HIV Digest	HIV Digest Archive

Abbott laboratories has announced an Early Access Program to make ABT-378/r (which is the new protease inhibitor ABT-378, which is combined with a small amount of ritonavir) available to a small number of patients outside of clinical trials, in the U.S. and some other countries.

Because of limited drug supply at this time, the initial entry criteria are very restrictive in order to get the drug to the sickest patients; later, the eligibility requirements will be expanded as more drug is available-- probably by January 2000. Right now, patients must have failed at least two protease-inhibitor-containing regimens, and either have a CD4 count under 50, or have had an opportunistic infection while on highly active antiretroviral therapy. Because ABT-378/r includes low-dose ritonavir (to maintain blood levels of ABT-378), it cannot be used together with drugs contraindicated for ritonavir; otherwise, most other medicines are okay.

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Patients, doctors, and other medical professionals can call 888-711-7193 (8:00 a.m. to 7:00 p.m. Eastern time) in the U.S. or Canada, or 00-800-49-68-59-90 outside North America, for more information about this program. [Note: Patients considering this program may want to wait, if possible, for PMPA, T-20, or other experimental antiretrovirals, so that they can start the new drugs together. This is because those who qualify for ABT-378/r under the current criteria are probably already resistant to most or all approved antiretrovirals. Any antiretroviral, including ABT-378/r, should be started with at least one and probably two other antiretrovirals which are expected to be effective for the patient, to prevent develo pment of resistance to the new drugs. Those who have no approved drugs likely to work for them may want to wait for at least one more experimental drug, to reduce the risk of losing ABT-378 as well. AIDS treatment activists in the Coalition for Salvage Therapy have been through long, hard, and apparently successful negotiations to make sure that the various rules allow the use of the different experimental drugs together.]

Editor's Note: from AIDS Treatment News