AEGiS-AP: FDA Approves New AIDS Drug Kaletra

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

FDA Approves New AIDS Drug Kaletra

Associated Press - Friday September 15, 2000
Lauran Neergaard, AP Medical Writer

WASHINGTON (AP) - Patients with the AIDS virus are about to get a new option that may help those who have failed standard therapy: a drug called Kaletra. The Food and Drug Administration approved Kaletra late Friday, for use by both adults as well as HIV-infected infants and children who are older than 6 months of age.

Kaletra is one of a class of AIDS drugs called protease inhibitors. But early evidence suggests it may work a little differently than its competitors - allowing higher HIV-fighting levels of drug to circulate in the blood system than other medicines do.

"This is all still a little theoretical," cautioned Dr. Heidi Jolson, the FDA's AIDS chief.

But in studies of patients who had failed other protease inhibitor treatment, enough saw their HIV levels dramatically drop - presumably because of this effect - to persuade the FDA to speedily approve Kaletra's sale.

Scientists with manufacturer Abbott Laboratories (NYSE:ABT - news) said in one study about 70 percent of such protease-failed patients improved on Kaletra, although Jolson cautioned that those patients also took another relatively new pill, so it's unclear if Kaletra should get all the credit.

Abbott said the prescription-only medicine - available in capsules or liquid taken twice a day as part of a cocktail of standard AIDS drugs - should be on pharmacy shelves around the end of next week. The company did not reveal the price.

Kaletra is a combination of a new chemical called lopinavir plus a small dose of Abbott's older AIDS drug Norvir. The company mixed the two because together they produce what co-inventor Dale Kempf calls a great drug reaction: The Norvir increases blood levels of lopinavir. Abbott calls that Kaletra's key, contending the drug can get to higher levels in the body than other protease inhibitors without causing more side effects than a standard dose would.

But Kaletra does cause side effects, Jolson stressed. It comes with a long list of drugs that physicians cannot prescribe together with Kaletra because the interactions are dangerous, she said. She urged doctors to carefully check that list, which includes certain heart drugs and sedatives.

About 10 percent of Kaletra users had significant rises in cholesterol and triglyceride levels, she said. About 1 percent suffered pancreatitis. Other side effects were typical for AIDS drugs, including diarrhea, fatigue and nausea. Parents got a special warning: Keep the bottle out of reach of children, because liquid Kaletra contains enough alcohol to be dangerous if a child overdoses.
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