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1 total messages Started by Varda Ullman Novick Fri, 27 Sep 1996 00:00
Drug Combo Reduces Viral Load 99.9%
#110
Author: Varda Ullman Novick
Date: Fri, 27 Sep 1996 00:00
77 lines
4610 bytes
For Immediate Release

COMBINATION OF TWO PROTEASE INHIBITORS REDUCES HIV VIRAL LOAD BY 
99.9 PERCENT

NEW ORLEANS, September 16, 1996 -- HIV viral load was reduced by 99.9
percent (2.97 logs) with a combination of two protease inhibitors, Abbott
Laboratories' Norvir(tm) (ritonavir) and Hoffmann-La Roche's Invirase(r)
(saquinavir mesylate), according to new data presented today at the 36th
Interscience Conference on Antimicrobial Agents and Chemotherapy.  This
represents an even greater reduction in the amount of HIV RNA than was
seen in this study after six weeks, at which time viral load was reduced
by 99.6 percent (2.4 logs). 

	"These data demonstrate not only the continued antiviral effect of
this combination of two protease inhibitors, but also the enhanced
activity of the combination over time," said investigator Calvin J. Cohen,
M.D. of Community Research Initiative, New En gland. 

	The 12 week data presented today come from the first-ever study to
examine the safety and efficacy of a combination of two protease
inhibitors.  The effect on disease progression and survival is unknown. 
Six week results from this trial were presented i n July at the XI
International AIDS Conference. 

	The multi-center, open-label study randomized approximately 136
patients to one of four different treatment arms.  All patients had
baseline CD4 cell counts of 100 - 500 prior to beginning the treatment
regimens, and none had previous exposure to proteas e inhibitors. 

	In the first two treatment arms, patients received either 400 mg
Norvir(tm) plus 400 mg Invirase(r)twice daily or 600 mg Norvir(tm) plus
400 mg Invirase(r) twice daily.  After 12 weeks of treatment (n=53), the
median viral RNA level declined 99.9 percent (2.97 logs), and the median
CD4 cell count increased by 95 cells.  The changes in these two treatment
arms were similar. 

	In the third and fourth treatment arms, patients received 400 mg
of Norvir(tm) plus 400 mg Invirase(r) three times a day or 600 mg
Norvir(tm) plus 600 mg Invirase(r) twice daily.  After six weeks of
treatment (n=39), the median viral RNA level dropped by 99.3 percent (2.14
logs), and the median CD4 cell count increased by 75 cells.  Again, the
changes in the two treatment groups were similar. 

	"The response in both of these dosing regimens demonstrates that
saquinavir and ritonavir appear to work synergistically," said Cohen.
"These drugs interact in a way that clearly results in high therapeutic
blood concentrations of both agents and increas ed antiviral activity." 

	The combined regimens were generally well-tolerated, with about
seven percent of patients discontinuing.  Most of these patients were in
the three times daily 400mg ritonavir/ 400 mg saquinavir regimen.
Continuation of this treatment arm is under review. Tingling around the
mouth, diarrhea, fatigue and nausea, the most commonly reported adverse
events, were generally mild and transient in nature.  Since Norvir(tm)
interacts wit h some drugs when taken together, patients should discuss
use of other medications with their doctor. 

     The study is jointly funded by Abbott Laboratories, which developed
and manufactures Norvir(tm); and Hoffmann-La Roche, which developed and
manufactures Invirase(r). 

	The Community Research Initiative of New England (CRI/New England)
is a non-profit agency that sponsors community-based research on HIV and
AIDS.  It was created in 1989 by people with HIV and their physicians, and
researchers, activists and other health care providers.  CRI is the only
agency in New England whose sole purpose is the research of HIV/AIDS
medications and therapies.  It is a member of the Community-Based Clinical
Trials Network of the American Foundation for AIDS Research (AmFAR). 

Contact:	Jim Marko
                CRI/New England
                (617) 566-4004  ext. 20

                         
			# # #
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