Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PR Newswire; Monday June 29, 9:27 am EST
"Providing potent, convenient and easily-tolerated therapies to people with HIV is critical to long-term treatment success," said Calvin Cohen, MD, MSc, of the Community Research Initiative of New England, Boston, MA, and principal investigator in the TID-BID study. "These preliminary results suggest that a twice-daily regimen of FORTOVASE has similar potency to its standard three-times-daily dosing, and offers much greater convenience."
TID-BID (NR15520) is a randomized, multicenter study in 93 sites in five countries designed to compare the efficacy of FORTOVASE, the new, soft gel formulation of saquinavir, in twice-daily and three-times-daily treatment regimens.
The ongoing study compares the virologic response of each regimen with respect to the percentage of patients whose viral load falls below the level of detection after 48 weeks of therapy.
More than seven hundred antiretroviral naive or nucleoside-experienced patients with more than 5,000 copies of HIV-RNA/uL of blood were randomized to receive: FORTOVASE(TM) 1200 mg TID or FORTOVASE 1600 mg BID, each in combination with two nucleosides of choice, or FORTOVASE 1200 mg BID + Viracept(R) (nelfinavir mesylate) 1250 mg BID + one new nucleoside of choice. Data are currently available on 242 patients who have reached sixteen weeks. For this group of patients, patients in all three arms had a mean baseline viral load of approximately 50,000 copies/uL. Mean CD4 cell counts for each of the arms were: 307 cells/mm3 for FORTOVASE TID (n=84), 366 cells/mm3 for FORTOVASE BID (n=81), and 335 cells/mm3 for FORTOVASE + Viracept (n=77).
Preliminary data on the 242 patients for whom sixteen-week data are available show that 75 percent of the patients in the FORTOVASE BID group had viral loads below the level of quantification, compared with 79 percent in the FORTOVASE TID group and 69 percent in the dual protease group. The CD4 cell count increases from baseline were 146 cells/mm3 for the FORTOVASE BID group, compared with 122 cells/mm3 in the FORTOVASE TID arm and 138 cells/mm3 in the dual protease arm. Each regimen was generally well-tolerated. The most frequently reported adverse events associated with study drug, and of moderate to severe intensity in greater than 5 percent of study participants, are diarrhea (14 percent of patients in the dual protease arm); nausea (8 percent of patients in the FORTOVASE TID arm, 5 percent in the dual protease arm); and headaches (7 percent of patients in the FORTOVASE TID arm). The 14 serious adverse events and one death reported were unrelated to study drug. An exacerbation of chronic liver dysfunction has been reported in patients taking FORTOVASE(TM). There have also been reports of hyperglycemia or diabetes, and spontaneous bleeding in patients with hemophilia associated with the use of protease inhibitors.
About Roche Laboratories Inc.
Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intensive pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology.
For further information about FORTOVASE(TM)
Patients can call: 800-910-4687
Healthcare professionals: 800-526-6367
Roche HIV Therapy Assistance Program: 800-282-7780
FORTOVASE Website: http://www.fortovase.com
For a copy of the FORTOVASE product package insert with complete prescribing information please call: Jeff Winton at 973-562-2373. FORTOVASE(TM) is a trademark of Hoffmann-La Roche Inc. Viracept(R) (nelfinavir mesylate) is a registered trademark of Agouron Pharmaceuticals Inc.
SOURCE: Roche Laboratories Inc.
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