AEGiS-GMHC: A Kinder, Gentler ddC. . . For $7,200 a Year

Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

A Kinder, Gentler ddC. . . For $7,200 a Year

GMHC Treatment Issues - Vol. 9, No. 12 - December 1995

Following its advisory committee recommendation (see last month's Treatment Issues), the Food and Drug Administration in December granted the first formal approval for a protease inhibitor to Hoffmann-La Roche's saquinavir (brand name: Invirase). The drug now can be marketed for use in individuals with "advanced HIV disease" in combination with approved nucleoside analogs such as AZT and ddC.

Side effects from saquinavir are relatively minor, but as the accompanying graph shows, the improvement in CD4 counts from Invirase by itself is very small and short-lived. Invirase performs no better than ddC, which itself has a minor effect. (The graph is from the preliminary analysis of 451 evaluable volunteers in a large ongoing trial of saquinavir and ddC in people with long prior AZT treatment.) By the sixteenth week, CD4 counts for both drugs used as monotherapy are below their pretreatment values. As for antiviral impact, ddC has a greater effect (based on the same trial). ddC yields a stable 50 percent decline in plasma HIV compared to a stable nine percent decline for saquinavir.

Saquinavir's main advantage is that it is a relatively benign way of slightly boosting the mediocre performance of nucleoside analogs, as the graph's top curve shows. But the retail price is $7,200 per year!

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