Clinical Study Indicates Patients Who Fail VIRACEPT(R) Therapy Are Not Excluded From Other Treatment Options
February 4, 1998 08:01 AM
LA JOLLA, Calif., Feb. 4 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. AGPH today reported positive results in patients who, after failing treatment with VIRACEPT(R) (nelfinavir mesylate), were treated with other protease inhibitors and experienced favorable anti-HIV responses. Results from the multicenter study were presented at the 5th Conference on Retroviruses and Opportunistic Infections in Chicago.
Pablo Tebas, M.D., from Washington University in St. Louis, MO, reported an evaluation of 26 patients from key clinical trials of VIRACEPT (studies 506 and 511) who had received VIRACEPT for an average of 55 weeks prior to experiencing virologic failure (two consecutive HIV viral RNA assays >5000 copies/mL). These patients were then switched to a combination of 400mg Norvir(TM) (ritonavir) BID (twice daily) + 400mg Invirase(R) (saquinavir hard gel) BID + 40mg Zerit(R) (d4T or stavudine) BID and 150mg Epivir(R) (3TC or lamivudine) BID. Of the 26 patients, 21 had received antiretroviral therapy before receiving treatment with VIRACEPT.
Twenty-four weeks after switching from VIRACEPT, 68% of patients (13/19) had viral loads (the amount of HIV in plasma) below the limit of detection using the bDNA assay (a branch DNA-based assay with a lower limit of quantification of <500 HIV RNA copies/mL). Two patients discontinued the study during the first four weeks due to GI intolerance.
Genotypic analyses were conducted on virus from 16 of the patients prior to their switching from VIRACEPT therapy. The most frequently observed mutations were D30N (the mutation commonly associated with resistance to VIRACEPT) in 11 of the patients, and L90M (a mutation commonly associated with resistance to saquinavir) in 5 patients. No increase in risk of virologic failure was observed for patients with the L90M mutation at baseline.
The most commonly observed adverse event of moderate or greater severity in clinical trials of VIRACEPT was diarrhea, 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, 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 analogs 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.
Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical company committed to discovery, development, manufacturing, and marketing of small molecule drugs engineered to inactivate proteins that play key roles in cancer, AIDS, and other serious diseases.
For further information about Agouron Pharmaceuticals, Inc., or about VIRACEPT, please see Agouron's website at agouron.com or dial toll free 1-888-VIRACEPT (847-2237). To receive full prescribing information for VIRACEPT via fax, dial 1-888-288-9639.
WIRES: Full prescribing information for VIRACEPT to follow.
VIRACEPT(R) is a registered trademark of Agouron Pharmaceuticals, Inc. Norvir(TM) is a trademark of Abbott Laboratories. Invirase(R) is a registered trademark of Roche Laboratories Inc. Zerit(R) is a registered trademark of Bristol-Myers Squibb Company. Epivir(R) is a registered trademark of Glaxo Wellcome Oncology/HIV.
SOURCE Agouron Pharmaceuticals, Inc.
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