Abstract
To evaluate if switching from dolutegravir/lamivudine (DTG/3TC) to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) improves neuropsychiatric tolerability in suppressed adults with stable neuropsychiatric comorbidities.
Methods
MIND was a phase IV, randomised, double-blind, multicentre trial. Participants were assigned (1:1) to switch to BIC/FTC/TAF or continue DTG/3TC. The primary endpoint was the proportion of grade 2-4 neuropsychiatric adverse events (NP-AEs) at week 24. Secondary endpoints included safety, virological maintenance, and patient-reported outcomes (PROs) through week 48.
Results
Eighty participants were randomised (BIC/FTC/TAF, n = 41; DTG/3TC, n = 39). At week 24, grade 2-4 NP-AEs occurred in 14.6% of the BIC/FTC/TAF arm vs 17.9% in the DTG/3TC group (difference: 3.3% [95%CI –19.5 to 12.9]; P = 0.688). At week 48, incidences were 21.9% vs 17.9% (difference: 4.0% [95%CI –13.5 to 21.5]; P = 0.650). NP-AE–related discontinuations were low (7.3% vs 5.1%). At week 24, BIC/FTC/TAF showed less moderate-to-severe nausea/vomiting (3.8% vs 23.2%; P = 0.027) and abdominal discomfort (16.8% vs 40.2%; P = 0.04). At week 48, BIC/FTC/TAF reported more headache (55.7% vs 26.1%; P = 0.03) but fewer skin symptoms (24.9% vs 49.2%; P = 0.022). All maintained virological suppression at week 48; four participants on DTG/3TC met failure criteria but achieved re-suppression without emergent resistance. PRO trajectories and treatment satisfaction remained high and stable throughout the study, with no significant between-group differences.
Conclusions
In PLWH with stable neuropsychiatric comorbidities, switching to BIC/FTC/TAF did not reduce NP-AEs or improve PROs versus continuing DTG/3TC. Both regimens were safe and highly effective at maintaining virological suppression through 48 weeks.
Référence : Perez-Valero, I., & al., International Journal of Antimicrobial Agents, avril 2026
