AIDS Treatment Update, Issue 55, July 1997
Keith Alcorn
The 3591 participants in the trial, code-named SV14604, had CD4 counts of about 200 and had not previously taken anti-HIV drugs (or less than 16 weeks of prior AZT use). They were originally assigned to receive either AZT alone, AZT/ddC, AZT/saquinavir or AZT/ddC/saquinavir. Following the results of the Delta and ACTG 175 studies, people receiving AZT were switched to the triple combination.
In the primary analysis comparing people who started on the triple combination with those who started on AZT/ddC, the risk of progressing to a first AIDS-defining event or death was reduced by 50% in the triple combination group (76 cases versus 142 in the AZT/ddC arm).
The release of these results coincided with the publication of the US treatment guidelines which also endorse the use of triple combinations that include a protease inhibitor as initial treatment. However, the guidelines recommend indinavir, ritonavir or nelfinavir - and specifically not saquinavir - as the best protease inhibitors to choose between when starting treatment, noting that "the current hard gel capsule formulation of saquinavir is not recommended due to poor bioavailability". Last month, New York's Treatment Action Group published a scathing critique of saquinavir's development and the alleged inadequacies of the current formulation on the Internet at http://www.aidsnyc.org/tag/sqv.html.
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