Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD) 
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  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Trial completion date, Trial initiation date, Trial primary completion date, Head-to-Head:  ELDORADO: DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-na (clinicaltrials.gov) -  Oct 30, 2024   
    P3,  N=610, Not yet recruiting, 
    Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain. Trial completion date: Apr 2027 --> Nov 2027 | Initiation date: Apr 2024 --> Nov 2024 | Trial primary completion date: Apr 2026 --> Nov 2026
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Three? versus two?drug doravirine?based regimens: a multicentre observational study () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_264;    
    DOR/3TC/TDF and DOR+3TC were comparable in terms of effectiveness and durability. DOR+3TC might be an option in case of complex interplay of metabolic disorders and history of intolerance, exclusively if full known susceptibility to the regimen and reinforced adherence.
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Discontinuation rates of doravirine/lamivudine/tenofovir?DF due to neuropsychiatric adverse effects () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_222;    
    Rates of NPAE leading to discontinuation of DOR/L/TDF when switching from RPV/F/TDF in this small cohort are higher than described in large randomized studies and ongoing vigilance is justified. Importantly, all patients were involved in their ART decision-making and regular screening of adverse effects is required.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Profile of people with HIV (PWH) switching prior antiretroviral treatment (ART) to a doravirine (DOR)? based regimen in the real?world clinical setting in Greece: the DORAVITO study () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_220;    
    Abbreviations: 3TC, lamivudine; ART, antiretroviral therapy; ARV, antiretroviral; CCI, Charlson Comorbidity Index; DOR, doravirine; HBV, hepatitis B; HCV, hepatitis C; INSTI, integrase strand transfer inhibitor; IQR, interquartile range; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; SD, standard deviation; TDF, tenofovir disoproxil fumarate. Real-world data from the DORAVITO study provide insight into the current prescription landscape of DOR in Greece, revealing that switching to a DOR-based regimen is a valuable option for PWH who require ART simplification, increased tolerability and avoidance of drug toxicities.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Viral blips in the doravirine phase III clinical trials DRIVE?FORWARD and DRIVE?AHEAD () -  Oct 26, 2024 - Abstract #HIVGlasgow2024HIV_Glasgow_172;    
    Real-world data from the DORAVITO study provide insight into the current prescription landscape of DOR in Greece, revealing that switching to a DOR-based regimen is a valuable option for PWH who require ART simplification, increased tolerability and avoidance of drug toxicities. Summary of viral blips in DRIVE-FORWARD and DRIVE-AHEAD DRIVE-FORWARD (1439-018) DRIVE-AHEAD (1439A-021) Double-blind phase (day 1
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  DeLiTE: Can INSTI-associated Weight Gain be Halted or Reversed With a Switch to Doravirine/Lamivudine/Tenofovir DF? (clinicaltrials.gov) -  May 9, 2024   
    P4,  N=4, Terminated, 
    No abstract available N=25 --> 4 | Trial completion date: Dec 2024 --> Mar 2024 | Enrolling by invitation --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; enrollment futility
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Enrollment closed, Trial completion date, Trial primary completion date:  DORASPEP: "Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk" (clinicaltrials.gov) -  Apr 19, 2024   
    P=N/A,  N=226, Active, not recruiting, 
    N=25 --> 4 | Trial completion date: Dec 2024 --> Mar 2024 | Enrolling by invitation --> Terminated | Trial primary completion date: Aug 2024 --> Mar 2024; enrollment futility Recruiting --> Active, not recruiting | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Trial completion:  Effects of Switching From ATRIPLA (clinicaltrials.gov) -  Feb 22, 2024   
    P2,  N=86, Completed, 
    Similarly, there is no observed impact on estradiol PKs and total testosterone following use of DOR/3TC/TDF. Active, not recruiting --> Completed
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Phase classification:  Effects of Switching From ATRIPLA (clinicaltrials.gov) -  Jan 11, 2024   
    P2,  N=86, Active, not recruiting, 
    Not yet recruiting --> Recruiting Phase classification: P2b --> P2
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Trial completion date, Trial primary completion date:  DoraDO: Doravirine Dose Optimisation in Pregnancy (clinicaltrials.gov) -  Jan 1, 2024   
    P4,  N=76, Recruiting, 
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Enrollment open:  DoraDO: Doravirine Dose Optimisation in Pregnancy (clinicaltrials.gov) -  Nov 14, 2023   
    P4,  N=76, Recruiting, 
    We found once-daily dosing of DOR FDC to be safe and well tolerated for maintaining viral suppression through 96 weeks in adolescents living with HIV-1. Not yet recruiting --> Recruiting
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD)
    Journal:  Doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed people living with HIV: A real-life experience. (Pubmed Central) -  Aug 11, 2023   
    Trial completion date: Nov 2026 --> Apr 2034 | Trial primary completion date: Jun 2025 --> Mar 2028 In our study, simplification to a single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate in virologically suppressed PLWHIV was effective and showed a good tolerability profile, in association with a significant improvement in serum lipid levels.
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD)
    Trial initiation date:  DoraDO: Doravirine Dose Optimisation in Pregnancy (clinicaltrials.gov) -  May 15, 2023   
    P4,  N=76, Not yet recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Jan 2023 --> Jun 2023
  • ||||||||||  Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  DAWN: Doravirine and Weight Gain in Antiretroviral Naive (clinicaltrials.gov) -  May 12, 2023   
    P3,  N=0, Withdrawn, 
    Initiation date: Jan 2023 --> Jun 2023 N=150 --> 0 | Trial completion date: Jun 2025 --> May 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2024 --> May 2023