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
Subject(s)
Anti-Retroviral Agents/adverse effects , Anti-Retroviral Agents/pharmacology , Anti-Retroviral Agents/therapy , Drug-Related Side Effects and Adverse ReactionsABSTRACT
Purpose: This study investigated mortality rate; early CD4 responses; pattern of ARVs substitutions and medication adherence of HIV-infected patients on first-line triple combination antiretroviral therapy (ART) in Central Hospital; Benin City; Nigeria. Methods: A retrospective assessment of 196 HIV-infected patients on first-line combination ART regimens was performed following 18 months of therapy. Medication adherence assessment of a 69-patient follow-up target group was based on a study-specific questionnaire. Paired sample t-test and simple linear correlation were used to test the association of the CD4-cell counts at different time intervals. Kaplan-Meier model was used to assess survival functions while log-rank test was applied to assess statistical difference at 95confidence interval (CI). Mean age of participants was 33.6 years (95CI; 32.1 - 35.2; 67.9were females. Results: At ART initiation; 27.0were at WHO clinical stage II; 47.0at stage III. Mortality rate (N = 196) was 20.3 deaths per 100 patient-months; 31.6occurred in 30 days while 52.6occurred post-120 days of treatment. The mean CD4-cell count (cells/mm3) at ART initiation was 179.2 which increased to 328.5 at 3 months; 325.6 at 6 months; 357.4 at 12 months; and 366.7 at 18 months; (p 0.01). Patients started on stavudine-based or efavirenz-based regimens were considerably more likely to have that drug substituted; compared to patients started on zidovudine-based or nevirapine-based regimens. The level of adherence reported after 18 months on ART was 73.8. Conclusion: In this setting; patients receiving ART showed significant improvements in CD4-cell status but adherence level was relatively poor. Patients were more stable on zidovudine-based or nevirapine-based regimens than on stavudine-based or efavirenz-based regimens. Early mortality rate was high; indicating a need for early interventions