Background:  The prevalence of active tuberculosis (TB) is high among patients accessing ART programs in Sub-Saharan Africa. Such patients are at risk of developing TB-associated immune reconstitution disease (IRD) after initiation of ART. However, the frequency, risk factors, and effect of TB-associated IRD in such programs are not known.

Methods:  A retrospective analysis of detailed data from a study cohort enrolled over 3 years within a community-based ART service in South Africa. Patients receiving treatment for TB at the time ART was initiated (n = 160) were studied. Cases of TB-associated IRD during the first 4 months ART were ascertained.

Results:  The median baseline CD4 cell count was 68 cells/μL (IQR 29 to 133). ART was initiated after a median of 105 days (IQR 61 to 164) from TB diagnosis, many patients having already completed part of their treatment course for TB prior to entering the ART programme. Overall, IRD was diagnosed in 12% of patients (n = 19). However, IRD developed in 32% (n = 12) of those who started ART with 2 months of TB diagnosis. Pulmonary involvement was observed among 84% (n = 16) and intra-abdominal manifestations were also common (37%). In multivariate analysis, risk of IRD was strongly associated with early ART initiation and low baseline CD4 cell count. Of patients with CD4 counts <50 cells/μL, the proportions who developed IRD following initiation of ART within 0 to 30, 31 to 60, 61 to 90, 91 to 120, and >120 days of TB diagnosis were 100%, 33%, 14%, 7%, and 0%, respectively. Overall, 4% (n = 7) of the cohort required secondary level health-care for IRD and 2 (1%) patients died.

Conclusions:  The risk of TB-associated IRD in this setting is very high for those with low baseline CD4 cell counts initiating ART early in the course of antituberculosis treatment. However, most cases were self-limiting; overall secondary health-care utilisation and mortality risk from IRD were low.