Pierre de Truchis1, Lambert Assoumou2, Roland Landman3,4, Dominique Mathez1, Damien Le Dû1, Jonathan Bellet2, Karine Amat3, Christine Katlama2,5, Guillaume Gras6, Olivier Bouchaud7, Martin Duracinsky8, Emuri Abe9, Jean-Claude Alvarez9, Jacques Izopet10, Juliette Saillard11, Jean-Claude Melchior1, Jacques Leibowitch1, Dominique Costagliola2, Pierre-Marie Girard2,3,12, Christian Perronne1. 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.
RCT Entities:
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.