Coralie Briand1, Catherine Dollfus2, Albert Faye3,4, Elie Kantor5, Véronique Avettand-Fenoel6,7, Marion Caseris3, Diane Descamps8,9, Véronique Schneider10, Marie-Dominique Tabone2, Geneviève Vaudre2, Florence Veber1, Stéphane Blanche1,11, Pierre Frange1,5,6. 1. Unité d'Immunologie, Hématologie et Rhumatologie Pediatriques, Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Universitaire Necker - Enfants Malades, Paris, France. 2. Service d'Hématologie et Oncologie Pédiatrique, AP-HP, Hôpital Trousseau, Paris, France. 3. Service de Pédiatrie Générale, AP-HP, Hôpital Robert Debré, Paris, France. 4. Université Paris Diderot, Sorbonne Paris Cité, INSERM 1123 (ECEVE), Paris, France. 5. Département d'Anesthésiologie, AP-HP, Hôpital Bichat - Claude Bernard, Paris, France. 6. Laboratoire de Microbiologie Clinique, AP-HP, Hôpital Universitaire Necker - Enfants Malades, Paris, France. 7. EA 7327, Université Paris Descartes, Sorbonne Paris Cité, Paris, France. 8. Laboratoire de Virologie, AP-HP, Hôpital Bichat - Claude Bernard, F-75018 Paris, France. 9. IAME, INSERM UMR1137, Université Paris Diderot, Sorbonne Paris Cité, Paris, France. 10. Laboratoire de Virologie, AP-HP, Hôpital Tenon, Paris, France. 11. EA 7323, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Abstract
Objectives: To assess the safety and efficacy of a dolutegravir-based regimen in perinatally HIV-1-infected adolescents. Patients and methods: We conducted a retrospective multicentre study of 50 adolescents beginning dolutegravir-based treatment regimens between January 2014 and December 2015. Clinical and biological data collected before and after dolutegravir initiation were analysed. The primary endpoint was the proportion of patients achieving a plasma viral load (PVL) <50 copies/mL within 3 months of dolutegravir initiation (for patients with detectable viraemia at baseline) and maintaining virological suppression (PVL <50 copies/mL) until the last follow-up visit (for all patients). Results: Virological suppression was noted for 17/50 adolescents at baseline. Dolutegravir-based regimens maintained virological success in 14/17 patients (82%). The other three patients experienced a transient viral rebound, before PVL fell to < 50 copies/mL again, with no need to change the antiretroviral regimen. Thirty-three viraemic adolescents were enrolled. All but one had already received antiretroviral drugs. Virological success was achieved and maintained in 19/33 subjects (58%). Another three adolescents with initial virological failure had an undetectable PVL at the end of follow-up, with reinforced measures to improve compliance. Overall, sustained virological success was observed in 66% of patients and 78% of patients had an undetectable PVL at the last visit. Dolutegravir was well tolerated. Only one patient stopped treatment for severe drug-related adverse effects (dizziness and sleep disturbance). No emergence of resistance mutations was observed in patients with virological failure. Conclusions: Dolutegravir was safe and virologically effective in these patients, for whom multiple interventions were required to improve compliance.
Objectives: To assess the safety and efficacy of a dolutegravir-based regimen in perinatally HIV-1-infected adolescents. Patients and methods: We conducted a retrospective multicentre study of 50 adolescents beginning dolutegravir-based treatment regimens between January 2014 and December 2015. Clinical and biological data collected before and after dolutegravir initiation were analysed. The primary endpoint was the proportion of patients achieving a plasma viral load (PVL) <50 copies/mL within 3 months of dolutegravir initiation (for patients with detectable viraemia at baseline) and maintaining virological suppression (PVL <50 copies/mL) until the last follow-up visit (for all patients). Results: Virological suppression was noted for 17/50 adolescents at baseline. Dolutegravir-based regimens maintained virological success in 14/17 patients (82%). The other three patients experienced a transient viral rebound, before PVL fell to < 50 copies/mL again, with no need to change the antiretroviral regimen. Thirty-three viraemic adolescents were enrolled. All but one had already received antiretroviral drugs. Virological success was achieved and maintained in 19/33 subjects (58%). Another three adolescents with initial virological failure had an undetectable PVL at the end of follow-up, with reinforced measures to improve compliance. Overall, sustained virological success was observed in 66% of patients and 78% of patients had an undetectable PVL at the last visit. Dolutegravir was well tolerated. Only one patient stopped treatment for severe drug-related adverse effects (dizziness and sleep disturbance). No emergence of resistance mutations was observed in patients with virological failure. Conclusions: Dolutegravir was safe and virologically effective in these patients, for whom multiple interventions were required to improve compliance.
Authors: Ana R Pascom; Rosana Egg Pinho; Fernanda Rick; Nazle Mc Veras; Filipe de Barros Perini; Mariana V Meireles; Gerson F Pereira; Adele S Benzaken; Vivian I Avelino-Silva Journal: J Int AIDS Soc Date: 2019-11 Impact factor: 5.396