AEGiS-PRn: Viracept(R) Combination Therapy Demonstrates Durable Response Following Switch From An NNRTI-Based Regimen: Treatment Failure and Tolerability Cited Most Often as Reason for Switch from NNRTI - PRNewswireImportant note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
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Viracept(R) Combination Therapy Demonstrates Durable Response Following Switch From An NNRTI-Based Regimen: Treatment Failure and Tolerability Cited Most Often as Reason for Switch from NNRTI -

PRNewswire - November 2, 2001

ATHENS, Greece, Nov. 2 /PRNewswire/ -- Agouron Pharmaceuticals, Inc. reported that VIRACEPT(R) (nelfinavir mesylate) provided a durable HIV viral load suppression, as well as an increase in CD4 cells, based on a multi-center, retrospective chart review of 234 patients living with HIV. The patients received VIRACEPT as their first protease inhibitor (PI) after switching from an initial regimen containing a non-nucleoside reverse transcriptase inhibitor (NNRTI). Results were presented this week at the 8th European Conference on Clinical Aspects and Treatment of HIV Infection in Athens, Greece.

The study consisted of a retrospective chart analysis of 234 people -- 24% women and 76% men; 40% African-American, 40% Caucasian, and 17% Latino -- who had been on a VIRACEPT-containing regimen for a least three months. 55% of the patients in this study changed from the NNRTI-based regimen to a VIRACEPT-containing regimen as a result of virologic failure and 39% due to tolerability. The mean number of years from HIV diagnosis was 11.7 years. Prior to the switch, mean time on NNRTI therapy was 8.9 months. At the time of the switch, median viral load was 6,659 copies/mL and median baseline CD4 cell count was 298 cells/uL.

Patients who switched from an NNRTI to a VIRACEPT-based regimen showed a mean viral load change of -0.98 log(10) and mean CD4 increase of 91 cells/uL. The average time spent on VIRACEPT following the switch from an NNRTI was 21 months, with 74.4% remaining on VIRACEPT at the time of analysis. Of those patients remaining on VIRACEPT, more than 60% had a viral load less than or equal to 400 copies/mL at the time of their most recent visit.

"With the growing need to provide antiretroviral treatment-experienced patients with additional therapeutic choices, the use of nelfinavir in second- line regimens merited further study," said Cal Cohen, MD, research director of the Community Research Initiative of New England and clinical instructor at Harvard Medical School in Boston. "Regimens using nelfinavir as the initial PI for patients who have failed their first NNRTI regimen are an important option."

VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The recommended dosage for VIRACEPT is 1250 mg (five 250 mg tablets) twice a day or 750 mg (three 250-mg tablets) three times daily. VIRACEPT has been shown to be generally well tolerated. The most commonly reported side effect attributable to VIRACEPT is diarrhea.

VIRACEPT is metabolized primarily by the liver. Therefore, caution should be exercised when administering VIRACEPT tablets to patients with impaired hepatic function. Redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy. The cause and long-term health effects of these conditions are not known at this time. Increased bleeding in patients with hemophilia, as well as diabetes mellitus and hyperglycemia, have been reported with protease inhibitors.

VIRACEPT should not be used with certain medications. Taking certain other prescription and nonprescription drugs and supplements with VIRACEPT could create the potential for serious side effects that could be life-threatening. In addition, some drugs may markedly reduce VIRACEPT plasma concentrations, resulting in suboptimal antiviral activity and subsequent emergence of drug resistance. Patients should always talk to their physician or healthcare provider before starting new medicines. HIV drugs do not cure HIV infection or prevent individuals from spreading the virus.

Agouron Pharmaceuticals, Inc., a Pfizer Company (NYSE: PFE), is committed to the discovery, development, and marketing of innovative therapeutic products engineered to inactivate proteins that play key roles in cancer, AIDS, and other serious diseases. Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best known over-the-counter brands.

For further information about Agouron Pharmaceuticals, Inc., or about VIRACEPT, please see Agouron's website at http://www.agouron.com, or dial toll free 1-888-VIRACEPT (847-2237).

VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron Pharmaceuticals, Inc.


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