Falcon-Neyra Lola, Palladino Claudia, Navarro Gómez María Luisa, Soler-Palacín Pere, González-Tomé María Isabel, De Ory Santiago J, Frick Marie Antoinette, Fortuny Clàudia, Noguera-Julian Antoni, Moreno Elena Bermúdez, Santos Juan Luis, Olbrich Peter, López-Cortés Luis F, Briz Verónica, Neth Olaf
Unidad de Enfermedades Infecciosas e Inmunopatologias, Hospital Infantil Virgen del Rocío, Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal Sección de Enfermedades Infecciosas, Servicio de Pediatría, Hospital General Universitario Gregorio Marañón, Madrid Unitat de Patologia Infecciosa i Immunodeficiències de Pediatria, Hospital Universitari Vall d'Hebron, Institut de Recerca Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona Servicio de Infecciosas Pediátricas, Hospital Universitario Doce de Octubre Laboratorio InmunoBiología Molecular, Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM); Networking Research Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Madrid Unitat d'Infectologia, Servei de Pediatria; Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain Servicio de Enfermedades Infecciosas, Hospital General Universitario Gregorio Marañón, Madrid Unidad de Enfermedades Infecciosas e Inmunodeficiencias, Sección Urgencias de Pediatría, Hospital Universitario Virgen de las Nieves, Granada Enfermedades Infecciosas, Microbiología y Medicina Preventiva. Instituto de Biomedicina de Sevilla/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville Unit of Viral Infection and Immunity, National Center for Microbiology, Institute of Health Carlos III, Majadahonda, Madrid, Spain.
Medicine (Baltimore). 2016 Jun;95(24):e3842. doi: 10.1097/MD.0000000000003842.
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.
为评估rilpivirine与恩曲他滨和替诺福韦联合使用（RPV/FTC/TDF）作为每日一次单片方案（STR）用于HIV-1感染儿童和青少年的安全性和有效性，我们对HIV-1感染患者进行了一项多中心病例系列研究。纳入标准为18岁之前开始使用RPV/FTC/TDF治疗。患者被分为病毒载量不可检测（uVL）组，即接受稳定的联合抗逆转录病毒治疗（cART）时HIV-1 RNA＜20拷贝/mL，以及病毒载量可检测（dVL）组，即开始使用RPV/FTC/TDF时HIV-1 RNA≥20拷贝/mL。从开始使用RPV/FTC/TDF之日起对患者进行监测，直至2015年6月30日、停用RPV/FTC/TDF或失访。纳入了17例年龄在11.6至17.6岁之间的患者（uVL组8例，dVL组9例）。uVL组换药原因是毒性（n = 4）和简化治疗方案（n = 4）；dVL组是病毒学失败（n = 8）和开始cART（n = 1）。在中位随访90周（uVL组）和40周（dVL组）后，7/8（86%）的患者维持了HIV-1抑制，8/9（89%）的患者实现并维持了HIV-1抑制。中位CD4细胞计数从542/μL增至780/μL（uVL组，P = 0.069），从480/μL增至830/μL（dVL组，P = 0.051）。5例患者（uVL组2例，dVL组3例）的免疫状态从中度免疫抑制改善为无免疫抑制。两组患者的血清脂质谱均有所改善；dVL组胆固醇显著下降（P = 0.008）。3例患者出现1级实验室不良事件（AE）。未发生临床AE。9例患者（uVL组5例，dVL组4例）治疗依从性良好；1名青少年中断治疗。对于部分HIV-1感染的青少年和儿童，每日一次的RPV/FTC/TDF单片方案可能是一种安全有效的选择。
