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https://www.readbyqxmd.com/read/28687550/sofosbuvir-velpatasvir-a-single-tablet-treatment-for-hepatitis-c-infection-of-all-genotypes
#1
REVIEW
Misty M Miller
PURPOSE: The pharmacology, pharmacokinetics, interaction potential, efficacy, and safety of the newest direct-acting antiviral (DAA) medication for the treatment of chronic hepatitis C are reviewed. SUMMARY: Nonstructural proteins 5A (NS5A) and 5B (NS5B) are key drivers of hepatitis C virus (HCV) replication. Velpatasvir, an inhibitor of NS5A, was coformulated with the NS5B inhibitor sofosbuvir to provide a single-tablet combination DAA (Epclusa, Gilead Sciences)...
July 15, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28677075/urticarial-reaction-to-ustekinumab-during-the-treatment-of-plaque-psoriasis-in-a-hepatitis-c-positive-patient
#2
Christopher H Chu, Charles Davis
A 62-year-old white woman with a history of hepatitis C and type 2 diabetes mellitus developed urticaria during treatment with ustekinumab for plaque psoriasis. The patient received two 45-mg ustekinumab injections in her first 2 months and then one 45-mg injection every 3 months for her psoriasis. After 10 months, she developed a round red rash on her skin diffusely on her body. She also complained of joint pain in her hands. Rheumatology became involved, and investigations revealed that her antinuclear antibody titer was negative, but her rheumatoid factor, erythrocyte sedimentation rate, and liver function enzymes were elevated...
December 2017: Drug Safety—Case Reports
https://www.readbyqxmd.com/read/28657199/interprep-internet-based-pre-exposure-prophylaxis-with-generic-tenofovir-disoproxil-fumarate-emtrictabine-in-london-analysis-of-pharmacokinetics-safety-and-outcomes
#3
X Wang, N Nwokolo, R Korologou-Linden, A Hill, G Whitlock, I Day-Weber, M O McClure, M Boffito
OBJECTIVES: The National Health Service in England (NHS England) does not provide pre-exposure prophylaxis (PrEP) against HIV, forcing people to purchase generic versions on the internet. However, there are concerns about the authenticity of medicines purchased online. We established an innovative service offering plasma tenofovir (TFV) and emcitrabine (FTC) therapeutic drug monitoring for people buying generic PrEP online, to ensure that drug concentrations in vivo were consistent with those of propriety brands and previously published data...
June 28, 2017: HIV Medicine
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
#4
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
#5
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
https://www.readbyqxmd.com/read/28644739/treatment-of-hepatitis-c-with-new-fixed-dose-combinations
#6
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/28573977/bioactive-glass-ceramic-with-two-crystalline-phases-bios-2p-for-bone-tissue-engineering
#7
Emanuela Ferraz, Gileade Freitas, Murilo Crovace, Oscar Peitl, Edgar Zanotto, Paulo Tambasco de Oliveira, Marcio Mateus Beloti, Adalberto Rosa
We aimed to evaluate the in vitro osteogenic and osteoinductive potentials of BioS-2P and its ability to promote in vivo bone repair. To investigate osteogenic potential, UMR-106 osteoblastic cells were cultured on BioS-2P and Bioglass 45S5 discs in osteogenic medium. The osteoinductive potential was evaluated using mesenchymal stem cells (MSCs) cultured on BioS-2P, Bioglass 45S5 and polystyrene in non-osteogenic medium. Rat bone calvarial defects were implanted with BioS-2P scaffolds alone or seeded with MSCs...
June 2, 2017: Biomedical Materials
https://www.readbyqxmd.com/read/28571503/managing-side-effects-of-jak-inhibitors-for-myelofibrosis-in-clinical-practice
#8
Iram Saeed, Donal McLornan, Claire N Harrison
Myelofibrosis (MF) is characterized by bone marrow fibrosis, abnormalities in peripheral counts, extramedullary hematopoiesis, splenomegaly and an increased risk of transformation to acute myeloid leukaemia. The disease course is often heterogeneous and management can range from observation alone through to allogeneic stem cell transplantation. As of 2017, the only approved medication for MF remains the JAK Inhibitor (JAKi), ruxolitinib (Novartis Pharmaceuticals, Basel, Switzerland; Incyte, Wilmington, Detroit, USA) although several others have reached advanced stages of clinical trials...
June 19, 2017: Expert Review of Hematology
https://www.readbyqxmd.com/read/28564569/sofosbuvir-velpatasvir-and-voxilaprevir-for-previously-treated-hcv-infection
#9
RANDOMIZED CONTROLLED TRIAL
Marc Bourlière, Stuart C Gordon, Steven L Flamm, Curtis L Cooper, Alnoor Ramji, Myron Tong, Natarajan Ravendhran, John M Vierling, Tram T Tran, Stephen Pianko, Meena B Bansal, Victor de Lédinghen, Robert H Hyland, Luisa M Stamm, Hadas Dvory-Sobol, Evguenia Svarovskaia, Jie Zhang, K C Huang, G Mani Subramanian, Diana M Brainard, John G McHutchison, Elizabeth C Verna, Peter Buggisch, Charles S Landis, Ziad H Younes, Michael P Curry, Simone I Strasser, Eugene R Schiff, K Rajender Reddy, Michael P Manns, Kris V Kowdley, Stefan Zeuzem
BACKGROUND: Patients who are chronically infected with hepatitis C virus (HCV) and who do not have a sustained virologic response after treatment with regimens containing direct-acting antiviral agents (DAAs) have limited retreatment options. METHODS: We conducted two phase 3 trials involving patients who had been previously treated with a DAA-containing regimen. In POLARIS-1, patients with HCV genotype 1 infection who had previously received a regimen containing an NS5A inhibitor were randomly assigned in a 1:1 ratio to receive either the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the protease inhibitor voxilaprevir (150 patients) or matching placebo (150 patients) once daily for 12 weeks...
June 1, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28530057/-hansen-s-disease-in-israel
#10
REVIEW
Leon Gilead, Ruth Wexler
Hansen's disease (HD) is an anthropophylic, infectious, chronic disease, caused by Mycobacterium leprae. The systemic disease, affecting both males and females at any age, involves mainly the skin and the peripheral nerves located in the limbs close to the skin. Traditionally the treatment of HD patients was entrusted to dermatologists. Current drug therapy given at an early stage can prevent many of the complications, and enables patients to go on with life. In 95% of the population there is an innate immunity, which following exposure, enables the development of an effective immune response preventing the development of overt clinical disease...
October 2016: Harefuah
https://www.readbyqxmd.com/read/28507772/clinically-significant-depressive-symptoms-and-sexual-behaviour-among-men-who-have-sex-with-men
#11
Ada R Miltz, Alison J Rodger, Janey Sewell, Andrew Speakman, Andrew N Phillips, Lorraine Sherr, Richard J Gilson, David Asboe, Nneka C Nwokolo, Amanda Clarke, Mark M Gompels, Sris Allan, Simon Collins, Fiona C Lampe
BACKGROUND: The relationship between depression and sexual behaviour among men who have sex with men (MSM) is poorly understood. AIMS: To investigate prevalence and correlates of depressive symptoms (Patient Health Questionnaire-9 score ≥10) and the relationship between depressive symptoms and sexual behaviour among MSM reporting recent sex. METHOD: The Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) is a cross-sectional study of UK genitourinary medicine clinic attendees without diagnosed HIV (2013-2014)...
May 2017: BJPsych Open
https://www.readbyqxmd.com/read/28453836/commonly-transmitted-hiv-1-drug-resistance-mutations-in-reverse-transcriptase-and-protease-in-antiretroviral-treatment-naive-patients-and-response-to-regimens-containing-tenofovir-disoproxil-fumarate-or-tenofovir-alafenamide
#12
MULTICENTER STUDY
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 (TDRMs) in antiretroviral treatment (ART)-naive patients can adversely affect the outcome of ART. Methods: Resistance testing was conducted in 6704 ART-naive subjects predominantly from the United States and Europe in 9 clinical studies conducted by Gilead Sciences from 2000 to 2013. Results: The presence of TDRMs increased during this period (from 5.2% to 11.4%), primarily driven by an increase in nonnucleoside reverse-transcriptase (RT) inhibitor (NNRTI) resistance mutations (from 0...
March 15, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28451713/potential-of-osteoblastic-cells-derived-from-bone-marrow-and-adipose-tissue-associated-with-a-polymer-ceramic-composite-to-repair-bone-tissue
#13
Gileade P Freitas, Helena B Lopes, Adriana L G Almeida, Rodrigo P F Abuna, Rossano Gimenes, Lucas E B Souza, Dimas T Covas, Marcio M Beloti, Adalberto L Rosa
One of the tissue engineering strategies to promote bone regeneration is the association of cells and biomaterials. In this context, the aim of this study was to evaluate if cell source, either from bone marrow or adipose tissue, affects bone repair induced by osteoblastic cells associated with a membrane of poly(vinylidene-trifluoroethylene)/barium titanate (PVDF-TrFE/BT). Mesenchymal stem cells (MSC) were isolated from rat bone marrow and adipose tissue and characterized by detection of several surface markers...
April 27, 2017: Calcified Tissue International
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
#14
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
#15
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
#16
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
#17
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
#18
(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
#19
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
#20
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
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