Adherence, effectiveness, safety, and predictors of treatment outcomes among children and adolescents receiving dolutegravir based antiretroviral therapy in Ethiopia

Abstract

The World Health Organization advised integrase inhibitor dolutegravir as the first- and second-line treatment of choice for Human Immunodeficiency Virus in July 2019 for all populations. Since 2019, the Ministry of Health in Ethiopia has recommended that adults, adolescents, and pregnant women adopt it as their first-line regimen for antiretroviral therapy. There are limited studies demonstrating the adherence, effectiveness, and safety of children and adolescent dolutegravir regimen therapy in Ethiopia. Institutional based retrospective follow up study conducted by involving children and adolescent with dolutegravir regimen therapy at antiretroviral therapy clinic of Amhara Region Specialized Hospitals. Medical records of eligible HIV-infected children and adolescents receiving dolutegravir-based antiretroviral therapy were retrospectively reviewed using documented follow-up data. The sample size of ART children and adolescents was 403 included in the study. A simple random sampling technique by lottery methods was used. Data were collecting using structured questionnaire from client medical record folder. The data was analysis by using SPSS Version 25 software and evaluate the data with Binary logistic regression Model. Descriptive statistics were computed depending on the nature of the variables. Binary logistic regression Model used to assess predictors. Predictors considered statistically significant if P -value was less than 0.05. In total, 90.1% of participants adhered well to the treatment. At the start, 65.9% of those on DTG were in WHO Clinical Stage III. After follow-up, 67.4% were in Stage I and 32.6% in Stage II. Initially, 97.8% had viral loads above 200 copies/mL, but after one year on DTG, 87.4% were dropped below the threshold. CD4 counts improved significantly: 51.6% began below 200 cells/mm³, but with most now at 350 or higher. Additionally, 33.3% of patients reported adverse drug effects (ADEs) following the DTG regimen. This study revealed that the use of DTG-based ART in children and adolescents was safe with minor ADEs. In addition, the DTG regimen was effective in this population, even in treatment-experienced children who had high viral load before switching to DTG-based therapy. On the other hand, adherence to DTG regimens was good among most children and adolescents.