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J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial.

Author information

1
Hôpitaux Universitaires Paris-Ile de France-Ouest, Hôpital Raymond Poincaré APHP, Garches, Université Versailles-Saint-Quentin, France.
2
Sorbonne Universités, INSERM, UPMC Université Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France.
3
Institut de Médecine et Epidémiologie Appliquée, Hôpital Bichat, Université Paris 7, Paris, France.
4
IAME, UMR 1137, Université Paris Diderot, Sorbonne Paris Cité, AP-HP, Hôpital Bichat-Claude Bernard, Service de Maladies Infectieuses et Tropicales, Paris, France.
5
APHP, Hôpital Pitié-Salpétrière, Service Maladies Infectieuses et Tropicales, Paris, France.
6
Centre Hospitalier Universitaire Bretonneau, Tours, France.
7
APHP, Centre Hospitalier Universitaire Avicenne, APHP, Bobigny 93, France.
8
Université Paris Sorbonne-Diderot, EA 7334, APHP Hotel-Dieu, URC-ECO, Paris, France.
9
APHP Hôpital R Poincaré, Département de Pharmacologie, Inserm U-1173, Université Paris-Ile de France Ouest, Garches 92, France.
10
INSERM U1043/CNRS5282, Université de Toulouse, CHU Purpan, Toulouse, France.
11
INSERM-ANRS, Agence Nationale pour la Recherche sur le Sida et les Hépatites, Paris, France.
12
APHP, Hôpital Saint Antoine, Service Maladies Infectieuses, Paris, France.

Abstract

Background:

Intermittent treatment could improve the convenience, tolerability and cost of ART, as well as patients' quality of life. We conducted a 48 week multicentre study of a 4-days-a-week antiretroviral regimen in adults with controlled HIV-1-RNA plasma viral load (VL).

Methods:

Eligible patients were adults with VL < 50 copies/mL for at least 1 year on triple therapy with a ritonavir-boosted PI (PI/r) or an NNRTI. The study protocol consisted of the same regimen taken on four consecutive days per week followed by a 3 day drug interruption. The primary outcome was the proportion of participants remaining in the strategy with VL < 50 copies/mL up to week 48. The study was designed to show an observed success rate of > 90%, with a power of 87% and a 5% type 1 error. The study was registered with ClinicalTrials.gov (NCT02157311) and EudraCT (2014-000146-29).

Results:

One hundred patients (82 men), median age 47 years (IQR 40-53), were included. They had been receiving ART for a median of 5.1 (IQR 2.9-9.3) years and had a median CD4 cell count of 665 (IQR 543-829) cells/mm3. The ongoing regimen included PI/r in 29 cases and NNRTI in 71 cases. At 48 weeks, 96% of participants (95% CI 90%-98%) had no failure while remaining on the 4-days-a-week regimen. Virological failure occurred in three participants, who all resumed daily treatment and became resuppressed. One participant stopped the strategy. No severe treatment-related events occurred.

Conclusions:

Antiretroviral maintenance therapy 4 days a week was effective for 48 weeks in 96% of patients, leading to potential reduction of long-term toxicities, high adherence to the antiretroviral regimen and drug cost saving.

PMID:
29186458
DOI:
10.1093/jac/dkx434
[Indexed for MEDLINE]

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