- |||||||||| 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
- |||||||||| 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)
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
- |||||||||| Trogarzo (ibalizumab IV) / Theratechnologies, TaiMed Biologics, Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) / Merck (MSD), Rukobia (fostemsavir) / ViiV Healthcare
Review, Journal: Efficacy and Safety of Two-Drug Regimens That Are Approved from 2018 to 2022 for the Treatment of Human Immunodeficiency Virus (HIV) Disease and Its Opportunistic Infections. (Pubmed Central) - Jun 28, 2023 However, DOR/3TC/TDF had shown a preferable safety profile with lower discontinuations due to adverse events (AEs), lower neuropsychiatric AEs, and a preferable lipid profile. Ibalizumab was also safe, well tolerated, and had been proven effective against multiple drug-resistant strains of viruses.
- |||||||||| 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
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