AEGiS-PRn: Norvir (Ritonavir) With Nucleoside Analogues Results in More Children With Undetectable HIV (less than 400 Copies/Ml) Compared With Nucleoside Analogues Alone; Study Arm Without Norvir Closed

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Norvir (Ritonavir) With Nucleoside Analogues Results in More Children With Undetectable HIV (less than 400 Copies/Ml) Compared With Nucleoside Analogues Alone; Study Arm Without Norvir Closed

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday September 29 11:09 AM EDT

TORONTO, Sept. 29 /PRNewswire/ -- A new study demonstrates that a significantly greater number of children receiving Abbott Laboratories' (NYSE:ABT) Norvir (ritonavir), in combination either with stavudine (d4T) or with zidovudine (ZDV) and lamivudine (3TC), had undetectable levels (less than 400 copies/mL) of virus in the blood, compared with children receiving only ZDV and 3TC. These data, from the Pediatric AIDS Clinical Trial Group (PACTG) study, are being presented today in a late-breaking session at the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy.

Of the 298 children enrolled in the study, HIV RNA data were available on 162 children and were included in this presentation. Median age was 7.1 years and median follow-up was 3.4 months. In the Norvir/d4T group, 61% of the children had undetectable plasma HIV RNA (less than 400 copies/mL) at 12 weeks and 57% in the Norvir/ZDV/3TC group had undetectable plasma HIV RNA compared with only 14% in the ZDV/3TC group. Based on these data, the PACTG closed the treatment arm without Norvir. Protease inhibitor therapy will be offered to the patients from the closed arm.

"These findings, from an ongoing study, suggest that a protease inhibitor, such as Norvir, is critical in anti-retroviral management of children," says Eugene Sun, M.D., venture head, anti-viral venture at Abbott Laboratories. "We are proud to be making significant advances for children with HIV and AIDS."

Abbott Laboratories received clearance from the U.S. Food and Drug Administration (FDA) for the use of Norvir in children with HIV and AIDS on March 14, 1997.

The current dosing recommendation for Norvir in children (age 2-16) is based primarily on pharmacokinetic and safety data from an ongoing Phase I/II study.

In HIV-infected patients age 2-16 years, the adverse event profile was similar to that seen during clinical trials and post-marketing experience in adults. The most common adverse events in adults include asthenia (weakness), nausea, vomiting, diarrhea, anorexia (loss of appetite), abdominal pain, taste disturbance and tingling sensation or numbness around the mouth or limbs. Safety of Norvir in children below age two has not been established. Norvir should not be used in combination with highly metabolized medications known to cause serious or life-threatening adverse events.

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.

SOURCE Abbott Laboratories

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