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| |  ROI CONFERENCE: Patients Respond To Protease Inhibitor Treatment After Viracept Failure LA JOLLA, CA -- Feb. 2, 1999 -- Researchers reported plasma HIV RNA levels below the level of quantification (less than 500 copies/mL, experimental Chiron bDNA assay) at a median follow-up of 60 weeks in a majority of patients who, after failing treatment with Agouron Pharmaceuticals Inc.’s Viracept(R) (nelfinavir mesylate) in combination therapy, were treated with other protease inhibitors in combination therapy. Results will be presented by investigators this week at the sixth conference on Retroviruses and Opportunistic Infections in Chicago. Pablo Tebas, M.D., from Washington University in St. Louis, MO., reported an evaluation of 24 patients who had failed (defined as two consecutive measurements of greater than 5,000 copies HIV RNA copies/mL by the experimental Chiron bDNA assay) a regimen of Viracept in combination with standard doses of reverse transcriptase inhibitors and were then switched to a combination of 400mg Norvir(R) (ritonavir) BID (twice daily) + 400mg Invirase(R) (saquinavir hard gel) BID + 40mg Zerit(R) BID + 150mg Epivir(R) BID. Twenty patients had received antiretroviral therapy before receiving treatment with Viracept, and the median duration of prior Viracept use for all patients was 48 weeks. All patients (24/24) experienced an initial response to the new protease inhibitor-containing regimen, achieving HIV RNA levels below the limit of quantification (less than 500 HIV RNA copies/mL, experimental Chiron bDNA assay). At a median follow-up interval of 60 weeks (40 to 98 weeks), 58 percent (14/24) maintained plasma HIV RNA levels below the limit of quantification in an intent-to-treat analysis (last observation carried forward). Patients with baseline viral HIV RNA levels greater than 30,000 copies/mL were less likely to preserve levels below the limit of quantification. The HIV protease mutations D30N, N88D, or M36I observed in some patients before switching therapy did not preclude initial response to treatment. The most commonly observed adverse event of moderate or greater severity in clinical trials of Viracept was diarrhea (10 to 30 percent of patients), which was generally controlled with over-the-counter medications. New onset or exacerbation of diabetes mellitus and hyperglycemia, as well as increased bleeding in patients with hemophilia types A and B, has been reported with protease inhibitors. Viracept is indicated for the treatment of HIV infection when antiretroviral therapy is warranted. This indication is based on analyses of surrogate marker changes in patients who received Viracept in combination with nucleoside analogues or alone for up to 24 weeks. At present, there are no results from controlled trials evaluating the effect of therapy with Viracept on clinical progression of HIV infection, such as survival or the incidence of opportunistic infections. Related Links: Viracept, Agouron Pharmaceuticals Inc.
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