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Alan Winston, Frank A Post, Edwin DeJesus, Daniel Podzamczer, Giovanni Di Perri, Vicente Estrada, François Raffi, Peter Ruane, Paula Peyrani, Gordon Crofoot, Patrick W G Mallon, Francesco Castelli, Mingjin Yan, Stephanie Cox, Moupali Das, Andrew Cheng, Martin S Rhee
BACKGROUND: Abacavir and tenofovir alafenamide offer reduced bone toxicity compared with tenofovir disoproxil fumarate. We aimed to compare safety and efficacy of tenofovir alafenamide plus emtricitabine with that of abacavir plus lamivudine. METHODS: In this randomised, double-blind, active-controlled, non-inferiority phase 3 trial, HIV-1-positive adults (≥18 years) were screened at 79 sites in 11 countries in North America and Europe. Eligible participants were virologically suppressed (HIV-1 RNA <50 copies per mL) and on a stable three-drug regimen containing abacavir plus lamivudine...
February 20, 2018: Lancet HIV
Charles D Burger, A Burak Ozbay, Howard M Lazarus, Ellen Riehle, Leslie B Montejano, Gregory Lenhart, R James White
BACKGROUND: Despite multiple treatment options, the prognosis of pulmonary arterial hypertension (PAH) remains poor. PAH patients experience a high economic burden due to comorbidities, hospitalizations, and medication costs. Although combination therapy has been shown to reduce hospitalizations, the relationship between treatment, health care utilization, and costs remains unclear. OBJECTIVE: To provide a characterization of health care utilization and costs in real-world settings by comparing periods before and after initiating PAH-specific treatment...
February 13, 2018: Journal of Managed Care & Specialty Pharmacy
Charles D Burger, Janis A Pruett, Cassandra A Lickert, Ariel Berger, Brian Murphy, William Drake
BACKGROUND: Prostacyclins play an important role in the management of pulmonary arterial hypertension (PAH). Intravenous prostacyclin was the first disease-specific treatment for patients with PAH. Subcutaneous and nonparenteral (oral or inhaled) formulations have subsequently become available. However, data are lacking on how these different prostacyclin formulations are being used in clinical practice. OBJECTIVES: To (a) conduct retrospective analyses of a large U...
December 18, 2017: Journal of Managed Care & Specialty Pharmacy
João Malta Barbosa, Daniel Navarro da Rocha, Ronaldo Hirata, Gileade Freitas, Estevam A Bonfante, Paulo G Coelho
PURPOSE: To evaluate the probability of survival and failure modes of different external hexagon connection systems restored with anterior cement-retained single-unit crowns. The postulated null hypothesis was that there would be no differences under accelerated life testing. MATERIALS AND METHODS: Fifty-four external hexagon dental implants (∼4 mm diameter) were used for single cement-retained crown replacement and divided into 3 groups: (3i) Full OSSEOTITE, Biomet 3i (n = 18); (OL) OEX P4, Osseolife Implants (n = 18); and (IL) Unihex, Intra-Lock International (n = 18)...
January 17, 2018: Implant Dentistry
Sebastián Marciano, Leila Haddad, María Virginia Reggiardo, Mirta Peralta, Cecilia Vistarini, Mónica Marino, Valeria Inés Descalzi, Claudia D'Amico, Sebastián Figueroa Escuti, Luis Alejandro Gaite, Roberto Pérez Ravier, Cristina Longo, Silvia Mabel Borzi, Omar Andrés Galdame, Fernando Bessone, Hugo Alberto Fainboim, Silvia Frías, Mariano Cartier, Adrián Carlos Gadano
We report the first real-world prospective multicenter cohort study that evaluated the effectiveness and safety of original or generic sofosbuvir-based regimens in patients with chronic hepatitis C in Latin America. The main endpoints were assessment of sustained virological response and serious adverse events rates. A total of 321 patients with chronic hepatitis C treated with the following regimens were included: sofosbuvir plus daclatasvir for 12 (n = 34) or 24 (n = 135) weeks, sofosbuvir plus daclatasvir plus ribavirin for 12 (n = 84) or 24 (n = 56) weeks, or sofosbuvir plus ribavirin for 12 (n = 8) or 24 (n = 2) weeks...
January 19, 2018: Journal of Medical Virology
Jason Grebely, Olav Dalgard, Brian Conway, Evan B Cunningham, Philip Bruggmann, Behzad Hajarizadeh, Janaki Amin, Julie Bruneau, Margaret Hellard, Alain H Litwin, Philippa Marks, Sophie Quiene, Sharmila Siriragavan, Tanya L Applegate, Tracy Swan, Jude Byrne, Melanie Lacalamita, Adrian Dunlop, Gail V Matthews, Jeff Powis, David Shaw, Maria Christine Thurnheer, Martin Weltman, Ian Kronborg, Curtis Cooper, Jordan J Feld, Chris Fraser, John F Dillon, Phillip Read, Ed Gane, Gregory J Dore
BACKGROUND: Despite revised guidelines that no longer exclude people who inject drugs (PWID) from treatment for hepatitis C virus (HCV) infection, many clinicians are reluctant to treat recent PWID. This study aimed to evaluate the efficacy of sofosbuvir and velpatasvir therapy in people with chronic HCV infection and recent injection drug use. METHODS: In this open-label, single-arm phase 4 trial (SIMPLIFY), we recruited participants with recent injection drug use (past 6 months) and chronic HCV genotype 1-6 infection from seven countries (19 sites)...
January 5, 2018: Lancet. Gastroenterology & Hepatology
Claire N Harrison, Alessandro M Vannucchi, Uwe Platzbecker, Francisco Cervantes, Vikas Gupta, David Lavie, Francesco Passamonti, Elliott F Winton, Hua Dong, Jun Kawashima, Julia D Maltzman, Jean-Jacques Kiladjian, Srdan Verstovsek
BACKGROUND: The Janus kinase (JAK) inhibitor ruxolitinib is the only approved therapy for patients with symptomatic myelofibrosis. After ruxolitinib failure, however, there are few therapeutic options. We assessed the efficacy and safety of momelotinib, a JAK 1 and JAK 2 inhibitor, versus best available therapy (BAT) in patients with myelofibrosis who had suboptimal responses or haematological toxic effects with ruxolitinib. METHODS: In this randomised, phase 3, open-label trial, patients were screened for eligibility from 52 clinical centres in Canada, France, Germany, Israel, Italy, Spain, the UK, and the USA...
February 2018: Lancet Haematology
Niranjan Manoharan, Prem Sagar Subramanian
Purpose: To report the first reported case of non-arteritic anterior ischemic optic neuropathy (NAION) associated with the use of Harvoni (Gilead Sciences, Foster City, CA, USA), a newly approved treatment for Hepatitis C. Observations: We report a case of NAION in a hepatitis C patient who completed Harvoni therapy just prior to presentation. Harvoni was suspected to be the causative agent given a lack of NAION risk factors in an otherwise healthy young patient...
June 2017: American Journal of Ophthalmology Case Reports
Hema Mistry, Chidozie Nduka, Martin Connock, Jill Colquitt, Theodoros Mantopoulos, Emma Loveman, Renata Walewska, James Mason
Venetoclax is licensed to treat relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL). As part of the Single Technology Appraisal (STA) ID944, the National Institute for Health and Care Excellence (NICE) invited AbbVie, the manufacturer, to submit evidence on the use of venetoclax, within its licensed indication. The Evidence Review Group (ERG), Warwick Evidence, was asked to provide an independent and critical review of the submitted evidence. Evidence came from three single-arm trials in CLL patients with or without 17p deletion [del(17p])/TP53 chromosomal abnormalities...
April 2018: PharmacoEconomics
Sajjad Iqbal, Muhammad Haroon Yousuf, Muhammad Iftikhar Yousaf
AIM: To prospectively evaluate the efficacy of sofobuvir (SOF) in hepatitis C patients infected with hepatitis C virus (HCV) genotype 3 in Pakistan. METHODS: The present study was performed with the coordination of gastroenterology and pathology departments of Shalamar Hospital Lahore from August 2014 to May 2016. The total number of patients included in this study was 1375 and all of them were infected with HCV genotype 3. On the basis of drug combinations, all the patients were separated into two groups...
November 28, 2017: World Journal of Gastroenterology: WJG
Nicola Lancki, Ellen Almirol, Leigh Alon, Moira McNulty, John A Schneider
BACKGROUND: Identification of clients at greatest risk of acquiring HIV is critical for preexposure prophylaxi (PrEP) implementation. Young black MSM (YBMSM) have high incidence of HIV. We examined published guidelines in identifying eligible PrEP candidates, including seroconverters, in a representative cohort of YBMSM. METHODS: The uConnect cohort included YBMSM aged 16-29 years during PrEP roll-out in Chicago from 2013 and 2016. YBMSM with indications for PrEP were determined using Center for Disease Control and Prevention (CDC) guidelines, the HIV incidence risk index for MSM (HIRI-MSM) scoring tool, and Gilead recommendations with calculation of sensitivities, specificities, and area under the curve (AUC) for HIV seroconversion over 18 months...
January 28, 2018: AIDS
Christopher McCoy, Melissa Badowski, Elizabeth Sherman, Rustin Crutchley, Ethan Smith, Daniel B Chastain
Antiretroviral (ART) therapy for treatment of human immunodeficiency virus (HIV) infection has undergone significant changes over the past 30 years. Many single tablet regimens (STR), including newer fixed dose combination (FDC) tablets, are available, offering patients several options for choosing a treatment regimen that works best for them. Given these changes, patients are more likely to adhere to treatment, achieve better clinical outcomes, and experience both fewer side effects and drug-drug interactions...
November 3, 2017: Pharmacotherapy
Thomas Reinke
Truvada is getting a new lease on life as a preventive agent. It is the only drug approved to prevent HIV infections, and Truvada is the key pharmaceutical component of pre-exposure prophylaxis, which is aimed at preventing, rather than treating, HIV infection and transmission.
September 2017: Managed Care
Gilead I Lancaster, Joseph P Drozda
No abstract text is available yet for this article.
October 3, 2017: Annals of Internal Medicine
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...
November 2017: Lancet HIV
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
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
(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.
October 2017: Cancer Discovery
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...
November 4, 2017: Lancet
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...
November 4, 2017: Lancet
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