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1. Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V

Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Darunavir/Cobicistat/Emtricitabine/Tenofoviralafenamid (HIV-Infektion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 22 December 2017). 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. A17-48 Darunavir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A17-48 Version 1.0 Darunavir/cobicistat/ emtricitabine/tenofovir alafenamide (HIV infection) 22 December 2017 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Darunavir

2018 Institute for Quality and Efficiency in Healthcare (IQWiG)

2. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) - Human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ® ). Reference number 2418. Page 1 of 3 Enc 9 Appx 2 AWMSG Secretariat Assessment Report – Limited submission Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza ®? ) 800 mg/150 mg/200 mg/10 mg film-coated tablet Company: Janssen-Cilag Ltd Licensed indication under (...) consideration: Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). ? This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Marketing authorisation date: 26 September 2017 Comparator(s) ? Darunavir/cobicistat (Rezolsta ® ) in combination with emtricitabine

2018 All Wales Medicines Strategy Group

3. Darunavir Krka - HIV

Darunavir Krka - HIV 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 9 November 2017 EMA/786959/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Darunavir Krka International non-proprietary name (...) : darunavir Procedure No. EMEA/H/C/004273/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/786959/2017 Page 2/26 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Steps taken for the assessment of the product 6 2. Scientific discussion 7 2.1. Introduction 7 2.2. Quality aspects 8 2.2.1. Introduction 8 2.2.2. Active substance 9 2.2.3. Finished medicinal product 11

2018 European Medicines Agency - EPARs

4. Darunavir Krka d.d. - HIV

Darunavir Krka d.d. - HIV 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 9 November 2017 EMA/786962/2017 Committee for Medicinal Products for Human Use (CHMP) Assessment report Darunavir Krka d.d. International non-proprietary (...) name: darunavir Procedure No. EMEA/H/C/004891/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/786962/2017 Page 2/27 Table of contents 1. Background information on the procedure 4 1.1. Submission of the dossier 4 1.2. Steps taken for the assessment of the product 6 2. Scientific discussion 7 2.1. Introduction 7 2.2. Quality aspects 8 2.2.1. Introduction 8 2.2.2. Active substance 8 2.2.3. Finished medicinal

2018 European Medicines Agency - EPARs

5. [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.

6. Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1

Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 - GOV.UK GOV.UK uses cookies to make the site simpler. Search Darunavir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1 New pharmacokinetic data show (...) mean exposure of darunavir (brand name Prezista) boosted with cobicistat (available in combination in Rezolsta▼, Symtuza▼) to be lower during the second and third trimesters of pregnancy than during 6–12 weeks postpartum. Low darunavir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the unborn child. Published 17 July 2018 From: Therapeutic area: , , , Contents Advice for healthcare professionals: pharmacokinetic data show low

2018 MHRA Drug Safety Update

7. Symtuza - Darunavir/cobicistat/emtricitabine/tenofovir alafenamide - HIV-1 infection

Symtuza - Darunavir/cobicistat/emtricitabine/tenofovir alafenamide - HIV-1 infection 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 (...) -retroviral agents, hiv, 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:

2017 Canadian Agency for Drugs and Technologies in Health - Common Drug Review

8. Darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza) - HIV Infections

Darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza) - HIV Infections 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 20 July 2017 EMA/496527/2017 Committee for Medicinal Products for Human Use (CHMP (...) ) Assessment report Symtuza International non-proprietary name: darunavir / cobicistat / emtricitabine / tenofovir alafenamide Procedure No. EMEA/H/C/004391/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/496527/2017 Page 2/106 Table of contents 1. Background information on the procedure 8 1.1. Submission of the dossier 8 1.2. Steps taken for the assessment of the product 9 2. Scientific discussion 10 2.1. Problem

2017 European Medicines Agency - EPARs

9. Reduced exposure to darunavir and cobicistat in HIV-1-infected pregnant women receiving a darunavir/cobicistat-based regimen. (Abstract)

Reduced exposure to darunavir and cobicistat in HIV-1-infected pregnant women receiving a darunavir/cobicistat-based regimen. The aim of the study was to evaluate darunavir and cobicistat pharmacokinetics in pregnant women with HIV-1 infection.This phase 3b, open-label study enrolled HIV-1-infected pregnant women (18-26 weeks of gestation) receiving combination antiretroviral therapy with once-daily darunavir/cobicistat 800/150 mg. The plasma pharmacokinetics of darunavir (total and unbound (...) women were enrolled in the study; six completed it. Total darunavir exposure was lower during pregnancy than postpartum (AUC24 h , 50-56% lower; Cmax , 37-49% lower; Cmin , 89-92% lower); unbound darunavir exposure was also reduced (AUC24 h , 40-45% lower; Cmax , 32-41% lower; Cmin , 88-92% lower). Cobicistat exposure was also lower during pregnancy than postpartum (AUC24 h , 49-63% lower; Cmax , 27-50% lower; Cmin , 83% lower). At study completion, five of six (83%) women were virologically

2019 HIV medicine

10. Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations. Full Text available with Trip Pro

Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations. When darunavir (DRV) 800 mg is boosted with 150 mg cobicistat (DRVcobi ), DRV trough concentration (Ctrough ) is about 30% lower as compared to 100 mg ritonavir (DRVrtv ). DRVcobi shows similar virological efficacy as DRVrtv when combined with two nucleos(t)ide analogue reverse-transcriptase inhibitors, but it is unknown whether a lower DRV Ctrough would undermine

2018 Journal of the International AIDS Society

11. Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. Full Text available with Trip Pro

Pharmacokinetic modelling of darunavir/ritonavir dose reduction (800/100 to 400/100 mg once daily) in a darunavir/ritonavir-containing regimen in virologically suppressed HIV-infected patients: ANRS 165 DARULIGHT sub-study. In the ANRS 165 DARULIGHT study (NCT02384967) carried out in HIV-infected patients, the use of a darunavir/ritonavir-containing regimen with a switch to a reduced dose of darunavir maintained virological efficacy (≤50 copies/mL) for 48 weeks with a good safety profile.To (...) assess the total and unbound blood plasma pharmacokinetics of darunavir and associated antiretrovirals, and their penetration into semen before and after dose reduction.Patients receiving a darunavir/ritonavir (800/100 mg q24h)-containing regimen for >6 months with plasma HIV-RNA ≤50 copies/mL for >12 months were switched to 400/100 mg darunavir/ritonavir q24h at week 0. A 24 h intensive pharmacokinetic blood sampling and a trough seminal sampling were performed before (week 0) and after (week 12

2018 Journal of Antimicrobial Chemotherapy

12. Darunavir/cobicistat (Rezolsta) - for the treatment of human immunodeficiency virus-1 (HIV-1)

Darunavir/cobicistat (Rezolsta) - for the treatment of human immunodeficiency virus-1 (HIV-1) Final Appraisal Recommendation Advice No: 2115 – July 2015 Darunavir/cobicistat (Rezolsta ® ? ) 800 mg/150 mg film-coated capsules Submission by Janssen-Cilag Ltd Additional note(s): • Please refer to the Summary of Product Characteristics for the full licensed indication. In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared by the AWMSG Secretariat (...) be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal Recommendation – 2115: Darunavir/cobicistat (Rezolsta ® ? ) 800 mg/150 mg film-coated capsules. July 2015. Recommendation of AWMSG Darunavir/cobicistat (Rezolsta ® ? ) is recommended as an option for use within NHS Wales in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years

2015 All Wales Medicines Strategy Group

13. Darunavir (Prezista) - for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients

Darunavir (Prezista) - for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients Final Appraisal Recommendation Advice No: 1815 – June 2015 Darunavir (Prezista ® ) film-coated tablets and 100 mg/ml oral suspension Limited submission by Janssen-Cilag Ltd Additional note(s): ? Please refer to the Summary of Product Characteristics for the full licensed indication. In reaching the above recommendation AWMSG has taken account of the appraisal documentation prepared (...) of this recommendation may be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal Recommendation – 1815: Darunavir (Prezista ® ) film-coated tablets and 100 mg/ml oral suspension. June 2015. Recommendation of AWMSG Darunavir (Prezista ® ) co-administered with low dose ritonavir in combination with other antiretroviral medicinal products is recommended as an option for use within NHS Wales for the treatment of human immunodeficiency virus

2015 All Wales Medicines Strategy Group

14. Interaction of Rifampicin and Darunavir/Ritonavir or Darunavir/Cobicistat <i>In Vitro</i>. Full Text available with Trip Pro

Interaction of Rifampicin and Darunavir/Ritonavir or Darunavir/Cobicistat In Vitro. Treatment of HIV-infected patients coinfected with Mycobacterium tuberculosis is challenging due to drug-drug interactions (DDIs) between antiretrovirals (ARVs) and antituberculosis (anti-TB) drugs. The aim of this study was to quantify the effect of cobicistat (COBI) or ritonavir (RTV) in modulating DDIs between darunavir (DRV) and rifampin (RIF) in a human hepatocyte-based in vitro model. Human primary

2017 Antimicrobial Agents and Chemotherapy

15. Dual therapy with darunavir and ritonavir plus lamivudine versus triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of HIV-1 viral suppression: randomised, open label Full Text available with Trip Pro

Dual therapy with darunavir and ritonavir plus lamivudine versus triple therapy with darunavir and ritonavir plus tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine for maintenance of HIV-1 viral suppression: randomised, open label Our objective was to assess the therapeutic noninferiority of dual therapy with darunavir/ritonavir and lamivudine compared to triple therapy with darunavir/ritonavir plus 2 nucleos(t)ides for maintenance of human immunodeficiency virus type 1 (...) (HIV-1) suppression.This was a multicenter, open-label, noninferiority trial (margin 12%). Patients with HIV-1 RNA <50 copies/mL for 6 months or longer on triple therapy with darunavir/ritonavir and 2 nucleos(t)ides (tenofovir disoproxil fumarate and emtricitabine or abacavir and lamivudine) and with no resistance were randomized to continue therapy (n = 128) or switch to darunavir/ritonavir and lamivudine (n = 129). The primary endpoint was the proportion of participants with HIV-RNA <50 copies/mL

2017 Clinical Infectious Diseases Controlled trial quality: predicted high

16. Influence of Ethanol on Darunavir Hepatic Clearance and Intracellular PK/PD in HIV-Infected Monocytes, and CYP3A4-Darunavir Interactions Using Inhibition and in Silico Binding Studies Full Text available with Trip Pro

Influence of Ethanol on Darunavir Hepatic Clearance and Intracellular PK/PD in HIV-Infected Monocytes, and CYP3A4-Darunavir Interactions Using Inhibition and in Silico Binding Studies Although the prevalence of alcohol consumption is higher in HIV+ people than general public, limited information is available on how alcohol affects the metabolism and bioavailability of darunavir (DRV).DRV was quantified by using LC-MS/MS method. All in vitro experiments were performed using human liver

2017 Pharmaceutical research

17. A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants

A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants - 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. A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants The safety and scientific validity

2017 Clinical Trials

18. Real-life study of dual therapy based on dolutegravir and ritonavir-boosted darunavir in HIV-1-infected treatment-experienced patients. Full Text available with Trip Pro

Real-life study of dual therapy based on dolutegravir and ritonavir-boosted darunavir in HIV-1-infected treatment-experienced patients. Dual therapy based on dolutegravir and ritonavir-boosted darunavir (DTG/DRV/r) is a combination of well-known drugs with a high genetic barrier to HIV resistance.A retrospective analysis of all HIV-1 infected treatment-experienced patients who switched to DTG/DRV/r from May 2014 till March 2017 in 4 Polish centres-results of a 48-week treatment.The study group

2019 PLoS ONE

19. Darunavir (Prezista®)

Darunavir (Prezista®) Darunavir (Prezista®) Darunavir (Prezista®) All Wales Medicines Strategy Group (AWMSG) Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation All Wales Medicines Strategy Group (AWMSG). Darunavir (Prezista®) Penarth: All Wales Therapeutics and Toxicology Centre (AWTTC), secretariat of the All Wales Medicines Strategy Group (AWMSG). AWMSG (...) Secretariat Assessment Report Advice No. 2579. 2015 Authors' conclusions Darunavir (Prezista®) co-administered with low dose ritonavir in combination with other antiretroviral medicinal products is recommended as an option for use within NHS Wales for the treatment of human immunodeficiency virus (HIV-1) infection in paediatric patients from the age of three years and at least 15 kg body weight. Final publication URL Indexing Status Subject indexing assigned by CRD MeSH Anti-HIV Agents; HIV Protease

2015 Health Technology Assessment (HTA) Database.

20. Short-term cost analysis of raltegravir versus atazanavir + ritonavir or darunavir + ritonavir for treatment-naive adults with HIV-1 infection in the United States. Full Text available with Trip Pro

Short-term cost analysis of raltegravir versus atazanavir + ritonavir or darunavir + ritonavir for treatment-naive adults with HIV-1 infection in the United States. Ninety-six-week costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating RAL, ATV/r, or DRV/r as first-line therapy for HIV-1 infection were estimated using an economic model. Efficacy and safety data (mean CD4 cell count changes, discontinuation rates, grade 3/4 adverse event incidence

2018 PLoS ONE Controlled trial quality: uncertain

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