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https://www.readbyqxmd.com/read/28919303/acquisition-of-wild-type-hiv-1-infection-in-a-patient-on-pre-exposure-prophylaxis-with-high-intracellular-concentrations-of-tenofovir-diphosphate-a-case-report
#1
Elske Hoornenborg, Maria Prins, Roel C A Achterbergh, Lycke R Woittiez, Marion Cornelissen, Suzanne Jurriaans, Neeltje A Kootstra, Peter L Anderson, Peter Reiss, Henry J C de Vries, Jan M Prins, Godelieve J de Bree
BACKGROUND: Pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir disoproxil fumarate is highly effective against acquisition of HIV infection, and only two cases of infection with a multidrug-resistant virus have been reported under adequate long-term adherence, as evidenced by tenofovir diphosphate concentrations in dried blood spots. We report a case of wild-type HIV-1 infection despite consistent use of emtricitabine and tenofovir disoproxil fumarate. METHODS: The patient participated in the Amsterdam PrEP project, a demonstration project of daily and event-driven PrEP...
September 14, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28903757/access-to-medicines-and-hepatitis-c-in-africa-can-tiered-pricing-and-voluntary-licencing-assure-universal-access-health-equity-and-fairness
#2
Yibeltal Assefa, Peter S Hill, Anar Ulikpan, Owain D Williams
BACKGROUND: The recent introduction of Direct Acting Antivirals (DAAs) for treating Hepatitis C Virus (HCV) can significantly assist in the world reaching the international target of elimination by 2030. Yet, the challenge facing many individuals and countries today lies with their ability to access these treatments due to their relatively high prices. Gilead Sciences applies differential pricing and licensing strategies arguing that this provides fairer and more equitable access to these life-saving medicines...
September 13, 2017: Globalization and Health
https://www.readbyqxmd.com/read/28892558/the-ask1-inhibitor-selonsertib-in-patients-with-nonalcoholic-steatohepatitis-a-randomized-phase-2-trial
#3
Rohit Loomba, Eric Lawitz, Parvez S Mantry, Saumya Jayakumar, Stephen H Caldwell, Hays Arnold, Anna Mae Diehl, C Stephen Djedjos, Ling Han, Robert P Myers, G Mani Subramanian, John G McHutchison, Zachary D Goodman, Nezam H Afdhal, Michael R Charlton
Inhibition of apoptosis signal-regulating kinase 1 (ASK1), a serine/threonine kinase, leads to improvement in inflammation and fibrosis in animal models of nonalcoholic steatohepatitis (NASH). We evaluated the safety and efficacy of selonsertib, a selective inhibitor of ASK1, alone or in combination with simtuzumab, in patients with NASH and stage 2 or 3 liver fibrosis. In this multicenter phase 2 trial, 72 patients were randomized to receive 24 weeks of open-label treatment with either 6 or 18 mg of selonsertib orally once daily with or without once-weekly injections of 125 mg of simtuzumab, or simtuzumab alone...
September 11, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/28877900/gilead-buying-kite-for-11-9-billion
#4
(no author information available yet)
Gilead Sciences will buy Kite Pharma-and its autologous CAR T-cell technology-for $11.9 billion. The acquisition will help Gilead build its oncology portfolio and boost its revenues.
September 6, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28867499/coformulated-bictegravir-emtricitabine-and-tenofovir-alafenamide-versus-dolutegravir-with-emtricitabine-and-tenofovir-alafenamide-for-initial-treatment-of-hiv-1-infection-gs-us-380-1490-a-randomised-double-blind-multicentre-phase-3-non-inferiority-trial
#5
Paul E Sax, Anton Pozniak, M Luisa Montes, Ellen Koenig, Edwin DeJesus, Hans-Jürgen Stellbrink, Andrea Antinori, Kimberly Workowski, Jihad Slim, Jacques Reynes, Will Garner, Joseph Custodio, Kirsten White, Devi SenGupta, Andrew Cheng, Erin Quirk
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) coadministered with two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs) are recommended as first-line treatment for HIV, and coformulated fixed-dose combinations are preferred to facilitate adherence. We report 48-week results from a study comparing initial HIV-1 treatment with bictegravir-a novel INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug interactions-coformulated with the NRTI combination emtricitabine and tenofovir alafenamide as a fixed-dose combination to dolutegravir administered with coformulated emtricitabine and tenofovir alafenamide...
August 31, 2017: Lancet
https://www.readbyqxmd.com/read/28867497/bictegravir-emtricitabine-and-tenofovir-alafenamide-versus-dolutegravir-abacavir-and-lamivudine-for-initial-treatment-of-hiv-1-infection-gs-us-380-1489-a-double-blind-multicentre-phase-3-randomised-controlled-non-inferiority-trial
#6
Joel Gallant, Adriano Lazzarin, Anthony Mills, Chloe Orkin, Daniel Podzamczer, Pablo Tebas, Pierre-Marie Girard, Indira Brar, Eric S Daar, David Wohl, Jürgen Rockstroh, Xuelian Wei, Joseph Custodio, Kirsten White, Hal Martin, Andrew Cheng, Erin Quirk
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug-drug interactions. We aimed to assess the efficacy and safety of bictegravir coformulated with emtricitabine and tenofovir alafenamide as a fixed-dose combination versus coformulated dolutegravir, abacavir, and lamivudine...
August 31, 2017: Lancet
https://www.readbyqxmd.com/read/28782339/role-of-generics-in-treatment-of-hepatitis-c-infection
#7
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
#8
Hengxing Ba, Boyin Jia, Guiwu Wang, Yifeng Yang, Gilead Kedem, Chunyi Li
Sika deer are an economically valuable species owing to their use in traditional Chinese medicine, particularly their 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...
September 7, 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
#9
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
#10
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...
September 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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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