Initial virological and immunologic response to highly active antiretroviral therapy predicts long-term clinical outcome

Little is known about the long-term clinical outcomes for human immunodefic iency virus (HIV)-infected patients who have received highly active antiret roviral therapy (HAART). Determining factors associated with long-term clin ical outcomes early in the course of treatment may allow modifications to b e made for patients who are at a greater risk of treatment failure. To eval uate these factors, we studied 213 HIV-infected patients who had received H AART for at least 115 weeks. In the univariate analysis, virological respon se, which was measured as the change in virus load from baseline at month 3 of treatment, was the single best predictor of clinical outcome (relative hazard, 0.722; P = .001), independent of virological suppression. In the mu ltivariate analysis, virological response and immunologic response, which w as measured as an increase in CD4 cell count of > 200 cells/mm(3), resulted in better prediction of clinical outcomes than did use of either variable alone (P=.02). Our results indicate that changes in virus load and immunolo gic response together are good predictors of clinical outcome and can be as sessed after the initiation of HAART, which would allow clinicians to ident ify patients early in the course of therapy who are at greater risk of nega tive outcome.