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hepatitis b phases

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https://www.readbyqxmd.com/read/29775791/an-imaging-biomarker-for-assessing-hepatic-function-in-patients-with-primary-sclerosing-cholangitis
#1
Jennifer Schulze, Henrike Lenzen, Jan B Hinrichs, Burckhardt Ringe, Michael P Manns, Frank Wacker, Kristina I Ringe
BACKGROUND & AIMS: We aimed to evaluate the potential of hepatobiliary phase magnetic resonance imaging (MRI) as parameter for assessment of hepatocellular function in patients with primary sclerosing cholangitis (PSC). METHODS: We collected data from 111 patients (83 male, 28 female; median, 44 years old), from March 2012 through March 2016, with a confirmed diagnosis of PSC who underwent MRI evaluation before and after injection (hepatobiliary phase) of a hepatocyte-specific contrast agent (gadoxetate disodium)...
May 15, 2018: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/29771789/raltegravir-1200-mg-once-daily-vs-400-mg-twice-daily-with-emtricitabine-and-tenofovir-disoproxil-fumarate-for-previously-untreated-hiv-1-infection-week-96-results-from-oncemrk-a-randomized-double-blind-non-inferiority-trial
#2
Pedro Cahn, Paul E Sax, Kathleen Squires, Jean-Michel Molina, Winai Ratanasuwan, Mohammed Rassool, Mark Bloch, Xia Xu, Yan Zhou, Brenda Homony, Deborah Hepler, Hedy Teppler, George J Hanna, Bach-Yen Nguyen, Wayne Greaves
BACKGROUND: Raltegravir 1200mg (2x600mg tablets) once daily (QD) demonstrated non-inferior efficacy and similar safety to raltegravir 400mg BID at Week 48 of the ONCEMRK trial. Here we report the Week 96 results from this study. METHODS: ONCEMRK is a phase 3, multicenter, double-blind, non-inferiority trial comparing raltegravir 1200mg QD to raltegravir 400mg BID in treatment-naïve HIV-1-infected adults. Participants were assigned (2:1) to raltegravir 2x600mg QD or 400mg BID, both with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) for 96 weeks...
May 3, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29770763/a-radiomics-nomogram-for-preoperative-prediction-of-microvascular-invasion-risk-in-hepatitis-b-virus-related-hepatocellular-carcinoma
#3
Jie Peng, Jing Zhang, Qifan Zhang, Yikai Xu, Jie Zhou, Li Liu
PURPOSE: We aimed to develop and validate a radiomics nomogram for preoperative prediction of microvascular invasion (MVI) in hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). METHODS: A total of 304 eligible patients with HCC were randomly divided into training (n=184) and independent validation (n=120) cohorts. Portal venous and arterial phase computed tomography data of the HCCs were collected to extract radiomic features. Using the least absolute shrinkage and selection operator algorithm, the training set was processed to reduce data dimensions, feature selection, and construction of a radiomics signature...
May 2018: Diagnostic and Interventional Radiology: Official Journal of the Turkish Society of Radiology
https://www.readbyqxmd.com/read/29762363/immunogenicity-and-safety-of-primary-and-booster-vaccinations-of-a-fully-liquid-dtap-ipv-hb-prp-t-hexavalent-vaccine-in-healthy-infants-and-toddlers-in-germany-and-the-czech-republic
#4
Roman Prymula, Dorothee Kieninger, Emmanuel Feroldi, Emilia Jordanov, Siham B'Chir, Xavier DaCosta
BACKGROUND: To support a fully liquid, diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine in Europe using a 2, 3, 4 month primary series and a booster at 11 to 15 months of age. METHODS: Phase III, randomized, observer-blind studies in Germany and the Czech Republic. Participants who had not received HB vaccine were randomized to a 2, 3, 4 month primary series of DTaP-IPV-HB-PRP-T (Group 1; N=266) or a reconstituted DTaPHB-IPV//PRP-T comparator (Group 2; N=263) and a booster of the same vaccine...
May 14, 2018: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29761171/coding-variants-in-pnpla3-and-tm6sf2-are-risk-factors-for-hepatic-steatosis-and-elevated-serum-alanine-aminotransferases-caused-by-a-glucagon-receptor-antagonist
#5
Cristina B Guzman, Suman Duvvuru, Anthony Akkari, Pallav Bhatnagar, Chakib Battioui, Wendra Foster, Xiaotian Michelle Zhang, Sudha S Shankar, Mark A Deeg, Naga Chalasani, Thomas A Hardy, Christof M Kazda, Sreekumar G Pillai
LY2409021 is a glucagon receptor antagonist that was associated with hepatic steatosis and elevated aminotransferases in phase 2 diabetes studies. We investigated the relationship between selected genetic variants and hepatic steatosis and elevated alanine aminotransferases (ALTs) associated with LY2409021. Patients participated in a 6-week placebo-controlled trial (I1R-MC-GLDI [GLDI], n = 246) and a 52-week placebo- and active comparator-controlled trial (I1R-MC-GLDJ [GLDJ], n = 158). GLDJ had endpoints at 6 months, including measures of hepatic fat fraction (HFF) by magnetic resonance imaging...
May 2018: Hepatology communications
https://www.readbyqxmd.com/read/29758333/hepatitis-b-virus-specific-t-cell-responses-after-stopping-nucleos-t-ide-analogue-therapy-in-hbeag-negative-chronic-hepatitis-b
#6
Franziska Rinker, Christine L Zimmer, Christoph Höner Zu Siederdissen, Michael P Manns, Anke R M Kraft, Heiner Wedemeyer, Niklas K Björkström, Markus Cornberg
BACKGROUND AND AIMS: Treatment with nucleos(t)ide analogues (NA) leads to HBV DNA suppression in most patients with chronic hepatitis B (CHB), but HBsAg loss rates are low. Upon NA discontinuation, HBV DNA can return rapidly with ensuing ALT flares and induction of cytokines. Several studies reported higher HBsAg loss rates after stopping therapy, but at present, it is unclear if cell-mediated immune responses are altered after treatment discontinuation. The aim of this study was to characterise T cell responses during the early phase of virological relapse following discontinuation of NA therapy in HBeAg-negative patients...
May 11, 2018: Journal of Hepatology
https://www.readbyqxmd.com/read/29756595/96-weeks-treatment-of-tenofovir-alafenamide-vs-tenofovir-disoproxil-fumarate-for-hepatitis-b-virus-infection
#7
Kosh Agarwal, Maurizia Brunetto, Wai Kay Seto, Young-Suk Lim, Scott Fung, Patrick Marcellin, Sang Hoon Ahn, Namiki Izumi, Wan-Long Chuang, Ho Bae, Manoj Sharma, Harry L A Janssen, Calvin Q Pan, Mustafa Kemal Çelen, Norihiro Furusyo, Dr Shalimar, Ki Tae Yoon, Huy Trinh, John F Flaherty, Anuj Gaggar, Audrey H Lau, Andrea L Cathcart, Lanjia Lin, Neeru Bhardwaj, Vithika Suri, G Mani Subramanian, Edward J Gane, Maria Buti, Henry L Y Chan
BACKGROUND & AIMS: Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection at a lower dose than tenofovir disoproxil fumarate (TDF) through more efficient delivery of tenofovir to hepatocytes. In 48-week results from two ongoing, double-blind, randomized phase III trials, TAF was non-inferior to TDF in efficacy with improved renal and bone safety. We report 96-week outcomes for both trials. METHODS: In two international trials, patients with chronic HBV infection were randomized 2:1 to receive 25 mg TAF or 300 mg TDF in a double-blinded fashion...
April 2018: Journal of Hepatology
https://www.readbyqxmd.com/read/29746728/an-open-label-phase-1-study-to-assess-the-effects-of-hepatic-impairment-on-pomalidomide-pharmacokinetics
#8
Yan Li, Xiaomin Wang, Liangang Liu, Chengyue Zhang, Diana Gomez, Josephine Reyes, Maria Palmisano, Simon Zhou
Pomalidomide is an immunomodulatory drug and the dosage of 4 mg per day taken orally on days 1-21 of repeated 28-day cycles has been approved in the European Union and United States to treat patients with relapsed/refractory multiple myeloma. Because pomalidomide is extensively metabolized prior to excretion, a total of 32 subjects (8 healthy subjects in group 1; 8 subjects with severe hepatic impairment in group 2; 8 subjects with moderate hepatic impairment in group 3; and 8 subjects with mild hepatic impairment in group 4) were enrolled in a multicenter, open-label, single-dose study to assess the impact of hepatic impairment on pomalidomide exposure...
May 10, 2018: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/29744672/efficacy-and-safety-of-neoadjuvant-treatment-with-bevacizumab-liposomal-doxorubicin-cyclophosphamide-and-paclitaxel-combination-in-locally-regionally-advanced-her2-negative-grade-iii-at-premenopausal-status-breast-cancer-a-phase-ii-study
#9
Ekaterini C Tampaki, Athanasios Tampakis, Constantinos E Alifieris, Dimitrios Krikelis, Anastasia Pazaiti, Michalis Kontos, Dimitrios T Trafalis
BACKGROUND: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. OBJECTIVE: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). METHODS: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma...
May 9, 2018: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29741286/comparison-of-overall-survival-between-antiviral-induced-viral-suppression-and-inactive-phase-chronic-hepatitis-b-patients
#10
Young Youn Cho, Jeong-Hoon Lee, Young Chang, Joon Yeul Nam, Hyeki Cho, Dong Hyeon Lee, Eun Ju Cho, Dong Ho Lee, Su Jong Yu, Jeong Min Lee, Yoon Jun Kim, Jung-Hwan Yoon
Nucleot(s)ide analogues (NAs) reduce the risk of hepatocellular carcinoma (HCC) in chronic hepatitis B (CHB) patients. However, the risk of HCC is reportedly higher for NA-treated patients than for patients in the inactive CHB phase. This study aimed to compare the long-term outcomes of CHB patients with NA-induced viral suppression and those of patients with inactive CHB. This retrospective study involved 1,118 consecutive CHB patients whose HBV DNA level was continuously <2,000 IU/mL during follow up with/without antiviral agents...
May 9, 2018: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29736851/towards-volumetric-thresholds-in-recist-1-1-therapeutic-response-assessment-in-hepatic-metastases
#11
Katharina S Winter, Felix O Hofmann, Kolja M Thierfelder, Julian W Holch, Nina Hesse, Alena B Baumann, Dominik P Modest, Sebastian Stintzing, Volker Heinemann, Jens Ricke, Wieland H Sommer, Melvin D'Anastasi
OBJECTIVES: To empirically determine thresholds for volumetric assessment of response and progress of liver metastases in line with the unidimensional RECIST thresholds. METHODS: Patients with metastatic colorectal cancer initially enrolled in a multicentre clinical phase-III trial were included. In all CT scans, the longest axial diameters and volumes of hepatic lesions were determined semi-automatically. The sum of diameters and volumes of 1, ≤2 and ≤5 metastases were compared to all previous examinations...
May 7, 2018: European Radiology
https://www.readbyqxmd.com/read/29736243/pharmacokinetics-safety-and-tolerability-of-the-2-and-3-direct-acting-antiviral-combination-of-al-335-odalasvir-and-simeprevir-in-healthy-subjects
#12
Thomas N Kakuda, Matthew W McClure, Christopher Westland, Jennifer Vuong, Marie-Claude Homery, Gwendoline Poizat, Laure Viguerie, Caroline Denot, Alain Patat, Qingling Zhang, James Hui, David Apelian, David B Smith, Sushmita M Chanda, John Fry
This Phase I, open-label, two-group, fixed-sequence study evaluated the pharmacokinetics and safety of AL-335, odalasvir, and simeprevir in healthy subjects. Group 1 (n   =   16) received AL-335 800 mg once daily (QD) (days 1-3, 11-13, and 21-23), simeprevir 150 mg QD (days 4-23), and odalasvir 150 mg (day 14) followed by 50 mg QD (days 15-23). Group 2 (n   =   16) received the same AL-335 regimen as in Group 1 plus odalasvir 150 mg (day 4) followed by 50 mg QD (days 5-23) and simeprevir 150 mg QD (days 14-23)...
June 2018: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/29723527/inhibitory-effect-of-fasiglifam-on-hepatitis-b-virus-infections-through-suppression-of-the-sodium-taurocholate-cotransporting-polypeptide
#13
Yasunori Nio, Yuichi Akahori, Hitomi Okamura, Koichi Watashi, Takaji Wakita, Makoto Hijikata
Fasiglifam is a selective partial agonist of G-protein-coupled receptor 40 (GPR40), which was developed for the treatment of type 2 diabetes mellitus. However, the clinical development of fasiglifam was voluntarily terminated during phase III clinical trials due to adverse liver effects. Fasiglifam showed an inhibitory effect on sodium taurocholate cotransporting polypeptide (NTCP) in human and rat hepatocytes. Recently, NTCP was reported to be a functional receptor for human hepatitis B virus (HBV) infections...
April 30, 2018: Biochemical and Biophysical Research Communications
https://www.readbyqxmd.com/read/29714713/molecular-jenga-the-percolation-phase-transition-collapse-in-virus-capsids
#14
Nicholas Brunk, Lye Siang Lee, James A Glazier, William D Butske, Adam Zlotnick
Virus capsids are polymeric protein shells that protect the viral cargo. About half of known virus families have icosahedral capsids that self-assemble from tens to thousands of subunits. Capsid disassembly is critical to the lifecycles of many viruses yet is poorly understood. Here, we apply a graph and percolation theory to examine the effect of removing capsid subunits on capsid stability and fragmentation. Based on the structure of the icosahedral capsid of Hepatitis B Virus (HBV), we constructed a graph of rhombic subunits arranged with icosahedral symmetry...
May 1, 2018: Physical Biology
https://www.readbyqxmd.com/read/29703432/antiviral-activity-safety-and-tolerability-of-multiple-ascending-doses-of-elbasvir-or-grazoprevir-in-participants-infected-with-hepatitis-c-virus-genotype-1-or-3
#15
Wendy W Yeh, Iain P Fraser, Patricia Jumes, Amelia Petry, Inge De Lepeleire, Martine Robberechts, Christina Reitmann, Kristien Van Dyck, Xiaobi Huang, Zifang Guo, Deborah Panebianco, Robert B Nachbar, Edward O'Mara, John A Wagner, Joan R Butterton, Frank J Dutko, Valentin Moiseev, Zhanna Kobalava, Andreas Hüser, Sorin Visan, Christian Schwabe, Edward Gane, Serghei Popa, Nelea Ghicavii, Markus Uhle, Frank Wagner
PURPOSE: Elbasvir (MK-8742) and grazoprevir (MK-5172; Merck & Co, Inc, Kenilworth, New Jersey) are hepatitis C virus (HCV)-specific inhibitors of the nonstructural protein 5A phosphoprotein and the nonstructural protein 3/4A protease, respectively. The aims of these studies were to evaluate the antiviral activity and safety of different doses of elbasvir or grazoprevir each administered as monotherapy to participants infected with either HCV genotype (GT) 1 or GT3. METHODS: These 2 double-blind, randomized, placebo-controlled, sequential-panel, multiple ascending dose studies were conducted to assess the safety and pharmacodynamics of 5 days of once-daily elbasvir or 7 days of once-daily grazoprevir in adult male participants chronically infected with either HCV GT1 or GT3...
April 24, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29696666/randomised-clinical-trial-a-leucine-metformin-sildenafil-combination-ns-0200-vs-placebo-in-patients-with-non-alcoholic-fatty-liver-disease
#16
N Chalasani, R Vuppalanchi, M Rinella, M S Middleton, M S Siddiqui, A S Barritt, O Kolterman, O Flores, C Alonso, M Iruarrizaga-Lejarreta, R Gil-Redondo, C B Sirlin, M B Zemel
BACKGROUND: Sirtuin 1 (Sirt1) is suppressed in non-alcoholic fatty liver disease (NAFLD), while its' stimulation or overexpression results in reduced disease severity in pre-clinical NAFLD models. Leucine allosterically activates Sirt1 and synergise with other Sirt/AMPK/NO pathway activators. We developed a triple combination of leucine, metformin and sildenafil (NS-0200), which was effective in a mouse model of non-alcoholic steatohepatitis (NASH). AIM: To report the results from a Phase 2, randomised clinical trial of of NS-0200 in 91 subjects with NAFLD (liver fat ≥15% by magnetic resonance imaging-proton-density fat fraction (MRI-PDFF))...
April 25, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29689122/efficacy-and-safety-of-peginterferon-alfa-2a-40kd-in-children-with-chronic-hepatitis-b-the-peg-b-active-study
#17
Stefan Wirth, Hongfei Zhang, Winita Hardikar, Kathleen B Schwarz, Etienne Sokal, Weibo Yang, Huimin Fan, Vyacheslav Morozov, Qing Mao, Hong Deng, Yang Huang, Lei Yang, Nicolas Frey, Clare Nasmyth-Miller, Vedran Pavlovic, Cynthia Wat
Children with chronic hepatitis B (CHB) represent an area of unmet medical need, due to increased lifetime risk of CHB sequelae and limited therapeutic options compared with adult CHB patients. The PEG-B-ACTIVE (NCT01519960) phase III study evaluated peginterferon (PegIFN) alfa-2a treatment in children aged 3 to <18 years with CHB. A total of 161 hepatitis B e antigen (HBeAg)-positive immune-active patients without advanced fibrosis/cirrhosis were randomized (2:1) to PegIFN alfa-2a (Group A, n = 101) or no treatment (Group B, n = 50); patients with advanced fibrosis were assigned to PegIFN alfa-2a (Group C, n = 10)...
April 24, 2018: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29685552/coefficient-of-variation-on-gd-eob-mr-imaging-correlation-with-the-presence-of-early-stage-hepatocellular-carcinoma-in-patients-with-chronic-hepatitis-b
#18
Jung Hun Lee, Youe Ree Kim, Guy Mok Lee, Jong Hyun Ryu, Eun Young Cho, Young Hwan Lee, Kwon-Ha Yoon
PURPOSE: To study whether the measurement of hepatic fibrosis on gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid (Gd-EOB-DTPA) magnetic resonance (MR) imaging using the coefficient of variation (CV) might be correlated with the presence of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB). MATERIALS AND METHODS: This study included 104 patients with and without CHB, who were divided into 4 groups: control group, CHB without liver cirrhosis (LC; Group I), CHB with LC (Group II), and CHB with LC and HCC (Group III)...
May 2018: European Journal of Radiology
https://www.readbyqxmd.com/read/29684791/the-role-of-promyelocytic-leukemia-protein-in-steatosis-associated-hepatic-tumors-related-to-chronic-hepatitis-b-virus-infection
#19
Yih-Lin Chung, Mei-Ling Wu
The persistence of hepatitis B surface antigen (HBsAg) is a risk factor for the development of steatosis-associated tumors in chronic hepatitis B virus (HBV) infection, yet little is known about the metabolic link with this factor. We correlated HBV-related pathogenesis in genetically engineered mice and human carriers with metabolic proteomics and lipogenic gene expression profiles. The immunohistochemistry showed that the promyelocytic leukemia protein (PML, a tumor suppressor involved in genome maintenance and fatty acid oxidation), being inversely influenced by the dynamic HBsAg levels from acute phase to seroclearance, appeared as a lipo-metabolic switch linking HBsAg-induced steatosis (lipogenesis) to HBsAg-lost fat-burning hepatocarcinogenesis (lipolysis)...
April 20, 2018: Translational Oncology
https://www.readbyqxmd.com/read/29682899/generalization-and-representativeness-of-phase-iii-immune-checkpoint-blockade-trials-in-non-small-cell-lung-cancer
#20
Shin Hye Yoo, Bhumsuk Keam, Miso Kim, Tae Min Kim, Dong-Wan Kim, Dae Seog Heo
BACKGROUND: Strict eligibility criteria for patient enrollment in phase III trials raise questions regarding generalization to ineligible patients. We evaluated whether pivotal phase III trials of immune checkpoint blockades (ICBs) represent the overall population of non-small cell lung cancer (NSCLC) patients. METHODS: We reviewed the inclusion and exclusion criteria of three phase III trials (CheckMate057, CheckMate017, and KEYNOTE-010). Stage IIIB or IV NSCLC patients diagnosed from 2011 to 2013 at Seoul National University Hospital (cohort 1) were reviewed...
April 22, 2018: Thoracic Cancer
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