Outcomes of the trial: Mortality and severe-IRIS-KS events.
EVENTS, EVENT, REMISSION
**similar results in per protocol analysis with 18 patients in the EG and 19 in the CG.*Incidence rate was the number of IRIS-KS events (could be more than one per patient in the control group) divided by the total days of observation, 5255 in the control group and 5657 in the experimental group.In the per-protocol analysis, we included 37 patients, 19 in the CG (one patient abandoned the protocol on week 12) and 18 in the EG (one patient died three days after randomization and another stopped valganciclovir on week 8.Valganciclovir did not reduce significantly the number of patients with at least one Severe-IRIS-KS episode, 2/18 in the EG and 4/19 in the CG (P = 0.66), Fisher´s exact test) as depicted in Four patients developed 12 episodes of Severe-IRIS-KS in the CG Incidence Rate (IR) (0.21 per 100 patient-observation days) and two patients developed one episode each in the EG (IR 0.038 per 100 patient-days, IRR 0.20, 95%CI 0.04–0.9, In a multivariate Poisson model, a higher HHV8 Log10 viral load (IRR 1.5, 95%CI 1.2–2.0, p = 0.002), IL6 (IRR 1.07, 95%CI, 1.02–1.12, p = 0.004) and CRP at baseline (IRR 1.1, 95%CI 0.96–1.27) increased the risk to develop Severe-IRIS-KS and valganciclovir use significantly decreased the risk of Severe-IRIS-KS occurrence (adjusted IRR = 0.05, 95%CI 0.003–0.6 p = 0.02) (We performed a linear mixed effect model analysis for longitudinal data for 4 variables IL-6, IL10, HHV-8 viral load, and CRP; the impact of treatment was not significant, at the p<0.05 level and with time, only CRP decreased significantly (P = 0.034).Of the nine patients with pulmonary KS, three of the four in the CG group died of Severe-IRIS-KS, whereas none of the five patients in the EG died (Fisher´s exact test, p = 0.048). No difference was found in the occurrence of non-severe-IRIS-KS events: 15 in the EG (from 7 patients) and 17 in the CG (from 8 patients) and eight patients in each group did not develop any IRIS event.There were no differences in the number of patients receiving or the number of cycles of vincristine/bleomycin administered. Seven patients in each group did not receive chemotherapy, four in each group had one cycle, eight had two cycles (CG = 3; EG = 5), three patients had three cycles (CG = 2; EG = 1), one patient had four cycles CG and three patients received five cycles (CG = 2; EG = 1).At week-48 follow-up 33 patients were alive and one CG was lost to follow-up. There were no group differences in remission rates; 12 (36.3%) achieved complete remission (six in each group); 15 (45.4.7%) achieved 80–95% remission (CG = seven, EG = eight); and six (18%) 50–70% remission (three in each group). We did not document any relapses or non-responders.