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"These data suggest that the combination of Norvir/Invirase reduces the virus harbored in the CSF," says Charles Farthing, M.D., AIDS Healthcare Foundation, and an investigator in the study. "This finding is another positive step in the fight against HIV."

These data come from an ongoing, multi-center, open-label study which randomized 141 protease inhibitor-naive patients to one of four different treatment arms. Of the patients who had reached 48 weeks of therapy, approximately 90% had undetectable plasma HIV RNA (less than 200 copies/mL). Thirteen patients with undetectable plasma HIV RNA (less than 200 copies/mL) after a median treatment duration of 60 weeks had CSF analysis performed. Twelve of these patients had undetectable CSF HIV RNA (less than 400 copies/mL). The median baseline plasma HIV RNA for this group was 5.7 x 104 copies/mL. The clinical significance of HIV RNA in CSF is unknown.

All regimens were generally well-tolerated. The most commonly reported adverse events were tingling around the mouth, diarrhea, fatigue and nausea. Patients with underlying liver disease may have a higher risk of liver enzyme abnormalities on this regimen.

Additional Norvir Information

Norvir is indicated in adults in combination with nucleoside analogues or as monotherapy for the treatment of HIV-infection when therapy is warranted. For patients with advanced HIV disease, this indication is based on the results from a study that showed a reduction in both mortality and AIDS- defining clinical events for patients who received Norvir. Median duration of follow-up in this study was six months. The clinical benefit from Norvir therapy for longer periods of treatment is unknown.

For patients with less advanced disease, this indication is based on changes in surrogate markers in studies evaluating patients who received Norvir alone or in combination with other anti-retroviral agents.

The most frequently reported adverse events among adult patients receiving 600 mg Norvir twice daily were asthenia (weakness), nausea, vomiting, diarrhea, anorexia (loss of appetite), abdominal pain, taste disturbance and tingling sensation or numbness around the mouth or limbs. Frequently observed adverse events, such as mild-to-moderate gastrointestinal disturbances or tingling or numbness around mouth or limbs, may diminish as therapy is continued.

Co-administration of Norvir with certain non-sedating antihistamines, sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events.

Norvir can produce large increases in plasma concentrations of certain highly metabolized drugs. Therefore, large dosage reductions (less than 50%) and/or increased monitoring of therapeutic drug concentrations and clinical response may be required for drugs extensively metabolized by the liver.

Additional Invirase Information

Invirase is indicated in combination with nucleoside analogues for the treatment of HIV infection when therapy is warranted. This indication is based on results from studies of surrogate marker responses and from a clinical study that showed a reduction in both mortality and AIDS-defining clinical events for patients who received Invirase in combination with Hivid compared to patients who received either Hivid or Invirase alone. In clinical studies, Invirase was well tolerated by most patients and reported adverse events were mostly of mild intensity. The most frequently reported adverse events, at least possibly related to Invirase treatment and of at least moderate intensity, include diarrhea (3.8 percent), abdominal discomfort (1.3 percent) and nausea (1.9 percent).

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 54,000 people and markets its products in more than 130 countries. In 1996, the company's sales and net earnings were $11.0 billion and $1.9 billion, respectively, with earnings per share of $2.41.

Abbott's news releases and other information are available on the company's web site at http://www.abbott.com. Further information is available at http://www.norvir.com.

Roche Laboratories Inc. is the marketing and sales subsidiary of Hoffmann-La Roche Inc., a leading research-intensive pharmaceutical company. Roche Laboratories markets more than 35 medications in major therapeutic areas including AIDS, oncology, transplantation, infectious diseases, cardiovascular diseases and dermatology.

SOURCE Abbott Laboratories

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