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).
Romain Palich, Minh P Lê, Antonella Castagna et al.
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In 30 seconds
DORAL was a multicentre, open-label, randomized phase II trial in virologically suppressed adults with HIV-1 on stable antiretroviral therapy, without prior doravirine exposure or raltegravir resistance. Participants switched immediately to once-daily doravirine plus raltegravir or continued baseline therapy before a delayed switch. By week 48, virological failure occurred in one participant in the immediate-switch group (1.3%; 95% CI, 0.0-6.9) and none in the delayed-switch group; no additional failures occurred through week 96. Immune measures remained stable, while three treatment-related adverse events led to discontinuation.
Key findings
- At week 48, virological failure occurred in 1.3% of the immediate-switch group (95% CI, 0.0-6.9) and in none of the delayed-switch group.
- No additional virological failures occurred through week 96, and immunological parameters remained stable during follow-up.
- Three adverse events considered related to doravirine and raltegravir led to treatment discontinuation; one related grade 3 event was reported.
Why it matters
A two-drug switch regimen may offer an alternative for selected people with sustained viral suppression when reducing drug–drug interactions or avoiding NRTI exposure is a priority. The trial provides preliminary evidence on virological control and tolerability, while its phase II, proof-of-concept design means the findings should be interpreted as support for feasibility rather than definitive comparative evidence.
What to keep in mind
This was a phase II proof-of-concept trial in selected, virologically suppressed adults; the abstract does not report a powered comparison establishing equivalence or superiority to continued baseline therapy.