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Clin Infect Dis. 2019 Jan 2. doi: 10.1093/cid/ciy1132. [Epub ahead of print]

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

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Service des Maladies Infectieuses et Tropicales, CHR d'Orléans - La Source, Orléans, France.
Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Nantes, France.
Service des Maladies Infectieuses, CHU Bretonneau, Tours, France.
Service des Maladies Infectieuses et Tropicales, CHG de Niort, Niort, France.
Service des Maladies Infectieuses, CHD de Vendée, La Roche-sur-Yon, France.
Le Trait d'Union, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
Service des Maladies Infectieuses, CHU La Milétrie, Poitiers, France.
Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle - Ré - Aunis, La Rochelle, France.
Service des Maladies Infectieuses, CHRU-Brabois, Nancy, France.
Département d'Informatique Médicale, CHR d'Orléans - La Source, Orléans, France.
Laboratoire de Microbiologie clinique, CHU Necker and Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Unité de Biostatistique et de Recherche Clinique, CHU de Caen; EA2656 Groupe de Recherche sur l'Adaptation Microbienne (GRAM 2.0), Université Caen Normandie, Caen, France.



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


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.


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.


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.


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