- Design
- Phase 2, randomised, open-label switch trial
- Population
- 114 virologically suppressed adults with HIV-1 in France, Italy and Spain
- Primary outcome
- Virological failure at week 48
- Effect
- 1.3% (95% CI 0.0–6.9) in the immediate-switch group; none in the delayed group
DORAL was an open-label phase 2 trial in France, Italy and Spain. It randomised 114 adults with long-standing HIV suppression (median ten years), no raltegravir resistance and no prior doravirine, to switch at once to doravirine 100 mg plus raltegravir 1,200 mg once daily, or to switch after 48 weeks.
One person in the immediate-switch group had virological failure by week 48 (1.3%, 95% CI 0.0–6.9), and none after that through week 96. CD4 counts stayed stable. Three people stopped because of side effects judged related to treatment.
This two-drug regimen avoids nucleoside reverse transcriptase inhibitors and has few drug interactions. It is proof of concept, not a new standard, but it may help in selected patients with kidney or bone concerns or complex medication lists.
- Consider doravirine plus raltegravir only for stably suppressed patients without raltegravir resistance.
- It may suit patients where nucleoside drugs or drug interactions are a problem.
- Check resistance history before any two-drug switch.
- Monitor viral load closely after switching; this is phase 2 evidence.
Why it matters
It widens the options for patients who cannot take nucleoside backbones.
Don't overread it
This is a small phase 2 trial; it does not show non-inferiority to standard three-drug therapy.
The statistics, in plain English
One failure in about 76 switched patients gives an upper confidence limit near 7%, so a failure rate of several per cent cannot be excluded. A trial this size shows feasibility, not equivalence to standard regimens.
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