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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
#1
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
#2
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
#3
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
#4
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...
March 31, 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
#5
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...
March 30, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28345441/prevalence-and-cost-of-subsequent-fractures-among-u-s-patients-with-an-incident-fracture
#6
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
#7
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
#8
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
https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#9
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28176188/adalimumab-for-treating-moderate-to-severe-hidradenitis-suppurativa-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#10
REVIEW
Paul Tappenden, Christopher Carroll, John W Stevens, Andrew Rawdin, Sabine Grimm, Mark Clowes, Eva Kaltenthaler, John R Ingram, Fiona Collier, Mohammad Ghazavi
As part of its single technology appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of adalimumab (AbbVie) to submit evidence on the clinical effectiveness and cost effectiveness of adalimumab for the treatment of moderate-to-severe hidradenitis suppurativa (HS). The appraisal assessed adalimumab as monotherapy in adult patients with an inadequate response to conventional systemic HS therapy. The School of Health and Related Research Technology Appraisal Group was commissioned to act as the independent Evidence Review Group (ERG)...
February 7, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28144917/impact-of-adalimumab-on-work-productivity-and-activity-impairment-in-japanese-patients-with-rheumatoid-arthritis-large-scale-prospective-single-cohort-anouveau-study
#11
Tsutomu Takeuchi, Ryo Nakajima, Shuichi Komatsu, Kiyotaka Yamazaki, Tomohiro Nakamura, Naoki Agata, Ataru Igarashi, Toshiro Tango, Yoshiya Tanaka
INTRODUCTION: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan. METHODS: Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire...
March 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28138560/leukemia-cell-proliferation-and-death-in-chronic-lymphocytic-leukemia-patients-on-therapy-with-the-btk-inhibitor-ibrutinib
#12
Jan A Burger, Kelvin W Li, Michael J Keating, Mariela Sivina, Ahmed M Amer, Naveen Garg, Alessandra Ferrajoli, Xuelin Huang, Hagop Kantarjian, William G Wierda, Susan O'Brien, Marc K Hellerstein, Scott M Turner, Claire L Emson, Shih-Shih Chen, Xiao-Jie Yan, Dominik Wodarz, Nicholas Chiorazzi
BACKGROUND. Ibrutinib is an effective targeted therapy for patients with chronic lymphocytic leukemia (CLL) that inhibits Bruton's tyrosine kinase (BTK), a kinase involved in B cell receptor signaling. METHODS. We used stable isotopic labeling with deuterated water ((2)H2O) to measure directly the effects of ibrutinib on leukemia cell proliferation and death in 30 patients with CLL. RESULTS. The measured average CLL cell proliferation ("birth") rate before ibrutinib therapy was 0.39% of the clone per day (range 0...
January 26, 2017: JCI Insight
https://www.readbyqxmd.com/read/28130434/selective-progesterone-receptor-modulator-sprm-ulipristal-acetate-upa-and-its-effects-on-the-human-endometrium
#13
L H R Whitaker, A A Murray, R Matthews, G Shaw, A R W Williams, P T K Saunders, H O D Critchley
STUDY QUESTION: What is the impact of administration of the selective progesterone receptor modulator (SPRM), ulipristal acetate (UPA) on the endometrium of women with fibroids? SUMMARY ANSWER: UPA administration altered expression of sex-steroid receptors and progesterone-regulated genes and was associated with low levels of glandular and stromal cell proliferation. WHAT IS KNOWN ALREADY: Administration of all SPRM class members results in PAEC (progesterone receptor modulator associated endometrial changes)...
March 1, 2017: Human Reproduction
https://www.readbyqxmd.com/read/28089635/venetoclax-plus-rituximab-in-relapsed-or-refractory-chronic-lymphocytic-leukaemia-a-phase-1b-study
#14
John F Seymour, Shuo Ma, Danielle M Brander, Michael Y Choi, Jacqueline Barrientos, Matthew S Davids, Mary Ann Anderson, Anne W Beaven, Steven T Rosen, Constantine S Tam, Betty Prine, Suresh K Agarwal, Wijith Munasinghe, Ming Zhu, L Leanne Lash, Monali Desai, Elisa Cerri, Maria Verdugo, Su Young Kim, Rod A Humerickhouse, Gary B Gordon, Thomas J Kipps, Andrew W Roberts
BACKGROUND: Selective BCL2 inhibition with venetoclax has substantial activity in patients with relapsed or refractory chronic lymphocytic leukaemia. Combination therapy with rituximab enhanced activity in preclinical models. The aim of this study was to assess the safety, pharmacokinetics, and activity of venetoclax in combination with rituximab. METHODS: Adult patients with relapsed or refractory chronic lymphocytic leukaemia (according to the 2008 Modified International Workshop on CLL guidelines) or small lymphocytic lymphoma were eligible for this phase 1b, dose-escalation trial...
February 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28063066/high-prevalence-of-undiagnosed-axial-spondyloarthritis-in-patients-with-chronic-low-back-pain-consulting-non-rheumatologist-specialists-in-belgium-suspect-study
#15
Laure Tant, Nadine Delmotte, Maria Van den Enden, Valerie Gangji, Herman Mielants
INTRODUCTION: Diagnosis of axial spondyloarthritis (SpA) can be delayed for several years mainly because of low awareness of axial SpA among non-rheumatologists who are the first interlocutors of potential SpA patients. One strategy to decrease the delay between appearance of first symptoms and diagnosis of axial SpA and to allow early management of the disease is to provide the non-rheumatologists with tools to identify patients requiring prompt referral to rheumatologists. This study was designed to evaluate in a real-world setting whether screening patients with chronic low back pain who consult physical medicine and rehabilitation (PMR) physicians, orthopedists, and ophthalmologists is useful in detecting axial SpA...
January 6, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28025919/amcp-partnership-forum-enabling-the-exchange-of-clinical-and-economic-information-pre-fda-approval
#16
(no author information available yet)
Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities...
January 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27999526/cme-cne-article-a-framework-of-care-in-multiple-sclerosis-part-1-updated-disease-classification-and-disease-modifying-therapy-use-in-specific-circumstances
#17
Scott D Newsome, Philip J Aliotta, Jacquelyn Bainbridge, Susan E Bennett, Gary Cutter, Kaylan Fenton, Fred Lublin, Dorothy Northrop, David Rintell, Bryan D Walker, Megan Weigel, Kathleen Zackowski, David E Jones
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: Apply new information about MS to a comprehensive individualized treatment plan for patients with MSIntegrate the team approach into long-term planning in order to optimize rehabilitation care of patients with MSAccreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group...
November 2016: International Journal of MS Care
https://www.readbyqxmd.com/read/27970810/economic-evaluation-of-abbvie-s-regimen-viekirax-for-patients-with-genotype-4-hcv-in-greece
#18
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970806/economic-evaluation-of-abbvie-s-regimen-viekirax-exviera-for-patients-with-genotype-1b-hcv-in-greece
#19
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27970804/economic-evaluation-of-abbvie-s-regimen-viekirax-exviera-for-patients-with-genotype-1a-hcv-in-greece
#20
C Mylonas, G Kourlaba, A Vernadaki, M Kakouros, N Maniadakis
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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