Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - November 2, 2001
Originally, 99 patients were randomized to receive VIRACEPT 750 mg TID in Agouron study 511. Of those, 56 qualified and entered the long-term extension study. Patients were eligible to enter the LTE if their plasma HIV RNA was <5000 copies/mL after completion of the initial 48-week study. LTE patients had a mean CD4 cell count of 310 cells/uL and a mean of 204,000 copies/mL of plasma HIV RNA.
In an on-treatment analysis of the LTE patients after four years of VIRACEPT treatment, 94.4% (34/36) of the patients had plasma HIV RNA levels <400 copies/ mL, and 86.1% (31/36) had plasma HIV RNA levels <50 copies/ mL. By intent-to-treat (NC=F) analysis, 61.8% (34/55) of these patients had a plasma HIV RNA level of <400 copies/mL, and 56.4% (31/55) had a plasma HIV RNA level of <50 copies/mL. During the same period, patients also experienced a mean increase of 403 CD4 cells/uL.
Diarrhea was the most commonly reported side effect in the study. In year 4, only 3.6% (2/56) of the patients experienced treatment-related diarrhea of moderate severity or greater, compared to 14.3% (8/56) during the initial year of the study. In general, treatment was well-tolerated by the majority of patients. All adverse events decreased markedly after the first year of the study. Of the 19 patients who withdrew from the study over the course of the LTE, six were due to protocol-defined failure, four were lost to follow-up, and nine withdrew due to reasons unrelated to the study drug. There were no withdrawals from the study due to drug toxicity.
"Long-term durability and tolerability are essential to the success of any antiretroviral therapy prescribed for people living with HIV," said Joseph Gathe, MD, chief investigator, Montrose Clinic, Houston, TX. "VIRACEPT in combination with AZT and 3TC proves effective and safe among those who remain on therapy over an extended period of time."
VIRACEPT(R) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. The recommended dosage for VIRACEPT is 750 mg (three 250-mg tablets) three times daily, or 1250 mg (five 250 mg tablets) twice a day. 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 VIRACEPT, please see Agouron's website at http://www.agouron.com, or call toll free 1-888-VIRACEPT (847-2237).
VIRACEPT(R) and Agouron(R) are registered trademarks of Agouron Pharmaceuticals, Inc.
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