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Sleep Initiation and Maintenance Disorders: HELP
Articles from Foster City
Based on 1 article published since 2008

This is the only published article about Sleep Initiation and Maintenance Disorders that originated from Foster City during 2008-2019.
+ Citations + Abstracts
1 Clinical Trial Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. 2015

Sax, Paul E / Wohl, David / Yin, Michael T / Post, Frank / DeJesus, Edwin / Saag, Michael / Pozniak, Anton / Thompson, Melanie / Podzamczer, Daniel / Molina, Jean Michel / Oka, Shinichi / Koenig, Ellen / Trottier, Benoit / Andrade-Villanueva, Jaime / Crofoot, Gordon / Custodio, Joseph M / Plummer, Andrew / Zhong, Lijie / Cao, Huyen / Martin, Hal / Callebaut, Christian / Cheng, Andrew K / Fordyce, Marshall W / McCallister, Scott / Anonymous7920999. ·Division of Infectious Diseases and Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA, USA. Electronic address: psax@partners.org. · Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. · Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA. · Department of HIV Medicine, King's College, Hospital NHS Foundation Trust, London, UK. · Orlando Immunology Center, Orlando, FL, USA. · Department of Medicine, University of Alabama Birmingham, Birmingham, AL, USA. · Department of Medicine, Chelsea and Westminster Hospital, NHS Foundation Trust, London, UK. · AIDS Research Consortium of Atlanta, Atlanta, GA, USA. · HIV Unit, Infectious Disease Service. Hospital Universitari de Bellvitge, Barcelona, Spain. · Hôpital Saint Louis, Paris, France. · AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan. · Instituto Dominicano de Estudios Virologicos (IDEV), Santo Domingo, Dominican Republic. · Clinique Medicale L'Actuale in Montreal, Montreal, Canada. · Unidad de VIH del Hospital Civil de Guadalajara, CUCS, U de G Guadalajara, Mexico. · Gordon Crofoot Research, Houston, TX, USA. · Gilead Sciences, Foster City, CA, USA. ·Lancet · Pubmed #25890673.

ABSTRACT: BACKGROUND: Tenofovir disoproxil fumarate can cause renal and bone toxic effects related to high plasma tenofovir concentrations. Tenofovir alafenamide is a novel tenofovir prodrug with a 90% reduction in plasma tenofovir concentrations. Tenofovir alafenamide-containing regimens can have improved renal and bone safety compared with tenofovir disoproxil fumarate-containing regimens. METHODS: In these two controlled, double-blind phase 3 studies, we recruited treatment-naive HIV-infected patients with an estimated creatinine clearance of 50 mL per min or higher from 178 outpatient centres in 16 countries. Patients were randomly assigned (1:1) to receive once-daily oral tablets containing 150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir alafenamide (E/C/F/tenofovir alafenamide) or 300 mg tenofovir disoproxil fumarate (E/C/F/tenofovir disoproxil fumarate) with matching placebo. Randomisation was done by a computer-generated allocation sequence (block size 4) and was stratified by HIV-1 RNA, CD4 count, and region (USA or ex-USA). Investigators, patients, study staff, and those assessing outcomes were masked to treatment group. All participants who received one dose of study drug were included in the primary intention-to-treat efficacy and safety analyses. The main outcomes were the proportion of patients with plasma HIV-1 RNA less than 50 copies per mL at week 48 as defined by the the US Food and Drug Adminstration (FDA) snapshot algorithm (pre-specified non-inferiority margin of 12%) and pre-specified renal and bone endpoints at 48 weeks. These studies are registered with ClinicalTrials.gov, numbers NCT01780506 and NCT01797445. FINDINGS: We recruited patients from Jan 22, 2013, to Nov 4, 2013 (2175 screened and 1744 randomly assigned), and gave treatment to 1733 patients (866 given E/C/F/tenofovir alafenamide and 867 given E/C/F/tenofovir disoproxil fumarate). E/C/F/tenofovir alafenamide was non-inferior to E/C/F/tenofovir disoproxil fumarate, with 800 (92%) of 866 patients in the tenofovir alafenamide group and 784 (90%) of 867 patients in the tenofovir disoproxil fumarate group having plasma HIV-1 RNA less than 50 copies per mL (adjusted difference 2·0%, 95% CI -0·7 to 4·7). Patients given E/C/F/tenofovir alafenamide had significantly smaller mean serum creatinine increases than those given E/C/F/tenofovir disoproxil fumarate (0·08 vs 0·12 mg/dL; p<0·0001), significantly less proteinuria (median % change -3 vs 20; p<0·0001), and a significantly smaller decrease in bone mineral density at spine (mean % change -1·30 vs -2·86; p<0·0001) and hip (-0·66 vs -2·95; p<0·0001) at 48 weeks. INTERPRETATION: Through 48 weeks, more than 90% of patients given E/C/F/tenofovir alafenamide or E/C/F/tenofovir disoproxil fumarate had virological success. Renal and bone effects were significantly reduced in patients given E/C/F/tenofovir alafenamide. Although these studies do not have the power to assess clinical safety events such as renal failure and fractures, our data suggest that E/C/F/tenofovir alafenamide will have a favourable long-term renal and bone safety profile. FUNDING: Gilead Sciences.