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
Background: The goals of antiretroviral therapy (ART) are to improve patient's health-related quality of life (HRQOL) and restore immunologic function among others. Objectives: The study evaluated HRQOL and CD4-cells response of HIV-infected patients at months 0 and 6 of receiving ART in Maitama District Hospital Abuja, Nigeria. Methods: HRQOL of a cohort of 150 HIV-infected patients was evaluated at months 0 and 6 of receiving ART using Medical Outcomes Study Short Form-36 (MOS SF-36) which has 8 domains. These include physical functioning, physically and emotionally related role limitations, social functioning, pain, energy/fatigue, emotional well-being and general health. A paired samples t-test was used to compare the HRQOL scores and CD4 cells count of participants at months 0 and 6. Wilcoxon's signed-ranks test was used to compare HRQOL of male and female participants. At two-tailed test, p value of <0.05 was considered significant. Results: The mean age (±SD) of the 150 participants at ART initiation was 34.3 ± 8.4 years; 59.3% were females. The mean (±SD) HRQOL of participants increased significantly from 71.9% ± 20.9 at ART initiation to 89.7% ± 10.6 after 6 months of ART (p<0.05). The change in all SF-36 domains was statistically significant (p<0.05) except for the domains of role limitation due to emotional problems, social functioning and pain. The improvement in the mental component score (MCS) was significant (p<0.05) unlike that of the physical component (PCS). The difference in the HRQOL of male and female participants at months 0 and 6 was not significant. The mean CD4 cell count (±SD) increased from 185.7 ±91.0 cells/mm3 at month 0 to 199.0 ±104.7 cells/mm3 after 6months of ART; though this increase was not statistically significant. Conclusion: There was significant improvement in the mean HRQOL scores of participants which was not associated with significant improvement in the CD4 cells status after six months of ART. The evaluation of HRQOL alongside the clinical and immunological parameters when monitoring treatment outcomes is recommended