Falcon Neyra, LolaPalladino, ClaudiaNavarro Gómez, María LuisaSoler Palacín, PereGonzález Tomé, Maria IsabelOry, Santiago J. deFrick, Marie AntonietteFortuny Guasch, ClaudiaNoguera Julian, AntoniBermúdez Moreno, ElenaSantos, Juan LuisOlbrich, PeterLópez Cortés, Luis F.Briz, VerónicaNeth, OlafCoRISpe working group2017-04-062017-04-062016-060025-7974https://hdl.handle.net/2445/109500To 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.5 p.application/pdfengcc-by (c) Falcon Neyra, Lola et al., 2016http://creativecommons.org/licenses/by/3.0/esVIH (Virus)AntiretroviralsInhibidors enzimàticsSida en els infantsPediatriaHIV (Viruses)Antiretroviral agentsEnzyme inhibitorsAIDS (Disease) in childrenPediatricsOff-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients: A multicenter study.info:eu-repo/semantics/article6689332017-04-06info:eu-repo/semantics/openAccess27310962