Background: The high antiviral potency and low toxicity of saquinavir/ritonavir (SQV/r) prompted us to assess a viable strategy in chronic virologically suppressed HIV-infected patients.
Methods: A randomized, multicenter pilot trial. Patients taking triple HAART with (VL <50 copies/mL) and no history of virological failure with a protease inhibitor (PI) or PI-related resistance were assigned in a 2:1 ratio to receive SQV 1000 mg/ritonavir 100 mg BID (SQV/r group) or to continue with their habitual treatment (control group). Comparisons were performed using the Mann-Whitney test for medians, the t test or ANOVA for means, and the χ² or Fisher's exact test for proportions.
Results: 28 patients were randomized: 17 to the SQV/r group and 11 to the control group. Only 1 patient from the SQV/r group experienced virological failure at week 48. A similar mean increase was observed in CD4+ T-cell counts in both groups at week 48. Three patients (17.6%) from the SQV/r group prematurely interrupted the study for reasons other than virological failure. HDL cholesterol increased significantly at week 48 in the SQV/r group (from 41±11 mg/dL to 56±35, P=.026); patients in the control group showed a decrease in LDL cholesterol (from 129±37 mg/dL to 107±17, P=.028). The median (IQR) trough plasma concentrations of SQV were 760 ng/mL (379.5-1332.25 ng/mL). Three patients had saquinavir concentrations lower than 100 ng/mL.
Conclusion: SQV/r as monotherapy has proven to be a valid, safe, and economical option for virologically suppressed HIV-infected patients, especially in those who experience intolerance or toxicity with nucleoside analogs.