AEGiS-ATDN: Update on Access to Kaletra (lopinavir, ABT-378)

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

Update on Access to Kaletra (lopinavir, ABT-378)

Information Bulletin #12 August/September 2000

Kaletra (other name: lopinavir, formerly known as ABT-378/r) is a new anti-HIV protease inhibitor developed by Abbott Laboratories. On September 15, Kaletra was approved for use by the US Food and Drug Administration (FDA). Kaletra should be available in pharmacies before the end of September. Early studies have shown that Kaletra has a strong anti-HIV effect. In a study of 100 people that had never taken HIV drugs before, the combination of Kaletra with d4T (Zerit) and 3TC (Epivir) reduced viral loads to less than 40 copies in 96#37; of the participants after 72 weeks of treatment. Studies results also suggest that Kaletra may have some effect on HIV that has become resistant to other available protease inhibitors. Only a few people have dropped out of Kaletra studies because of side effects. Kaletra side effects can include stomach pain, diarrhea, increases in blood fats (cholesterol and triglycerides), feeling weak or tired, headache, nausea and vomiting.

Kaletra may also be linked to a side effect called pancreatitis. Pancreatitis is a potentially dangerous inflammation of an organ called the pancreas. Currently this side effect has been seen in less than 1#37; (1 out of 100) people taking Kaletra. It is not certain whether Kaletra caused the problem. All cases have involved people taking other drugs. Researchers are now investigating the cases to find out if Kaletra played a role. Abbott Laboratories recommends monitoring triglycerides and amylase in people taking Kaletra to watch for signs of pancreatitis.

The standard dose of Kaletra is three pills taken twice a day with food. Each Kaletra pill contains 100mg of Kaletra and 33mg of the protease inhibitor Norvir (ritonavir). If you're taking Kaletra at the recommended dose, it's important to know that you'll also be taking a total of 200mg of Norvir each day. If you're allergic to Norvir it may not be possible for you to take Kaletra - check with your doctor.
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