| HIGHLIGHTS FROM ICAAC
�97 INVIRASE�
Combinations Decrease HIV Viral Load
Saquinavir in Combination with AZT/3TC
and Ritonavir: A Convenient BID Regimen
Data presented this week show that treating
HIV infection with a four-drug, twice-daily combination regimen including INVIRASE� (saquinavir
mesylate) produced dramatic, sustained reductions in levels of HIV RNA, a key indicator of
viral activity.
Dr. Andrew Talal of the Aaron Diamond AIDS
Research Center, New York, presented preliminary data from a study involving twelve
subjects treated with INVIRASE + ritonavir + AZT + 3TC in twice-daily doses. Among the ten
subjects remaining in the study at week 32, the mean reduction in HIV RNA was 3.41 log10
and the mean increase in CD4 was 64.
This study is particularly important because
it included drugs that participants took twice a day � currently, many people with
HIV/AIDS face extremely complex dosing regimens that are very difficult to adhere to,
raising the possibility of the emergence of drug-resistant HIV strains.
Subjects at baseline had a mean HIV RNA of 4.97 log10
with a mean CD4 count of 342. The study will continue with aggressive tissue sampling at
one year to document viral clearance from various body compartments, an important measure
of the long-term ability of anti-HIV treatments to attack the disease throughout the body.
Impact of INVIRASE + Ritonavir + d4T
A second study found a dramatic impact on HIV RNA viral
load with the combination of INVIRASE + ritonavir + d4T and provided further insights into
the use of INVIRASE in combination with other antiretroviral therapies. Dr. Manuel
Battegay of the University Hospital of Basle, Switzerland and Dr. Pietro Vernazza of the
Institute for Clinical Microbiology and Immunology, St. Gallen, Switzerland, presented
data from the M61001 study evaluating the safety and efficacy of INVIRASE + ritonavir +
d4T, as well as the combination�s virologic effect. This open label study has
enrolled 38 subjects who were protease inhibitor- and d4T-na�ve with <250 CD4 cells
and HIV RNA � 10,000. The baseline HIV RNA was 5.14 log10 and CD4 count was
80.
Data available for seven subjects at week 9 show a mean
viral load drop of 2.65 log10 to below the level of detection in six of seven
subjects, and a CD4 count increase of 95. These preliminary data confirm that this regimen
results in a potent viral load response in a high percentage of subjects with advanced HIV
disease and that virologic phenotype at baseline does not appear to influence the effect
of this therapy.
Table of Contents |
