14th International AIDS Conference


Barcelona, Spain — July 7-12, 2002


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[TITLE:] Adverse drug reactions (ADR) during HAART in paediatric HIV infection - The Italian multicentric collaborative study

[AUTHOR(S):] G. Castelli-Gattinara1, S. Mannino, M. Villa2, P.A. Tovo, C. Gabiano3, M. De Martino, L. Galli4, P. Palma, P. Rossi5

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. MoOrB1133


[ABSTRACT:] Objective: To estimate the incidence of ADRs following antiretroviral treatment in HIV+ children.

METHODS: A cohort study based on data collected between 1998-2000. All treated children, aged 1-18 years, followed by 29 Institutions of the Italian Register for Paediatric HIV were enrolled. All ADRs, consisting in clinical symptoms or laboratory abnormalities, were reported by the centre and graded for severity (1 to 4).

RESULTS: Out of 486 treated children, 191 (39%) reported at least one ADR for a total of 239 events; 13% were considered "serious" by the investigators (severity 3-4). All ADRs resolved without sequela, but 2 patient were left with permanent symptoms (hypercreatinaemia, diarrhoea) and one died. During the study period, hypercholesterolaemia and hypertriglyceridaemia presented the highest cumulative incidence (8.4%), followed by hypertransaminasaemia, bone marrow toxicity and rash (all at 5.1%); 3.7% of children presented lipodystrophy (lipohypertrophy and/or lipoatrophy). After stratification by age, we estimated for lipodystrophy and abnormal lipid values a risk of 4.4% & 10.4% respectively in females, compared to 3% & 6.4% in males. Lipodystrophy and lipid abnormalities were also twice as high in children over 10 years of age, compared to younger children.Looking at severity, 66.7% of all the reported cardiac disturbances and alterations of pancreatic function had a score 3-4; among the most frequently reported ADRs, ¼ of those regarding kidney stones and bone marrow toxicity were severe.

CONCLUSIONS: ADRs to HAART in HIV+ children are similar to those described in adults. Even if they appear of mild severity (85% score 1-2) they can compromise compliance to therapy. Lipodystrophy and alterations of lipids were less frequent than expected, probably in relation to the lack of clear diagnostic criteria in childhood. Further analysis will help to clarify whether our results reflect a true lower incidence or is the effect of under-reporting.

Presenting author: Paolo Rossi.

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1Bambino Gesù Hospital, Bambino Gesù Hospital, P. S. Onofrio 4, 00165 Roma, Italy.

2CNR, Milano, Italy.

3University of Torino, Torino, Italy.

4University of Firenze, Firenze, Italy.

5Bambino Gesù Hospital, Roma, Italy.

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MoOrB1133

Copyright © 2002 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.