Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Friday September 26 4:05 PM EDT
"What we're seeing is that long-term HIV suppression below the limit of detection is possible using nevirapine in combination with other potent AIDS drugs," remarked Julio Montaner, MD of the Canadian HIV Trial Network and lead investigator of the INCAS trial. "These data point to the potency of triple combination therapy with nevirapine and suggest that driving virus down to undetectable levels in the blood may be a key to suppression of HIV."
Results
Fifty-two week data from the INCAS (Italy, Netherlands, Canada, Australia, US) trial showed that VIRAMUNE in combination with two nucleoside analogues can reduce plasma HIV RNA levels to below the detection limits of currently available assays in more than 50% of patients with no prior antiretroviral experience. Data presented today examine five HIV-positive Canadian patients from the Vancouver trial site who reached undetectable plasma HIV RNA levels.
All were randomized to receive VIRAMUNE + AZT + ddI and continued on VIRAMUNE + AZT + (ddI or 3TC) following the one year INCAS study. Plasma HIV RNA remained below the 20 copies/mL limit of detection in all patients who have been on the triple therapy for two to three years. These patients continue to be followed to see if their plasma HIV RNA levels will remain below the limit of detection.
The median baseline plasma HIV RNA level for the five patients was 7,257 copies/mL (2,142-15,351). The median CD4+ count was 415 cells/mm (220-510).
The INCAS trial is an international, randomized, double-blind, controlled trial investigating the use of VIRAMUNE in 151 HIV-infected patients with no previous antiretroviral experience. The trial compares the triple combination VIRAMUNE (400 mg/day) + AZT (600 mg/day) + ddI (250 or 400 mg/day) vs. VIRAMUNE + AZT vs. ddI + AZT.
VIRAMUNE
VIRAMUNE, the first NNRTI to receive marketing clearance by the Food and Drug Administration, is currently indicated for use in combination with nucleoside analogues for the treatment of HIV infected adults who have experienced clinical and/or immunologic deterioration. VIRAMUNE is generally well tolerated. The most commonly reported adverse events associated with VIRAMUNE are rash, fever, nausea and headache. Severe and life-threatening skin reactions have occurred in patients treated with VIRAMUNE, including Stevens-Johnson Syndrome (SJS).
Viramune(R) (nevirapine) is marketed by Roxane Laboratories, Inc., headquartered in Columbus, OH. Viramune is a product of original research done at Boehringer Ingelheim Pharmaceuticals, Inc., located in Ridgefield, CT, which is a sister company of Roxane Laboratories, Inc.
SOURCE Roxane Laboratories
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