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Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial.
- Source :
-
The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2018 Mar 01; Vol. 73 (3), pp. 738-747. - Publication Year :
- 2018
-
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).<br />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).<br />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.<br />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.
- Subjects :
- Adult
Anti-Retroviral Agents therapeutic use
CD4 Lymphocyte Count
Drug Administration Schedule
Drug Therapy, Combination
Female
HIV Infections virology
Humans
Longitudinal Studies
Male
Middle Aged
Quality of Life
RNA, Viral blood
Reverse Transcriptase Inhibitors therapeutic use
Treatment Outcome
Viral Load drug effects
Anti-Retroviral Agents administration & dosage
HIV Infections drug therapy
HIV-1 drug effects
Reverse Transcriptase Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1460-2091
- Volume :
- 73
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- The Journal of antimicrobial chemotherapy
- Publication Type :
- Academic Journal
- Accession number :
- 29186458
- Full Text :
- https://doi.org/10.1093/jac/dkx434