The table describes the demographic, clinical, and immunological characteristics of patients included in the analysis. Of 5625 adults (aged >14 years) receiving clinical care from TASO in Gulu District, a total of 1625 are receiving combination antiretroviral therapy and were included in our analysis—100% of all patients who ever received combination antiretroviral therapy from TASO in Gulu District. The cohort represented a cumulative 1981 patient years of follow-up. Most (72%) patients were women, and the median age was 39 (interquartile range 33-46) years. Of all internally displaced people in the study, 14.0% resided in official government camps and the rest resided in outlying areas. All patients were started on non-nucleoside reverse transcriptase inhibitor based regimens.
Demographic, clinical, and immunological characteristics of patients (n=1625). Values are numbers (percentages) unless stated otherwise
Patients started treatment with a median CD4 count of 157 (interquartile range 90-220) cells/μl, and most (63%) had WHO stage 2 disease. A total of 62 patients had been diagnosed as having pulmonary tuberculosis at baseline. The median follow-up time was 12.8 (7.7-23.1) months; 69 (4.2%) patients died during follow-up, giving a mortality incidence rate of 3.48 (95% confidence interval 2.66 to 4.31) per 100 person years.
Of the 982 patients with available baseline CD4 counts, 664 (68%) had CD4 counts of 200 cells/μl or less. Median follow-up was similar by baseline CD4 count: 10.5 (interquartile range 6.3-15.0) months for patients with CD4 counts 200 cells/μl or less and 14.4 (9.3-27.5) months for those with CD4 counts above 200 cells/μl. Mortality varied by baseline CD4 cell count: 21/664 (3.2%, 3.22/100 patient years) patients with CD4 counts of 200 cells/μl or less died compared with 3/316 (0.9%, 0.68/100 patient years) patients with CD4 counts above 200 cells/μl. For the 643 patients with no initial CD4 count available, the median follow-up time was 14.3 (9.1-26.1) months and 45 patients died (7.0%, 50.8/100 person years). Patients without CD4 counts were less likely to be in a camp and were less likely to have tuberculosis at the start of treatment than were patients who had CD4 cell counts available (internally displaced persons’ camp: 69/643 (10.7%) v 158/982 (16.1%), P=0.002; tuberculosis: 5/643 (0.8%) v 57/980 (5.8%), P<0.0001). We found no significant difference between patients without or with cell counts in terms of sex: 458/643 (71.2%) v 704/982 (71.7%) (P=0.8). Figure 1 shows the Kaplan-Meier plot for survival in patients with CD4 counts of 200 cells/μl or lower and above 200 cells/μl and for those without CD4 cell evaluations.
Fig 1Kaplan-Meier plot for survival in patients with CD4 cell count at start of treatment >200 cells/μl or ≤200 cells/μl and in those with no CD4 data available
The median follow-up time for the 1521 patients who had complete adherence data was 13.7 (8.4-23.6) months. Of the 1521 patients with complete data for adherence, 118 (7.8%) patients had adherence below 95% and 1403 (92.2%) had adherence of 95% or above. The median follow-up was 26.0 (14.4-28.4) months for patients with adherence below 95% and 12.8 (8.1-22.4) months for those with adherence of 95% or above. A total of 11/118 (9.3%, 5.24/100 patient years) patients with less than 95% adherence died compared with 17/1403 (1.2%, 1.00/100 patient years) patients with at least 95% adherence. Figure 2 shows the Kaplan-Meier plot for survival of patients defined as adherent or not adherent (<95% or ≥95%).
Fig 2Kaplan-Meier plot for survival in patients defined as adherent or not adherent (<95% or ≥95% adherence)
Of the 69 people who died, the shortest time between the start of treatment and death was eight days. Of the deaths, 17 (25%) occurred within 1.3 months of starting treatment, 35 (50%) within 2.5 months of starting treatment, and 52 (75%) within 5.1 months of starting treatment. No violent deaths occurred in this cohort.
Lower mortality was associated with female sex (hazard ratio 0.70, 95% confidence interval 0.55 to 0.91, P=0.02), higher baseline CD4 count (hazard ratio per 100 cell increase 0.14, 0.06 to 0.34, P<0.0001), and at least 95% adherence (hazard ratio 0.14, 0.10 to 0.21, P<0.0001). Residence in a camp (0.39, 0.14 to 1.05, P=0.06) and age (hazard ratio per year increase 1.00, 0.99 to 1.02) were not associated with mortality outcomes.
Female sex was associated with higher CD4 cells counts at baseline (odds ratio 1.56, 1.15 to 2.13, P=0.005). Presence of tuberculosis at baseline was associated with lower CD4 counts (0.49, 0.25 to 0.95, P=0.04). Residence in a camp was not associated with CD4 counts at start of treatment (0.84, 0.58 to 1.22, P=0.34).