Tablets more acceptable than syrups in the ARROW trial

Provided accurate dosing is possible, tablets are usually more feasible than syrups for treating children in resource limited settings.

A substudy of the ARROW trial – an ongoing randomised paediatric trial of antiretroviral monitoring and treatment strategies conducted in Uganda and Zimbabwe – looked at the acceptability of syrup and scored tablets among children substituting syrups with tablets. The children were dosed in accordance with WHO weight band tables, which recommend substitution of liquids with tablets at around three years of age.

A poster authored by P Nahirya Ntege and colleagues showed findings from questionnaires given to the childrens carers to discover their experiences with syrups and with tablets.

A total of 1207 children, aged 3 months to 17 years, were enrolled during 2007/2008. At enrollment, 34% (406/1207) of children received the antiretrovirals in their regimen (NNRTI + two or three of zidovudine, abacavir and lamivudine) as syrups.

Just over half (236/406, 58%) of this group substituted scored tablets for syrups between May 2008 and December 2009. The first questionnaires were given at baseline (time of substitution) and follow up questionnaires eight weeks later.

The investigators found, among the 186/236 (79%) of questionnaires included in the analysis, the median age of the children at time of substitution was 2.9 years (IQR 2.4-3.4).

Over three quarters (77%) of carers reported problems with the number and weight of the bottles as they were difficult to transport. About half (53%) expected difficulties with the tablets at baseline but only 27% of carers reported problems at 8 weeks.

Most tablets were dissolved/crushed in liquid. The most frequent problems were with taste, swallowing and vomiting.

Overall 69% of carers at baseline and 93% at eight weeks reported a preference for tablets. They also reported that 24% of children at baseline and 56% at eight weeks preferred tablets to syrups.

At eight weeks none had switched back to syrups. The investigators are evaluating longer-term information after the children have received tablets for 24 weeks. They will also evaluate the affect of tablet acceptability on adherence.

comment

These data reinforce the WHO recommendation of solid formulations as the preferred regimens for children. They should also act as an incentive to manufacturers (particularly generic) to produce more innovative solid formulations including fixed dose combinations.

Liquid formulations have been a barrier to more rapid scale up and are less convenient and more costly for all involved in treating children with HIV.

Ref: Nahirya Ntege P et al. Tablets are more acceptable and give fewer problems than syrups among young HIV-infected children in resource-limited settings in the ARROW trial. 18th IAS Conference, 1823 July 2010, Vienna. Poster abstract TUPDB206.
http://pag.aids2010.org/Abstracts.aspx?AID=13055