Etravirine in treatment-experienced, HIV-1-infected children and adolescents: 48-week safety, efficacy and resistance analysis of the phase II PIANO study

Gareth Tudor-Williams, P. Cahn, K. Chokephaibulkit, J. Fourie, C. Karatzios, S. Dincq, M. Opsomer, T. N. Kakuda, S. Nijs, L. Tambuyzer, F. L. Tomaka, Rosa Bologna, Pedro Cahn, Esaú João, José Henrique Pilotto, Marisa Mussi-Pinhata, Jorge Pinto, Chris Karatzios, Normand Lapointe, Albert FayeKamila Kebaili, Steven Welch, Stefania Bernardi, Luisa Galli, Carlo Giaquinto, Nicola Principi, Gian Vincenzo Zuccotti, Henriette J. Scherpbier, Laura Marques, Isabel Soares, Margarida Tavares, Midnela Acevedo, Dan Duiculescu, Sorin Rugina, Jan Fourie, Gulam H. Latiff, Claudia Fortuny, Juan Antonio Leon Leal, Marissa Navarro, Jose T. Ramos, Kulkanya Chokephaibulkit, Tawee Chotpitayasunondh, Pope Kosalaraksa, Kiat Ruxrungtham, Jacobo Abadi, Tess Barton, William Borkowsy, Janet Chen, Joseph Church, Patricia Flynn, Sohail Rana, Richard Rutstein, Leonard Weiner

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: PIANO (Paediatric study of Intelence As an NNRTI Option; TMC125-C213; NCT00665847) assessed the safety/tolerability, antiviral activity and pharmacokinetics of etravirine plus an optimized background regimen (OBR) in treatment-experienced, HIV-1-infected children (≥6 to 95%, male sex, low baseline etravirine weighted genotypic score and high etravirine trough concentration (C0h). Seventy-six patients (75%) completed the trial; most discontinuations occurred because of protocol noncompliance or AEs (8% each). Sixty-five per cent of patients were >95% adherent by questionnaire and 39% by pill count. Forty-one patients experienced virological failure (VF; time-to-loss-of-virological-response non-VF-censored algorithm) (29 nonresponders; 12 rebounders). Of 30 patients with VF with paired baseline/endpoint genotypes, 18 (60%) developed nonnucleoside reverse transcriptase inhibitor (NNRTI) mutations, most commonly Y181C. Mean etravirine area under the plasma concentration-time curve over 12h (AUC0-12h; 5216ng h/mL) and C0h (346ng/mL) were comparable to adult target values. Conclusions: Results with etravirine 5.2mg/kg bid (with OBR) in this treatment-experienced paediatric population and etravirine 200mg bid in treatment-experienced adults were comparable. Etravirine is an NNRTI option for treatment-experienced paediatric patients. Copyright.

Original languageEnglish
Pages (from-to)513-524
Number of pages12
JournalHIV Medicine
Volume15
Issue number9
DOIs
Publication statusPublished - 2014

Keywords

  • Efficacy
  • Etravirine
  • HIV
  • Paediatrics
  • Safety

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)
  • Health Policy
  • Medicine(all)

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