Saquinavir/ritonavir monotherapy as a new nucleoside-sparing maintenance strategy in long-term virologically suppressed HIV-infected patients.
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.


CONCLUSIONS
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.
Patricia
Echeverria
E
Germans Trias i Pujol University Hospital, Barcelona, Spain. pecheverria@flsida.org
Domingo
Pere
P
Gutierrez
Mar
M
Gracia
Mateo
M
Fuster
Monse
M
Molto
José
J
Puig
Jordi
J
Perez-Alvarez
Nuria
N
Clotet
Bonaventura
B
Negredo
Eugenia
E
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000493:pharmacokinetics / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019438:Ritonavir / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019258:Saquinavir / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013030:Spain
D017320:HIV Protease Inhibitors; D019258:Saquinavir; D019438:Ritonavir