 17, 2016: Journal of Medical Virology
D Hüppe, P Buggisch, S Christensen, H Heiken, S Mauss, U Naumann, C Fischer, H Kleine, J Huelsenbeck
In 2014, the first interferon-free treatment options for chronic Hepatitis C (CHC) became available in Europe introducing a new era of highly effective and well tolerated oral treatment options for CHC. The data from the cross-sectional study CURRENT-C highlights the epidemiological characteristics of patients with CHC in Germany. During the period that the study was conducted, the approval of the combination drugs for the treatment of CHC was imminent.Between June and November 2014, 1471 CHC-patients not receiving anti-HCV treatment were included nationwide in 40 German centers specializing in viral hepatitis...
August 2016: Zeitschrift Für Gastroenterologie
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