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LONG-TERM EFFICACY AND SAFETY OF FOSAMPRENAVIR IN HUMAN IMMUNODEFICIENCY VIRUS-INFECTED PEDIATRIC PATIENTS

Palladino, Claudia PhD*; Briz, Verónica PhD*; Policarpo, Sergio Negre MD†; Silveira, Laura Fernandez MD‡; de José, M Isabel MD§; González-Tomé, M Isabel MD¶; Moreno, David MD∥; León Leal, Juan A. MD**; Mellado, M José MD††; de Ory, Santiago J. BSc*; Ramos, José T. MD‡‡; Muñoz-Fernández, M Ángeles PhD, MD*

Pediatric Infectious Disease Journal: June 2010 - Volume 29 - Issue 6 - pp 563-566
doi: 10.1097/INF.0b013e3181d285ac
Brief Reports

Fosamprenavir (FPV) efficacy in human immunodeficiency virus (HIV)-infected pediatric patients is still being evaluated in ongoing clinical trials. The long-term efficacy and safety of FPV boosted with ritonavir (FPV/r) was evaluated in 20 antiretroviral-naive and antiretroviral-experienced HIV-vertically infected pediatric patients. Analyses of CD4+ T-cells, HIV-ribonucleic acid (RNA), and clinical status were performed during a median of 180 weeks. Initially, median HIV-RNA was 4.6 log10 in naive and 4.4 log10 in pretreated patients. Median CD4+ T-cell was 17% and 31%, respectively. After FPV/r treatment, 18 of 20 patients achieved undetectable HIV-RNA and 4 of 20 experienced adverse events. To date, FPV/r treatment has shown sustained antiviral response and immunologic improvement in our 20 patients.

From the *Laboratorio de Inmuno-Biología Molecular, Hospital General Universitario “Gregorio Marañón,” Madrid, Spain; †Servicio de Enfermedades Infecciosas, Hospital Universitari “La Fe,” Valencia, Spain; ‡Servicio de Urgencias, Hospital de Sagunto, Valencia, Spain; §Servicio Infecciosas Infantil, Hospital Universitario “La Paz,” Madrid, Spain; ¶Servicio de Infecciosas Pediátricas, Hospital Universitario “Doce de Octubre,” Madrid, Spain; ∥Servicio de Pediatría, Unidad de Infectología e Inmunodeciciencias, Hospital Regional Universitario “Carlos Haya,” Málaga, Spain; **Unidad de Infectología/Medicina Interna Pediátrica, Hospital Infantil Unversitario “Virgen del Rocío,” Sevilla, Spain; ††Servicio de Pediatría, Hospital Universitario “Carlos III,” Madrid, Spain; and ‡‡Servicio de Pediatría, Hospital Universitario de Getafe, Madrid, Spain.

Accepted for publication December 11, 2009.

Supported by grants from Fundación para la Investigación y Prevención del SIDA en España, FIPSE (24632/07), Fundación Caja Navarra, Red Temática de Investigación Cooperativa Sanitaria ISCIII (RD06-0006-0035), Fondo de Investigación Sanitaria (FIS) of The Ministerio de Ciencia e Innovación (PI052476, PI061479), Pediatric European network for treatment of AIDS (PENTA), and Task Force in Europe for Drug Development for the Young (TEDDY). Supported by Fundación Para la Investigación Biomédica del Hospital General Universitario “Gregorio Marañón” (to C.L.). Supported by Fondo de Investigación Sanitaria (FI05/01046) (to V.B.).

The authors declare that they share no conflicts of interest.

The first two authors contributed equally to the manuscript.

Address for correspondence: Ma Ángeles Muñoz-Fernández, PhD, MD, Laboratorio Inmuno-Biología Molecular, Hospital General Universitario “Gregorio Marañón,” C/Doctor Esquerdo 46, 28007 Madrid, Spain. E-mail: mmunoz.hgugm@salud.madrid.org.

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© 2010 Lippincott Williams & Wilkins, Inc.