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Dolutegravir monotherapy versus dolutegravir/abacavir/lamivudine for virologically suppressed people living with chronic HIV infection: the randomized non-inferiority MONCAY trial.

BACKGROUND
We investigated whether dolutegravir monotherapy was able to maintain virological suppression in people living with HIV on a successful dolutegravir-based triple-therapy.


METHODS
MONCAY was a 48-week multicentric, randomized, open-label, 12% non-inferiority margin trial. Patients with CD4 nadir>100/μL, plasma HIV-1 RNA <50 copies/mL for ≥12 months and stable regimen with dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) were 1:1 randomized to continue their regimen or to DTG monotherapy. The primary endpoint was the proportion of patients with HIV RNA <50 copies/mL at week (W) 24 in intention-to-treat (ITT) snapshot analysis. Virologic failure (VF) was defined as two consecutive HIV-RNA >50 copies/mL within 2 weeks apart.


RESULTS
Seventy-eight patients were assigned to DTG monotherapy and 80 to continue DTG/ABC/3TC. By W24, two patients in DTG group experienced VF without resistance to the INSTI class; one patient discontinued DTG/ABC/3TC due to adverse event. The success rate at W24 was 73/78 (93.6%) in the DTG arm and 77/80 (96.3%) in the DTG/ABC/3TC arm; difference 2.7%, 95% CI: -5.0 to 10.8. During subsequent follow-up, five additional VF occurred in the DTG arm (two of which harbored emerging resistance mutation to INSTI). The cumulative incidence of VF at W48 was 9.7% (95% CI: 2.8 to 16.6) in the DTG arm compared with 0% in the DTG/ABC/3TC arm (p=0.005, by the log-rank test). The DSMB recommended to re-intensify the DTG arm with standardized triple-therapy.


CONCLUSIONS
Because the risk of virological failure with resistance increases overtime, we recommend avoiding dolutegravir monotherapy as a maintenance strategy among people living with chronic HIV infection.