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| |  ROI CONFERENCE: Viracept Therapy Produces Anti-HIV Effects In Women At 12 Months LA JOLLA, CA -- Feb. 3, 1999 -- Preliminary results from an ongoing women's study, which is evaluating the safety, efficacy and tolerability of Agouron Pharmaceuticals, Inc.’s HIV protease inhibitor, Viracept(R) (nelfinavir mesylate), in women, will be presented this week at the sixth conference on Retroviruses and Opportunistic Infections in Chicago. This study, called Women First, is also evaluating the efficacy of twice daily (BID) and three times daily (TID) dosing regimens. Women typically comprise about 10 percent of participants in previous trials of antiretroviral therapy. In an ongoing study at six sites that will continue for two years, 68 HIV-infected women not previously treated with a protease inhibitor (PI naive) were randomised into two groups. The BID dosing group, with a mean baseline HIV RNA level in plasma of 4.9 log10 copies/ml, received 1,250mg Viracept BID + 1,000mg Invirase(R) (saquinavir hard gel capsules) BID + standard doses of Zerit(R) (d4T or stavudine) and Epivir(R) (3TC or lamivudine). The TID dosing group, with a mean baseline HIV RNA level in plasma of 4.8 log10 copies/ml, received the standard doses of 750mg Viracept TID + 600mg saquinavir hard gel capsules TID + standard doses of stavudine and 3TC. Similar improvements in antiviral markers were seen in an on-treatment analysis of patients from both groups who have reached the 12 month time point. At 12 months, HIV RNA in plasma was below the limit of quantification by the Roche Amplicor(TM) HIV-1 Monitor test (less than 400 copies HIV RNA/mL) in approximately 91 percent of patients (10/11) in the BID dosing group and 73 percent of patients (eight of 11) in the TID dosing group. Seventy-three percent of patients (eight of 11) in the BID dosing group and 73 percent of patients (eight of 11) in the TID dosing group achieved HIV RNA levels below the limit of quantification by an experimental ultrasensitive assay (less than 50 copies/mL) at 12 months, with mean reductions of 2.89 log10 and 2.25 log10 in those dosing groups, respectively. The Women First study is also addressing compliance issues inherent in a combination treatment regimen. Tools are used to educate patients living with HIV and to assist them in integrating the medications into their daily routines. Resources supplied to patients include pill boxes labelled with the proper dosing schedules, dosing instruction cards, patient planners, personalised graphs tracking their individual HIV RNA and CD4+ T-cell counts and bimonthly patient newsletters to provide continuing education and feedback on disease management issues. "The Women First study has been a significant opportunity for HIV-positive women to participate in a study that is specifically focused on their treatments and outcomes," said Judith Currier, M.D., Women First Principal Investigator at the University of California at Los Angeles. "This study is of unique concern to HIV-positive women and will provide insight into the use of Viracept in their daily lives." Viracept-containing combination therapy was generally well-tolerated in HIV-infected women after 48 weeks of therapy in the Women First study. In this study, diarrhea of moderate or greater severity occurred in four percent of patients. New onset or exacerbation of diabetes mellitus and hyperglycemia, as well as increased bleeding in patients with hemophilia types A and B, have 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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