Abstract

Tablets are more acceptable and give fewer problems than syrups among young HIV-infected children in resource-limited settings in the ARROW trial

Presented by Patricia Nahirya Ntege (Uganda).

P. Nahirya Ntege¹, M.F. Bwakura Dangarembizi², J. Byaruhanga³, A. Cook⁴, S. Bakeera-Kitaka⁵, R. Keishanyu³, S. Mudzingwa², G. Nabulime¹, A. Kekitiinwa⁵, M. Spyer⁴, F. Nankya¹, K. Nathoo², J. Tezikyabbiri³, P. Kasirye⁵, D. Gibb⁴, and the ARROW Trial Team

¹MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda, ²University of Zimbabwe Medical School, Harare, Zimbabwe, ³Joint Clinical Research Centre, Kampala, Uganda, ⁴MRC Clinical Trails Unit, London, United Kingdom, ⁵Baylor-Uganda, Paediatric Infectious Disease Centre, Mulago Hospital, Kampala, Uganda

Background: Provision of anti-retrovirals (ARVs) for children is complicated by syrup formulations, which are more expensive than tablets, harder to transport and store and difficult for carers to administer. Therefore, provided correct doses can be given, tablets are often more appropriate for children in resource-limited settings. We studied the acceptability of syrup and scored tablet ARVs among children substituting syrups with tablets.
Methods: ARROW is an ongoing randomised trial of paediatric ART monitoring and treatment strategies, 1207 children enrolled in Uganda/Zimbabwe during 2007/08. At enrolment, 406(34%) received syrups of individual drugs (NNRTI + 2 of ZDV,ABC,3TC), of whom 236(58%) substituted scored tablets (also individual drugs) between May 2008 and December 2009. At substitution, baseline questionnaires administered to carers elicited their experience with syrups and expectations of tablets; eight weeks later follow-up questionnaires asked their experience with tablets.
Results: Questionnaires from 186(79%) children changing formulation were analysed (exclusions: on tablets < 8 weeks, n=17; missing forms, n=33). Median age of children was 2.9 years (IQR 2.4,3.4), and most carers dissolved tablets in liquid. At baseline, most carers (77%) reported problems with syrups, commonly related to the number, weight and transportation of bottles. Difficulties with tablets were expected by 99(53%) carers but reported after 8 weeks by only 50(27%); most frequently expected and experienced problems were taste, swallowing and vomiting. At baseline, 69% of carers expected to prefer tablets and 24% thought their child would. After 8 weeks, 93% of carers preferred tablets and 56% reported that their child did.
Conclusions: Carers anticipated fewer difficulties using tablets than syrups, and experienced even less. After eight weeks use most children reportedly preferred tablets, none had switched back to syrups. These results show that scored tablets can be used in young children with few problems, and also that most children and their carers prefer them.