Adherence to Antiretroviral Therapy and Acceptabil

Authors: Linda Harrison Jintanat Ananworanich Djamel Hamadache Alexandra Compagnucci Martina Penazzato Torsak Bunupuradah Antonio Mazza Jose Tomas Ramos Jacquie Flynn Osvalda Rampon Maria Jose Mellado Pena Daniel Floret Magdalena Marczynska Ana Puga Silvia Forcat Yoann Riault Marc Lallemant Hannah Castro Diana M Gibb Carlo Giaquinto On Behalf of the Paediatric European Network for Treatment of AIDS PENTA 11 Trial Team

Publish Date: 2012/05/15

Volume: 17, Issue: 1, Pages: 193-202

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Abstract

There have been no paediatric randomised trials describing the effect of planned treatment interruptions PTIs of antiretroviral therapy ART on adherence or evaluating acceptability of such a strategy In PENTA 11 HIVinfected children were randomised to CD4guided PTIs n = 53 or continuous therapy CT n = 56 Carers and children if appropriate completed questionnaires on adherence to ART and acceptability of PTIs There was no difference in reported adherence on ART between CT and PTI groups nonadherence reporting missed doses over the last 3 days or marking 100  adherence since the last clinical visit on a visual analogue scale was 18  20/111 and 14  12/83 on carer questionnaires in the CT and PTI groups respectively odds ratios OR 95  CI = 104 020 541 χ2 1 = 0003 p = 096 Carers in Europe/USA reported nonadherence more often 31/121 26  than in Thailand 1/73 1  OR 95  CI = 5465 368 81055 χ2 1 = 845 p = 0004 The majority of families indicated they were happy to have further PTIs carer 23/36 64  children 8/13 62  however many reported more clinic visits during PTI were a problem carer 15/36 42  children 6/12 50 No ha habido estudios pediátricos randomizados que describan el efecto de las interrupciones planificadas del tratamiento IPT antirretroviral en el seguimiento del tratamiento o en la aceptabilidad de dicha estrategia En PENTA11 niños infectados con HIV fueron randomizados o bien en IPT guiadas por sus CD4 n = 53 o bien en terapia continua TC n = 56 Tanto los cuidadores como los niños cuando era apropiado completaron cuestionarios de seguimiento de la terapia antirretroviral y de aceptabilidad de las interrupciones No se encontró diferencia en cuanto al seguimiento del tratamiento entre los dos grupos No seguimiento dosis perdidas durante los últimos 3 días o 100  desde la ultima visita a la clínica en una escala visual analógica fue del 18  20/111 y del 14  12/183 en los cuestionarios de los cuidadores en TC y en IPT respectivamente odds ratios OR 95  CI = 104 020 541 χ2 1 = 0003 p = 096 Los cuidadores en Europa/USA informaron de un no seguimiento del tratamiento más a menudo 31/121 26  que en Tailandia 1/73 1 OR 95  CI = 5465 368 81055 χ2 1 = 845 p = 0004 La mayoría de las familias indicaron que les gustaría realizar más ITP cuidador 23/36 64  niños 8/13 62  sin embargo muchos indicaron que el mayor numero de visitas a la clínica durante la IPT era un problema cuidador 15/35 43  niños 6/12 50 AIDS related mortality and morbidity has declined substantially in HIVinfected children since the introduction of combination antiretroviral therapy ART 1 2 However complete HIV suppression requires a high level of adherence to ART to be sustained over a lifetime 3 4 In children the lifelong exposure to treatment also raises concerns regarding potential longterm toxicity such as lipodystrophy osteopenia and mitochondrial dysfunction 5 6 Additionally treatment sequencing given the greater potential for inadequate dosing and the absence of appropriate licensed drug formulations is often challenging 7 Therefore planned treatment interruptions PTIs may be welcomed by children and their families but may also have a negative impact on adherence once ART is restartedTrials evaluating treatment interruptions in adults have reported higher rates of AIDS events/death and serious nonAIDS events in those stopping ART 8 9 10 11 12 and the SMART trial reported that CD4guided episodic use of ART resulted in inferior quality of life QOL 13 PENTA 11 was a pilot study evaluating CD4guided PTIs in HIVinfected children and the key finding of the trial was that no serious clinical outcomes were reported in children undergoing PTIs 14 Nevertheless there was a significant excess of minor clinical events in the PTI group after stopping ART compared to children on continuous therapy CT which may have been problematic for children and familiesThere have been no paediatric studies describing the effect of PTIs on adherence within a randomised trial or evaluating acceptability of such a strategy In the PENTA 11 trial adherence to ART and acceptability of PTIs was measured routinely and this paper presents findings from analyses of these dataNonadherence during followup by randomised group and region Nonadherence was defined as reporting one or more missed doses over the last 3 days and/or marking 100  adherence since the last clinical visit on the VAS All child questionnaires were completed in Europe/USA CT continuous therapy PTI planned treatment interruptionCarers and children if appropriate were asked to complete adherence questionnaires adapted from previous PENTA studies 15 16 at baseline weeks 24 48 and 72 in the CT group and at baseline then at 4 12 24 and 48 weeks after each ART restart in the PTI group Questionnaires were completed at the time of scheduled clinic visits with the help of the nurse or doctor if required

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