The absence of hyperbilirubinaemia is highly predictive of treatment failure in advanced HIV-infected patients treated with indinavir

In order to determine prognostic factors associated with treatment failure (TF) in advanced HN-infected patients treated with a regimen including indi navir, a prospective cohort study of 80 patients was set up between 1 March and 31 December 1996. TF time was calculated using the Kaplan-Meier method , from treatment induction to the first of the following events: treatment modification for adverse event or lack of significant virological and/or im munological response, AIDS-defining diagnosis or death. Date of point was 3 1 December 1998. Multivariate analysis was performed using a Cox model. At baseline, 60% of the patients were AIDS-free, median viral load and CD4(+) count were respectively 4.8 log/ml and 79/mul. After a median follow-up of 26 months, 70% of the patients experienced a TF in a median time of 8 month s. Seventy-two per cent presented an hyperbilirubinaemia (>2 mg/dl). In mul tivariate analysis, initial AIDS stage (hazard ratios [HR]=1.94, P=0.04) an d digestive intolerance (HR=2.32, P=0.003)were predictive of TF. Conversely , hyperbilirubinaemia was associated with a better outcome (HR=0.35, P<0.00 01). These 2 latter parameters very likely reflected patients' treatment co mpliance.