Format

Send to

Choose Destination
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.

Author information

1
Service des Maladies Infectieuses et Tropicales, CHR d'Orléans - La Source, Orléans, France.
2
Service des Maladies Infectieuses, CHU Hôtel Dieu and INSERM UIC 1413 Nantes University, Nantes, France.
3
Service des Maladies Infectieuses, CHU Bretonneau, Tours, France.
4
Service des Maladies Infectieuses et Tropicales, CHG de Niort, Niort, France.
5
Service des Maladies Infectieuses, CHD de Vendée, La Roche-sur-Yon, France.
6
Le Trait d'Union, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
7
Service des Maladies Infectieuses, CHU La Milétrie, Poitiers, France.
8
Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle - Ré - Aunis, La Rochelle, France.
9
Service des Maladies Infectieuses, CHRU-Brabois, Nancy, France.
10
Département d'Informatique Médicale, CHR d'Orléans - La Source, Orléans, France.
11
Laboratoire de Microbiologie clinique, CHU Necker and Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
12
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.

Abstract

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.

PMID:
30601976
DOI:
10.1093/cid/ciy1132

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center