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1. [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.

2. 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

3. 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. (PubMed)

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

4. Darunavir/cobicistat showing similar effectiveness as darunavir/ritonavir monotherapy despite lower trough concentrations. (PubMed)

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

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2018 Journal of the International AIDS Society

5. 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 (PubMed)

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

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2017 Clinical Infectious Diseases

6. Interaction of Rifampicin and Darunavir/Ritonavir or Darunavir/Cobicistat <i>In Vitro</i>. (PubMed)

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

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2017 Antimicrobial Agents and Chemotherapy

7. 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

8. 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 (PubMed)

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

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2017 Pharmaceutical research

9. Real-life study of dual therapy based on dolutegravir and ritonavir-boosted darunavir in HIV-1-infected treatment-experienced patients. (PubMed)

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

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2019 PLoS ONE

10. Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial. (PubMed)

Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial. Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce.Randomised Clinical Trial.This is the body composition substudy of NEAT 001/ANRS (...) 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults. The primary endpoint was percentage change in limb fat at week 96. Secondary endpoints were associations among these changes and metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23).126 subjects (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) were included. The rate of change in BMI between groups for RAL versus

2019 PLoS ONE

11. 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

12. 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)

13. Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. (PubMed)

Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial. PROTEA is a randomized controlled trial to assess the efficacy and safety of darunavir/ritonavir (DRV/r) monotherapy as an alternative to triple therapy.Patients fully suppressed on first-line antiretrovirals (viral load < 50 HIV-1 RNA copies/mL) were switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 137) or with two

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2016 HIV medicine

14. Pharmacokinetic Interactions Between the HCV Inhibitors Elbasvir and Grazoprevir and HIV Protease Inhibitors Ritonavir, Atazanavir, Lopinavir, or Darunavir in Healthy Participants. (PubMed)

Pharmacokinetic Interactions Between the HCV Inhibitors Elbasvir and Grazoprevir and HIV Protease Inhibitors Ritonavir, Atazanavir, Lopinavir, or Darunavir in Healthy Participants. The combination of the hepatitis C virus (HCV) NS5A inhibitor elbasvir and NS3/4A protease inhibitor grazoprevir is a potent, once-daily therapy indicated for the treatment of chronic HCV infection in individuals coinfected with human immunodeficiency virus-1 (HIV). We explored the pharmacokinetic interactions (...) of elbasvir and grazoprevir with ritonavir and ritonavir-boosted HIV protease inhibitors in three phase 1 trials. Drug-drug interaction trials in healthy participants were conducted to evaluate the effect of ritonavir on the pharmacokinetics of grazoprevir (N = 10) and the potential 2-way pharmacokinetic interaction of elbasvir (N = 30) or grazoprevir (N = 39) when coadministered with ritonavir-boosted atazanavir, lopinavir, or darunavir. Coadministration of ritonavir with grazoprevir increased

2019 Antimicrobial Agents and Chemotherapy

15. Effectiveness of Once-Daily Dolutegravir plus Boosted Darunavir as a Switch Strategy in Human Immunodeficiency Virus-Infected, Heavily Treated Patients. (PubMed)

Effectiveness of Once-Daily Dolutegravir plus Boosted Darunavir as a Switch Strategy in Human Immunodeficiency Virus-Infected, Heavily Treated Patients. Dual therapy with once-daily dolutegravir (DTG) plus boosted darunavir (DRV/b) may be a suitable and effective strategy with a high genetic barrier to resistance in human immunodeficiency virus (HIV)-infected patients. Our aim was to evaluate the effectiveness of DTG plus DRV/b (DTG+DRV/b) as a switch strategy in HIV-infected patients (...) . The historical genotypes from 44 patients showed 41 (93.2%) patients with nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance-associated mutations (RAMs), 32 (72.7%) with nonnucleoside reverse transcriptase inhibitor (NNRTI) RAMs, and 12 (27.3%) with primary protease inhibitor (PI) RAMs; 7 (15.9%) had darunavir RAMs, and no patients had baseline integrase strand transfer inhibitor RAMs. Thirty-seven (84.1%) patients had resistance to at least two antiretroviral classes. After a median

2019 Pharmacotherapy

16. Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial. (PubMed)

Body composition and adipokines changes after initial treatment with darunavir-ritonavir plus either raltegravir or tenofovir disoproxil fumarate-emtricitabine: A substudy of the NEAT001/ANRS143 randomised trial. Comparison of changes in body composition, adipokines and inflammatory markers after initial therapy with a nucleos(t)ide reverse transcriptase inhibitor (N(t)RTI)- sparing or containing regimen are scarce.Randomised Clinical Trial.This is the body composition substudy of NEAT 001/ANRS (...) 143, a randomised trial comparing darunavir/ritonavir (DRV/r) plus either raltegravir (RAL) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 805 ART naïve HIV-infected adults. The primary endpoint was percentage change in limb fat at week 96. Secondary endpoints were associations among these changes and metabolic markers (IL-6, insulin, leptin, adiponectin, FGF-23).126 subjects (61 DRV/r + RAL and 65 DRV/r + TDF/FTC) were included. The rate of change in BMI between groups for RAL versus

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2019 PloS one

17. Effectiveness and safety of dual therapy with rilpivirine and boosted darunavir in treatment-experienced patients with advanced HIV infection: a preliminary 24 week analysis (RIDAR study). (PubMed)

Effectiveness and safety of dual therapy with rilpivirine and boosted darunavir in treatment-experienced patients with advanced HIV infection: a preliminary 24 week analysis (RIDAR study). The objective was to analyze the effectiveness and safety of dual therapy with rilpivirine plus boosted-darunavir (RPV + bDRV) in real-life patients.Observational, retrospective, multi-center study in HIV+ patients who had received RPV + bDRV for 24 weeks to optimize/simplify their previous antiretroviral

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2019 BMC Infectious Diseases

18. Therapeutic drug monitoring of darunavir/ritonavir in pregnancy. (PubMed)

Therapeutic drug monitoring of darunavir/ritonavir in pregnancy. Physiological changes during pregnancy can have a significant impact on antiretroviral pharmacokinetics (PK), which may result in reduced drug efficacy. Here we describe the PK of darunavir/ritonavir (DRV/r) 800/100 QD in a cohort of pregnant women undergoing routine therapeutic drug monitoring (TDM) as well as transplacental passage of DRV by measuring and comparing cord blood and maternal blood samples at delivery.Pregnant HIV

2019 Antiviral Therapy

19. Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling. (PubMed)

Evaluating darunavir/ritonavir dosing regimens for HIV-positive pregnant women using semi-mechanistic pharmacokinetic modelling. Darunavir 800 mg once (q24h) or 600 mg twice (q12h) daily combined with low-dose ritonavir is used to treat HIV-positive pregnant women. Decreased total darunavir exposure (17%-50%) has been reported during pregnancy, but limited data on unbound exposure are available.To evaluate total and unbound darunavir exposures following standard darunavir/ritonavir dosing (...) and to explore the value of potential optimized darunavir/ritonavir dosing regimens for HIV-positive pregnant women.A population pharmacokinetic analysis was conducted based on data from 85 women. The final model was used to simulate total and unbound darunavir AUC0-τ and Ctrough during the third trimester of pregnancy, as well as to assess the probability of therapeutic exposure.Simulations predicted that total darunavir exposure (AUC0-τ) was 24% and 23% lower in pregnancy for standard q24h and q12h dosing

2019 Journal of Antimicrobial Chemotherapy

20. Efficacy and safety of dolutegravir plus boosted-darunavir dual therapy among highly treatment-experienced patients. (PubMed)

Efficacy and safety of dolutegravir plus boosted-darunavir dual therapy among highly treatment-experienced patients. Dual therapies decrease toxicity, pill-burden, and treatment-associated cost. The combination of high genetic barrier drugs such as dolutegravir plus boosted-darunavir may be suitable as simplification regimen for patients harboring multidrug-resistant virus.Patients switched to a once-daily regimen consisting in dolutegravir plus darunavir, boosted with cobicistat or ritonavir (...) suppressed for a median of 33 months (interquartile range, 12-60). Only 5 patients had reduced sensitivity to darunavir and mean genotypic susceptibility score of dual therapy was 1.95 over 2. At week 48, there were no virologic failures, three patients discontinued the regimen due to neuropsychiatric adverse events, two were lost to follow-up, and therefore the efficacy was 90% (95% confidence interval, 82-99%, intention-to-treat analysis). Mean estimated glomerular filtration rate decreased by 8.8 mL

2019 Antiviral Therapy

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