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Off-label use of rilpivirine in combination with emtricitabine and tenofovir in HIV-1-infected pediatric patients
Falcon-Neyra, Lola (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Palladino, Claudia (Hospital General Universitario Gregorio Marañón)
Navarro Gómez, María Luisa (Hospital General Universitario Gregorio Marañón)
Soler-Palacín, Pere (Hospital Universitari Vall d'Hebron)
González-Tomé, María Isabel (Hospital Universitario 12 de Octubre (Madrid))
De Ory, Santiago J. (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Frick, Marie Antoinette (Hospital Universitari Vall d'Hebron)
Fortuny Guasch, Claudia (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Noguera-Julian, Antoni (Hospital Sant Joan de Déu (Barcelona, Catalunya))
Moreno, Elena Bermúdez (Hospital General Universitario Gregorio Marañón)
Santos, Juan Luis (Hospital Universitario Virgen de las Nieves (Granada))
Olbrich, Peter (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
López-Cortés, Luis F. (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Briz, Verónica (Instituto de Salud Carlos III)
Neth, Olaf (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Universitat Autònoma de Barcelona

Data: 2016
Resum: 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.
Ajuts: Instituto de Salud Carlos III CP13-00098
Instituto de Salud Carlos III RD06-006
Instituto de Salud Carlos III RD12-0017-0035
Instituto de Salud Carlos III RD12-0017-0037
Instituto de Salud Carlos III MPY1039-14
Nota: Altres ajuts: Financial support was provided by FIPSE (grant number: 36-0910-10). CP is supported by the Portuguese Fundação para a Ciência e Tecnologia (FCT) (grant number SFRH/BPD/77448/2011, part of the EDCTP2 program supported by the European Union).
Drets: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. Creative Commons
Llengua: Anglès
Document: Article ; recerca ; Versió publicada
Matèria: Adolescents ; Antiretroviral therapy ; Children ; HIV-1 ; Rilpivirine
Publicat a: Medicine, Vol. 95 (june 2016) , ISSN 1536-5964

DOI: 10.1097/MD.0000000000003842
PMID: 27310962


5 p, 183.9 KB

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