doravirine/islatravir (MK-8591A) / Merck (MSD) 
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  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
    Preclinical, Journal:  Combined doravirine and islatravir cooperate to inhibit NRTI and NNRTI resistant HIV-1 in vitro. (Pubmed Central) -  May 30, 2025   
    MuSyC scores showed a negative correlation with doravirine FC values, number of NRTI mutations and presence of M184V/I, but not with islatravir FC values. Doravirine and islatravir may cooperatively inhibit NRTI and NNRTI resistant viruses despite complex mutational profiles, however the accumulation of resistance mutations may reduce the combinatorial activity.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Switching to Doravirine/Islatravir (100 mg/0.25 mg) once daily maintained viral suppression in the presence of archived M184I/V resistance-associated mutations in proviral DNA () -  May 10, 2025 - Abstract #IASHIV2025IAS_HIV_646;    
    P3
    BACKGROUND: In three Phase 3 studies (P051: NCT05631093; P052: NCT05630755; P054: NCT05766501) virologic suppression was maintained in people living with HIV who switched to doravirine/islatravir (DOR/ISL 100 mg/0.25 mg); 2 studies (P051 and P052) were comparative and demonstrated noninferiority to baseline antiretroviral therapy (bART) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Switching to DOR/ISL 100 mg/0.25 mg in Phase 3 clinical studies maintained viral suppression for at least 48 weeks in the presence of preexisting M184I/V in proviral DNA.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Switch to DOR/ISL (100/0.25 mg) QD From Oral ART: An Open-Label Phase III Study in Adults With HIV-1 (San Francisco Ballroom B) -  Mar 3, 2025 - Abstract #CROI2025CROI_332;    
    P3
    MK-8591A-051 is a phase 3 study evaluating the efficacy and safety of switching from oral ART to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen...Conclusions Switching to DOR/ISL (100/0.25 mg) maintained viral suppression and was non-inferior to continuing bART at week 48. DOR/ISL was well tolerated with a similar safety profile to bART and did not adversely affect lymphocytes.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Review, Journal:  Doravirine/Islatravir for the treatment of HIV. (Pubmed Central) -  Jan 3, 2025   
    ISL doses as low as 0.25?mg proved non-inferior to current treatments. Therefore, evaluation of the long-term efficacy and safety of DOR/ISL should focus on reduced doses of ISL and minimizing CD4 reduction.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Enrollment closed:  DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) -  Oct 21, 2024   
    P3,  N=500, Active, not recruiting, 
    Therefore, evaluation of the long-term efficacy and safety of DOR/ISL should focus on reduced doses of ISL and minimizing CD4 reduction. Recruiting --> Active, not recruiting
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Trial completion date:  DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) -  Sep 20, 2024   
    P3,  N=500, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Nov 2026 --> Aug 2029
  • ||||||||||  Journal:  Challenges for novel antiretroviral development in an era of widespread TLD availability. (Pubmed Central) -  Jul 11, 2024   
    We illustrate when generic TLD will become available worldwide and compare this with trial programmes and approval timelines for two case-study novel ART combinations: islatravir/doravirine and cabotegravir/rilpivirine. We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD.
  • ||||||||||  P3 data, Journal, Head-to-Head:  Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) -  May 30, 2024   
    P3
    We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD. Switching to daily doravirine (100 mg) and islatravir (0
  • ||||||||||  Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
    P3 data, Journal, Head-to-Head:  Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) -  May 30, 2024   
    P3
    Switching to daily doravirine (100 mg) and islatravir (0 Switching to single-tablet doravirine (100 mg) and islatravir (0
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Switching to Doravirine/Islatravir Maintains Viral Suppression Regardless of Archived Mutations (Poster hall) -  Mar 16, 2024 - Abstract #CROI2024CROI_1304;    
    P3
    Background: In 2 phase 3 clinical trials, switching to the 2-drug combination doravirine/islatravir (DOR/ISL) 100/0.75mg was non-inferior to continuing the prior antiretroviral (ART) regimen. Switching to DOR/ISL 100/0.75mg maintains viral suppression for up to 96 weeks regardless of archived M184I/V or NNRTI RAMs in proviral DNA.
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Trial completion date, Trial primary completion date:  DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) -  Aug 18, 2023   
    P3,  N=500, Recruiting, 
    Decreases in cell counts accounted for many treatment-related AEs and discontinuations due to AEs with DOR/ISL. Trial completion date: Jul 2026 --> Nov 2026 | Trial primary completion date: Mar 2025 --> Oct 2025
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    Enrollment open:  DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) -  Mar 16, 2023   
    P3,  N=500, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  doravirine/islatravir (MK-8591A) / Merck (MSD)
    New P3 trial:  DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) -  Jan 30, 2023   
    P3,  N=500, Not yet recruiting,