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

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). Eligible patients were adults...

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Published in:Journal of antimicrobial chemotherapy Vol. 73; no. 3; p. 738
Main Authors: de Truchis, Pierre, Assoumou, Lambert, Landman, Roland, Mathez, Dominique, Le Dû, Damien, Bellet, Jonathan, Amat, Karine, Katlama, Christine, Gras, Guillaume, Bouchaud, Olivier, Duracinsky, Martin, Abe, Emuri, Alvarez, Jean-Claude, Izopet, Jacques, Saillard, Juliette, Melchior, Jean-Claude, Leibowitch, Jacques, Costagliola, Dominique, Girard, Pierre-Marie, Perronne, Christian
Format: Journal Article
Language:English
Published: England 01.03.2018
Subjects:
Adult
Anti-Retroviral Agents - administration & dosage
Anti-Retroviral Agents - therapeutic use
CD4 Lymphocyte Count
Drug Administration Schedule
Drug Therapy, Combination
Female
HIV Infections - drug therapy
HIV Infections - virology
HIV-1 - drug effects
Humans
Longitudinal Studies
Male
Middle Aged
Quality of Life
Reverse Transcriptase Inhibitors - administration & dosage
Reverse Transcriptase Inhibitors - therapeutic use
RNA, Viral - blood
Treatment Outcome
Viral Load - drug effects
ISSN:1460-2091, 1460-2091
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Summary: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). 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). 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. 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.
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ISSN:1460-2091
1460-2091
DOI:10.1093/jac/dkx434