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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/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
#2
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
#3
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/27994911/liver-apparent-diffusion-coefficient-changes-during-telaprevir-based-therapy-for-chronic-hepatitis-c
#4
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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/27859444/spending-on-hepatitis-c-antivirals-in-the-united-states-2009-2015
#8
Katie J Suda, Drew J Halbur, Robert J Hunkler, Linda M Matusiak, Glen T Schumock
STUDY OBJECTIVE: New hepatitis C virus (HCV) antivirals have been shown to be highly effective with minimal adverse effects, but they are costly. Little is known, however, about the impact of the new HCV antivirals on expenditures in the overall U.S. health care system or by health care sector. Thus the objective of this study was to describe HCV antiviral expenditures by agent, year, and health care sector. DESIGN: Retrospective cross-sectional study. DATA SOURCE: QuintilesIMS National Sales Perspectives database...
January 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/27855589/twice-daily-telaprevir-for-posttransplant-genotype-1-hepatitis-c-virus-a-prospective-safety-efficacy-and-pharmacokinetics-study
#9
Raymond A Rubin, Mark W Russo, Kimberly A Brown, Robert J Fontana, Josh Levitsky, Hugo Vargas, Eric M Yoshida, Robert S Brown
OBJECTIVES: Our objective was to determine the safety, efficacy, and pharmacokinetics of telaprevir plus pegylated interferon alfa 2a and ribavirin for chronic, posttransplant genotype 1 hepatitis C virus infection. MATERIALS AND METHODS: A prospective, single-arm, multicenter, open-label, phase 2b study was conducted at 22 North American sites to assess the safety, efficacy, and pharmacokinetics of pegylated interferon alfa 2a, ribavirin, and twice daily telaprevir in liver transplant recipients with recurrent, chronic hepatitis C without cirrhosis...
November 18, 2016: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/27844412/anti-rods-rings-autoantibody-seropositivity-does-not-affect-response-to-telaprevir-treatment-for-chronic-hepatitis-c-infection
#10
S John Calise, Nicola Bizzaro, Thuy Nguyen, Danila Bassetti, Brunetta Porcelli, Paolo Almi, Giuseppina Barberio, Giampaola Pesce, Minoru Satoh, Edward K L Chan
PURPOSE: Autoantibodies to intracellular 'rods and rings' structures (anti-rods/rings or anti-RR) are strongly associated with hepatitis C (HCV) patients treated with interferon-α/ribavirin (IFN/RBV) and are linked with non-responsiveness to IFN/RBV or relapse, especially in Italian patients. This is the first study to determine whether there is any correlation of anti-RR with non-responsiveness to IFN/RBV treatment in patients also treated with telaprevir (TPV), one of several new therapies for chronic HCV recently implemented...
December 2016: Auto- Immunity Highlights
https://www.readbyqxmd.com/read/27757504/network-meta-analysis-of-first-and-second-generation-protease-inhibitors-for-chronic-hepatitis-c-genotype-1-efficacy-based-on-rvr-and-svr-24
#11
REVIEW
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...
January 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27749900/a-randomized-study-of-peginterferon-lambda-1a-compared-to-peginterferon-alfa-2a-in-combination-with-ribavirin-and-telaprevir-in-patients-with-genotype-1-chronic-hepatitis-c
#12
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
https://www.readbyqxmd.com/read/27741230/treatment-selection-choices-should-not-be-based-on-benefits-or-costs-alone-a-head-to-head-randomized-controlled-trial-of-antiviral-drugs-for-hepatitis-c
#13
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
https://www.readbyqxmd.com/read/27741116/assessment-of-cost-of-innovation-versus-the-value-of-health-gains-associated-with-treatment-of-chronic-hepatitis-c-in-the-united-states-the-quality-adjusted-cost-of-care
#14
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)
https://www.readbyqxmd.com/read/27715018/mechanistic-design-of-chemically-diverse-polymers-with-applications-in-oral-drug-delivery
#15
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...
November 14, 2016: Biomacromolecules
https://www.readbyqxmd.com/read/27711230/the-role-of-hepatitis-c-virus-core-antigen-testing-in-the-era-of-direct-acting-antiviral-therapies-what-we-can-learn-from-the-protease-inhibitors
#16
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
https://www.readbyqxmd.com/read/27690214/low-pretreatment-acoustic-radiation-force-impulse-imaging-arfi-values-predict-sustained-virological-response-in-antiviral-hepatitis-c-virus-hcv-therapy
#17
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
https://www.readbyqxmd.com/read/27650326/direct-acting-antiviral-agents-for-patients-with-hepatitis-c-virus-genotype-1-infection-are-cost-saving
#18
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
https://www.readbyqxmd.com/read/27641989/diagnostics-in-hepatitis-c-the-end-of-response-guided-therapy
#19
REVIEW
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
https://www.readbyqxmd.com/read/27622264/eruptive-seborrheic-keratoses-secondary-to-telaprevir-related-dermatitis
#20
Preston W Chadwick, Warren R Heymann
No abstract text is available yet for this article.
August 2016: Cutis; Cutaneous Medicine for the Practitioner
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