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https://www.readbyqxmd.com/read/27894270/evaluation-of-tolerability-with-the-co-formulation-elvitegravir-cobicistat-emtricitabine-and-tenofovir-disoproxil-fumarate-for-post-hiv-exposure-prophylaxis
#1
Nadia Valin, Laurent Fonquernie, Anne Daguenel, Pauline Campa, Theresita Anthony, Marguerite Guiguet, Pierre Marie Girard, Marie Caroline Meyohas
BACKGROUND: The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (Stribild(®)) prescribed as one pill taken once daily for HIV PEP in terms of tolerability and adherence...
November 29, 2016: BMC Infectious Diseases
https://www.readbyqxmd.com/read/27592195/when-food-can-make-the-difference-the-case-of-elvitegravir-based-co-formulation
#2
Dario Cattaneo, Sara Baldelli, Davide Minisci, Paola Meraviglia, Emilio Clementi, Massimo Galli, Cristina Gervasoni
Stribild should be administered under fed conditions to optimize drugs exposure. Here we assessed to what extent this advice is applied in the real life scenario by therapeutic drug monitoring in 75 HIV-infected patients given Stribild-based antiretroviral therapy. Fifty-three percent of our patients took Stribild at lunch/supper time, 23% in the morning with breakfast, and 24% middle in the morning or late in the evening. Twelve out of the 75 patients had unquantifiable elvitegravir concentrations, whereas in the remaining the levels were largely distributed...
October 15, 2016: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/27530904/a-severe-hypersensitivity-reaction-to-abacavir-following-re-challenge
#3
Sej Todd, C R Emerson
We report this case to highlight the possibility of a severe hypersensitivity reaction as an important potential consequence of couples, living with HIV, sharing anti-retroviral treatment. An HIV-1 positive and carrier of HLA-B*57:01 allele, treatment experienced man was commenced one pill Regimen Stribild (tenofovir, emtricitabine, elvitegravir and cobicistat) in July 2015. On running short of medication, he admitted to sharing his partner's treatment (Triumeq; abacavir, lamivudine and dolutegravir). On the second occasion, re-introduction resulted in whole body rash 4 h post dose and was associated with fever, respiratory symptoms, headache and vomiting...
August 16, 2016: International Journal of STD & AIDS
https://www.readbyqxmd.com/read/27225853/safety-and-tolerability-of-stribild-in-the-southeast-united-states
#4
Caroline Boyd Derrick, Zhiqiang Kevin Lu, Celeste Rudisill Caulder, Elizabeth Kelly Hester, Tyler David Wagner, Paul Brandon Bookstaver
PURPOSE: The purpose of this study is to assess postmarketing safety and tolerability of Stribild (elvitegravir [EVG]/cobicistat [COBI]/tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC]). METHODS: A retrospective, pharmacoepidemiologic study in 2 outpatient HIV clinics in the Southeast United States was conducted among adults receiving EVG/COBI/TDF/FTC. We evaluated incidence and treatment-related adverse events, including change in serum creatinine (SCr)...
September 2016: Journal of the International Association of Providers of AIDS Care
https://www.readbyqxmd.com/read/27050630/neither-boosted-elvitegravir-nor-darunavir-with-emtricitabine-tenofovir-disoproxil-fumarate-increase-insulin-resistance-in-healthy-volunteers-results-from-the-stribild-ir-study
#5
Christoph D Spinner, Kristina E Kern, Alexander Zink, Eva Wolf, Annamaria Balogh, Sebastian Noe, Alexander Von Werder, Christiane Schwerdtfeger, Roland M Schmid, Roman Iakoubov
BACKGROUND: Insulin resistance (IR) was one of the first reported complications in HIV-positive patients who were receiving antiretroviral therapy (ART). However, the metabolic effects of newer fixed-dose ART combinations are unclear. METHODS: This Phase I prospective randomized open-label study evaluated the effects on IR in 30 healthy volunteers who were receiving newer fixed-dose combinations of tenofovir disoproxil fumarate, emtricitabine, elvitegravir and cobicistat (E/C/F/TDF, 10 patients) or the established ART regimens, such as tenofovir disoproxil fumarate/emtricitabine with lopinavir/ritonavir (F/TDF+LPV/r, 9 patients) or darunavir/ritonavir (F/TDF+DRV/r, 9 patients)...
April 6, 2016: Antiviral Therapy
https://www.readbyqxmd.com/read/27041642/cobicistat-significantly-increases-tacrolimus-serum-concentrations-in-a-renal-transplant-recipient-with-human-immunodeficiency-virus-infection
#6
Zhe Han, Brenna M Kane, Lindsay A Petty, Michelle A Josephson, Jozefa Sutor, Kenneth J Pursell
Cobicistat is a pharmacokinetic booster in several fixed-dose combination products for treatment of human immunodeficiency virus (HIV) infection. As a potent inhibitor of cytochrome P450 (CYP) 3A enzymes, significant drug-drug interactions are expected between cobicistat and medications that are metabolized primarily through the CYP3A pathway, including calcineurin inhibitors (e.g., tacrolimus and cyclosporine). We describe a case of tacrolimus toxicity due to supratherapeutic tacrolimus concentrations when Stribild(®) (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) was initiated for newly diagnosed HIV infection in a 50-year-old renal transplant recipient who was previously receiving a stable tacrolimus regimen...
April 3, 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/26679246/dolutegravir-and-elvitegravir-plasma-concentrations-following-cessation-of-drug-intake
#7
Emilie Elliot, Alieu Amara, Akil Jackson, Graeme Moyle, Laura Else, Saye Khoo, David Back, Andrew Owen, Marta Boffito
OBJECTIVES: To evaluate dolutegravir and elvitegravir/cobicistat pharmacokinetics in HIV-negative volunteers up to 10 days after drug cessation. METHODS: Healthy volunteers received 50 mg of dolutegravir once-daily for 10 days, then underwent a 9 day wash-out period, and then received elvitegravir/cobicistat as part of Stribild(®) (245 mg of tenofovir, 200 mg of emtricitabine, 150 mg of elvitegravir and 150 mg of cobicistat) for 10 days. Serial pharmacokinetic (PK) sampling occurred prior to the final dose of each course and at regular intervals for up to 216 h (10 days) after drug cessation...
April 2016: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/26286337/patient-reported-symptoms-over-48-weeks-in-a-randomized-open-label-phase-3b-non-inferiority-trial-of-adults-with-hiv-switching-to-coformulated-elvitegravir-cobicistat-emtricitabine-and-tenofovir-df-versus-continuation-of-ritonavir-boosted-protease-inhibitor
#8
RANDOMIZED CONTROLLED TRIAL
Joseph Gathe, Jose R Arribas, Jan Van Lunzen, Will Garner, Rebecca M Speck, Randall Bender, Sanatan Shreay, Thai Nguyen
BACKGROUND: Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a recommended integrase inhibitor-based regimen in treatment guidelines from the US Department of Health and Human Services and the British HIV Association. The purpose of this analysis was to determine the change in patient-reported symptoms over time among HIV-infected adults who switch to Stribild(®) versus those continuing on a protease inhibitor (PI) with FTC/TDF...
October 2015: Patient
https://www.readbyqxmd.com/read/26045359/patient-reported-symptoms-over-48-weeks-in-a-randomized-open-label-phase-iiib-non-inferiority-trial-of-adults-with-hiv-switching-to-co-formulated-elvitegravir-cobicistat-emtricitabine-and-tenofovir-df-versus-continuation-of-non-nucleoside-reverse-transcriptase
#9
RANDOMIZED CONTROLLED TRIAL
Anthony Mills, Will Garner, Anton Pozniak, Juan Berenguer, Rebecca M Speck, Randall Bender, Thai Nguyen
BACKGROUND: Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF; Stribild(®)) is a guideline-recommended regimen for HIV treatment-naïve patients and a switch option for virologically suppressed patients. OBJECTIVE: The purpose of this analysis was to understand how HIV patients' symptoms change after switching to Stribild(®) versus continuing a regimen consisting of a non-nucleoside reverse transcriptase inhibitor (NNRTI) with emtricitabine and tenofovir disoproxil fumarate...
August 2015: Patient
https://www.readbyqxmd.com/read/25807445/stribild-a-review-of-component-characteristics-and-combination-drug-efficacy
#10
REVIEW
D E Murrell, J P Moorman, S Harirforoosh
BACKGROUND: Numerous methods have been devised to combat human immunodeficiency virus (HIV) replication and disease progression. Composed of an integrase strand transfer inhibitor, a pharmacoenhancer, and two reverse transcriptase inhibitors, Stribild is a relatively new combination HIV drug formulated for once-a-day dosing. METHODS: Relevant information, original research articles and reviews, were gathered primarily through the use of the PubMed database. The search was conducted without date restrictions in order to collect both historical and recent information concerning HIV, individual drugs, and combinations for a thorough overview...
2015: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/25553805/the-pharmacokinetics-pharmacodynamics-and-clinical-efficacy-of-elvitegravir-cobicistat-emtricitabine-tenofovir-combination-therapy-for-the-treatment-of-hiv
#11
REVIEW
Sonia Raffe, Martin Fisher
INTRODUCTION: Co-formulated elvitegravir, cobicistat, emtricitabine and tenofovir (EVG/COBI/FTC/TDF or Stribild™) is the latest antiretroviral tablet approved in the EU. This review aims to provide an overview of its role in the management of HIV-1 infection. AREAS COVERED: This review covers material searched and obtained through Medline and Pubmed up to July 2014. EXPERT OPINION: Antiretroviral treatment prevents the progressive destruction of the immune system by the HIV, significantly reducing morbidity and mortality...
March 2015: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/24876793/critical-appraisal-of-elvitegravir-in-the-treatment-of-hiv-1-aids
#12
REVIEW
Krishan K Pandey
Human immunodeficiency virus type 1 (HIV-1) integrase inhibitors belong to a novel class of antiretroviral drugs with high potency and better tolerability. Elvitegravir (EVG) is the second integrase inhibitor approved by the US Food and Drug Administration when administered in combination with a novel pharmacoenhancer, cobicistat (COBI), and two nucleoside/nucleotide reverse transcriptase inhibitors, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). This combination of drugs (EVG/COBI/FTC/TDF) developed and marketed by Gilead Sciences Inc...
2014: HIV/AIDS: Research and Palliative Care
https://www.readbyqxmd.com/read/24597519/drug-safety-profile-of-integrase-strand-transfer-inhibitors
#13
REVIEW
Maria del Mar Gutierrez, Maria Gracia Mateo, Francesc Vidal, Pere Domingo
INTRODUCTION: HIV-1 integrase strand transfer inhibitors (INSTIs) are a novel class of antiretroviral drugs with a good safety profile. Several INSTIs have been developed clinically. AREAS COVERED: The purpose of this review is to examine the safety data of the three FDA-approved INSTIs: Raltegravir (RAL), Elvitegravir (EVG) and Dolutegravir (DTG). The most relevant papers related to the safety profile of integrase inhibitors were selected and summarized. EXPERT OPINION: INSTIs have demonstrated a favorable safety profile in Phase II and III trials...
April 2014: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/24584107/stribild%C3%A2-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-a-new-paradigm-for-hiv-1-treatment
#14
REVIEW
Christian Manzardo, José M Gatell
Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) is a new single-tablet, fixed-dose formulation approved by both the US Food and Drug Administration and the European Medicine Agency as antiretroviral therapy. It is the first once-a-day therapy option containing an integrase inhibitor and cobicistat, a novel pharmacokinetic boosting agent without activity on HIV. Stribild® has demonstrated non-inferior virological efficacy and a similar recovery of CD4+ T-cells when compared to Atripla® (efavirenz/emtricitabine/tenofovir) and to ritonavir-boosted atazanavir plus emtricitabine/tenofovir in two large, phase III randomized clinical trials at 48, 96, and 144 weeks...
January 2014: AIDS Reviews
https://www.readbyqxmd.com/read/24338165/elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-single-tablet-regimen-stribild%C3%A2-a-review-of-its-use-in-the-management-of-hiv-1-infection-in-adults
#15
REVIEW
Caroline M Perry
A new single-tablet, fixed-dose formulation consisting of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI); cobicistat, a pharmacokinetic enhancer; emtricitabine, a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil fumarate (tenofovir DF), a nucleotide reverse transcriptase inhibitor (elvitegravir/cobicistat/emtricitabine/tenofovir DF 150 mg/150 mg/200 mg/300 mg; Stribild®) is available in some countries for the once-daily treatment of HIV-1 infection in antiretroviral therapy-naïve adults...
January 2014: Drugs
https://www.readbyqxmd.com/read/24214102/does-an-increase-in-serum-creatinine-always-reflect-renal-injury-the-case-of-stribild%C3%A2
#16
Vikram Arya, Jeffry Florian, Kendall A Marcus, Kellie S Reynolds, Linda L Lewis, Adam I Sherwat
Single tablet, once-daily HIV treatment regimens offer patient convenience, the potential for increased adherence, and fewer patient-related dosing errors([1]) . Stribild® (manufactured and marketed by Gilead Sciences; referred to as "applicant" in this report), a 4-drug fixed-dose combination (FDC) tablet, is approved for the treatment of HIV-1 infection in treatment-naïve adult patients. Stribild® contains elvitegravir (an integrase strand transfer inhibitor), cobicistat (an inhibitor of cytochrome P450 enzymes), and the nucleoside/nucleotide reverse transcriptase inhibitors emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)...
November 8, 2013: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/24138510/combination-therapy-the-propitious-rationale-for-drug-development
#17
REVIEW
Neetu Phougat, Savita Khatri, Anu Singh, Mrridula Dangi, Manish Kumar, Rajesh Dabur, Anil Kumar Chhillar
Therapeutic options for many infections are extremely limited and at crisis point. We run the risk of entering a second pre-antibiotic era. There had been no miracle drug for the patients infected by resistant microbial pathogens. Most of the very few new drugs under development have problems with their toxicity, or pharmacokinetics and pharmacodynamics. We are already decades behind in the discovery, characterization and development of new antimicrobials. In that scenario, we could not imagine surviving without newer and effective antimicrobial agents...
January 2014: Combinatorial Chemistry & High Throughput Screening
https://www.readbyqxmd.com/read/23495004/a-cutting-edge-view-on-the-current-state-of-antiviral-drug-development
#18
REVIEW
Erik De Clercq
Prominent in the current stage of antiviral drug development are: (i) for human immunodeficiency virus (HIV), the use of fixed-dose combinations (FDCs), the most recent example being Stribild(TM); (ii) for hepatitis C virus (HCV), the pleiade of direct-acting antivirals (DAAs) that should be formulated in the most appropriate combinations so as to obtain a cure of the infection; (iii)-(v) new strategies (i.e., AIC316, AIC246, and FV-100) for the treatment of herpesvirus infections: herpes simplex virus (HSV), cytomegalovirus (CMV), and varicella-zoster virus (VZV), respectively; (vi) the role of a new tenofovir prodrug, tenofovir alafenamide (TAF) (GS-7340) for the treatment of HIV infections; (vii) the potential use of poxvirus inhibitors (CMX001 and ST-246); (viii) the usefulness of new influenza virus inhibitors (peramivir and laninamivir octanoate); (ix) the position of the hepatitis B virus (HBV) inhibitors [lamivudine, adefovir dipivoxil, entecavir, telbivudine, and tenofovir disoproxil fumarate (TDF)]; and (x) the potential of new compounds such as FGI-103, FGI-104, FGI-106, dUY11, and LJ-001 for the treatment of filoviruses (i...
November 2013: Medicinal Research Reviews
https://www.readbyqxmd.com/read/23183388/a-4-drug-combination-stribild-for-hiv
#19
(no author information available yet)
No abstract text is available yet for this article.
November 26, 2012: Medical Letter on Drugs and Therapeutics
https://www.readbyqxmd.com/read/23136357/elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-fumarate-single-tablet-for-hiv-1-infection-treatment
#20
REVIEW
Jacqueline L Olin, Linda M Spooner, Olga M Klibanov
OBJECTIVE: To review the clinical trials, pharmacologic characteristics, safety, and efficacy of the elvitegravir/cobicistat/emtricitabine/tenofovir single tablet formulation (Stribild). DATA SOURCES: Literature searches were performed in MEDLINE (1948-September 2012) and PubMed (1966-September 2012) using the search terms GS-9137, elvitegravir, GS 9350, cobicistat, quad pill, Stribild, and integrase inhibitors. Abstracts from HIV/AIDS conferences were reviewed...
December 2012: Annals of Pharmacotherapy
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