Abstract:
Background: With the recommendation of highly active anti-retroviral therapy (HAART) as the standard of care for
children infected with HIV, their quality of life has improved dramatically. However anti-retroviral (ARV) drugs used in
HAART regimens are often associated with adverse drug reactions (ADRs), some of which may be life-threatening. This
study aimed to determine the frequency and pattern of adverse drug reactions to ARVs in children in a large treatment
centre in Nigeria. Methods: HIV-infected children initiated on ART between April 2008 and March 2013 at AIDS
Prevention Initiative in Nigeria (APIN)-supported HIV clinic of Jos University Teaching Hospital, Jos, Nigeria were
included in the study. Each child was followed up for a period of 12 months. A thorough symptom checklist, physical
examination, and laboratory evaluation were done at baseline. We reviewed them on each scheduled monthly visit and
on any event-triggered visit and assessed for adverse drug reactions. Routine laboratory evaluations were repeated at 3
months, 6 months, and 12 months after initiation of ART in accordance with monitoring guidelines. Results: Three
hundred and eighty-two patients were initiated on first line ART within the stated period. One hundred and ninety-eight
ADRs were observed in 139 (36.4%) patients after 12 months on ART. The commonest clinical ADRs observed were
pallor (41.4%), skin rash (19.7%), vomiting (7.1%), diarrhoea (3.5%), and sleep disturbance (3.0%) while the
commonest laboratory ADRs were severe anaemia (16.7%), elevated alanine transaminase (10.1%), thrombocytopenia
(3.0%), and neutropenia (1.5%). About 45% of the ADRs were observed in the first 3 months of initiation of ART and
about 75% in the first 6 months. Conclusion: ADRs were common in HIV-infected children that were initiated on ART in
this study. Regular clinical and laboratory monitoring is necessary so that HIV-infected children on ART with ADRs can
be identified early and managed appropriately in order to improve their overall treatment outcome
