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Mathewos Alemu Gebremichael, Mekdes Kondale Gurara, Haymanot Nigussie Weldehawaryat Department of Public Health, College of Medicine and Health Sciences, Arba Minch University, Arba Minch, EthiopiaCorrespondence: Haymanot Nigussie Weldehawaryat Tel +251921875816Email jhaymi463@yahoo.comBackground: The effectiveness of the initial antiretroviral therapy regimen is the key to treatment success. However, regimen change affects this treatment success. Yet, evidence on the incidence and predictors of regimen change is scarce. Therefore, the aim of this study was to assess the incidence and predictors of initial antiretroviral therapy regimen change among HIV-infected adults receiving antiretroviral therapy.Methods: An institutional-based retrospective cohort study was conducted. Data were collected from patients’ charts selected by simple random sampling. Data entered into EpiData version 4.43 and analyzed by STATA version 13. The life table was used to estimate cumulative survival. Kaplan–Meir curve and Log-rank test were used to compare the survival experience of explanatory variables. Cox proportional hazard model was used to identify predictors.Results: Five hundred and eight patients were followed for 871.87 person-years of observation with the median follow-up period of 16.12 months. The incidence rate of initial ART regimen change was 11.36 (95% CI: 9.32– 13.83) per 100 person-year and the median survival time is 54 months. Not disclosing HIV status (adjusted hazard ratio (AHR) = 5.41, 95% CI = 2.38– 12.27), co-medication with ART (AHR = 4.64, 95% CI = 1.43– 15.10), occurrence of side effect on initial regimen (AHR = 7.32, 95% CI = 4.43– 12.10), baseline CD4 count < 200 cells/mm3 (AHR = 2.18, 95% CI = 1.37– 3.47), ambulatory/bedridden baseline functional status (AHR = 3.55, 95% CI = 2.30– 5.48) were significant predictors of initial regimen change.Conclusion: The incidence rate