Baseline HIV‐1 RNA Level and CD4 Cell Count Predict Time to Loss of Virologic Response to Nelfinavir, but Not Lopinavir/Ritonavir, in Antiretroviral Therapy–Naive Patients

Abstract

Baseline CD4 cell counts and human immunodeficiency virus (HIV)-1 RNA levels have been shown to predict immunologic and virologic responses in HIV-infected patients receiving antiretroviral therapy. In our randomized, double-blind, comparative trial, 653 antiretroviral therapy-naive patients received lopinavir/ritonavir or nelfinavir, plus stavudine and lamivudine, for up to 96 weeks. The risk of loss of virologic response was significantly higher for nelfinavir-treated patients than for lopinavir/ritonavir-treated patients (Cox model hazard ratio, 2.2; 95% confidence interval, 1.7–3.0; P <.001). For nelfinavir-treated patients, but not for lopinavir/ritonavirtreated patients, higher baseline HIV-1 RNA levels and lower baseline CD4 cell counts were associated with a higher risk of loss of virologic response.