Switch to fixed-dose doravirine (100 mg) and islatravir (0·25 mg) once daily in virologically suppressed adults with HIV-1 on oral antiretroviral therapy: 48-week results of a phase 3, multicentre, ra

3 months ago

The study evaluated switching to a fixed-dose combination of doravirine (100 mg) and islatravir (0.25 mg) once daily in virologically suppressed adults with HIV-1.
This was a phase 3, randomized, open-label, non-inferiority trial conducted across 53 sites in eight countries.
Participants were adults with a viral load <50 copies/mL on stable ART for at least 3 months, with no history of treatment failure or resistance to doravirine.
The primary endpoint was the percentage of participants with viral load ≥50 copies/mL at week 48, assessed using the FDA snapshot approach.
Doravirine and islatravir demonstrated non-inferiority to baseline ART, with 1.4% vs. 4.9% of participants having viral loads ≥50 copies/mL at week 48.
Treatment-related adverse events were more common with doravirine and islatravir (12.0%) compared to baseline ART (4.9%).
Serious adverse events and discontinuation rates due to adverse events were similar between groups.
The regimen represents the first non-INSTI-based, two-drug option for HIV-1 treatment, addressing concerns about INSTI resistance.
The study supports the ongoing development of islatravir, which has long-acting potential.
Funding was provided by Merck Sharp & Dohme, a subsidiary of Merck & Co.

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