RT Journal Article
T1 Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study.
A1 Falcon-Neyra, Lola
A1 Palladino, Claudia
A1 Navarro Gómez, María Luisa
A1 Soler-Palacín, Pere
A1 González-Tomé, María Isabel
A1 De Ory, Santiago J
A1 Frick, Marie Antoinette
A1 Fortuny, Clàudia
A1 Noguera-Julian, Antoni
A1 Bermúdez Moreno, Elena
A1 Santos, Juan Luis
A1 Olbrich, Peter
A1 López-Cortés, Luis F
A1 Briz, Verónica
A1 Neth, Olaf
K1 Adolescents
K1 Antiretroviral therapy
K1 Children
K1 HIV-1
K1 Rilpivirine
K1 Fármacos anti-VIH
K1 Recuento de linfocito CD4
K1 Colesterol
K1 Estudios de seguimiento
K1 VIH-1
K1 Humanos
K1 Lípidos
K1 ARN
K1 Comprimidos
K1 Carga viral
K1 Adolescente
K1 Combinación emtricitabina, rilpivirina y tenofovir
AB 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.
PB Lippincott, Williams & Wilkins
SN 0025-7974
YR 2016
FD 2016-06
LK http://hdl.handle.net/10668/2485
UL http://hdl.handle.net/10668/2485
LA en
NO Falcon-Neyra L, Palladino C, Navarro Gómez ML, Soler-Palacín P, González-Tomé MI, De Ory SJ, et al. Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study. Medicine (Baltimore). 2016                         ; 95(24):e3842
NO Journal Article.                            This study was registered under reference number RIS-EPICLIN-13/2015.               This article has been corrected. See Medicine (Baltimore). 2016 August; 95(31): e5074.
DS RISalud
RD Apr 19, 2025