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Kaletra (ABT-378/r) Approved

by John S. James

September 22, 2000

On September 15, the FDA approved Kaletra™ (formerly called ABT-378/r), a protease inhibitor, for use in combination with other antiretroviral agents for treatment of HIV infection. Kaletra was already in use by several thousand patients, through a pre-approval expanded access program for persons who could not otherwise put together a satisfactory antiretroviral combination; Abbott Laboratories will continue to supply the drug through this program for up to two months as patients obtain coverage (for information about the expanded access program which is now being phased out, call 1-888-711-7193). Kaletra is already in a few pharmacies as we go to press, and should be widely available in about a week.

The U.S. price is $6,500 annually "wholesale acquisition cost" (Kaletra has not yet been approved in any other country). For patients who have no other way of affording the drug, there will be a patient assistance program similar the Abbott's program for Norvir; for information, patients can call 1-800-222-6885 Monday through Friday 8:00 a.m. to 4:30 p.m. Central time.

It is not known if most physicians will use this drug for first-line treatment, or keep it in reserve for cases of failure of other antiretrovirals (which is how it was used in the expanded access program). It is not known which strategy would be best overall. But in either case, many more physicians will now use the drug; and many of them will be less experienced in HIV treatment, and less knowledgeable about this drug, than the doctors in the early-access program.

If you are prescribed Kaletra, be sure that you receive a patient information sheet from Abbott Laboratories (probably titled Kaletra Patient Information -- do not confuse this with general drug information sheets or printouts which some pharmacies may give you). The patient information material includes:

If you cannot get the Kaletra Patient Information sheet from your pharmacy, it is on the Web, as the last four pages of the physicians' information at

The main importance of Kaletra is that it can be effective even against some viruses which have become resistant to other approved protease inhibitors -- and resistance to Kaletra may be slower to develop than resistance to the other protease inhibitors, because Kaletra has an unusually wide therapeutic window between the high levels achievable in blood, and the substantially lower levels which can suppress most HIV. However, resistance to Kaletra can develop, at least in patients already resistant to other protease inhibitors; and it is important not to lose this valuable drug by using it thoughtlessly or improperly. As with any antiretroviral, doctors need to prescribe Kaletra as part of appropriate combinations that are likely to keep HIV well suppressed, to minimize ongoing viral reproduction and the risk of resistance development. And patients need to use the drugs as directed, to avoid having blood levels too low to fully suppress the virus.


For more information, see the drug "label" (the prescribing information for physicians), which is available at (or at Physicians should note that the "Microbiology" section of this label has clinical information about both phenotypic and genotypic HIV resistance testing.

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.

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