Triple Therapy Benefits with Norvir for AIDS/HIV Sustained at 60 Weeks
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Triple Therapy Benefits with Norvir for AIDS/HIV Sustained at 60 Weeks

VANCOUVER, July 8, 1996 -- Abbott Laboratories' (NYSE: ABT) protease inhibitor Norvir (ritonavir), in combination with the nucleoside analogues AZT and ddC, sustained its demonstrated potent antiviral activity against the AIDS virus after 60 weeks of treatment, according to research presented today. The findings, presented at the 11th International Conference on AIDS in Vancouver, British Columbia, are the latest data from a continuing study of this combined regimen in patients with advanced AIDS, first presented in February 1996 at the Third Conference on Retroviruses and Opportunistic Infections in Washington, D.C.

In the open-label study, conducted at five investigational sites in France, 17 patients with advanced, previously-untreated HIV infection and CD4 cell counts of fewer than 250 cells received a combined regimen of 1,200 mg Norvir, 600 mg AZT and 2.25 mg of ddC daily and were followed for 60 weeks. After 60 weeks of therapy, the CD4 cell count of analyzed patients had increased substantially to a mean of 337 cells from the mean baseline count of 155 cells.

Concurrently, the number of viral particles in blood plasma (viral load) was reduced from baseline by an average of almost 2 logs among patients on treatment at 60 weeks. Additionally, the number of infectious blood cells -- another measure of virus levels -- was reduced dramatically from baseline by more than 2 logs (approximately 99 percent) after 60 weeks of treatment, and continued to decline through the duration of the study.

"The combination of Norvir, AZT and ddC continues to afford impressive reductions in HIV-1 activity," said Andre Pernet, Ph.D., vice president of pharmaceutical products research and development at Abbott Laboratories.

In addition, investigators said, the results confirm that open-label trials assessing the antiviral effectiveness of drugs in real time allow for a rapid identification of potent antiretroviral combinations at low cost and without the need for control groups.

In the study, the most common adverse events seen in patients using this combination regimen were nausea, diarrhea, vomiting, paresthesia, excessive menstrual bleeding, and weakness.

Norvir, manufactured by Abbott Laboratories, was cleared March 1 by the U.S. Food and Drug Administration for the treatment of HIV infection.

Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.

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