Efficacy and safety of switching to once-daily oral doravirine plus raltegravir in virologically suppressed people with HIV-1: a randomized, open-label, multicentre phase 2 study (DORAL)

We evaluated the efficacy and safety of a once-daily oral two-drug regimen (2DR) combining doravirine and raltegravir in virologically suppressed people with HIV (PWH).

DORAL is a multicentre, open-label, randomized phase II trial conducted in France, Italy, and Spain. Virologically suppressed adults receiving stable antiretroviral therapy (ART), naïve to doravirine and without raltegravir resistance, were randomized (2:1) either to switch immediately to doravirine (100 mg) plus raltegravir (1200 mg) or to continue baseline ART until week 48 before switching to doravirine plus raltegravir. The primary endpoint was virological failure (VF; confirmed plasma HIV-1-RNA ≥50 copies/mL) at week 48. Secondary endpoints included maintenance of virological suppression through W96, immunological outcomes, safety, and pharmacokinetics in a genital sub-study.