Evaluation of time to first adverse drug reaction among treatment-experienced adult persons living with HIV/AIDS: a retrospective cohort study

Adverse drug reactions (ADRs) are a significant concern in the treatment ofHIV infection. These reactions can range from mild to severe and may affectpatient adherence to antiretroviral therapy (ART), potentially compromising treatment effectiveness. The aim of this study was to assess the incidence and predictors of adverse drug reactions among adult persons living with HIVand receiving antiretroviral therapy from 2018 to 2023. A retrospective cohort study was carried out at the State Specialist Hospital Gombe (SSHG), Nigeria . Records of adult individuals living with HIV/AIDS were included in the study. Univariate and multivariate Cox regression proportional hazardwas applied to identify predictors of viral load suppression and ART-related ADRs. Kaplan-Meier and log-rank test survival curves were used to determine the time to achieve viral load suppression and first ADR due to ART. A p-value<0.05 was considered statistically significant at the 95% confidence level. The study included 332 adult persons living with HIV (PLHIV). Nearly half of the participants experienced at least one adverse drug reaction (ADR) (n =133; 40.1%), of which 71.4% (n = 95) were attributable to antiretroviral therapy (ART). The most commonly reported ADRs were skin rashes, pruritus, and chest pain (n = 25; 7.5%). The overall incidence density of adverse drug reactions was 4.8 per 100 person-months while ART-related ADR was 3.4 per 100 person’s months. After adjusting for potential confounders using a multivariable Cox proportional hazards model, PLHIV receiving TDF/3TC/EFV had a 50% lower risk of experiencing ADRs (adjusted hazard ratio [AHR] = 0.50; 95% CI 0.26–0.96; p = 0.03), while PLHIV on abacavir-based regimens demonstrated a 60% reduced risk (AHR = 0.40;95% CI 0.20–0.80; p = 0.009). WHO stage II at ART initiation had more than twice the risk of developing ADRs compared with those in stage I (AHR =2.19; 95% CI 1.34–3.58; p = 0.002). In this study, the incidence of adverse reaction was associatedwith tenofovir and abacavir based regimens and World Health Organization(WHO) clinical staging. Enhanced ADR monitoring and pharmacovigilanceshould be prioritized for PLHIV with early WHO clinical staging, those ontuberculosis prophylaxis, and individuals with unsuppressed viral loads.