DETERMINANTS AND OUTCOMES OF ADVERSE DRUG REACTIONS AMONG PATIENTS ON ANTIRETROVIRAL THERAPY IN NIGERIA FROM 2014 TO 2018

Abstract

The occurrence of adverse drug reactions to antiretroviral therapy in the management and care of HIV/AIDS can significantly affect treatment adherence, prevent viral suppression and contribute to HIV associated morbidity and mortality. Clinical trials are not able to identify rare and long-term adverse drug reactions in diverse patient populations. Assessing the effects of long term ART has not received sufficient attention, particularly in resource-constrained settings like Nigeria. This study seeks to investigate the determinants, severity and outcomes of adverse drug reactions to antiretroviral therapy in Nigeria from 2014 to 2018. This study employed a retrospective record review of individual case safety reports submitted to the National Pharmacovigilance Centre, Nigeria, and key informant interviews of healthcare providers involved in antiretroviral care and counselling. A total of 3398 individual case safety reports (ICSRs) were received by the National Pharmacovigilance Centre between 2014 to 2018. Adverse Drug Reactions were extracted from the individual case safety reports using the WHO System Organ Classification. Age of patient, sex, weight, duration of ADR, concomitant medicines used and ART regimen were extracted. Data from the quantitative analysis were analysed using descriptive statistics, chi-square, and multivariate logistic regression. Data from the Key Informant Interviews were transcribed and the themes were identified. Over half (55.9%) of those who reported ADRs were aged 16-35, with a mean age 34.7 ± 11 years. Majority of the reported ADRs were from female patients (71.5%). Neuropsychiatric disorders (29.8%), Skin and appendages disorders (17.1%), Peripheral nervous system disorders (6.7%), Musculoskeletal disorders (4.3%) and Anaemia (2.1%) were the most commonly reported system organ categories reported. Female sex (OR= 1.4, p=0.03), Efavirenz based therapy (OR=5.5, p=0.00) and Tenofovir based therapy (OR=1.6, p=0.02) were associated with Neuropsychiatric disorders. Being younger than 15 years old (OR=2.56, p=0.000) and use of Nevirapine based therapy (OR=3.7, p=0.000) were associated with cutaneous adverse drug reactions. Use of cotrimoxazole (OR=0.582, p=0.001) and Zidovudine based therapy (OR=32, p=0.000) were associated with anaemia. Healthcare providers reported a wide range of ADRs among patients on antiretroviral therapy. Treatment switching and referral for specialist care were used to manage patients with ADRs. Twenty-two percent (22%) of patients recovered from ADRs, 1.2% were fatal while 71.5% had unknown outcomes. Adverse Drug Reactions to Antiretroviral therapy are common among patients in Nigeria. Active surveillance is required for the detection of ADRs among patients on ART. This will help prevent ART-associated morbidity and mortality.