Falcon-Neyra, LolaPalladino, ClaudiaNavarro Gómez, María LuisaSoler-Palacín, PereGonzález-Tomé, María IsabelDe Ory, Santiago JFrick, Marie AntoinetteFortuny, ClàudiaNoguera-Julian, AntoniBermúdez Moreno, ElenaSantos, Juan LuisOlbrich, PeterLópez-Cortés, Luis FBriz, VerónicaNeth, Olaf2016-10-212016-10-212016-06Falcon-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):e38420025-7974http://hdl.handle.net/10668/2485Journal 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.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.enAdolescentsAntiretroviral therapyChildrenHIV-1RilpivirineFármacos anti-VIHRecuento de linfocito CD4ColesterolEstudios de seguimientoVIH-1HumanosLípidosARNComprimidosCarga viralAdolescenteCombinación emtricitabina, rilpivirina y tenofovirMedical Subject Headings::Named Groups::Persons::Age Groups::AdolescentMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents::Anti-Retroviral Agents::Anti-HIV AgentsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cell Count::Blood Cell Count::Leukocyte Count::Lymphocyte Count::CD4 Lymphocyte CountMedical Subject Headings::Chemicals and Drugs::Lipids::Sterols::CholesterolMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up StudiesMedical Subject Headings::Organisms::Viruses::RNA Viruses::Retroviridae::Lentivirus::Lentiviruses, Primate::HIV::HIV-1Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Chemicals and Drugs::LipidsMedical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNAMedical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Dosage Forms::TabletsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Microbiological Techniques::Viral LoadMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Nitriles::Rilpivirine::Emtricitabine, Rilpivirine, Tenofovir Drug Combinationresearch article27310962open access10.1097/MD.00000000000038421536-5964PMC4998448