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https://www.readbyqxmd.com/read/28404092/tenofovir-alafenamide-versus-tenofovir-disoproxil-fumarate-for-the-treatment-of-patients-with-hbeag-negative-chronic-hepatitis-b-virus-infection-a-randomised-double-blind-phase-3-non-inferiority-trial
#1
Maria Buti, Edward Gane, Wai Kay Seto, Henry L Y Chan, Wan-Long Chuang, Tatjana Stepanova, Aric-Josun Hui, Young-Suk Lim, Rajiv Mehta, Harry L A Janssen, Subrat K Acharya, John F Flaherty, Benedetta Massetto, Andrea L Cathcart, Kyungpil Kim, Anuj Gaggar, G Mani Subramanian, John G McHutchison, Calvin Q Pan, Maurizia Brunetto, Namiki Izumi, Patrick Marcellin
BACKGROUND: The novel prodrug tenofovir alafenamide delivers the nucleotide reverse transcriptase inhibitor tenofovir to target cells more efficiently at a lower dose than tenofovir disoproxil fumarate, thereby reducing systemic exposure. We compared the efficacy and safety of the two drugs in patients with HBeAg-negative chronic hepatitis B virus (HBV) infection in a non-inferiority study. METHODS: In this ongoing randomised, double-blind, phase 3, non-inferiority study in 105 centres in 17 countries, patients with HBeAg-negative chronic HBV were randomly assigned (2:1) by a computer-generated allocation sequence (block size six), stratified by plasma HBV DNA concentration and previous treatment status, to receive once-daily oral doses of tenofovir alafenamide 25 mg or tenofovir disoproxil fumarate 300 mg, each with matching placebo...
November 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404091/tenofovir-alafenamide-versus-tenofovir-disoproxil-fumarate-for-the-treatment-of-hbeag-positive-chronic-hepatitis-b-virus-infection-a-randomised-double-blind-phase-3-non-inferiority-trial
#2
Henry L Y Chan, Scott Fung, Wai Kay Seto, Wan-Long Chuang, Chi-Yi Chen, Hyung Joon Kim, Aric Josun Hui, Harry L A Janssen, Abhijit Chowdhury, Tak Yin Owen Tsang, Rajiv Mehta, Edward Gane, John F Flaherty, Benedetta Massetto, Anuj Gaggar, Kathryn M Kitrinos, Lanjia Lin, G Mani Subramanian, John G McHutchison, Young-Suk Lim, Subrat K Acharya, Kosh Agarwal
BACKGROUND: Tenofovir alafenamide is a novel prodrug formulated to deliver the active metabolite to target cells more efficiently than tenofovir disoproxil fumarate at a lower dose, thereby reducing systemic exposure. In patients with HIV, tenofovir alafenamide was as efficacious as tenofovir disoproxil fumarate, with reduced bone and renal toxic effects. We compared the efficacy and safety of the two drugs in patients with HBeAg-positive chronic hepatitis B virus (HBV) infection in a non-inferiority study...
November 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404069/patient-reported-outcomes-with-sofosbuvir-and-velpatasvir-with-or-without-ribavirin-for-hepatitis-c-virus-related-decompensated-cirrhosis-an-exploratory-analysis-from-the-randomised-open-label-astral-4-phase-3-trial
#3
Zobair M Younossi, Maria Stepanova, Michael Charlton, Michael P Curry, Jacqueline G O'Leary, Robert S Brown, Sharon Hunt
BACKGROUND: Hepatitis C virus (HCV) treatment regimens with direct-acting antivirals have not been extensively studied in patients with decompensated cirrhosis. We assessed patient-reported outcomes (PROs) in patients with decompensated cirrhosis given a fixed-dose combination of sofosbuvir and velpatasvir with and without ribavirin. METHODS: This study was an exploratory analysis of data collected in a randomised, open-label phase 3 trial (ASTRAL-4) in which patients with HCV-related decompensated cirrhosis were randomly assigned to an all-oral fixed-dose combination of sofosbuvir (400 mg) and velpatasvir (100 mg) once daily for 12 weeks, sofosbuvir and velpatasvir plus oral ribavirin (weight-based 1000 mg or 1200 mg) for 12 weeks, or sofosbuvir and velpatasvir for 24 weeks...
October 2016: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28397698/ledipasvir-sofosbuvir-for-6-weeks-to-treat-acute-hepatitis-c-virus-genotype-1-or-4-infection-in-patients-with-hiv-coinfection-an-open-label-single-arm-trial
#4
Jürgen K Rockstroh, Sanjay Bhagani, Robert H Hyland, Chohee Yun, Hadas Dvory-Sobol, Wei Zheng, Diana M Brainard, Patrick Ingiliz, Thomas Lutz, Christoph Boesecke, Mark Nelson
BACKGROUND: The latest European Association for the Study of the Liver (EASL) guidelines now recommend that patients with acute hepatitis C virus (HCV) infection should be treated with a combination of sofosbuvir and an NS5A inhibitor for 8 weeks. However, the ideal duration of treatment with interferon-free regimens, particularly in HIV-coinfected individuals, remains unknown. We assessed the efficacy and safety of 6 weeks of ledipasvir-sofosbuvir for acute genotype 1 or 4 HCV in HIV-1-coinfected patients...
May 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28397696/hepatitis-c-virus-prevalence-and-level-of-intervention-required-to-achieve-the-who-targets-for-elimination-in-the-european-union-by-2030-a-modelling-study
#5
(no author information available yet)
BACKGROUND: Hepatitis C virus (HCV) is a leading cause of liver-related morbidity and mortality worldwide. In the European Union (EU), treatment and cure of HCV with direct-acting antiviral therapies began in 2014. WHO targets are to achieve a 65% reduction in liver-related deaths, a 90% reduction of new viral hepatitis infections, and 90% of patients with viral hepatitis infections being diagnosed by 2030. This study assessed the prevalence of HCV in the EU and the level of intervention required to achieve WHO targets for HCV elimination...
May 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28370177/blood-safety-implications-of-donors-using-hiv-pre-exposure-prophylaxis
#6
C R Seed, H Yang, J F Lee
HIV pre-exposure prophylaxis (PrEP) is the use of one or more antiretroviral medications (in combination) to prevent HIV infection. The most commonly used PrEP medication (Truvada(®) , Gilead Sciences, Inc.) acts by inhibiting HIV-1 reverse transcriptase. If someone who is using PrEP unknowingly becomes HIV infected (termed 'PrEP breakthrough infection'), there may be suppressed viral replication resulting in a virus level undetectable by the most sensitive HIV NAT. Failure to seroconvert and seroreversion (loss of previously detectable HIV antibodies) have also both been observed with 2nd, 3rd and 4th generation screening immunoassays, as well as Western blot assays...
March 31, 2017: Vox Sanguinis
https://www.readbyqxmd.com/read/28345441/prevalence-and-cost-of-subsequent-fractures-among-u-s-patients-with-an-incident-fracture
#7
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/28329343/commonly-transmitted-hiv-1-drug-resistance-mutations-in-reverse-transcriptase-and-protease-in-antiretroviral-treatment-na%C3%A3-ve-patients-do-not-affect-response-to-tenofovir-disoproxil-fumarate-or-tenofovir-alafenamide-containing-regimens
#8
Nicolas A Margot, Pamela Wong, Rima Kulkarni, Kirsten White, Danielle Porter, Michael E Abram, Christian Callebaut, Michael D Miller
Background.: The presence of transmitted drug-resistance mutations (TDRM) in antiretroviral (ARV) treatment-naïve patients can adversely affect the outcome of ARV therapy. Methods.: Resistance testing was conducted in 6704 ARV-naïve subjects predominantly from the U.S. and Europe in 9 Gilead clinical studies from 2000 to 2013. Results.: The presence of TDRM increased during this period (5.2% to 11.4%), primarily driven by non-nucleoside RT inhibitor resistance mutations (NNRTI; 0...
January 30, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28259777/switching-from-tenofovir-disoproxil-fumarate-to-tenofovir-alafenamide-coformulated-with-rilpivirine-and-emtricitabine-in-virally-suppressed-adults-with-hiv-1-infection-a-randomised-double-blind-multicentre-phase-3b-non-inferiority-study
#9
Chloe Orkin, Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Bernard Vandercam, Joseph de Wet, Jürgen Rockstroh, Adriano Lazzarin, Bart Rijnders, Daniel Podzamczer, Anders Thalme, Marcel Stoeckle, Danielle Porter, Hui C Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide, a tenofovir prodrug, results in 90% lower tenofovir plasma concentrations than does tenofovir disproxil fumarate, thereby minimising bone and renal risks. We investigated the efficacy, safety, and tolerability of switching to a single-tablet regimen containing rilpivirine, emtricitabine, and tenofovir alafenamide compared with remaining on rilpivirine, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, multicentre, placebo-controlled, non-inferiority trial, HIV-1-infected adults were screened and enrolled at 119 hospitals in 11 countries in North America and Europe...
March 1, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28259776/switching-from-efavirenz-emtricitabine-and-tenofovir-disoproxil-fumarate-to-tenofovir-alafenamide-coformulated-with-rilpivirine-and-emtricitabine-in-virally-suppressed-adults-with-hiv-1-infection-a-randomised-double-blind-multicentre-phase-3b-non-inferiority
#10
Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Claudia T Martorell, Joseph de Wet, Hans-Jürgen Stellbrink, Jean-Michel Molina, Frank A Post, Ignacio Pérez Valero, Danielle Porter, YaPei Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao
BACKGROUND: Tenofovir alafenamide is a prodrug that reduces tenofovir plasma concentrations by 90% compared with tenofovir disoproxil fumarate, thereby decreasing bone and renal risks. The coformulation of rilpivirine, emtricitabine, and tenofovir alafenamide has recently been approved, and we aimed to investigate the efficacy, safety, and tolerability of switching to this regimen compared with remaining on coformulated efavirenz, emtricitabine, and tenofovir disoproxil fumarate. METHODS: In this randomised, double-blind, placebo-controlled, non-inferiority trial, HIV-1-infected adults were enrolled at 120 hospitals and outpatient clinics in eight countries in North America and Europe...
March 1, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28257752/efficacy-and-safety-of-idelalisib-in-combination-with-ofatumumab-for-previously-treated-chronic-lymphocytic-leukaemia-an-open-label-randomised-phase-3-trial
#11
Jeffrey A Jones, Tadeusz Robak, Jennifer R Brown, Farrukh T Awan, Xavier Badoux, Steven Coutre, Javier Loscertales, Kerry Taylor, Elisabeth Vandenberghe, Malgorzata Wach, Nina Wagner-Johnston, Loic Ysebaert, Lyndah Dreiling, Ronald Dubowy, Guan Xing, Ian W Flinn, Carolyn Owen
BACKGROUND: Idelalisib, a selective inhibitor of PI3Kδ, is approved for the treatment of patients with relapsed chronic lymphocytic leukaemia (CLL) in combination with rituximab. We aimed to assess the efficacy and safety of idelalisib in combination with a second-generation anti-CD20 antibody, ofatumumab, in a similar patient population. METHODS: In this global, open-label, randomised, controlled phase 3 trial, we enrolled patients with relapsed CLL progressing less than 24 months from last therapy...
March 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28223549/membranous-nephropathy-associated-with-hepatitis-c-virus-infection-treated-with-corticosteroids-and-ledipasvir-sofosbuvir-a-case-report-and-review-of-literature
#12
Qinjie Weng, Xiao Li, Hong Ren, Jingyuan Xie, Xiaoxia Pan, Jing Xu, Nan Chen
BACKGROUND: Membranous nephropathy (MN) is the most common cause of nephrotic syndrome in adults. As many clinical cases have reported, it may be associated with hepatitis C virus (HCV) infection. Antiviral therapy can be various. CASE SUMMARY: We report a case of patient with chronic HCV infection and MN, who presented with was proteinuria. He was treated with ledipasvir and sofosbuvir (Harvoni; Gilead Sciences, Foster City, CA) and was found to be virus-free. CONCLUSION: We have reported this case to provide insight into whether Ledipasvir-Sofosbuvir should be administered for HCV-related glomerulonephritis...
March 28, 2017: Oncotarget
https://www.readbyqxmd.com/read/28219610/bictegravir-versus-dolutegravir-each-with-emtricitabine-and-tenofovir-alafenamide-for-initial-treatment-of-hiv-1-infection-a-randomised-double-blind-phase-2-trial
#13
Paul E Sax, Edwin DeJesus, Gordon Crofoot, Douglas Ward, Paul Benson, Robin Dretler, Anthony Mills, Cynthia Brinson, Julie Peloquin, Xuelian Wei, Kirsten White, Andrew Cheng, Hal Martin, Erin Quirk
BACKGROUND: All recent treatment guidelines recommend integrase strand transfer inhibitors (INSTIs) as components of initial HIV therapy. Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity in a 10 day monotherapy study and has a high in-vitro resistance barrier. On the basis of these results, we did a phase 2 trial comparing bictegravir with dolutegravir. METHODS: In this randomised, double-blind, phase 2 trial, we recruited previously untreated adults (aged ≥18 years) with HIV-1 infections from 22 outpatient centres in the USA...
February 14, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28139405/idelalisib-or-placebo-in-combination-with-bendamustine-and-rituximab-in-patients-with-relapsed-or-refractory-chronic-lymphocytic-leukaemia-interim-results-from-a-phase-3-randomised-double-blind-placebo-controlled-trial
#14
Andrew D Zelenetz, Jacqueline C Barrientos, Jennifer R Brown, Bertrand Coiffier, Julio Delgado, Miklós Egyed, Paolo Ghia, Árpád Illés, Wojciech Jurczak, Paula Marlton, Marco Montillo, Franck Morschhauser, Alexander S Pristupa, Tadeusz Robak, Jeff P Sharman, David Simpson, Lukáš Smolej, Eugen Tausch, Adeboye H Adewoye, Lyndah K Dreiling, Yeonhee Kim, Stephan Stilgenbauer, Peter Hillmen
BACKGROUND: Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population. METHODS: For this international, multicentre, double-blind, placebo-controlled trial, adult patients (≥18 years) with relapsed or refractory chronic lymphocytic leukaemia requiring treatment who had measurable lymphadenopathy by CT or MRI and disease progression within 36 months since their last previous therapy were enrolled...
March 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28108232/ns5a-resistance-associated-substitutions-in-patients-with-genotype-1-hepatitis-c-virus-prevalence-and-effect-on-treatment-outcome
#15
Stefan Zeuzem, Masashi Mizokami, Stephen Pianko, Alessandra Mangia, Kwang-Hyub Han, Ross Martin, Evguenia Svarovskaia, Hadas Dvory-Sobol, Brian Doehle, Charlotte Hedskog, Chohee Yun, Diana M Brainard, Steven Knox, John G McHutchison, Michael D Miller, Hongmei Mo, Wan-Long Chuang, Ira Jacobson, Gregory J Dore, Mark Sulkowski
BACKGROUND & AIMS: The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). We analyzed data from 35 phase I, II, and III studies in 22 countries to determine the pretreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with ledipasvir-sofosbuvir in patients with genotype 1 HCV. METHODS: NS5A gene deep sequencing analysis was performed on samples from 5397 patients in Gilead clinical trials...
January 18, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28103111/oxidative-stress-and-carcinogenesis-potential-of-phytochemicals-in-breast-cancer-therapy
#16
Gilead Ebiegberi Forcados, Dorcas Bolanle James, Abdullahi Balarabe Sallau, Aliyu Muhammad, Peace Mabeta
Breast cancer remains a burden in both developed and developing countries, with higher mortality in developing countries. Attempts to eradicate cancer have not been successful despite the progress made in the development of more novel chemotherapeutic drugs. Reactive-oxygen-species-mediated oxidative stress is known to play a role in breast cancer pathogenesis via genetic and epigenetic modifications, resulting in uncontrolled cell proliferation. Phytochemicals could provide leads for the development of alternative therapeutic agents due to their antioxidant activity, as well as their ability to induce apoptosis in cancer cells...
April 2017: Nutrition and Cancer
https://www.readbyqxmd.com/read/28044265/improvement-of-subjective-well-being-by-ranolazine-in-patients-with-chronic-angina-and-known-myocardial-ischemia-imwell-study
#17
Anthony A Bavry, Ki E Park, Calvin Y Choi, Ahmed N Mahmoud, Xuerong Wen, Islam Y Elgendy
INTRODUCTION: We aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia. METHODS: Eligible subjects had chronic stable angina and at least one coronary stenosis with fractional flow reserve (FFR) ≤0.80 or at least one chronic total occlusion (CTO) without attempted revascularization. Subjects were randomized to oral ranolazine 500 mg twice daily for 1 week, then ranolazine 1000 mg twice daily for 15 weeks versus matching placebo...
January 2, 2017: Cardiology and Therapy
https://www.readbyqxmd.com/read/28029529/ledipasvir-plus-sofosbuvir-fixed-dose-combination-for-6-weeks-in-patients-with-acute-hepatitis-c-virus-genotype-1-monoinfection-hepnet-acute-hcv-iv-an-open-label-single-arm-phase-2-study
#18
Katja Deterding, Christoph D Spinner, Eckart Schott, Tania M Welzel, Guido Gerken, Hartwig Klinker, Ulrich Spengler, Johannes Wiegand, Julian Schulze Zur Wiesch, Anita Pathil, Markus Cornberg, Andreas Umgelter, Caroline Zöllner, Stefan Zeuzem, Armin Papkalla, Kristina Weber, Svenja Hardtke, Heiko von der Leyen, Armin Koch, Dorothee von Witzendorff, Michael P Manns, Heiner Wedemeyer
BACKGROUND: Early treatment of acute hepatitis C virus (HCV) infection with interferon alfa is highly effective, but can be associated with frequent side-effects. We investigated the safety and efficacy of an interferon-free regimen for treatment of acute HCV infection. METHODS: In this prospective, open-label, multicentre, single-arm pilot study, we enrolled adults (≥18 years) with acute HCV genotype 1 monoinfection from ten centres in Germany. Patients were given ledipasvir (90 mg) plus sofosbuvir (400 mg) as a fixed-dose combination tablet once daily for 6 weeks...
February 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28025931/a-review-of-clinical-trial-endpoints-of-patients-with-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension-and-how-they-relate-to-patient-outcomes-in-the-united-states
#19
Christine Divers, David Platt, Edward Wang, Jay Lin, Melissa Lingohr-Smith, Stephen C Mathai
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are subgroups of pulmonary hypertension and are considered rare diseases. Understanding how endpoints of clinical trials (and patient registry studies) of patients with PAH and CTEPH are associated with patient outcomes is important in order to address the concerns of patients, health care providers, decision makers, and payers. The purpose of this review was to examine how endpoints used in clinical trials and patient registry studies are associated with outcomes of patients with PAH and CTEPH...
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
#20
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
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