Prezista (darunavir) / J&J 
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  • ||||||||||  Prezista (darunavir) / J&J
    Darunavir resistance among patients exposed to protease inhibitors failing ARV therapy (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_322;    
    Among patients with PI-DRM, full activity to darunavir was compromised in many cases and efforts to detect failure at earlier time is warranted, particularly for cases treated in early HAART era or infected with HIV-1 subtype F, both associated to darunavir resistance. NRTI mutations may serve as a proxy for a minimal level of therapy adherence necessary for PI-DRM emergence.
  • ||||||||||  Use of ibalizumab in a heavily treatment-experienced HIV-1-infected subject harbouring a multidrug-resistant virus (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_208;    
    A Genotyping Susceptibility Tests (GSTs) was performed and, according to the Stanford HIVdb interpretation, identified: - on plasma RNA: susceptibility to doravirine (DOR)/etravirine (ETV)/rilpivirine (RPV), all integrase strand transfer inhibitors (INSTIs) and enfuvirtide (ENF); different degrees of resistance to DRV/r, all nucleoside reverse transcriptase inhibitors (NRTIs); a R5-tropic virus was found; - on blood DNA: susceptibility to DRV/r and emtricitabine (FTC)/abacavir (ABC); different degrees of resistance to tenofovir(TDF)/ABC, DOR/ETV, RPV, dolutegravir (DTG), ENF; a X4-tropic virus was found...Thanks to the “5% Fund” of the Italian Medicines Agency, this man received an initial loading dose of IBA (2000 mg/iv) followed by maintenance doses (800 mg/iv every 15 days) in association with a recycling regimen including FTC/RPV/tenofovir alafenamide 200/25/25 mg QD, DTG 50 mg BID, maraviroc 150 mg BID, ENF 90 mg BID (replaced with DRV/r 600/100 mg BID after 12 weeks to improve acceptability)...In this man IBA, plus an OBT with residual antiviral activity, favoured the achievement of virological control, at least in the short-term. Management of patients with no fully active drugs is an unmet clinical need and novel classes such as CD4-binding monoclonal antibodies may have a key role.
  • ||||||||||  Prezista (darunavir) / J&J, emtricitabine/tenofovir disoproxil fumarate / Generic Mfg., Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Evaluation of the “test and treat” strategy in an high-income setting: data from a multicenter Italian cohort (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_194;    
    We enrolled 196 patients from 9 Italian clinical centers: 120 patients started a triple therapy with tenofovir/emtricitabine plus an integrase inhibitor (83 with dolutegravir, 21 with elvitegravir and 16 with raltegravir), 32 with abacavir/lamivudine/dolutegravir, 17 with tenofovir/emtricitabine plus boosted darunavir, 11 with tenofovir/emtricitabine plus rilpivirine. In our cohort, we did not observe an advantage in using a one-day treatment approach compared to other strategies of ARV initiation.
  • ||||||||||  Prezista (darunavir) / J&J, Tivicay (dolutegravir) / ViiV Healthcare
    No metabolic or renal benefits when switching to an NRTI-free dolutegravir-containing 2 drug regimen (2DR) - a subanalysis of the DUALIS study (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_139;    
    Purpose: The DUALIS study assessed efficacy and safety of switching to Dolutegravir (DTG) and boosted darunavir (bDRV) (2DR) and has demonstrated non-inferiority as compared to 2 NRTI+bDRV (3DR). While being non-inferior with regard to virologic suppression, a switch to a 2DR consisting of DTG+bDRV does not yield significant metabolic or renal advantages by substituting the NRTI components of a comparative 3DR antiretroviral therapy.
  • ||||||||||  Prezista (darunavir) / J&J, Pifeltro (doravirine) / Merck (MSD), lamivudine / Generic Mfg.
    Biologic sex is not the only difference between men and women: data from the Doravirine phase 2/3 clinical trials (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_138;    
    Although women had similar efficacy and safety results, women represented 15% of participants. Increased enrollment of women in clinical trials or women-only trials should be considered to further understand antiretroviral efficacy and safety in this important population.
  • ||||||||||  Lamivudine-based maintenance 2-drugs regimens: an algorithm for the estimation of 2-years risk of virological failure in clinical practice (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_83;    
    From a multicentre Italian cohort of patients with undetectable HIV-RNA (according to the centre-specific threshold) and negative HBsAg-serostatus, starting lamivudine plus a bPI (darunavir, atazanavir or lopinavir) or dolutegravir, predictors of VF (i.e., a single HIV-RNA≥1000 cp/mL or 2 consecutive HIV-RNA≥50 cp/mL) at 2 years were analysed by Cox regression. Some viro-immunological characteristics of patients switching to a lamivudine-based maintenance dual-therapy can be incorporated in a useful algorithm to identify subjects at higher risk of VF.
  • ||||||||||  Prezista (darunavir) / J&J
    Simplifying salvage regimens with darunavir-based dual therapy in HIV-infected individuals harboring multidrug-resistance (Exhibition hall) -  Nov 15, 2019 - Abstract #EACS2019EACS_68;    
    P=N/A
    Virologic effectiveness and safety were illustrated in a real world setting with < 5% discontinuations due to ADRs and < 2% due to virologic failure. The simplification to a dual regimen with boosted darunavir plus raltegravir after a long period of virologic suppression was not associated with higher rates of treatment failure, even in patients with multidrug-resistant HIV infection harboring PIs-RAMs.
  • ||||||||||  Prezista (darunavir) / J&J
    Clinical, Journal:  A case of late presentation of darunavir-related cholestatic hepatitis. (Pubmed Central) -  Nov 10, 2019   
    Darunavir withdrawal resulted in a progressive decrease in liver enzyme levels. We highlight the importance of recognising late development of liver injury secondary to the use of darunavir, and the importance of monitoring liver function in patients undergoing prolonged treatment involving darunavir.
  • ||||||||||  Prezista (darunavir) / J&J
    Differential Effects of HIV Protease Inhibitors on Release and Activation of Platelet-Derived TGF-β1: Potential Association with HIV-Linked CVD (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_3496;    
    We examined the impact of clinically relevant doses of ritonavir, alone and in combination with two other contemporary PIs, atazanavir and darunavir, which are currently used along with low dose ritonavir in so-called PI-boosted cART regimens...Future work will examine the effects of other contemporary cART agents, including cobicistat, which is currently replacing ritonavir in many PI-boosted therapies and some integrase-boosted regimens, on TGF-β1 release and activation, for which correlations with clinical CVD are not yet available . Identification of the mechanism of pathologic fibrosis in the heart, and potentially other organs affected by certain cART regimens, such as the kidney, may suggest specific therapeutic interventions.
  • ||||||||||  Clinical, Journal:  Drug-Drug Interactions Studies between HCV Antivirals Sofosbuvir/Velpatasvir and Boosted and Unboosted HIV Antiretroviral Regimens in Healthy Volunteers. (Pubmed Central) -  Nov 6, 2019   
    SOF/VEL and ARV regimens were administered alone and in combination; ARVs (and pharmacokinetic enhancers) included atazanavir (ATV), cobicistat (COBI), darunavir (DRV), dolutegravir (DTG), efavirenz (EFV), elvitegravir (EVG), emtricitabine (FTC), lopinavir (LPV), raltegravir (RAL), rilpivirine (RPV), ritonavir (RTV), tenofovir alafenamide (TAF), and tenofovir disoproxil fumarate (TDF)...No clinically relevant differences in the pharmacokinetics (PK) of SOF, SOF metabolite GS-331007, or VEL were observed other than an approximate 50% decrease in VEL exposure when administered with EFV/FTC/TDF...SOF/VEL and ARV regimens including ATV, COBI, DRV, DTG, EVG, FTC, LPV, RAL, RPV, RTV, TAF, or TDF may be coadministered without dose adjustment. Use of SOF/VEL with EFV-containing regimens is not recommended due to ~50% reduction in VEL exposure.
  • ||||||||||  Prezista (darunavir) / J&J, Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead, Epzicom (abacavir/lamivudine) / ViiV Healthcare
    Clinical, Journal:  Low-dose ritonavir-boosted darunavir in virologically suppressed HIV-1-infected adults: an open-label trial (ANRS 165 Darulight). (Pubmed Central) -  Oct 24, 2019   
    A total of 212 adverse events (AEs) occurred in 64 patients (64%); 9 AEs were serious, none leading to treatment discontinuation. In HIV-infected patients well suppressed with darunavir/r (800/100 mg) and two NRTIs, a reduction of the darunavir dose to 400 mg/day maintained virological efficacy and was safe over 48 weeks.
  • ||||||||||  Prezista (darunavir) / J&J, Truvada (emtricitabine/tenofovir disoproxil fumarate) / Gilead
    Transient Nephrotic Range Proteinuria After Acute HIV Infection () -  Oct 23, 2019 - Abstract #KIDNEYWEEK2019KIDNEY_WEEK_5827;    
    Proteinuria developed with reconstitution of T cell immunity and decrease in HIV viral load and resolved without pharmacologic therapy. We propose that asymptomatic podocytopathy early in the course of infection could be a novel form of HIV-mediated renal disease.
  • ||||||||||  Prezista (darunavir) / J&J, Tivicay (dolutegravir) / GSK, ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    Preclinical, Journal:  Differential Effects of Antiretroviral Drugs on Neurons In Vitro: Roles for Oxidative Stress and Integrated Stress Response. (Pubmed Central) -  Oct 9, 2019   
    Further, we expanded our assessment to include three integrase strand transfer inhibitors, raltegravir, dolutegravir, and elvitegravir...Future in vivo studies will be critical to confirm the neurotoxicity profiles of these drugs for incorporation of these findings into patient management. The EAR and ISR pathways are potential access points for the development of adjunctive therapies to complement antiretroviral therapies and limit their contribution to HAND persistence.
  • ||||||||||  PK/PD data, Journal:  Pharmacokinetics of Tenofovir Alafenamide When Co-administered With Other HIV Antiretrovirals. (Pubmed Central) -  Oct 9, 2019   
    Our meta-analysis indicated that DRV/r-based regimens were effective and tolerable for both types of patients, which was consistent with published data. Evaluation of the drug interaction between TAF and other commonly prescribed boosted and unboosted ARVs provides characterization of the susceptibility of TAF and/or TFV PK to inhibitors or inducers of Pgp/BCRP transporters.