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https://www.readbyqxmd.com/read/28802816/safety-and-efficacy-of-an-8-week-regimen-of-grazoprevir-plus-ruzasvir-plus-uprifosbuvir-compared-with-grazoprevir-plus-elbasvir-plus-uprifosbuvir-in-participants-without-cirrhosis-infected-with-hepatitis-c-virus-genotypes-1-2-or-3-c-crest-1-and-c-crest-2-part
#1
Edward J Gane, Stephen Pianko, Stuart K Roberts, Alexander J Thompson, Stefan Zeuzem, Eli Zuckerman, Ziv Ben-Ari, Graham R Foster, Kosh Agarwal, Alex L Laursen, Jan Gerstoft, Wei Gao, Hsueh-Cheng Huang, Brian Fitzgerald, Doreen Fernsler, Jerry J Li, Anjana Grandhi, Hong Liu, Feng-Hsiu Su, Shuyan Wan, Zhen Zeng, Huei-Ling Chen, Frank J Dutko, Bach-Yen T Nguyen, Janice Wahl, Michael N Robertson, Eliav Barr, Wendy W Yeh, Rebeca M Plank, Joan R Butterton, Rafael Esteban
BACKGROUND: New hepatitis C virus (HCV) therapies with pan-genotypic efficacy are needed. The goals of part A of C-CREST-1 and C-CREST-2 were to compare the efficacies of two doses (300 mg or 450 mg once daily) of uprifosbuvir (MK-3682; NS5B inhibitor) in an 8-week regimen combined with grazoprevir (NS3/4A inhibitor; 100 mg once daily) and an NS5A inhibitor, either elbasvir (50 mg once daily) or ruzasvir (MK-8408; 60 mg once daily), and to evaluate the safety and tolerability of these combination regimens in individuals infected with genotypes 1, 2, or 3...
August 9, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28802814/safety-and-efficacy-of-a-fixed-dose-combination-regimen-of-grazoprevir-ruzasvir-and-uprifosbuvir-with-or-without-ribavirin-in-participants-with-and-without-cirrhosis-with-chronic-hepatitis-c-virus-genotype-1-2-or-3-infection-c-crest-1-and-c-crest-2-part-b-two
#2
Eric Lawitz, Maria Buti, John M Vierling, Piero L Almasio, Savino Bruno, Peter J Ruane, Tarek I Hassanein, Beat Muellhaupt, Brian Pearlman, Ligita Jancoriene, Wei Gao, Hsueh-Cheng Huang, Aimee Shepherd, Brynne Tannenbaum, Doreen Fernsler, Jerry J Li, Anjana Grandhi, Hong Liu, Feng-Hsiu Su, Shuyan Wan, Frank J Dutko, Bach-Yen T Nguyen, Janice Wahl, Michael N Robertson, Eliav Barr, Wendy W Yeh, Rebeca M Plank, Joan R Butterton, Eric M Yoshida
BACKGROUND: There is a need for hepatitis C virus (HCV) therapies with excellent efficacy across genotypes and in diverse populations. Part A of the C-CREST-1 and C-CREST-2 trials led to the selection of a three-drug regimen of grazoprevir (MK-5172; an HCV NS3/4A protease inhibitor; 100 mg/day) plus ruzasvir (MK-8408; an NS5A inhibitor; 60 mg/day) plus uprifosbuvir (MK-3682; an HCV NS5B polymerase inhibitor; 450 mg/day). Part B of the studies tested this combination as a single formulation in different treatment durations in a broader population...
August 9, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28795582/current-status-of-bioanalytical-outsourcing-a-pharma-perspective
#3
(no author information available yet)
Eric Woolf, Ajai Chaudhary and Sheila Breidinger from Merck, spoke to Sankeetha Nadarajah (Commissioning Editor, Bioanalysis) about outsourcing strategy implementation.
August 10, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28782467/current-and-under-development-treatment-modalities-of-psoriasis-a-review
#4
Abdul Albaghdadi
BACKGROUND AND OBJECTIVE: Psoriasis is a chronic and complex autoimmune inflammatory skin disease that affects over 125 million people worldwide. It can exhibit at any age, in spite of the fact that children are less normally influenced than adults. It is characterized by distinct erythematous plaques shielded with conspicuous silvery scales that shows up in different areas of the skin. Knowledge of pathophysiology, especially the pathogenesis of psoriasis, has significantly progressed in the recent decade...
August 4, 2017: Endocrine, Metabolic & Immune Disorders Drug Targets
https://www.readbyqxmd.com/read/28780744/advances-in-transgenic-animal-models-and-techniques
#5
Séverine Ménoret, Laurent Tesson, Séverine Remy, Claire Usal, Laure-Hélène Ouisse, Lucas Brusselle, Vanessa Chenouard, Ignacio Anegon
On May 11th and 12th 2017 was held in Nantes, France, the international meeting "Advances in transgenic animal models and techniques" ( http://www.trm.univ-nantes.fr/ ). This biennial meeting is the fifth one of its kind to be organized by the Transgenic Rats ImmunoPhenomic (TRIP) Nantes facility ( http://www.tgr.nantes.inserm.fr/ ). The meeting was supported by private companies (SONIDEL, Scionics computer innovation, New England Biolabs, MERCK, genOway, Journal Disease Models and Mechanisms) and by public institutions (International Society for Transgenic Technology, University of Nantes, INSERM UMR 1064, SFR François Bonamy, CNRS, Région Pays de la Loire, Biogenouest, TEFOR infrastructure, ITUN, IHU-CESTI and DHU-Oncogeffe and Labex IGO)...
August 5, 2017: Transgenic Research
https://www.readbyqxmd.com/read/28770387/data-to-decisions-creating-a-culture-of-model-driven-drug-discovery
#6
Frank K Brown, Farida Kopti, Charlie Zhenyu Chang, Scott A Johnson, Meir Glick, Chris L Waller
Merck & Co., Inc., Kenilworth, NJ, USA, is undergoing a transformation in the way that it prosecutes R&D programs. Through the adoption of a "model-driven" culture, enhanced R&D productivity is anticipated, both in the form of decreased attrition at each stage of the process and by providing a rational framework for understanding and learning from the data generated along the way. This new approach focuses on the concept of a "Design Cycle" that makes use of all the data possible, internally and externally, to drive decision-making...
August 2, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28754797/elastase-inhibitors-as-potential-therapies-for-elane-associated-neutropenia
#7
Vahagn Makaryan, Merideth L Kelley, Breanna Fletcher, Audrey Anna Bolyard, Andrew Aprikyan, David C Dale
Mutations in ELANE, the gene for neutrophil elastase (NE), a protease expressed early in neutrophil development, are the most frequent cause of cyclic (CyN) and severe congenital neutropenia (SCN). We hypothesized that inhibitors of NE, acting either by directly inhibiting enzymatic activity or as chaperones for the mutant protein, might be effective as therapy for CyN and SCN. We investigated β-lactam-based inhibitors of human NE (Merck Research Laboratories, Kenilworth, NJ, USA), focusing on 1 inhibitor called MK0339, a potent, orally absorbed agent that had been tested in clinical trials and shown to have a favorable safety profile...
July 28, 2017: Journal of Leukocyte Biology
https://www.readbyqxmd.com/read/28750155/a-comparison-using-faraday-cups-with-10-13-%C3%AE-amplifiers-and-a-secondary-electron-multiplier-to-measure-os-isotopes-by-negative-thermal-ionization-mass-spectrometry
#8
Guiqin Wang, Tiantian Sun, Jifeng Xu
RATIONALE: According to the Johnson-Nyquist noise equation, the value of electron noise is proportional to the square root of the resistor value. This relationship gives a theoretical improvement of √100 in the signal/noise ratio by going from 10(11) Ω to 10(13) Ω amplifiers for Faraday detection in thermal ionization mass spectrometry (TIMS). METHODS: We measured Os isotopes using static Faraday cups with 10(13) Ω amplifiers in a negative thermal ionization mass spectrometry (NTIMS) and compared the results with those obtained with 10(11) Ω amplifiers and by peak hopping on a single secondary electron multiplier (SEM)...
July 27, 2017: Rapid Communications in Mass Spectrometry: RCM
https://www.readbyqxmd.com/read/28737992/temporal-trends-in-use-of-biologic-dmards-for-rheumatoid-arthritis-in-the-united-states-a-cohort-study-of-publicly-and-privately-insured-patients
#9
Rishi J Desai, Daniel H Solomon, Yinzhu Jin, Jun Liu, Seoyoung C Kim
BACKGROUND: Ten biologic disease-modifying antirheumatic drugs (bDMARDs) are available as treatment for rheumatoid arthritis (RA), but relatively little is known about population-level time trends in the use of these agents. OBJECTIVE: To describe time trends in the use of bDMARDs in RA patients with private or public insurance in the United States. METHODS: Claims data from private (Optum Clinformatics, 2004-2015) and public (Medicaid Analytic eXtract [MAX], 2000-2010) insurance programs were used...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28729151/standard-dose-pembrolizumab-in-combination-with-reduced-dose-ipilimumab-for-patients-with-advanced-melanoma-keynote-029-an-open-label-phase-1b-trial
#10
Georgina V Long, Victoria Atkinson, Jonathan S Cebon, Michael B Jameson, Bernie M Fitzharris, Catriona M McNeil, Andrew G Hill, Antoni Ribas, Michael B Atkins, John A Thompson, Wen-Jen Hwu, F Stephen Hodi, Alexander M Menzies, Alexander D Guminski, Richard Kefford, Benjamin Y Kong, Babak Tamjid, Archana Srivastava, Anna J Lomax, Mohammed Islam, Xinxin Shu, Scot Ebbinghaus, Nageatte Ibrahim, Matteo S Carlino
BACKGROUND: Reduced-dose nivolumab in combination with standard-dose ipilimumab improves objective response and progression-free survival compared with standard-dose ipilimumab alone, but increases toxicity. We assessed the safety and anti-tumour activity of standard-dose pembrolizumab in combination with reduced-dose ipilimumab. METHODS: In this open-label, phase 1b trial, we recruited patients from 12 medical centres in Australia, New Zealand, and the USA. Eligible patients were aged at least 18 years, had advanced melanoma, had an Eastern Coooperative Oncology Group performance status of 0 or 1, had measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1...
July 17, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28720462/a-novel-trivalent-hpv-16-18-58-vaccine-with-anti-hpv-16-and-18-neutralizing-antibody-responses-comparable-to-those-induced-by-the-gardasil-quadrivalent-vaccine-in-rhesus-macaque-model
#11
Fei Yin, Yajun Wang, Na Chen, Dunquan Jiang, Yefeng Qiu, Yan Wang, Mei Yan, Jianping Chen, Haijiang Zhang, Yongjiang Liu
Persistent infection with human papillomavirus (HPV) is a key factor in the development of precancerous lesions and invasive cervical cancer. Prophylactic vaccines to immunize against HPV are an effective approach to reducing HPV related disease burden. In this study, we investigated the immunogenicity and dosage effect of a trivalent HPV 16/18/58 vaccine (3vHPV) produced in Escherichia coli (E.coli), with Gardasil quadrivalent vaccine (4vHPV, Merck & Co.) as a positive control. Sera collected from rhesus macaques vaccinated with three dosage formulations of 3vHPV (termed low-, mid-, and high-dosage formulations, respectively), and the 4vHPV vaccine were analyzed by both Pseudovirus-Based Neutralization Assay (PBNA) and Enzyme-Linked Immunosorbent Assay (ELISA)...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28712188/a-novel-link-between-adipokines-and-lipoprotein-a-to-contemplate-their-diagnostic-role-in-patients-with-stemi-and-nstemi
#12
Shazia Rashid, Rukhshan Khurshid, Uzma Faryal Amir, Arif Malik, Sumera Qazi
BACKGROUND: Early detection of cardiac events allow better and cost-effective triage and welltimed management of these patients. Study was conducted to evaluate the prognostic significance of plasma adiponectin, resistin and lipoprotein (a) in a group of patients with ST segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction. These parameters were also compared with other predictors like troponin T, troponin I and CK-MB. METHODS: Present study was based on the 100 patients with AMI of whom 52 had a diagnosis of STEMI, and 48 had NSTEMI...
January 2017: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28700541/merck-kgaa-f-star-shake-on-immune-oncology-bispecifics
#13
(no author information available yet)
No abstract text is available yet for this article.
July 12, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28695415/the-real-life-effectiveness-and-care-patterns-of-diabetes-management-study-for-balkan-region-slovenia-croatia-serbia-bulgaria-a-multicenter-observational-cross-sectional-study
#14
Sanja Klobucar Majanovic, Andrej Janez, Ivaylo Lefterov, Sanja Tasic, Tatjana Cikac
INTRODUCTION: Recent large randomized controlled trials highlighted the clinical significance of hypoglycemic episodes in the treatment of diabetes. The present survey was conducted to provide information from real-life practice on the incidence of hypoglycemia in type 2 diabetic patients treated with sulfonylureas. METHODS: This multicenter, observational, cross-sectional study collected data on incidence of side effects of sulfonylurea-based therapy in type 2 diabetic patients in four countries of the Balkan region (Slovenia, Croatia, Serbia, Bulgaria) from October 2014 to June 2015...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28682222/the-clinical-effectiveness-and-cost-effectiveness-of-cetuximab-review-of-technology-appraisal-no-176-and-panitumumab-partial-review-of-technology-appraisal-no-240-for-previously-untreated-metastatic-colorectal-cancer-a-systematic-review-and-economic-evaluation
#15
Nicola Huxley, Louise Crathorne, Jo Varley-Campbell, Irina Tikhonova, Tristan Snowsill, Simon Briscoe, Jaime Peters, Mary Bond, Mark Napier, Martin Hoyle
BACKGROUND: Colorectal cancer is the fourth most commonly diagnosed cancer in the UK after breast, lung and prostate cancer. People with metastatic disease who are sufficiently fit are usually treated with active chemotherapy as first- or second-line therapy. Targeted agents are available, including the antiepidermal growth factor receptor (EGFR) agents cetuximab (Erbitux(®), Merck Serono UK Ltd, Feltham, UK) and panitumumab (Vecitibix(®), Amgen UK Ltd, Cambridge, UK). OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of panitumumab in combination with chemotherapy and cetuximab in combination with chemotherapy for rat sarcoma (RAS) wild-type (WT) patients for the first-line treatment of metastatic colorectal cancer...
June 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28677020/treatment-discontinuation-adherence-and-real-world-effectiveness-among-patients-treated-with-ledipasvir-sofosbuvir-in-the-united-states
#16
Amy Puenpatom, Michael Hull, Jeffrey McPheeters, Kay Schwebke
INTRODUCTION: Ledipasvir/sofosbuvir (LDV/SOF) for hepatitis C virus (HCV) treatment provides an oral interferon-free treatment regimen with high rates of sustained virologic response (SVR). This study assessed treatment discontinuation, factors associated with treatment completion, and real-world effectiveness. METHODS: Patients with HCV treated with LDV/SOF between October 2014 and June 2015 and enrolled in a large US health plan were identified. Expected treatment duration was calculated based on IDSA/AASLD treatment guidelines and US labels using data for genotype, initial treatment regimen, baseline cirrhosis, and prior treatments...
July 4, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28674310/distribution-of-rotavirus-genotypes-from-the-2008-2009-to-2015-2016-season-in-nara-prefecture-japan
#17
Daichi Sugimoto, Mamoru Nakano, Machi Inada, Misako Fujitani, Shoko Chiba, Takeshi Sakai
This study was conducted to investigate the distribution of rotavirus genotypes in Nara Prefecture, Japan before and after introduction of vaccination in 2011. Since the 2011/2012 season, DS-1-like G1P[8] strains have been detected in Nara Prefecture, accounting for about half of all strains in the 2014/2015 season. During the 2015/2016 season, no DS-1-like G1P[8] strain was detected. G2P[4] was the predominant genotype. Group A rotavirus (RVA), a major cause of severe gastroenteritis in infants and young children, poses an important public health issue in Japan...
July 1, 2017: Japanese Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28661847/keytruda-crosses-first-line-finish-line-first
#18
Thomas Reinke
Approval of Merck's checkpoint inhibitor is further evidence that cancer treatment decisions are increasingly dependent on the PD-L1 biomarker and other molecular-level differences in tumor cells. But testing for PD-L1 is tricky, and variations in the concentration of PD-L1 cells in different regions of the sample can produce different test results.
May 2017: Managed Care
https://www.readbyqxmd.com/read/28650253/diagnosis-and-treatment-of-osteoporosis-before-and-after-fracture-a-side-by-side-analysis-of-commercially-insured-and-medicare-advantage-osteoporosis-patients
#19
Jessica Weaver, Shiva Sajjan, E Michael Lewiecki, Steven T Harris
BACKGROUND: Although treatment for osteoporosis is recommended by U.S. clinical guidelines, a lack of diagnosis and treatment is common among patients with osteoporotic fractures. OBJECTIVE: To determine the rates of osteoporosis diagnosis and treatment before and after various types of fractures. METHODS: This was a retrospective claims analysis using data from the Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (Commercial group)...
July 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28650246/economic-outcomes-of-first-line-regimen-switching-among-stable-patients-with-hiv
#20
Lisa Rosenblatt, Ami R Buikema, Jerry Seare, Lindsay G S Bengtson, Jonathan Johnson, Feng Cao, Angelina Villasis-Keever
BACKGROUND: Although switching of antiretroviral therapy (ART) is a valid approach for addressing treatment failure in patients with human immunodeficiency virus (HIV), ART changes among those who are well maintained on their current regimens may lead to the development of new side effects or resistance. OBJECTIVE: To examine the effect of first-line regimen switching on subsequent health care utilization and cost among stable HIV patients. METHODS: This was a retrospective claims data study of adult patients with HIV who initiated ART between 2007 and 2013 and had been treated with their initial regimens for at least 6 continuous months...
July 2017: Journal of Managed Care & Specialty Pharmacy
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