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1. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Elvitegravir/Cobicistat/Emtricitabin/Tenofovir- alafenamid (HIV-Infektion bei Kindern) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 April 2018). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German (...) original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A18-01 Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV-infected children) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A18-01 Version 1.0 EVG/COBI/FTC/TAF (HIV-infected children) 12 April 2018 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic

2019 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (TBC)

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (TBC) Darunavir/cobicistat/emtricitabine/tenofovir alafenamide | CADTH.ca Find the information you need Darunavir/cobicistat/emtricitabine/tenofovir alafenamide Darunavir/cobicistat/emtricitabine/tenofovir alafenamide Last Updated: August 8, 2018 Result type: Reports Project Number: SR0552-000 Product Line: Generic Name: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide Brand Name: Symtuza Manufacturer: Janssen Inc. Indications (...) , hiv/aids, Symtuza; darunavir; cobicistat; emtricitabine; tenofovir alafenamide; HIV; Antiretroviral Files Follow us: © 2019 Canadian Agency for Drugs and Technologies in Health Get our newsletter:

2018 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

3. 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-inferiori (PubMed)

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-inferiori 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.In this randomised, double-blind, multicentre, placebo

2017 Lancet

4. [Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - benefit assessment according to õ35a Social Code Book V]

[Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - benefit assessment according to õ35a Social Code Book V] Darunavir/cobicistat/emtricitabin/tenofoviralafenamid (HIV-infektion): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A17-48 [Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - benefit assessment according to §35a Social Code Book V] Darunavir/cobicistat/emtricitabin/tenofoviralafenamid (HIV-infektion): nutzenbewertung gemäß (...) § 35a SGB V; dossierbewertung; auftrag A17-48 [Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - benefit assessment according to §35a Social Code Book V] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im

2018 Health Technology Assessment (HTA) Database.

5. HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies

HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies | CADTH.ca CADTH Document Viewer HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies Table of Contents Search this document HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil (...) of high-risk sexual encounters — precautions that may not be accepted by some individuals. This situation changed in 2012 with the FDA approval and availability of the fixed-dose antiviral combination emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) Truvada, manufactured by Gilead, for HIV pre-exposure prophylaxis (PrEP) in the US. Taking the antivirals once daily lowers the likelihood of HIV establishing a productive infection in the human host. 4 Clinical trials have shown this treatment

2017 Canadian Agency for Drugs and Technologies in Health - Environmental Scanning

6. HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies

HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies | CADTH.ca CADTH Document Viewer HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil Fumarate — Regulatory and Reimbursement Policies Table of Contents Search this document HIV Pre-Exposure Prophylaxis with Emtricitabine/Tenofovir Disoproxil (...) of high-risk sexual encounters — precautions that may not be accepted by some individuals. This situation changed in 2012 with the FDA approval and availability of the fixed-dose antiviral combination emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) Truvada, manufactured by Gilead, for HIV pre-exposure prophylaxis (PrEP) in the US. Taking the antivirals once daily lowers the likelihood of HIV establishing a productive infection in the human host. 4 Clinical trials have shown this treatment

2017 Canadian Agency for Drugs and Technologies in Health - Environmental Scanning

7. Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya) and HIV

Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya) and HIV Prescrire IN ENGLISH - Spotlight ''Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV'', 1 June 2017 {1} {1} {1} | | > > > Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV Spotlight Every month, the subjects in Prescrire’s Spotlight. 100 most recent :  |   |   |   |   |   |   |    (...) |   |  Spotlight Tenofovir alafenamide + emtricitabine + elvitegravir + cobicistat (Genvoya°) and HIV FEATURED REVIEW First-line therapy for human immunodeficiency virus (HIV) infection is based on a combination of at least three antiretroviral drugs. A formulation of tenofovir, tenofovir alafenamide, was authorised in the EU in late 2015 as part of a fixed-dose combination containing emtricitabine + elvitegravir + cobicistat (Genvoya°). This four-drug fixed-dose combination does

2017 Prescrire

8. Emtricitabine/Tenofovir for Post-Exposure Prophylaxis Against HIV: A Review of Clinical Effectiveness and Cost-Effectiveness

Emtricitabine/Tenofovir for Post-Exposure Prophylaxis Against HIV: A Review of Clinical Effectiveness and Cost-Effectiveness Emtricitabine/Tenofovir for Post-Exposure Prophylaxis Against HIV: A Review of Clinical Effectiveness and Cost-Effectiveness | CADTH.ca Find the information you need Emtricitabine/Tenofovir for Post-Exposure Prophylaxis Against HIV: A Review of Clinical Effectiveness and Cost-Effectiveness Emtricitabine/Tenofovir for Post-Exposure Prophylaxis Against HIV: A Review (...) of Clinical Effectiveness and Cost-Effectiveness Published on: March 17, 2017 Project Number: RC0868-000 Product Line: Research Type: Drug Report Type: Summary with Critical Appraisal Result type: Report Question What is the clinical effectiveness of emtricitabine/tenofovir, with or without integrase strand transfer inhibitors, compared with alternative antiretroviral drug regimens for post-exposure prophylaxis against HIV? What is the cost-effectiveness of emtricitabine/tenofovir, with or without

2017 Canadian Agency for Drugs and Technologies in Health - Rapid Review

9. [Emtricitabine/tenofovir alafenamide (HIV) - addendum to Commission A16-30]

[Emtricitabine/tenofovir alafenamide (HIV) - addendum to Commission A16-30] Emtricitabin/tenofoviralafenamid (HIV-Infektion): addendum zum auftrag A16-30; auftrag A16-58 [Emtricitabine/tenofovir alafenamide (HIV) - addendum to Commission A16-30] Emtricitabin/tenofoviralafenamid (HIV-Infektion): addendum zum auftrag A16-30; auftrag A16-58 [Emtricitabine/tenofovir alafenamide (HIV) - addendum to Commission A16-30] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Record (...) Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Emtricitabin/tenofoviralafenamid (HIV-Infektion): addendum zum auftrag A16-30; auftrag A16-58. [Emtricitabine/tenofovir alafenamide (HIV) - addendum to Commission A16-30] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im

2017 Health Technology Assessment (HTA) Database.

10. [Emtricitabine/rilpivirine/tenofovir alafenamide (HIV infection) - benefit assessment according to õ35a SGB V]

[Emtricitabine/rilpivirine/tenofovir alafenamide (HIV infection) - benefit assessment according to õ35a SGB V] Emtricitabin/eilpivirin/ tenofoviralafenamid (HIV-Infektion): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A16-49 [Emtricitabine/rilpivirine/tenofovir alafenamide (HIV infection) - benefit assessment according to §35a SGB V] Emtricitabin/eilpivirin/ tenofoviralafenamid (HIV-Infektion): nutzenbewertung gemäß § 35a SGB V; dossierbewertung; auftrag A16-49 [Emtricitabine (...) /rilpivirine/tenofovir alafenamide (HIV infection) - benefit assessment according to §35a SGB V] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). Emtricitabin/eilpivirin/ tenofoviralafenamid (HIV-Infektion

2017 Health Technology Assessment (HTA) Database.

11. Emtricitabine/tenofovir disoproxil fumarate (Truvada)

Emtricitabine/tenofovir disoproxil fumarate (Truvada) Emtricitabine/tenofovir disoproxil fumarate | CADTH.ca Find the information you need Emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate Last Updated: February 4, 2016 Result type: Reports Project Number: SR0479-000 Product Line: Generic Name: Emtricitabine/tenofovir disoproxil fumarate Brand Name: Truvada Manufacturer: Gilead Sciences Canada Inc. Indications: HIV-1 infection, pre-exposure prophylaxis

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

12. Emtricitabine /tenofovir alafenamide (TBC)

Emtricitabine /tenofovir alafenamide (TBC) Emtricitabine /tenofovir alafenamide | CADTH.ca Find the information you need Emtricitabine /tenofovir alafenamide Emtricitabine /tenofovir alafenamide Last Updated: October 9, 2018 Result type: Reports Project Number: SR0470-000 Product Line: Generic Name: Emtricitabine /tenofovir alafenamide Brand Name: Descovy Manufacturer: Gilead Sciences Canada, Inc. Indications: HIV-1 infection Submission Type: New Project Status: Complete Date Recommendation

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

13. emtricitabine/rilpivirine/ tenofovir alafenamide (TBC)

emtricitabine/rilpivirine/ tenofovir alafenamide (TBC) emtricitabine/rilpivirine/ tenofovir alafenamide | CADTH.ca Find the information you need emtricitabine/rilpivirine/ tenofovir alafenamide emtricitabine/rilpivirine/ tenofovir alafenamide Last Updated: October 27, 2016 Result type: Reports Project Number: SR0507-000 Product Line: Generic Name: emtricitabine/rilpivirine/ tenofovir alafenamide Brand Name: Odefsey Manufacturer: Gilead Sciences Canada, Inc. Indications: HIV-1 infection

2016 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

14. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppr (PubMed)

Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppr Simplified regimens with reduced pill burden and fewer side-effects are desirable for people living with HIV. We investigated the efficacy and safety of switching to a single-tablet regimen of darunavir, cobicistat, emtricitabine (...) , and tenofovir alafenamide versus continuing a regimen of boosted protease inhibitor, emtricitabine, and tenofovir disoproxil fumarate.EMERALD was a phase-3, randomised, active-controlled, open-label, international, multicentre trial, done at 106 sites across nine countries in North America and Europe. HIV-1-infected adults were eligible to participate if they were treatment-experienced and virologically suppressed (viral load <50 copies per mL for ≥2 months; one viral load of 50-200 copies per mL

2018 The lancet. HIV

15. Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. (PubMed)

Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI. HIV-1-infected, virologically suppressed adults wanting to simplify or change their non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimens may benefit from switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine

2018 HIV clinical trials

16. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-i (PubMed)

Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-i Tenofovir alafenamide is a prodrug that reduces tenofovir plasma concentrations by 90% compared with tenofovir disoproxil fumarate, thereby decreasing bone and renal risks. The coformulation of rilpivirine, emtricitabine, and tenofovir (...) alafenamide has recently been approved, and we aimed to investigate the efficacy, safety, and tolerability of switching to this regimen compared with remaining on coformulated efavirenz, emtricitabine, and tenofovir disoproxil fumarate.In this randomised, double-blind, placebo-controlled, non-inferiority trial, HIV-1-infected adults were enrolled at 120 hospitals and outpatient clinics in eight countries in North America and Europe. Participants were virally suppressed (HIV-1 RNA <50 copies per mL

2018 The lancet. HIV

17. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. (PubMed)

Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. Antiretroviral therapy (ART) simplification to a single-tablet regimen can benefit HIV-1-infected, virologically suppressed, individuals on ART composed of multiple pills.We assessed long-term efficacy and safety of switching to co-formulated elvitegravir (...) , cobicistat, emtricitabine, and tenofovir disoproxil fumarate (E/C/F/TDF) from multi-tablet ritonavir-boosted protease inhibitor (PI + RTV) plus F/TDF (TVD) regimens.STRATEGY-PI was a 96-week, phase 3b, randomized (2:1), open-label, non-inferiority study examining the efficacy, safety, and tolerability of switching to E/C/F/TDF from PI + RTV + TVD regimens in virologically suppressed individuals (HIV-1 RNA <50 copies/mL). Participants were randomized to switch to E/C/F/TDF (switch group) or to continue

2018 HIV clinical trials

18. Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomi (PubMed)

Efficacy and safety of emtricitabine/tenofovir alafenamide (FTC/TAF) vs. emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as a backbone for treatment of HIV-1 infection in virologically suppressed adults: subgroup analysis by third agent of a randomi FTC/TAF was shown to be noninferior to FTC/TDF with advantages in markers of renal and bone safety.To evaluate the efficacy and safety of switching to FTC/TAF from FTC/TDF by third agent (boosted protease inhibitor [PI] vs. unboosted third

2018 HIV clinical trials

19. First-line antiretroviral therapy with efavirenz plus tenofovir disiproxil fumarate/emtricitabine or rilpivirine plus tenofovir disiproxil fumarate/emtricitabine: a durability comparison. (PubMed)

First-line antiretroviral therapy with efavirenz plus tenofovir disiproxil fumarate/emtricitabine or rilpivirine plus tenofovir disiproxil fumarate/emtricitabine: a durability comparison. The aim of this study was to compare the durabilities of efavirenz (EFV) and rilpivirine (RPV) in combination with tenofovir/emtricitabine (TDF/FTC) in first-line regimens.A multicentre prospective and observational study was carried out. We included all patients participating in the Italian Cohort Naive

2018 HIV medicine

20. Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer (...) to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults (Alliance) The safety and scientific validity of this study

2018 Clinical Trials

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