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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/34788
Title: Etravirine in treatment-experienced, HIV-1-infected children and adolescents: 48-week safety, efficacy and resistance analysis of the phase II PIANO study
Authors: Gareth Tudor-Williams
Pedro Cahn
Kulkanya Chokephaibulkit
Jan Fourie
Chris Karatzios
S. Dincq
M. Opsomer
T. N. Kakuda
S. Nijs
L. Tambuyzer
F. L. Tomaka
Rosa Bologna
Esaú João
José Henrique Pilotto
Marisa Mussi-Pinhata
Jorge Pinto
Normand Lapointe
Albert Faye
Kamila 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
Gulam H. Latiff
Claudia Fortuny
Juan Antonio Leon Leal
Marissa Navarro
Jose T. Ramos
Tawee Chotpitayasunondh
Pope Kosalaraksa
Kiat Ruxrungtham
Jacobo Abadi
Tess Barton
William Borkowsy
Janet Chen
Joseph Church
Patricia Flynn
Sohail Rana
Richard Rutstein
Leonard Weiner
Imperial College London
Fundacion Huesped
Mahidol University
Dr Jan Fourie Medical Practice
Centre universitaire de sante McGill
Janssen Infectious Diseases BVBA
Janssen
Keywords: Medicine
Issue Date: 1-Jan-2014
Citation: HIV Medicine. Vol.15, No.9 (2014), 513-524
Abstract: © 2014 British HIV Association 15 9 October 2014 10.1111/hiv.12141 Original research Original research. © 2014 British HIV Association. 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 <12 years) and adolescents (≥12 to <18 years) over 48 weeks. Methods: In a phase II, open-label, single-arm study, 101 treatment-experienced patients (41 children; 60 adolescents) with screening viral load (VL) ≥500 HIV-1 RNA copies/mL received etravirine 5.2mg/kg (maximum dose 200mg) twice a day (bid) plus OBR. Results: Sixty-seven per cent of patients had previously used efavirenz or nevirapine. At week 48, the most common treatment-related grade ≥2 adverse event (AE) was rash (13%); 12% experienced grade 3 AEs. Only two grade 4 AEs occurred (both thrombocytopaenia, not etravirine related). At week 48, 56% of patients (68% children; 48% adolescents) achieved a virological response (VL<50copies/mL; intent-to-treat, noncompleter=failure). Factors predictive of response were adherence >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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84925954399&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/34788
ISSN: 14681293
14642662
Appears in Collections:Scopus 2011-2015

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