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Background: Plasma viral load (pVL) is a key indicator of therapeutic response in HIV-infected patients receiving combination antiretroviral therapy (cART), but is often unavailable in routine clinical care in resource-limited settings. Previous model-based simulation studies have suggested that the benefits of routine pVL monitoring among patients on first-line regimens in resource-limited settings are modest, but this needs corroboration in well-defined study populations., Methods: We investigated virological suppression levels and identified predictors of detectable viraemia among 870 randomly selected patients who started cART between May 2009 and April 2012 in 10 health-care facilities in Addis Ababa, Ethiopia. A total of 656 (75.4%) patients, who were alive, were retained in HIV care and receiving cART for at least 6 months provided a blood sample for pVL measurement. Predictors of detectable viraemia were identified in a multivariate logistic regression model., Results: In on-treatment analysis, 94.5% (95% CI 92.5, 96.1) of the patients achieved virological suppression below 400 copies/ml after a median (IQR) of 26 (17-35) months on cART. When patients who were lost to follow-up, dead or stopped were assumed to have had detectable viraemia, the proportion of patients with virological suppression <400 copies/ml decreased to 74.6% (95% CI 71.5%, 77.4%). Younger age, lower educational status, <95% medication adherence, lower CD4(+) T-cell count at cART initiation and/or the diagnosis of immunological failure thereafter significantly predicted detectable viraemia., Conclusions: Virological suppression levels can be high in an established ART programme in a resource-limited setting, even without the availability of routine pVL monitoring. Efforts to improve treatment outcomes should focus on younger and illiterate patients, earlier detection of HIV-positive status and cART initiation before patients are severely immunocompromised, and improving retention in care.