ABSTRACT
BACKGROUND: The inconsistent use of antiretroviral therapy can lead to the risk of cross-resistance between drugs. This reduces subsequent antiretroviral drug options. The burden of initial antiretroviral therapy ranges from 11.3% in South Africa to 71.8% in Malaysia. There is evidence that it is important to maintain children's initial antiretroviral therapy regimens. However, the incidence and predictive factors of initial antiretroviral therapy regimen changes in the research context are still unknown in the study setting. So, the study was aimed to assess incidence and predictors of initial antiretroviral therapy regimen changes among children in public health facilities of Bahir Dar city. METHODS: A retrospective follow-up study was conducted in 485 children who received antiretroviral therapy between January 1, 2011 and December 30, 2020. These children were selected using simple random sampling techniques. The data were entered by Epi data 3.1 and the analysis was completed by STATA 14.0. The missing data was treated with multiple imputation method. The data were also summarized by median or mean, interquartile range or standard deviation, proportion and frequency. The survival time was determined using the Kaplan Meier curve. The Cox Proportional Hazard model was fitted to identify predictors of initial antiretroviral therapy regimen change. The global and Shoenfeld graphical proportional hazard tests were checked. Any statistical test was considered significant at P-value < 0.05. Finally, the data were presented in the form of tables, graphics and text. RESULT: Among the 459 study participants, 315 of them underwent initial regimen changes during the study accumulation period. The shortest and longest follow up time of the study were 1 month and 118 months, respectively. The overall incidence rate of initial regimen change was 1.85, 95% CI (1.66-2.07) per 100 person-month observation and the median follow up time of 49 (IQR 45, 53) months. The independent predictors of initial regimen changes were poor adherence (AHR = 1.49, 95%CI [1.16, 1.92]), NVP based regimen (AHR = 1.45, 95%CI [1.15, 1.84]) comparing to EFV based regimen, LPVr based regimen (AHR = 0.22, 95%CI: (0.07, 0.70)) comparing to EFV based regimen, history of tuberculosis (AHR = 1.59, 95%CI [1.14, 2.23]) and being male (AHR = 1.28, 95%CI [1.02, 1.60]). CONCLUSIONS AND RECOMMENDATIONS: In this study, the incidence of initial regimen change was high. The risk of initial regimen change would be increased by being male, poor adherence, having history of tuberculosis and NVP based initial regimen. Therefore, strengthening the health care providers' adherence counseling capability, strengthening tuberculosis screening and prevention strategies and care of initial regimen type choice needs attention in the HIV/AIDS care and treatment programs.