Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial - Archive ouverte HAL
Journal Articles Journal of Antimicrobial Chemotherapy Year : 2018

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

Pierre de Truchis (1) , Lambert Assoumou (2) , Roland Landman (3, 4) , Dominique Mathez (1) , Damien Le Dû (1) , Jonathan Bellet (2) , Karine Amat (3) , Christine Katlama (2, 5) , Guillaume Gras (6) , Olivier Bouchaud (7) , Martin Duracinsky (8) , Emuri Abe (9) , Jean-Claude Alvarez (9) , Jacques Izopet (10) , Juliette Saillard (11) , Jean-Claude Melchior (1) , Jacques Leibowitch (1) , Dominique Costagliola (2) , Pierre-Marie Girard (12, 2, 3) , Christian Perronne (1) , Anrs 162-4d Study Group , Irène Zamord , Cécile Goujard , Frédéric Fourreau , Véronique Joly , Bao Phung , Laurence Weiss , Lio Collias , Claire Rouzaud , Fatima Touam , Luminita Schneider , Stéphanie Landowski , Huguette Berthe , Karine Lacombe , Jean-Luc Meynard , Julie Chas , Pélagie Thibault , Arnaud de La Blanchardiere , Sylvie Dargère , Alain Devidas , Amélie Chabrol , Lionel Piroth , Sandrine Gohier , André Cabie , Mathilde Pircher , Jacques Reynes (13, 14) , Vincent Le Moing (13, 14) , David Zucman , Dominique Bornarel , Louis Bernard , Adrien Lemaignen , Pierre Delobel , Noemie Biezunski , Aida Benalicherif , Babacar Sylla , Severine Gibowski , Soizic Le Mestre , Jean-François Delfraissy
Pierre de Truchis
  • Function : Author
Hôpital Raymond Poincaré [AP-HP]
Lambert Assoumou
  • Function : Author
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Roland Landman
  • Function : Author
  • PersonId : 904788
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Infection, Anti-microbiens, Modélisation, Evolution
Dominique Mathez
  • Function : Author
Hôpital Raymond Poincaré [AP-HP]
Damien Le Dû
  • Function : Author
Hôpital Raymond Poincaré [AP-HP]
Jonathan Bellet
  • Function : Author
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Karine Amat
  • Function : Author
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Christine Katlama
  • Function : Author
Institut Pierre Louis d'Epidémiologie et de Santé Publique
CHU Pitié-Salpêtrière [AP-HP]
Guillaume Gras
  • Function : Author
Hôpital Bretonneau
Olivier Bouchaud
  • Function : Author
  • PersonId : 948528
Hôpital Avicenne [AP-HP]
Martin Duracinsky
  • Function : Author
  • PersonId : 969636
Recherche Clinique ville-hôpital, Méthodologies et Société
Emuri Abe
  • Function : Author
Infection et inflammation
Jean-Claude Alvarez
  • Function : Author
Infection et inflammation
Jacques Izopet
Centre de Physiopathologie Toulouse Purpan
Juliette Saillard
  • Function : Author
ANRS France Recherche Nord & sud Sida-hiv hépatites
Jean-Claude Melchior
  • Function : Author
Hôpital Raymond Poincaré [AP-HP]
Jacques Leibowitch
  • Function : Author
Hôpital Raymond Poincaré [AP-HP]
Dominique Costagliola
  • Function : Author
Institut Pierre Louis d'Epidémiologie et de Santé Publique
Pierre-Marie Girard
  • Function : Author
CHU Saint-Antoine [AP-HP]
Institut Pierre Louis d'Epidémiologie et de Santé Publique
AP-HP - Hôpital Bichat - Claude Bernard [Paris]
Christian Perronne
  • Function : Author
  • PersonId : 1013954
Hôpital Raymond Poincaré [AP-HP]
Anrs 162-4d Study Group
  • Function : Author
Irène Zamord
  • Function : Contributor
Cécile Goujard
  • Function : Contributor
Frédéric Fourreau
  • Function : Contributor
Véronique Joly
  • Function : Contributor
Bao Phung
  • Function : Contributor
Laurence Weiss
  • Function : Contributor
Lio Collias
  • Function : Contributor
Claire Rouzaud
  • Function : Contributor
Fatima Touam
  • Function : Contributor
Luminita Schneider
  • Function : Contributor
Stéphanie Landowski
  • Function : Contributor
Huguette Berthe
  • Function : Contributor
Karine Lacombe
Jean-Luc Meynard
  • Function : Contributor
Julie Chas
  • Function : Contributor
Pélagie Thibault
  • Function : Contributor
Arnaud de La Blanchardiere
  • Function : Contributor
Sylvie Dargère
  • Function : Contributor
Alain Devidas
  • Function : Contributor
Amélie Chabrol
  • Function : Contributor
Lionel Piroth
  • Function : Contributor
  • PersonId : 1136581
Sandrine Gohier
  • Function : Contributor
André Cabie
Mathilde Pircher
  • Function : Contributor
Jacques Reynes
  • Function : Contributor
Centre Hospitalier Régional Universitaire [Montpellier]
Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes
Vincent Le Moing
  • Function : Contributor
Centre Hospitalier Régional Universitaire [Montpellier]
Recherches Translationnelles sur le VIH et les maladies infectieuses endémiques et émergentes
David Zucman
Dominique Bornarel
  • Function : Contributor
Louis Bernard
  • Function : Contributor
Adrien Lemaignen
  • Function : Contributor
Pierre Delobel
  • Function : Contributor
Noemie Biezunski
  • Function : Contributor
Aida Benalicherif
  • Function : Contributor
Babacar Sylla
  • Function : Contributor
Severine Gibowski
  • Function : Contributor
Soizic Le Mestre
  • Function : Contributor
Jean-François Delfraissy
  • Function : Contributor

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.

Domains

Infectious diseases Microbiology and Parasitology Pharmacology

Anthony Herrada  : Connect in order to contact the contributor

https://hal.science/hal-01740290

Submitted on : Wednesday, March 21, 2018-5:50:40 PM

Last modification on : Thursday, November 7, 2024-2:21:47 PM

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hal-01740290 , version 1 (21-03-2018)

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Pierre de Truchis, Lambert Assoumou, Roland Landman, Dominique Mathez, Damien Le Dû, et al.. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. Journal of Antimicrobial Chemotherapy, 2018, 73 (3), pp.738 - 747. ⟨10.1093/jac/dkx434⟩. ⟨hal-01740290⟩

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