ABSTRACT
Background: Over 415;000 HIV-infected patients are receiving antiretroviral therapy (ART) in Nigeria but studies documenting their adverse reactions are limited. Objectives: This study determined the incidence and type of ADRs of severity grades II to IV in ART patients following pharmaceutical care directed active ADR surveillance program in Nigeria. Methods: This was a longitudinal study. A study-specific pharmaceutical care daily work sheet and national ADR reporting form were used for ADR screening and reporting respectively. Study population included 73;589 ART patients who were screened for ADR from April 2009 to December 2010 in 69 HIV treatment centres. All individual case safety reports (ICSRs) of severity grades II to IV in these patients were collated and analyzed. Chi-square was used to test the association between groups of variables at 95 Confidence Interval. Results: A total of 4600 ICSRs of severity grades II to IV reported were analyzed. Mean age of patients was 35.5(95CI; 35.2-35.9) years; 68.1 were females; and 7002 ADRs were reported; an average of 1.5 ADR perpatient. ADR incidences were 18.2 for d4T/3TC/EFV; 13.9 for d4T/3TC/NVP; and 4.4 for AZT/3TC/NV Pregimens; however overall incidence was 6.3. Major reported ADRs included skin rash (16.5); peripheral neuropathy (12.7); and headache (9.4). ADR occurrence was associated with specific ART regimens; concomitant medicines and age groups (p0.05); unlike gender. Lipodystrophy was associated withd4T/3TC/NVP [OR