Edurant (rilpivirine) / J&J 
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  • ||||||||||  Edurant (rilpivirine) / J&J
    Journal:  The development of an effective synthetic route of rilpivirine. (Pubmed Central) -  Apr 7, 2021   
    These findingsmay be of relevance in the search of novel anti-fibrotic targets for the treatment of liver diseases. Overall, through a series of process optimization, we have developed a practical synthesis method of rilpivirine, which is easy to scale with higher yield and shorter reaction time.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare
    Journal:  An evaluation of cabotegravir for HIV treatment and prevention. (Pubmed Central) -  Mar 18, 2021   
    Expert opinion Cabotegravir has the potential to play a primary role in the treatment and prevention of HIV infection. The future availability of LAI CAB + RPV and LAI CAB may mark the beginning of an era of LAI ART and PrEP, respectively.
  • ||||||||||  Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J, Cabenuva (cabotegravir long acting/rilpivirine long acting) / J&J, GSK, ViiV Healthcare, Pfizer, Shionogi
    [VIRTUAL] WEIGHT AND LIPID CHANGES IN PHASE 3 CABOTEGRAVIR AND RILPIVIRINE LONG-ACTING TRIALS () -  Mar 18, 2021 - Abstract #CROI2021CROI_715;    
    Since InSTI-associated weight changes have only recently emerged, collection of weight data across the CAB development program was not standardized at sites and limited metabolic data were collected. Future and on-going studies will further characterize potential InSTI-associated weight gain and metabolic perturbations.
  • ||||||||||  Juluca (dolutegravir/rilpivirine) / ViiV Healthcare, J&J
    [VIRTUAL] INFLAMMATORY AND ATHEROGENESIS MARKERS 148 WEEKS POSTSWITCH TO DTG+RPV IN SWORD-1/ -2 () -  Mar 18, 2021 - Abstract #CROI2021CROI_699;    
    In the controlled ES phase, no significant differences between arms were observed at W48 except for sCD14 favoring DTG+RPV. Longitudinally up to W148, there was no consistent, reproducible pattern of change post-switch, providing no evidence of increased inflammation or atherogenesis markers on the 2-drug regimen, DTG+RPV, while maintaining viral suppression.
  • ||||||||||  Edurant (rilpivirine) / J&J
    [VIRTUAL] RPV ACTIVATES STAT1 IN STELLATE CELLS TO REGULATE LIVER INJURY IN PLWHIV AND NAFLD () -  Mar 18, 2021 - Abstract #CROI2021CROI_662;    
    PLWHIV with NAFLD who receive RPV-based therapy showed increased STAT1 activation, pointing to ongoing HSC inactivation and apoptosis to reduce the progression of hepatic damage. Our results suggest RPV-based ART would be especially indicated in HIV-infected patients with NAFLD-derived liver injury to prevent liver fibrosis and inflammation.
  • ||||||||||  [VIRTUAL] MUTATIONS IN GP41 IN PRIMARY HIV-1 ISOLATES CONFER RESISTANCE TO ANTIRETROVIRALS () -  Mar 18, 2021 - Abstract #CROI2021CROI_633;    
    We propagated clinically relevant HIV-1 strains [subtype B NL(AD8) and subtype C, transmitted founder K3016] in the presence of DTG, rilpivirine and emtricitabine to select variants exhibiting resistance to these drugs...These Env mutants exhibit faster-than-WT replication but reduced cell-free infectivity relative to WT and showed reduced sensitivity to DTG (3.6 – 30 fold), efavirenz (9.5 – 23 fold) and nelfinavir (13 – 25 fold), but not to T-20, in spreading infection... Our findings suggest that Env-mediated drug resistance may broadly affect HIV sensitivity to ARVs and provide clues towards understanding how ART failure occurs without mutations in drug-target genes.
  • ||||||||||  Rekambys (rilpivirine LA) / J&J
    [VIRTUAL] POPPK MODELING OF Q2M IM RPV LA FOR MANAGING DOSING INTERRUPTIONS IN HIV-1 PATIENTS () -  Mar 18, 2021 - Abstract #CROI2021CROI_612;    
    Oral therapy to cover planned dosing interruptions of RPV LA injections can provide exposures within ranges observed in clinical studies. Recommendations for managing dosing interruptions are aligned for RPV LA and CAB LA, to facilitate dosing for the complete regimen.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare
    [VIRTUAL] IN SILICO PREDICTION OF LONG-ACTING CABOTEGRAVIR PK IN LIVERIMPAIRED PATIENTS () -  Mar 18, 2021 - Abstract #CROI2021CROI_582;    
    These data suggest that IM LA CBV may be used safely in patients with liver impairment, considering the overall steady-state and increment in unbound plasma concentrations. This approach could also be utilised for the prediction of risk related to altered PK for IM LA therapy in liver impaired patients as well as supporting the design of future clinical trials.
  • ||||||||||  Vocabria (cabotegravir oral) / ViiV Healthcare
    [VIRTUAL] CABOTEGRAVIR PPK SIMULATION TO INFORM Q2M STRATEGIES FOLLOWING DOSING INTERRUPTIONS () -  Mar 18, 2021 - Abstract #CROI2021CROI_581;    
    When the 2nd, 3rd, or 4th injection is delayed, dosing delays of up to 1 week were predicted to have minimal impact, but longer delays may have a greater impact, particularly for the 2nd injection. Oral bridging provides therapeutic and safe exposures for planned interruptions in IM dosing.
  • ||||||||||  Edurant (rilpivirine) / J&J
    [VIRTUAL] PHARMACOKINETICS OF 2 CONTRACEPTIVE IMPLANTS AMONG WOMEN ON RILPIVIRINE-BASED ART () -  Mar 18, 2021 - Abstract #CROI2021CROI_576;    
    Over the 24-week study period, concentrations of ENG and LNG from a contraceptive implant were modestly higher, but not clinically different in women receiving RPV-based ART compared to the historical control groups. Our results support that both the ENG and LNG implant are effective contraceptive options for women receiving RPV-based ART.
  • ||||||||||  Edurant (rilpivirine) / J&J, Descovy (emtricitabine/tenofovir alafenamide) / Gilead, Rekambys (rilpivirine LA) / J&J
    [VIRTUAL] VIRUS REMISSION WITH AN OPTIMIZED EARLY ART REGIMEN IN MACAQUES () -  Mar 18, 2021 - Abstract #CROI2021CROI_491;    
    We identified in macaques a suppressive ART regimen that results in virus remission following early treatment. The lack of viral rebound 20 months after treatment cessation and CD8 depletion is encouraging and highlights the need to further define the effect of optimized early ART regimens on virus remission.
  • ||||||||||  Edurant (rilpivirine) / J&J
    Clinical, Journal:  A case of rilpivirine drug-induced liver injury. (Pubmed Central) -  Feb 20, 2021   
    TAF appears to have an impact on weight gain, similarly to what observed in naïve patients, also in experienced PLWHIV with good virologic control. No abstract available
  • ||||||||||  Edurant (rilpivirine) / J&J
    Journal:  Effect of the anti-retroviral drug, rilpivirine, on human subcutaneous adipose cells and its nutritional management using quercetin. (Pubmed Central) -  Feb 3, 2021   
    However, further assessment of lipid metabolism and adipose tissue function in patients administered with rilpivirine-based regimes is advisable considering that totally neutral effects of rilpivirine on lipid homeostasis cannot be anticipated from the current study in vitro. It is concluded that rilpivirine causes an anti-adipogenic and pro-inflammatory response pattern but only at high concentrations, whereas quercetin has been observed to decrease inflammation and restore the levels of anti-oxidant enzymes.
  • ||||||||||  Edurant (rilpivirine) / J&J, Pifeltro (doravirine) / Merck (MSD)
    Journal:  Drug Interactions with Gender-Affirming Hormone Therapy: Focus on Antiretrovirals and Direct Acting Antivirals. (Pubmed Central) -  Jan 30, 2021   
    ARV- and/or DAA-associated side effects (including depression, cardiovascular disease, hyperlipidemia) are important to consider in the clinical management of trans patients. Clinicians must evaluate potential DDIs and overlapping side effects between ARVs, DAAs and GAHT when providing care for trans patients.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare
    Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date:  Contribution of Dolutegravir to Obesity and Cardiovascular Disease (clinicaltrials.gov) -  Jan 13, 2021   
    P4,  N=30, Recruiting, 
    Active, not recruiting --> Completed Not yet recruiting --> Recruiting | Trial completion date: Mar 2021 --> Jan 2022 | Initiation date: Jun 2020 --> Sep 2020 | Trial primary completion date: Jan 2021 --> Sep 2021
  • ||||||||||  Edurant (rilpivirine) / J&J, Isentress (raltegravir) / Merck (MSD)
    Journal:  Dual Inhibitor Design for HIV-1 Reverse Transcriptase and Integrase Enzymes; A Molecular Docking Study. (Pubmed Central) -  Dec 30, 2020   
    These binding scores demonstrate that these ligands are more active than Raltegravir for integrase and Rilpivirine for reverse transcriptase which are also used for docking method validation. B205, B214, B233, B242, B246, B249, B253 and B254 are the some of ligands found to have good binding scores for both enzymes and could be considered as new inhibitor candidates as dual inhibitors.
  • ||||||||||  bictegravir (GS-9883) / Gilead
    PK/PD data, Journal:  Pharmacokinetics of Co-encapsulated Antiretrovirals with Ingestible Sensors. (Pubmed Central) -  Dec 18, 2020   
    To assess the safety and impact, if any, coencapsulation might have on ARV concentrations, we evaluated the pharmacokinetics of ARVs coencapsulated with an ingestible sensor for eight commonly used fixed-dose combination ARVs: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF); FTC/tenofovir alafenamide (TAF); efavirenz (EFV)/FTC/TDF; abacavir (ABC)/lamivudine (3TC); dolutegravir (DTG)/ABC/3TC; rilpivirine (RPV)/TAF/FTC; elvitegravir (EVG)/cobicistat (COBI)/FTC/TAF; and bictegravir (BIC)/FTC/TAF...In a subsequent evaluation of FTC/TDF and BIC/FTC/TAF using a crossover design, the geometric mean ratio (GMR) between the coencapsulated and the unencapsulated formulations for FTC/TDF were the following: FTC, 84.6% (90% confidence interval [CI] 66.6-107.4) for AUC and 77.5% (60.1-99.9) for Cmax...The observed deviation in FTC/TDF (Truvada) may be due to participant characteristics, fasted/fed conditions, and/or random variation and may warrant further investigations with a larger sample size. These findings provide assurance for use of co-encapsulated ARVs for future HIV treatment-adherence research.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Clinical, Journal:  Rational Design of Doravirine: From Bench to Patients. (Pubmed Central) -  Dec 18, 2020   
    Learning from the liabilities of approved NNRTIs, as well as past development failures, facilitated a rational approach to the discovery of doravirine by focusing on addressing the known safety/tolerability issues of commonly prescribed NNRTIs, such as central nervous system toxicity with efavirenz and potential cardiotoxicity due to off target effects on cardiac ion channels with rilpivirine, using structural biology and characterization of resistance in vitro to address resistance liabilities, and concentrating on the metabolic profile to limit the potential for drug-drug interactions. These preclinical efforts were critical to the design and selection of doravirine as a novel NNRTI that possessed the desired next-generation profile, with the ultimate proof that these attributes translate to patients derived from clinical trials.
  • ||||||||||  paritaprevir/ritonavir (ABT-450/r) / AbbVie
    Journal:  The potential of Paritaprevir and Emetine as inhibitors of SARS-CoV-2 RdRp. (Pubmed Central) -  Dec 8, 2020   
    The recent elucidation of the experimental structure of SARS-CoV-2 RdRp enzyme complexed with triphosphate form of Remdesivir (RTP) has opened an avenue for structure-based identification of potent inhibitors...The top 3 hits among the FDA approved drugs were Paritaprevir (D33), Rilpivirine (D19) and Simeprevir (D31) which scored binding energies between -8.08 kcal/mol and -10.46 kcal/mol...Further, the physicochemical properties of the molecules were evaluated. These identified potential inhibitors warrant further experimental investigations before their acceptance as drug candidates for the treatment of the disease.
  • ||||||||||  Edurant (rilpivirine) / J&J, Rekambys (rilpivirine LA) / J&J
    Journal:  Creation of a long-acting rilpivirine prodrug nanoformulation. (Pubmed Central) -  Oct 25, 2020   
    Taken together, proof-of-concept is provided that nanoformulated RPV prodrugs can extend the apparent drug's half-life and improve tissue biodistribution. These results warrant further development for human use.
  • ||||||||||  [VIRTUAL] The NNRTI-Based Single-Tablet Regimens for the Antiretroviral Treatment of Naive Adults Living with HIV-1 in Russia - Cost-Minimization Analysis () -  Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_688;    
    METHODS Indirect treatment comparison (ITC) by Bucher`s method was performed based on DRIVE-AHEAD and STaR trial data, using FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate as common comparator to assess the relative clinical effectiveness of compared STRs...When compared to RPV/TDF/FTC, one-year therapy with DOR/TDF/3TC was associated with lower costs and saves an average €1,323 (31.4%) per patient. CONCLUSIONS STR DOR/TDF/3TC provides significant cost-savings to the Russian health care system with non-inferior efficacy to RPV/FTC/TDF in treatment-naive HIV-patients with initial viral load (VL) <100 000 copies/mL.