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Clinical Trial
. 2013 Jan;17(1):193-202.
doi: 10.1007/s10461-012-0197-y.

Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children

Linda Harrison  1 , 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; Paediatric European Network for Treatment of AIDS (PENTA) 11 Trial Team
Collaborators, Affiliations
Clinical Trial

Adherence to antiretroviral therapy and acceptability of planned treatment interruptions in HIV-infected children

Linda Harrison et al. AIDS Behav. 2013 Jan.

Abstract
in English, Spanish

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, HIV-infected children were randomised to CD4-guided 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; non-adherence (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) = 1.04 (0.20, 5.41), χ(2) (1) = 0.003, p = 0.96). Carers in Europe/USA reported non-adherence more often (31/121, 26 %) than in Thailand (1/73, 1 %; OR (95 % CI) = 54.65 (3.68, 810.55), χ(2) (1) = 8.45, p = 0.004). 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) = 1.04 (0.20, 5.41), χ2 (1) = 0.003, p = 0.96). 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) = 54.65 (3.68, 810.55), χ2 (1) = 8.45, p = 0.004). 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 %).

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Figures

Fig. 1
Fig. 1
Non-adherence during follow-up by randomised group and region. Non-adherence 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 interruption
Fig. 2
Fig. 2
PTI planned treatment interruption. Carer and child responses to the question “How do you think (baseline)/did (end of study) stopping medicines as part of a PTI make things for you?”, by randomised group and region
Fig. 3
Fig. 3
PTI planned treatment interruption. Carer and child responses to the questions “Do you have any concerns about the possible disadvantages of a PTI?” (baseline, left graph) and “Are you happy to have further PTIs?” (end of study, right graph), by randomised group and region
See this image and copyright information in PMC

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