Fixed-dose daily doravirine (100 mg) with islatravir (0·25 mg) versus bictegravir, emtricitabine, and tenofovir alafenamide for initial HIV-1 therapy: 48-week results of a phase 3, randomised, control
6 hours ago
- #doravirine-islatravir
- #HIV-1 treatment
- #non-inferiority trial
- The study compared the efficacy and safety of a two-drug regimen (doravirine and islatravir) versus a three-drug regimen (bictegravir, emtricitabine, and tenofovir alafenamide) for initial HIV-1 treatment in treatment-naive adults.
- At 48 weeks, doravirine-islatravir was non-inferior to bictegravir-emtricitabine-tenofovir, with 91.8% vs. 90.6% of participants achieving HIV-1 RNA <50 copies/mL.
- Mean CD4 count increases were similar between groups: 218 cells/μL (doravirine-islatravir) vs. 226 cells/μL (bictegravir-emtricitabine-tenofovir).
- Treatment-emergent mutations occurred in a small number of participants with high baseline HIV-1 RNA and low CD4 counts, with phenotypic resistance to doravirine observed in two cases.
- Common adverse events included weight gain, headache, and dizziness in the doravirine-islatravir group, and weight gain, headache, and decreased eGFR in the bictegravir-emtricitabine-tenofovir group.
- The study suggests that doravirine-islatravir could provide an effective, once-daily, two-drug option for initial HIV-1 treatment without an integrase strand transfer inhibitor.