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https://www.readbyqxmd.com/read/28645740/safety-of-the-2d-3d-direct-acting-antiviral-regimen-in-hcv-induced-child-pugh-a-cirrhosis-a-pooled-analysis
#1
Fred Poordad, David R Nelson, Jordan J Feld, Michael W Fried, Heiner Wedemeyer, Lois Larsen, Daniel E Cohen, Eric Cohen, Niloufar Mobashery, Fernando Tatsch, Graham R Foster
BACKGROUND & AIMS: Chronic hepatitis C virus (HCV)-infected patients with cirrhosis are a high-priority population for treatment. To help inform the benefit-risk profile of the all-oral direct-acting antiviral (DAA) combination regimen of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir (OBV/PTV/r ± DSV) in patients with Child-Pugh A cirrhosis, we undertook a comprehensive review of AbbVie-sponsored clinical trials enrolling patients with Child-Pugh A cirrhosis. METHODS: Twelve phase II or III clinical trials of the 2-DAA regimen of OBV/PTV/r ± ribavirin (RBV) or the 3-DAA regimen of OBV/PTV/r + DSV ± RBV that included patients with Child-Pugh A cirrhosis were reviewed; patients who completed treatment by November 16, 2015 were included in a pooled, post hoc safety assessment...
June 20, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28644739/treatment-of-hepatitis-c-with-new-fixed-dose-combinations
#2
Vicente Soriano
The advent of oral direct-acting antivirals (DAA) has revolutionized the hepatitis C virus (HCV) therapeutic landscape providing cure rates over 90%. However, a subset of patients remains at higher risk for treatment failure, including those infected with: i) genotype 3 and cirrhosis; ii) resistance-associated substitutions (RAS) occurring either as natural polymorphisms or selected after prior DAA failure; and iii) poor drug adherence associated with social disabilities (homeless, psychiatric illnesses, injection drug use, alcoholism, etc...
June 23, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28636480/the-emerging-role-of-pimavanserin-in-the-management-of-parkinson-s-disease-psychosis
#3
Neal Hermanowicz, Gustavo Alva, Fernando Pagan, Alberto J Espay, Amita Patel, Katya Cruz Madrid, Daniel Kremens, Jim Kenney, Sheila Arquette, Gary Tereso, Maria Lopes, Carolyn Farnum
A panel of experts drawn from neurology, psychiatry, geropsychiatry, geriatrics, and pharmacy representatives of 3 health plans convened in New York City on July 30, 2016, with the objective of sharing opinions, ideas, and information regarding the optimal management of Parkinson's disease psychosis (PDP). Three key points emerged from the discussion: (1) Because of the nature of Parkinson's disease and PDP, finding appropriate treatment can prove challenging; (2) emerging therapies may present an opportunity for effective disease management; and (3) moving forward, provider and patient education regarding PDP and available treatment options is essential for well-managed symptoms and better quality of life...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28631218/an-observational-study-of-the-effect-of-levodopa-carbidopa-intestinal-gel-on-activities-of-daily-living-and-quality-of-life-in-advanced-parkinson-s-disease-patients
#4
Rejko Krüger, Paul Lingor, Triantafyllos Doskas, Johanna M L Henselmans, Erik H Danielsen, Oriol de Fabregues, Alessandro Stefani, Sven-Christian Sensken, Juan Carlos Parra, Koray Onuk, Ashley Yegin, Angelo Antonini
INTRODUCTION: Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) by percutaneous endoscopic gastrojejunostomy (PEG-J) in advanced Parkinson's disease (PD) patients reduces variability in plasma levels, providing better control of motor fluctuations ("on" and "off" states). The MONOTREAT study assessed the effect of LCIG on activities of daily living, motor and non-motor symptoms, and quality of life in advanced PD patients. METHODS: This prospective, observational study included patients with advanced, levodopa-responsive PD with either 2-4 h of "off" time or 2 h of dyskinesia daily...
June 19, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28603465/spinal-cord-as-an-adjunct-to-brain-magnetic-resonance-imaging-in-defining-no-evidence-of-disease-activity-in-multiple-sclerosis
#5
Subhash Tummala, Tarun Singhal, Vinit V Oommen, Gloria Kim, Fariha Khalid, Brian C Healy, Rohit Bakshi
ACTIVITY AVAILABLE ONLINE: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. TARGET AUDIENCE: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). LEARNING OBJECTIVES: 1) Describe the concept of "no evidence of disease activity" in MS.2) Recognize the role of spinal cord imaging in routine monitoring of MS disease activity...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28536999/randomized-phase-3-trial-of-ombitasvir-paritaprevir-ritonavir-and-ribavirin-for-hepatitis-c-virus-genotype-2-infected-japanese-patients
#6
Ken Sato, Kazuaki Chayama, Katia Alves, Hidenori Toyoda, Fumitaka Suzuki, Koji Kato, Lino Rodrigues, Xinyan Zhang, Carolyn Setze, Tami Pilot-Matias, Margaret Burroughs, Rebecca Redman, Hiromitsu Kumada
INTRODUCTION: In Japan, hepatitis C virus (HCV) genotype (GT) 2 accounts for approximately 32% of HCV infections. Limited treatment options exist in Japan for HCV GT2-infected patients. GIFT-II was a phase 3, randomized, open-label study evaluating the efficacy and safety of 16- and 12-week regimens of co-formulated ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) plus ribavirin (RBV) in Japanese adults with HCV GT2 infection. METHODS: Patients were randomized in a 1:1 ratio to once-daily, co-formulated OBV/PTV/r (25/150/100 mg) with weight-based RBV for 16 or 12 weeks...
May 23, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28525302/treatment-of-endometriosis-associated-pain-with-elagolix-an-oral-gnrh-antagonist
#7
Hugh S Taylor, Linda C Giudice, Bruce A Lessey, Mauricio S Abrao, Jan Kotarski, David F Archer, Michael P Diamond, Eric Surrey, Neil P Johnson, Nelson B Watts, J Chris Gallagher, James A Simon, Bruce Carr, W Paul Dmowski, Nicholas Leyland, Jean P Rowan, W Rachel Duan, Juki Ng, Brittany Schwefel, James W Thomas, Rita I Jain, Kristof Chwalisz
Background Endometriosis is a chronic, estrogen-dependent condition that causes dysmenorrhea and pelvic pain. Elagolix, an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist, produced partial to nearly full estrogen suppression in previous studies. Methods We performed two similar, double-blind, randomized, 6-month phase 3 trials (Elaris Endometriosis I and II [EM-I and EM-II]) to evaluate the effects of two doses of elagolix - 150 mg once daily (lower-dose group) and 200 mg twice daily (higher-dose group) - as compared with placebo in women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain...
May 19, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28497757/safety-and-tolerability-of-veliparib-combined-with-capecitabine-plus-radiotherapy-in-patients-with-locally-advanced-rectal-cancer-a-phase-1b-study
#8
Brian G Czito, Dustin A Deming, Gayle S Jameson, Mary F Mulcahy, Houman Vaghefi, Matthew W Dudley, Kyle D Holen, Angela DeLuca, Rajendar K Mittapalli, Wijith Munasinghe, Lei He, John R Zalcberg, Samuel Y Ngan, Philip Komarnitsky, Michael Michael
BACKGROUND: Further optimisation of present standard chemoradiation is needed in patients with locally advanced rectal cancer. Veliparib, an oral poly(ADP-ribose) polymerase inhibitor, has been shown to enhance the antitumour activity of chemotherapy and radiotherapy in preclinical models. We aimed to establish the maximum tolerated dose and establish the recommended phase 2 dose of veliparib combined with neoadjuvant capecitabine and radiotherapy. METHODS: This phase 1b, open-label, multicentre, dose-escalation study was done at six hospitals (one in Australia and five in the USA)...
June 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28478975/efficacy-and-safety-of-adalimumab-every-other-week-versus-methotrexate-once-weekly-in-children-and-adolescents-with-severe-chronic-plaque-psoriasis-a-randomised-double-blind-phase-3-trial
#9
Kim Papp, Diamant Thaçi, Danielle Marcoux, Lisa Weibel, Sandra Philipp, Pierre-Dominique Ghislain, Ian Landells, Peter Hoeger, Carol Kotkin, Kristina Unnebrink, Marieke Seyger, David Williams
BACKGROUND: Adalimumab is indicated for the treatment of moderate to severe psoriasis in adults. We assessed the efficacy and safety of adalimumab in children and adolescents with severe plaque psoriasis. METHODS: This randomised, double-blind, multiperiod, phase 3 trial was done at 38 clinics in 13 countries. Patients (aged ≥4 to <18 years) with severe plaque psoriasis who had not responded to topical therapy were randomly assigned with an interactive voice or web-response system (1:1:1) to receive adalimumab 0·8 mg/kg or 0·4 mg/kg subcutaneously at week 0, then every other week starting at week 1, or oral methotrexate once weekly (0·1-0·4 mg/kg) for 16 weeks...
May 4, 2017: Lancet
https://www.readbyqxmd.com/read/28455782/rpc4046-a-novel-anti-interleukin-13-antibody-blocks-il-13-binding-to-il-13-%C3%AE-1-and-%C3%AE-2-receptors-a-randomized-double-blind-placebo-controlled-dose-escalation-first-in-human-study
#10
Catherine S Tripp, Carolyn Cuff, Andrew L Campbell, Barbara A Hendrickson, Jeff Voss, Terry Melim, Chengbin Wu, Andrew D Cherniack, Kenneth Kim
INTRODUCTION: A unique anti-interleukin (IL)-13 monoclonal antibody, RPC4046, was generated on the basis of differential IL-13 receptor (R) blockade as assessed in a murine asthma model; the safety, tolerability, pharmacokinetics, and pharmacodynamics of RPC4046 were evaluated in a first-in-human study. METHODS: Anti-IL-13 antibodies with varying receptor blocking specificity were evaluated in the ovalbumin-induced murine asthma model. A randomized, double-blind, placebo-controlled, dose-escalation first-in-human study (NCT00986037) was conducted with RPC4046 in healthy adults and patients with mild to moderate controlled asthma...
April 28, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28448782/amcp-partnership-forum-driving-value-and-outcomes-in-oncology
#11
(no author information available yet)
Innovation in cancer treatment has provided a wealth of recently available therapeutic agents and a healthy drug pipeline that promises to change the way we approach this disease and the lives of those affected in the years to come. However, the majority of these new agents, many of which are targeted to specific genomic features of various tumors, may challenge the health care system's ability to afford cancer care. This innovation drives the need to focus on the value of the treatments provided to patients with cancer and on methods to optimize the efficiency of the dollars we spend, in addition to the clinical value itself...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28448778/economic-impact-of-above-label-dosing-with-etanercept-adalimumab-or-ustekinumab-in-patients-with-psoriasis
#12
Steven R Feldman, Yang Zhao, Huanxue Zhou, Vivian Herrera, Haijun Tian, Yunfeng Li
BACKGROUND: Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. OBJECTIVE: To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012...
May 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28416221/ombitasvir-paritaprevir-and-ritonavir-plus-dasabuvir-for-8-weeks-in-previously-untreated-patients-with-hepatitis-c-virus-genotype-1b-infection-without-cirrhosis-garnet-a-single-arm-open-label-phase-3b-trial
#13
Tania M Welzel, Tarik Asselah, Emily O Dumas, Stefan Zeuzem, David Shaw, Rawi Hazzan, Xavier Forns, Tami Pilot-Matias, Wenjing Lu, Daniel E Cohen, Jordan J Feld
BACKGROUND: Clinical studies have shown high rates of sustained virological response (hepatitis C virus [HCV] RNA <15 IU/mL) at post-treatment week 12 (SVR12) in patients with genotype 1b infection with and without cirrhosis who received coformulated ombitasvir, paritaprevir, and ritonavir, plus dasabuvir, without ribavirin, for 12 weeks. In this study, we aimed to assess 8-week treatment with ombitasvir, paritaprevir, and ritonavir, plus dasabuvir, without ribavirin in patients infected with HCV genotype 1b without cirrhosis...
April 13, 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404110/ombitasvir-paritaprevir-and-ritonavir-plus-ribavirin-for-chronic-hepatitis-c-virus-genotype-4-infection-in-egyptian-patients-with-or-without-compensated-cirrhosis-agate-ii-a-multicentre-phase-3-partly-randomised-open-label-trial
#14
Imam Waked, Gamal Shiha, Roula B Qaqish, Gamal Esmat, Ayman Yosry, Mohamed Hassany, Reham Soliman, Mohammad A Mohey, Naglaa Allam, Naglaa Zayed, Tarik Asselah, Coleen Hall, Rebecca Redman, Niloufar Mobashery, Wahid Doss
BACKGROUND: In Egypt, chronic hepatitis C virus (HCV) infection occurs in around 10% of the population (about 8 million individuals), and is a leading cause of liver cirrhosis, hepatocellular carcinoma, and mortality. Although HCV genotype 4 constitutes about 20% of HCV infections worldwide, the prevalence in Egypt is more than 90%. We assessed the efficacy and safety of the two direct-acting antiviral drugs ombitasvir, an NS5A inhibitor, and paritaprevir, an NS3/4A protease inhibitor dosed with ritonavir, plus ribavirin in treatment of chronic HCV infection in Egypt...
September 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404108/ombitasvir-paritaprevir-and-ritonavir-plus-ribavirin-in-adults-with-hepatitis-c-virus-genotype-4-infection-and-cirrhosis-agate-i-a-multicentre-phase-3-randomised-open-label-trial
#15
Tarik Asselah, Christophe Hézode, Roula B Qaqish, Magdy ElKhashab, Tarek Hassanein, George Papatheodoridis, Jordan J Feld, Christophe Moreno, Stefan Zeuzem, Peter Ferenci, Yao Yu, Rebecca Redman, Tami Pilot-Matias, Niloufar Mobashery
BACKGROUND: Hepatitis C virus (HCV) genotype 4 infection is most commonly reported in sub-Saharan Africa and the Middle East; however, prevalence is increasing worldwide through immigration. HCV genotype 4 accounts for 20% of all infections, but clinical trial data for treatment remain limited. We assessed the combination of two direct-acting antivirals, ombitasvir (NS5A inhibitor) and paritaprevir (NS3/4A protease inhibitor; co-dosed with ritonavir) plus ribavirin in patients with HCV genotype 4 infection and compensated cirrhosis...
September 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28364381/adalimumab-with-methotrexate-in-treatment-na%C3%A3-ve-japanese-patients-with-rheumatoid-arthritis-at-risk-of-progressive-structural-joint-damage-a-postmarketing-observational-study
#16
Yukiko Ito, Kaori Hozumi, Yukiko Okada, Sarina Kurimoto
INTRODUCTION: The objective of this study was to evaluate the real-world safety and effectiveness of adalimumab with methotrexate (MTX) in disease-modifying antirheumatic drug (DMARD)- and biologic-naïve Japanese patients with rheumatoid arthritis (RA) at risk of progressive structural joint damage. METHODS: This multicenter, prospective, observational, postmarketing surveillance study was conducted between February 2013 and April 2015 at 84 centers in Japan. Patients with RA at risk of progressive structural joint damage were enrolled and initiated treatment with adalimumab and MTX...
June 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28361468/impact-of-participation-in-the-adalimumab-humira-patient-support-program-on-rheumatoid-arthritis-treatment-course-results-from-the-passion-study
#17
Filip Van den Bosch, Andrew J K Ostor, Siegfried Wassenberg, Naijun Chen, Chen Wang, Vishvas Garg, Jasmina Kalabic
INTRODUCTION: Patients with rheumatoid arthritis (RA) who are treated with adalimumab (ADA) are offered a proprietary patient support program (PSP, AbbVie Care(®)). The main objective of this study was to examine the effectiveness of ADA on RA treatment course over time in the context of PSP utilization. METHODS: PASSION was a 78-week post-marketing observational study of RA patients with an insufficient response to ≥1 DMARD newly initiating ADA in routine clinical care that was conducted in Europe, Israel, Mexico, Puerto Rico, and Australia...
June 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28345441/prevalence-and-cost-of-subsequent-fractures-among-u-s-patients-with-an-incident-fracture
#18
Jessica Weaver, Shiva Sajjan, E Michael Lewiecki, Steven T Harris, Panagiotis Marvos
BACKGROUND: The prevalence and cost of subsequent fractures among patients with an incident fracture are not well defined. OBJECTIVE: To assess the prevalence of, and costs associated with, subsequent fractures in the year after an incident fracture. METHODS: This was a retrospective claims database analysis using data from Humana Medicare Advantage claims (Medicare group) and Optum Insight Clinformatics Data Mart commercial claims (commercial group)...
April 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28314410/enabling-chemistry-technologies-and-parallel-synthesis-accelerators-of-drug-discovery-programmes
#19
A Vasudevan, A R Bogdan, H F Koolman, Y Wang, S W Djuric
There is a pressing need to improve overall productivity in the pharmaceutical industry. Judicious investments in chemistry technologies can have a significant impact on cycle times, cost of goods and probability of technical success. This perspective describes some of these technologies developed and implemented at AbbVie, and their applications to the synthesis of novel scaffolds and to parallel synthesis.
2017: Progress in Medicinal Chemistry
https://www.readbyqxmd.com/read/28263457/ombitasvir-paritaprevir-ritonavir-and-dasabuvir-drug-interactions-with-antiretroviral-agents-and-drugs-forsubstance-abuse
#20
Jennifer R King, Rajeev M Menon
AbbVie's 3 direct-acting antiviral (3D) regimen containing ombitasvir, paritaprevir, ritonavir, and dasabuvir with and without ribavirin is approved for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Safe and efficacious antiviral regimens resulting in minimal to no drug-drug interactions (DDIs) with antiretrovirals are needed to ensure that patients coinfected with HCV and the human immunodeficiency virus (HIV) achieve 12-week sustained virologic response rates similar to HCV-monoinfected patients...
March 2017: Clinical Pharmacology in Drug Development
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