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A phase 3 international trial published in The Lancet HIV evaluated a two-drug, once-daily tablet for initial treatment of HIV-1. Led by Jurgen Rockstroh, the study compared a fixed-dose combination of doravirine and islatravir with bictegravir, emtricitabine, and tenofovir alafenamide, an established first-line regimen.
The randomized, double-blind, noninferiority trial enrolled treatment-naive adults at 116 clinics across 20 countries and assigned participants in equal numbers to the two once-daily regimens. The primary endpoint was the proportion of participants with HIV-1 RNA below 50 copies per milliliter at week 48, using a prespecified noninferiority margin of 10 percentage points.
At week 48, doravirine and islatravir met the trial's noninferiority criterion compared with the three-drug regimen. Viral suppression rates and overall safety findings were similar between groups. Treatment-related adverse events occurred in 14 percent of participants receiving doravirine and islatravir and 18 percent of participants receiving the comparator. The combination used in the study included a lower islatravir dose than an earlier version of the regimen after reductions in immune cell counts were observed at higher doses.
The findings may be relevant to managed care because the comparator is widely used as a first-line HIV therapy in the United States. If approved or adopted in practice, an additional two-drug option could be considered in formulary design and preferred-agent decisions. The authors described doravirine and islatravir as a two-drug, once-daily regimen with efficacy and safety findings similar to the three-drug comparator.
