Determinants and outcomes of adverse drug reactions among people living with HIV on antiretroviral therapy in Nigeria.

Adverse drug reactions (ADRs) to Antiretroviral Therapy (ART) among people living with HIV/AIDS (PLWHA) can significantly affect treatment adherence, viral suppression and contribute to HIV-related morbidity and mortality. ADRs to long-term ART use is not well understood in resource-constrained countries like Nigeria. This study identified the determinants and outcomes of ADRs to ART among PLWHA in Nigeria. Secondary data analysis of the 2014 to 2018 National Pharmacovigilance records was conducted using 3,397 individual case safety reports (ICSRs). The outcome variables were the actual adverse drug reactions reported (e.g., headache, dizziness, anaemia) and the seriousness of the ADR (Serious vs. Non-serious ADR). In contrast, the explanatory variables included the patient's age, sex, weight, duration of ADR, concomitant medicines used, and ART regimen. ADRs were determined using the WHO System Organ Classification, which groups ADRs by the organ system or body part affected. Data were analysed using multivariate logistic regression, with a p-value set at 5%. The mean age of the participants was 34.7 ± 11 years, and the majority were female (71.5%). The most commonly reported ADRs were neuropsychiatric disorders (29.8%), skin and appendage disorders (17.1%), peripheral nervous system disorders (6.7%), musculoskeletal disorders (4.3%), and anaemia (2.1%). On multivariate analysis, factors associated with development of neuropsychiatric disorders were female were female gender (AOR = 1.43, 95% CI (1.20-1.71): p < 0.001), Efavirenz-based therapy (AOR = 5.58, 95% CI: (4.41-7.05) p < 0.001), older age [16-35 years [AOR = 3.34; 95% CI: (1.72-6.48); p-value: <0.001, [36-50 years: AOR = 2.32; 95% CI: (1.19-4.52); p-value: 0.014; > 50 years AOR = 2.77; 95% CI: (1.36-5.63); p-value: 0.005] Use of Tenofovir [AOR = 1.65; 95% CI: (1.20-2.30); p-value: 0.002], and Zidovudine [AOR = 1.44; 95% CI: (1.13-1.85); p-value: 0.003] were associated with cutaneous adverse drug reactions. Anaemia was associated with the use of Zidovudine [AOR = 32.56; 95% CI: (4.41 - 7.05); p-value: <0.001], but was inversely associated with cotrimoxazole use [AOR = 0.58; 95% CI: (0.42- 0.79); p-value: 0.001]. Some (22%) of the patients recovered from ADRs; 1.2% were fatal, while 71.5% outcomes were unknown. ADRs were common among ART patients in Nigeria., with female gender, older age and types of ART regimen being major determinants of ADRs Active surveillance is necessary to ensure early detection of ADRs among patients on ART and thereby prevent ART-associated morbidity and mortality.