PMID- 27310962
OWN - NLM
STAT- MEDLINE
DCOM- 20170207
LR  - 20210109
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 95
IP  - 24
DP  - 2016 Jun
TI  - Off-label use of rilpivirine in combination with emtricitabine and tenofovir in 
      HIV-1-infected pediatric patients: A multicenter study.
PG  - e3842
LID - 10.1097/MD.0000000000003842 [doi]
LID - e3842
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/muL (uVL, P = 0.069) and 
      480 to 830/muL (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.
FAU - Falcon-Neyra, Lola
AU  - Falcon-Neyra L
AD  - Unidad de Enfermedades Infecciosas e Inmunopatologias, Hospital Infantil Virgen 
      del Rocio, Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain Research 
      Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, University of 
      Lisbon, Lisbon, Portugal Seccion de Enfermedades Infecciosas, Servicio de 
      Pediatria, Hospital General Universitario Gregorio Maranon, Madrid Unitat de 
      Patologia Infecciosa i Immunodeficiencies de Pediatria, Hospital Universitari 
      Vall d'Hebron, Institut de Recerca Vall d'Hebron, Universitat Autonoma de 
      Barcelona, Barcelona Servicio de Infecciosas Pediatricas, Hospital Universitario 
      Doce de Octubre Laboratorio InmunoBiologia Molecular, Hospital General 
      Universitario Gregorio Maranon. Instituto de Investigacion Sanitaria Gregorio 
      Maranon (IiSGM); Networking Research Center on Bioengineering, Biomaterials and 
      Nanomedicine (CIBER-BBN), Madrid Unitat d'Infectologia, Servei de Pediatria; 
      Hospital Sant Joan de Deu, Universitat de Barcelona, Barcelona, Spain Servicio de 
      Enfermedades Infecciosas, Hospital General Universitario Gregorio Maranon, Madrid 
      Unidad de Enfermedades Infecciosas e Inmunodeficiencias, Seccion Urgencias de 
      Pediatria, Hospital Universitario Virgen de las Nieves, Granada Enfermedades 
      Infecciosas, Microbiologia y Medicina Preventiva. Instituto de Biomedicina de 
      Sevilla/Hospital Universitario Virgen del Rocio/CSIC/Universidad de Sevilla, 
      Seville Unit of Viral Infection and Immunity, National Center for Microbiology, 
      Institute of Health Carlos III, Majadahonda, Madrid, Spain.
FAU - Palladino, Claudia
AU  - Palladino C
FAU - Navarro Gomez, Maria Luisa
AU  - Navarro Gomez ML
FAU - Soler-Palacin, Pere
AU  - Soler-Palacin P
FAU - Gonzalez-Tome, Maria Isabel
AU  - Gonzalez-Tome MI
FAU - De Ory, Santiago J
AU  - De Ory SJ
FAU - Frick, Marie Antoinette
AU  - Frick MA
FAU - Fortuny, Claudia
AU  - Fortuny C
FAU - Noguera-Julian, Antoni
AU  - Noguera-Julian A
FAU - Moreno, Elena Bermudez
AU  - Moreno EB
FAU - Santos, Juan Luis
AU  - Santos JL
FAU - Olbrich, Peter
AU  - Olbrich P
FAU - Lopez-Cortes, Luis F
AU  - Lopez-Cortes LF
FAU - Briz, Veronica
AU  - Briz V
FAU - Neth, Olaf
AU  - Neth O
CN  - CoRISpe working group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Anti-HIV Agents)
RN  - 0 (RNA, Viral)
RN  - 99YXE507IL (Tenofovir)
RN  - G70B4ETF4S (Emtricitabine)
SB  - IM
EIN - Medicine (Baltimore). 2016 Aug 07;95(31):e5074. PMID: 31265618
MH  - Adolescent
MH  - Anti-HIV Agents/administration & dosage
MH  - Child
MH  - Drug Therapy, Combination
MH  - Emtricitabine/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Infections/*drug therapy/virology
MH  - HIV-1/*genetics
MH  - Humans
MH  - Male
MH  - Off-Label Use
MH  - RNA, Viral/*analysis
MH  - Retrospective Studies
MH  - Tenofovir/*administration & dosage
MH  - Treatment Outcome
PMC - PMC4998448
COIS- The funders had no role in the study design, data collection and analysis, 
      decision to publish, or preparation of the manuscript. The authors have no 
      conflicts of interest to disclose.
EDAT- 2016/06/17 06:00
MHDA- 2017/02/09 06:00
PMCR- 2016/06/17
CRDT- 2016/06/17 06:00
PHST- 2016/06/17 06:00 [entrez]
PHST- 2016/06/17 06:00 [pubmed]
PHST- 2017/02/09 06:00 [medline]
PHST- 2016/06/17 00:00 [pmc-release]
AID - 00005792-201606140-00022 [pii]
AID - 10.1097/MD.0000000000003842 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2016 Jun;95(24):e3842. doi: 10.1097/MD.0000000000003842.