Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Saturday September 26, 1998
"These results suggest that a twice-daily regimen of FORTOVASE has similar potency to its standard three-times-daily dosing, and offers greater convenience," said Cal Cohen, MD, MSc, of the Community Research Initiative of New England, Boston, MA, and principal investigator in the TID-BID study. "As the importance of adherence to therapy becomes more evident, we are obliged to find easier, more convenient treatment regimens for people with HIV/AIDS."
TID-BID (NR15520) is a randomized, multicenter study in 93 sites in five countries designed to compare the efficacy of FORTOVASE, the 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.
At full accrual, a total of 825 antiretroviral naive or nucleoside- experienced patients with more than 5,000 copies of HIV-RNA/uL of blood will be randomized to receive: FORTOVASE 1600 mg BID or FORTOVASE 1200 mg TID, 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.
Preliminary data on the 242 patients for whom 24-week data are available show that 69 percent of the patients in the FORTOVASE BID group had viral loads below the level of quantification, compared with 74 percent in the FORTOVASE TID group and 78 percent in the dual protease group. The CD4 cell count increases from baseline were 147 cells/mm3 for the FORTOVASE BID group, compared with 153 cells/mm3 in the FORTOVASE TID arm and 155 cells/mm3 in the dual arm.
Each regimen was generally well-tolerated. The most frequently reported adverse events associated thus far with study drug, and of moderate to severe intensity in greater than 5 percent of study participants, are diarrhea (seven percent in the FORTOVASE BID arm; six percent in the FORTOVASE TID arm; 17 percent of patients in the dual protease protease arm); nausea (no patients in the FORTOVASE BID arm; 12 percent of patients in the FORTOVASE TID arm; and five percent in the dual protease arm); and headaches (no patients in the FORTOVASE BID; eight percent of patients in the FORTOVASE TID arm; and no patients in the dual protease arms). Of the 18 serious adverse events reported through week 24, only one, diarrhea, was related to study drug.
In other clinical trial experience, adverse events of at least moderate intensity occurred at similar rates for patients who received treatment regimens consisting of FORTOVASE and two nucleoside analogues. In NV15355, patients experienced diarrhea (15.6%), nausea (17.8%), and headaches (8.9%). Additionally, an exacerbation of chronic liver dysfunction has been reported in patients taking FORTOVASE. 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: Amy Sunshine 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: Hoffman-La Roche Inc.
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