Abstract
BACKGROUND: Dolutegravir (DTG)-based antiretroviral therapy (ART) is a preferred first-line treatment for HIV/AIDS, but concerns about adverse drug events (ADEs) persist. This study aimed to determine the prevalence of ADEs and identify associated independent risk factors among Thai people living with HIV (PLWH) on DTG-based regimens for at least one year. METHODS: This retrospective cohort study examined 1,270 Thai individuals living with HIV receiving a DTG/3TC/TDF regimen for ≥ 1 year at a secondary care hospital between 2021 and 2023. The primary outcome was any ADE (Grade ≥ 1) documented during the first 12 months of DTG therapy. Multivariate logistic regression, adjusted for confounders including sex, was used to identify independent predictors of ADEs. RESULTS: Among 1,270 participants, 684 (53.86%) experienced at least one ADE. The cohort was predominantly ART-experienced, with a median duration since HIV diagnosis of 6.00 years (IQR 4.00-9.00 years). The most frequent ADEs included a decline in estimated glomerular filtration rate (eGFR) (17.72%), anemia (15.43%), weight gain (9.29%), and nausea (7.80%). Independent risk factors associated with increased ADE odds were: older age (≥ 40 years vs. 18-29 years, global p = 0.040), psychiatric comorbidity (aOR 3.13; 95% CI 1.02-9.56; p = 0.046), history of cryptococcosis (aOR 1.45; 95% CI 1.05-2.13; p = 0.035) ,underweight status (BMI < 18.5 kg/m²) (aOR 2.22; 95% CI 1.50-3.38; p < 0.001), and baseline eGFR < 90 mL/min/1.73m(2) (aOR 1.45; 95% CI 1.09-1.93; p < 0.011). Conversely, a longer duration on ART prior to DTG initiation (> 15 years) was associated with a 68% reduction in ADE odds (aOR 0.32; 95% CI 0.14-0.75; p = 0.008). CONCLUSIONS: Over half (53.86%) of patients on long-term DTG-based therapy experienced at least one ADE. Risk was significantly elevated in older adults, those with psychiatric illness, previous cryptococcosis, underweight status, or lower baseline eGFR. Healthcare providers should implement proactive monitoring and tailored management strategies for these high-risk patients to optimize ART safety and efficacy outcomes.