[Articles] 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

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Source: The Lancet

Original: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01948-8/fullt...

Published: 2026-02-07

The study is a phase 3, multicenter, randomized, controlled, double-blind, non-inferiority trial in virologically suppressed adults with HIV-1 who switched from bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy) to fixed-dose doravirine (100 mg) and islatravir (0.25 mg) once daily. The primary endpoint was the 48-week results, where the combination of doravirine and islatravir demonstrated non-inferior virological suppression to Biktarva, with the percentage of patients with HIV-1 RNA ≥50 copies/mL below the non-inferiority threshold of 4%. The combination was safe and highly effective in patients previously suppressed by Biktarva. It is a two-drug, once-a-day oral tablet without an integrase inhibitor, suitable for adults who want to switch antiretroviral therapy. Doravirine is an approved anti-HIV drug, islatravir belongs to a new class of nucleoside reverse transcriptase translocation inhibitors. In patients with HIV and HBV co-infection, there was no reactivation of HBV or elevation of liver enzymes.