Vaccines and Immunotherapies (VIT)
Evaluate the antiviral activity and safety of saquinavir SGC/mini-dose ritonavir once a day to that of efavirenz in HIV-positive patients.
Participants with a viral load of at least 5000 copies/ml, a CD4 cell count above 75 cells/mm3, and no more than two weeks of antiretroviral therapy were randomized in a 48-week, multicenter, open-label study to receive either saquinavir SGC1600 mg+ritonavir 100 mg once a day or efavirenz 600 mg once a day, each in combination with two nucleoside analogs.
One hundred and fifty-nine patients were enrolled internationally. The mean viral load was 4.78 log10 copies/ml in the saquinavir/rtv group and 4.72 log10 copies/ml for the efavirenz group; the mean CD4 cell count was 372 cells/mm3 and 341 cells/mm3, respectively.
The 24-week analysis revealed that 70% of the participants in the saquinavir/rtv group reached a level of viral load below 400 copies/ml compared to 82% of the participants in the efavirenz group. The percentage reaching a viral load below 50 was 60% and 78%, respectively. When only the participants remaining on treatment were analyzed, the percentage for under 400 copies/ml was 97% in the saquinavir/rtv group and 94 % in the efavirenz group; for under 50 copies/ml, 83% and 90%, respectively. The mean increase in CD4 count was 166 cells/mm3 in the saquinavir/rtv group and 144 cells/mm3 in the efavirenz group.
The saquinavir/rtv once a day therapy provided potent HIV suppression. The differences between arms observed in the intent-to-treat analysis are likely related to GI tolerability problems with the SGC formulation of saquinavir (Fortovase®). It is a convenient once daily protease inhibitor regimen.
Note: These results were taken from an abstract presented at the 41st Annual ICAAC, Chicago 2001.