The results of a trial looking at whether taking the drug Kaletra once a day was as good as taking it twice a day for children with HIV were presented at the Conference on Retroviruses and Opportunistic Infections last week. The KONCERT study results do not support the routine use of once-daily Kaletra dosing for children with HIV.
The KONCERT trial investigated whether children with HIV need to take the drug Kaletra (also called Aluvia) twice a day. Reducing the doses to once a day would simplify treatment, which is particularly important for children and adolescents. 84% of carers and children in the trial preferred the once daily to twice daily doses.
The trial involved 173 children from Thailand, Europe and South America. Children in the trial had already been on Kaletra long enough to suppress their virus to fewer than 50 copies of the virus per ml of blood before the trial started. The trial looked at whether taking Kaletra once a day was as good as taking it twice a day at keeping the virus below this level.
Although the trial results provided no evidence that once daily dosing was worse than twice daily dosing, this possibility could not be ruled out on the basis of these results. However, the virus remained suppressed in most children in the trial. Among those children whose virus levels increased to above 50 copies per ml, most resuppressed the virus without needing to change drugs or dosing. Only 5 children in the trial developed any new drug resistance (3 in the once daily arm, and 2 in the twice daily arm).
Once daily dosing might be acceptable for children who have problems adhering to twice-daily doses, if they can be closely monitored.
KONCERT was carried out by the Paediatric European Network for Treatment of AIDS with financial support from the European Union Seventh Framework and Abbott Laboratories.