| HIGHLIGHTS FROM ICAAC
�97 Largest AIDS
Trial of Triple Combination Therapy with INVIRASE�
PISCES (SV 14604)
Data from the Protease Inhibitor with Saquinavir Clinical
Endpoints Study, or PISCES, presented from the largest-ever clinical trial involving
anti-HIV therapies, conclusively shows that treating people with HIV/AIDS with a
combination of three drugs suppresses viral load, increases CD4 cell counts and extends
survival when compared to combinations of only two drugs.
PISCES, also known as SV 14604, showed that the combination
of INVIRASE, HIVID (zalcitabine, or ddC) and AZT delayed disease progression and prolonged
survival in treatment-naive patients by an additional 50 percent compared with HIVID plus
AZT alone.
Treatment for HIV in the early days of the epidemic
consisted of AZT monotherapy. More recently, two major studies (Delta and ACTG 175) showed
that the addition of ddC or ddI to AZT greatly improved clinical outcome. The PISCES study
results are the latest milestone in HIV treatment, proving conclusively what many HIV
treating physicians have suspected for years. PISCES shows the dramatic benefit of
combining INVIRASE with HIVID and AZT -- a 50 percent reduction in the onset of AIDS.
Importantly, the PISCES findings reflect the additional
clinical benefits of including INVIRASE in a combination regimen, over and above the
effects of the ddC and AZT combination alone which were already proven to work well in the
Delta and ACTG 175 studies.
INVIRASE Effective in Heavily Pre-treated
Individuals with HIV/AIDS
A study of heavily pre-treated individuals with advanced
HIV disease has shed new light on the use of INVIRASE. At baseline, the 100 participants
studied, 61 percent of who were intravenous drug users, had a median CD4 count of 184 and
a median viral load of 4.26 log10.
In addition to INVIRASE, 83 percent of subjects studied
were also treated with nucleoside analogue therapy. Participants experienced an increase
in CD4 counts to 223 at 3 months, 260 at 6 months, and 257 at 9 months. Median viral load
fell to 3.1 log10 at 1 month, 2.8 log10 at 3 months, 2.4 log10 at
6 months, and 2.6 log10 at 9 months.
In addition, the study compared data for participants
receiving INVIRASE therapy with two groups: subjects undergoing therapy with indinavir and
others undergoing therapy with ritonavir. The study did not find significant differences
between the groups when measuring CD4 counts or viral load at 3, 6, or 9 months.
Significantly more participants on ritonavir had to be switched to another therapy due to
intolerance -- INVIRASE, however, was well-tolerated.
The study investigators concluded that INVIRASE is an
effective therapy in heavily pre-treated, HIV-infected individuals, especially if those
patients have CD4 counts higher than 100.
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