- Design
- Phase 2, randomised 2:1, open-label, multicentre
- Population
- 114 virologically suppressed adults with HIV-1
- Primary outcome
- Virological failure (HIV-1 RNA 50 copies/mL or more) at week 48
- Effect
- 1.3% (95% CI 0.0 to 6.9) immediate switch; none in delayed switch; none more to week 96
DORAL was a phase 2, open-label randomised trial in France, Italy and Spain. It enrolled 114 adults with HIV who had been virologically suppressed for a median of 10 years, with no raltegravir resistance and no prior doravirine. They switched 2:1 to once-daily doravirine 100 mg plus raltegravir 1,200 mg either immediately or after 48 weeks on their existing regimen.
One virological failure occurred by week 48 in the immediate-switch group (1.3%, 95% CI 0.0 to 6.9) and none in the delayed group, with no further failures to week 96. CD4 counts stayed stable. Three participants stopped because of adverse events linked to the regimen. Drug concentrations in genital fluid were mostly above inhibitory levels.
This is a regimen without a nucleoside reverse transcriptase inhibitor and with few drug interactions, which matters for older patients on many medicines. But it is a small phase 2 study in long-suppressed patients, and doravirine availability in India is not established. It does not change standard regimens.
- Consider this regimen only for selected long-suppressed patients where avoiding NRTIs or interactions is a priority.
- Confirm no prior raltegravir resistance and no NNRTI resistance before any such switch.
- Monitor viral load closely after any two-drug switch.
- Standard dolutegravir-based regimens remain the default.
Why it matters
Older people with HIV increasingly need regimens chosen for what they avoid, not just for potency.
Don't overread it
A 114-person phase 2 trial cannot establish non-inferiority to standard therapy.
The statistics, in plain English
One failure in about 76 patients gives a point estimate of 1.3%, but the upper confidence limit of 6.9% means the true failure rate could be several times higher. Only a larger trial can narrow that.
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