Statistical analysis
deaths, HHV-8 and HIV VL
EVENT
The sample size was calculated for a study power of 80% and an alpha of 0.05, with an estimated event rate (Severe-IRIS-KS-associated deaths) in the control group of 40%, and in the treated group of 5%. The sample number estimated in each group was 19, for a total of 38 patients.Descriptive statistics were performed, including the number of deaths, and the number of participants with Severe-IRIS-KS, in the CG and EG groups. Comparisons between EG and CG were performed as intention-to-treat (ITT), and as per-protocol analysis, for the primary outcome of mortality attributed to Severe-IRIS-KS by a Fisher´s exact test, and also comparing survival curves by Log-rank test. We also compared the EG and the CG groups by a Fisher´s exact test on the incidence of Severe-IRIS-KS, on overall mortality, and mortality in patients with pulmonary KS. During the study, we observed that some individuals had more than one Severe-IRIS-KS episode during the 48 weeks of follow-up, so we also compared the total number of Severe-IRIS-KS episodes in each group.The impact of treatment and time on IL-6, IL10, HHV-8 viral load, and C reactive protein were evaluated by fitting linear mixed effect models, and the impact of some covariates (baseline CD4+, CD4+/CD8+ cell ratio, HHV-8 and HIV VL, plasmatic IL-6, CRP, and by the presence of concomitant coinfections) on outcomes by fitting multivariate Poisson models. Analyses were performed using Stata Statistical program.