TULBPE027 - Poster Exhibition
Safety and efficacy of etravirine in HIV-1-infected, treatment-experienced children and adolescents (6-17 years): week 24 primary analysis of the phase II PIANO study
G. Tudor-Williams1, P. Cahn2, K. Chokephaibulkit3, J. Fourie4, C. Karatzios5, S. Dincq6, T.N. Kakuda7, S. Nijs6, J. Vingerhoets6, F. Tomaka7
1Imperial College, London, United Kingdom, 2Fundación Huesped, Buenos Aires, Argentina, 3Mahido University, Bangkok, Thailand, 4Dr Jan Fourie Medical Practice, Dundee, KZN, South Africa, 5McGill University Health Centre, Montreal, Canada, 6Tibotec BVBA, Beerse, Belgium, 7Tibotec Inc, Titusville, United States
Background: The ongoing PIANO study (TMC125-C213; NCT00665847) is investigating the safety, efficacy and pharmacokinetics of etravirine 5.2mg/kg BID (maximum dose 200mg BID) in HIV-1-infected children/adolescents aged 6-17 years over 48 weeks.
Methods: In an open-label, single-arm study, treatment-experienced, HIV-1-infected children/adolescents with viral load (VL) ≥500 HIV-1 RNA copies/mL received etravirine 5.2mg/kg BID with optimised background regimen (OBR; boosted PI plus other ARVs) for 48 weeks; the Week 24 primary analysis is presented.
Results: 101 patients (63% female, 49% white) received etravirine+OBR: 41 children and 60 adolescents. Median baseline VL was 3.9 log10 copies/mL. More children (44%) than adolescents (15%) had ≥3 sensitive drugs in their OBR; 19% (9% children, 26% adolescents) had 0-1 sensitive drugs. 68% of patients showed ≥80% etravirine adherence (pill count); 73% were adherent by questionnaire data. Safety/efficacy results are shown (Table). 8% of patients discontinued due to AEs (4% due to grade 2 or 3 rash). There were no clinically relevant changes in laboratory and ECG parameters. Response rates were higher in children than adolescents (Table), and similar regardless of etravirine adherence (pill count): 48% (< 95% adherent) versus 53% (>95% adherent). Of 29 patients with available genotype at the time of VF, 15 (52%) developed NNRTI RAMs, mainly Y181C, E138A, and V90I.
Conclusion: Paediatric populations remain difficult to treat given the known challenges with adherence and limited number of available ARVs. Etravirine 5.2mg/kg BID plus OBR demonstrated efficacy and safety in this generally highly treatment-experienced population. There was no clear relationship between etravirine adherence and virological response.
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