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Report from ICAAC:
Ritonavir+Saquinavir combination study
12 week data
In Vancouver, the initial 6 weeks of efficacy and safety data were presented from this small (about 30 individuals per regimen) pilot open-label study for 2 of the 4 dosing regimens being explored in this study. Those taking 400 mg ritonavir bid + 400 mg saquinavir bid experienced about a 2.14 log RNA reduction and about a 70 CD4 increase from baseline after 6 weeks; about 50% of this group had undetectable RNA (under 200 copies/ml as measured by Roche PCR). Those subjects taking 600 mg ritonavir bid + 400 mg saquinavir bid experienced about a 2.42 log reduction and a 115 CD4 increase from baseline after 6 weeks; about 65% of this group had undetectable RNA (lower limit of measure--200 copies/ml). The side effect profile did not appear to be any different than that for ritonavir monotherapy. The discontinuation rate was relatively low. Refer to the post-Vancouver NATAP report of saquinavir+ritonavir for more comprehensive details.
At this meeting, 12 weeks of efficacy and safety data were presented for the two afore-mentioned dose regimen groups, and 6 weeks of data were presented for 2 additional dose regimen groups. Those taking 400 mg ritonavir bid + 400 mg saquinavir bid experienced about a 2.74 RNA reduction and an 91 CD4 increase from baseline after 12 weeks; about 75% had undetectable RNA (lower limit of measure--200 copies/ml). Those taking 600 mg ritonavir bid + 400 mg saquinavir bid experienced a 3.06 RNA reduction and 113 CD4 increase from baseline after 12 weeks; about 70% had undetectable RNA (below 200 copies/ml). There was a difference in the baseline RNA between these 2 dose regimen groups; this could account for the differential in % undetectable between the 2 groups. The baseline RNA numbers are available in the NATAP post-Vancouver report of this combination.
For the 2 additional dose regimen groups, the first 6 weeks of data were presented. Those taking 400 mg RTV tid (3X/day) + 400 mg tid SQV experienced a 2.09 RNA log reduction and 74 CD4 increase from baseline after 6 weeks; about 30% had undetectable RNA at 6 weeks. Those taking 600 mg RTV + 600 mg SQV experienced a 2.19 RNA log reduction and an 88 CD4 increase from baseline after 6 weeks; about 45% had undetectable RNA (below 200 copies).
The differences between treatment regimens in the above RNA and CD4 responses were not statistically significant. It is still uncertain which of the 4 dose regimens may be superior. The tid regimen appears to cause more side effects and therefore may be the least preferable. But, the efficacy data for all the groups is similar. We do not yet know the longer term durability of these benefits nor the longer term safety profile. Follow-up studies utilizing the combination of saquinavir+ritonavir in 4-drug regimens are planned. Even a 5-drug therapy may be planned.
Discontinuations-- 9 in total, but 5 from the 400+400 tid group. Individuals taking this tid regimen will be offered a bid regimen. Asymptomatic triglyceride elevations have been observed and ought to be followed for individuals taking ritonavir+saquinavir.
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About the author: Jules Levin is the Executive Director of NATAP, based in New York City.
The National AIDS Treatment Advocacy Project (NATAP) is a New York State non-profit corporation dedicated to facilitating the effort for development of effective treatment for HIV.
Last modified 9/17/96
by Jules Levin
Copyright © 1996 natap
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