Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients

To assess the safety and efficacy of rilpivirine in combination with emtricitabine and tenofovir (RPV/FTC/TDF) as a once-daily single-tablet regimen (STR) in HIV-1-infected children and adolescents we performed a multicenter case series study of HIV-1-infected patients. Inclusion criteria were initi...

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Detalles Bibliográficos
Autores: Falcon-Neyra, Lola, Palladino, Claudia, Navarro Gómez, María Luisa, Soler-Palacín, Pere|||0000-0002-0346-5570, González-Tomé, María Isabel, De Ory, Santiago J., Frick, Marie Antoinette|||0000-0002-2553-5090, Fortuny Guasch, Claudia, Noguera-Julian, Antoni|||0000-0001-7485-0583, Moreno, Elena Bermúdez, Santos, Juan Luis, Olbrich, Peter, López Cortés, Luis Fernando|||0000-0002-3804-3458, Briz, Verónica|||0000-0003-2297-5098, Neth, Olaf|||0000-0001-5018-0466
Tipo de recurso: artículo
Fecha de publicación:2016
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:185901
Acceso en línea:https://ddd.uab.cat/record/185901
https://dx.doi.org/urn:doi:10.1097/MD.0000000000003842
Access Level:acceso abierto
Palabra clave:Adolescents
Antiretroviral therapy
Children
HIV-1
Rilpivirine
Descripción
Sumario:To assess the safety and efficacy of rilpivirine in combination with emtricitabine and tenofovir (RPV/FTC/TDF) as a once-daily single-tablet regimen (STR) in HIV-1-infected children and adolescents we performed a multicenter case series study of HIV-1-infected patients. Inclusion criteria were initiation of therapy with RPV/FTC/TDF before the age of 18. Patients were divided into undetectable viral load (uVL) group, HIV-1 RNA < 20 copies/mL on stable combined antiretroviral therapy (cART), and detectable viral load (dVL) group, HIV-1 RNA ≥ 20 copies/mL at RPV/FTC/TDF initiation. Patients were monitored from the date of RPV/FTC/TDF initiation until June 30, 2015, RPV/FTC/TDF discontinuation or failure to follow-up. Seventeen patients (8 in uVL and 9 in dVL group) with age between 11.6 and 17.6 were included. Reasons for switching were toxicity (n = 4) and simplification (n = 4) in uVL; viral failure (n = 8) and cART initiation (n = 1) in the dVL group. After a median follow-up of 90 (uVL) and 40 weeks (dVL), 7/8 (86%) patients maintained and 8/9 (89%) achieved and maintained HIV-1 suppression. Median CD4 count increased from 542 to 780/μL (uVL, P = 0.069) and 480 to 830/μL (dVL, P = 0.051). Five patients (2 in uVL and 3 in dVL) improved their immunological status from moderate to no immunosuppression. Serum lipid profiles improved in both groups; cholesterol dropped significantly in the dVL group (P = 0.008). Grade 1 laboratory adverse events (AEs) were observed in 3 patients. No clinical AEs occurred. Adherence was complete in 9 patients (5 in uVL and 4 in dVL); 1 adolescent interrupted treatment. Once-daily STR with RPV/FTC/TDF may be a safe and effective choice in selected HIV-1-infected adolescents and children.

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