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https://www.readbyqxmd.com/read/28782339/role-of-generics-in-treatment-of-hepatitis-c-infection
#1
Muhammad Umar, Tayyab Saeed Akhter, Ibrar Akbar, Gul Nisar, Muhammad Osama, Tayyab Saeed Akhter
With the discovery of newer and newer DAAs, the cure of Hepatitis C seems to be a reality. But their high price and availability is a big hindrance. Sofosbuvir launched by Gilead costs about $ 84000 per 12-week course. Since its launch there is a huge debate regarding the complex pricing mechanism of DAAs. The pricing involves negotiation of patent holder with health insurance companies through their Pharmacy Benefit Managers (PBMs). Several rebates are also involved in this pricing mechanism amongst which only few are declared ones...
October 2016: Journal of Ayub Medical College, Abbottabad: JAMC
https://www.readbyqxmd.com/read/28751500/genome-wide-snp-discovery-and-analysis-of-genetic-diversity-in-farmed-sika-deer-cervus-nippon-in-northeast-china-using-double-digest-restriction-site-associated-dna-sequencing
#2
Hengxing Ba, Boyin Jia, Guiwu Wang, Yifeng Yang, Gilead Kedem, Chunyi Li
Sika deer are an economically valuable species for their use in traditional Chinese medicine, particularly velvet antlers. Sika deer in northeast China are mostly farmed in enclosure. Therefore, genetic management of farmed sika deer would benefit from detailed knowledge of their genetic diversity. In this study, we generated over 1.45 billion high-quality paired-end reads (288 Gbp) across 42 unrelated individuals using double-digest restriction-site associated DNA sequencing (ddRAD-seq). A total of 96,188 (29...
July 27, 2017: G3: Genes—Genomes—Genetics
https://www.readbyqxmd.com/read/28749925/the-role-of-screening-and-treatment-in-national-progress-toward-hepatitis-c-elimination-georgia-2015-2016
#3
Muazzam Nasrullah, David Sergeenko, Lia Gvinjilia, Amiran Gamkrelidze, Tengiz Tsertsvadze, Maia Butsashvili, David Metreveli, Lali Sharvadze, Maia Alkhazashvili, Shaun Shadaker, John W Ward, Juliette Morgan, Francisco Averhoff
Georgia, a country in the Caucasus region of Eurasia, has a high prevalence of hepatitis C virus (HCV) infection. In April 2015, with technical assistance from CDC, Georgia embarked on the world's first program to eliminate hepatitis C, defined as a 90% reduction in HCV prevalence by 2020 (1,2). The country committed to identifying infected persons and linking them to care and curative antiviral therapy, which was provided free of charge through a partnership with Gilead Sciences (1,2). From April 2015 through December 2016, a total of 27,595 persons initiated treatment for HCV infection, among whom 19,778 (71...
July 28, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28747274/efficacy-safety-and-effect-on-sexual-behaviour-of-on-demand-pre-exposure-prophylaxis-for-hiv-in-men-who-have-sex-with-men-an-observational-cohort-study
#4
Jean-Michel Molina, Isabelle Charreau, Bruno Spire, Laurent Cotte, Julie Chas, Catherine Capitant, Cecile Tremblay, Daniela Rojas-Castro, Eric Cua, Armelle Pasquet, Camille Bernaud, Claire Pintado, Constance Delaugerre, Luis Sagaon-Teyssier, Soizic Le Mestre, Christian Chidiac, Gilles Pialoux, Diane Ponscarme, Julien Fonsart, David Thompson, Mark A Wainberg, Veronique Doré, Laurence Meyer
BACKGROUND: Data for on-demand pre-exposure prophylaxis (PrEP) are scarce. We implemented a cohort study to assess its efficacy, safety, and effect on sexual behaviour. METHODS: We invited men and transgender women who have sex with men, previously enrolled in the randomised placebo-controlled ANRS IPERGAY trial at seven sites (six in France and one in Canada), to participate in an open-label extension with on-demand tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) to be taken before and after sexual intercourse...
July 21, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28745218/ventricular-extrasystoles-after-first-dose-of-sofosbuvir-in-a-patient-treated-with-propranolol-but-not-with-amiodarone-a-case-report
#5
Samir Rouabhia, Sabah Baghazza, Hamza Sadouki, Sihem Djezzar, Rafik Bencherif, Rofia Guehimeche, Mourad Sadelaoud, Djamel Mallem, Karima Chaabna
BACKGROUND: Sofosbuvir is a direct-acting antiviral drug used to treat chronic hepatitis C infection. In 2015, Gilead Sciences, the manufacturer of sofosbuvir, warned that bradycardia could occur when sofosbuvir is administered in combination with amiodarone. Interestingly, among reported cases of patients with sofosbuvir and amiodarone related bradycardia, some of them were also treated with propranolol. OBJECTIVE: We herein report a case of ventricular extrasystoles within three hours after the coadministration of sofosbuvir-containing regimen with propranolol...
July 25, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28737989/incremental-effect-of-the-addition-of-prescriber-restrictions-on-a-state-medicaid-s-pharmacy-only-patient-review-and-restriction-program
#6
Shellie L Keast, Timothy Pham, Ashley Teel, Nancy J Nesser
BACKGROUND: Patient review and restriction programs (PRRPs), used by state Medicaid programs to limit potential abuse and misuse of opioids and related controlled medications, often restrict members to a single pharmacy for controlled medications. While most states use a restricted pharmacy access model, not all states include restricted prescriber access. Oklahoma Medicaid (MOK) added a restricted prescriber access feature to its PRRP in July 2014. OBJECTIVE: To evaluate the incremental effect that the addition of a prescriber restriction to MOK's pharmacy-only PRRP had on the pharmacy and resource utilization of the enrolled members...
August 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28687550/sofosbuvir-velpatasvir-a-single-tablet-treatment-for-hepatitis-c-infection-of-all-genotypes
#7
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
#8
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
#9
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
#10
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
#11
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
#12
Vincent Soriano, José V Fernandez-Montero, Carmen de Mendoza, Laura Benitez-Gutierrez, José M Peña, Ana Arias, Pablo Barreiro
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...
July 30, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28573977/bioactive-glass-ceramic-with-two-crystalline-phases-bios-2p-for-bone-tissue-engineering
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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