Combination Drug Approved to Treat HIV

In September, the Food and Drug Administration gave accelerated approval for a new treatment that combines two drugs to fight human immunodeficiency virus (HIV) infection. Called Kaletra, the new therapy relies on the antiviral properties of lopinavir, a drug that inhibits a critical HIV enzyme called protease, combined with a low dose of ritonavir, a drug that slows down the rate at which the body metabolizes lopinavir. This results in blood levels of lopinavir that enhance its effectiveness against HIV.

FDA approved Kaletra for adults and children older than six months. It is used with other anti-HIV drugs and should be taken with food to increase absorption into the blood stream. Kaletra was studied in six controlled clinical trials and one expanded access trial. Side effects include diarrhea, fatigue, headache, and nausea. The drug also increases blood lipid levels (cholesterol and triglycerides), which may require treatment for some patients. People with high levels of triglycerides in the blood can be at risk for pancreatitis. Infrequent cases of pancreatitis have been observed among patients receiving antiretroviral regimens that included Kaletra.

Like other protease inhibitors, Kaletra may be associated with other significant or serious adverse events, including increases in blood glucose, redistribution of body fat, and potentially serious or life-threatening drug interactions. To prevent such drug interactions and potential loss of drug effectiveness, healthcare providers and patients should find out about drugs that should not be used with Kaletra and other antiretrovirals.

Abbott Laboratories in North Chicago, Ill., manufactures Kaletra.