Lancet (new data): Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on biktarvy: 48-week results of a PH 3, multicentre, randomised, controlled, double-blind, non-inferiority trial

This phase 3, randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of switching virologically suppressed adults with HIV‑1 from a bictegravir, emtricitabine, and tenofovir alafenamide regimen to a fixed-dose, once-daily single-tablet combination of doravirine (100 mg) and islatravir (0.25 mg). The study was conducted at 49 sites across six countries and included adults with sustained viral suppression and no prior treatment failure or resistance to doravirine.

Participants were randomized 2:1 to either switch to doravirine/islatravir or continue their baseline regimen for 48 weeks. The primary endpoint was the proportion of participants with HIV‑1 RNA ≥50 copies/mL at week 48.

At week 48, doravirine and islatravir demonstrated non-inferiority to bictegravir, emtricitabine, and tenofovir alafenamide, with low and comparable rates of virologic failure between groups. Safety outcomes, including overall adverse events, treatment-related adverse events, serious adverse events, and discontinuations due to adverse events, were similar across both treatment arms, and no deaths were reported.

Overall, doravirine and islatravir showed efficacy and safety comparable to the standard three-drug regimen and may offer a two-drug, once-daily, oral single-tablet treatment option without an integrase strand-transfer inhibitor for virologically suppressed adults seeking to switch antiretroviral therapy.

Additional information to the following link: Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on bictegravir, emtricitabine, and tenofovir alafenamide: 48-week results of a phase 3, multicentre, randomised, controlled, double-blind, non-inferiority trial - The Lancet