Project Inform Perspectives 41 - June, 2006

Drug companies typically make experimental new drugs available to patients in need prior to the completion of their approval by the FDA. This is done in the form of Expanded Access Programs (EAPs), one of the most important victories achieved by early AIDS activism. This is not, however, the only way to access free drugs. Additionally, most companies offer a Patient Assistance Program designed to provide treatment to people who "fall through the cracks" of all insurance and payer programs. Though Patient Assistance Programs usually include a requirement that a patient receives an income level that makes purchasing the drugs impossible, many companies supply the drugs free regardless of a patient's income.

Here's a list of currently available and soon-to-be available drugs through Expand Access, along with a description of a special Patient Assistance Program that provides the drug Norvir free of charge under certain circumstances.

Expanded Access Programs:

AVAILABLE NOW: TMC-114 (darunavir). This new protease inhibitor has shown great promise as a drug for "salvage therapy"—that is, for people who have failed most other protease inhibitors. To learn about the program and how to access it, go to www.tibotec.com or call 1-866-889-2074 in the US or, in other countries: earlyaccess@parexel.com.

"SORT OF" AVAILABLE NOW: TMC-125. This is a new "non-nucleoside reverse transcriptase inhibitor" (NNRTI, drugs similar to Sustiva or Viramune). It is designed to work when resistance has developed to the other drugs in this class. A regular expanded access program for this drug will open in the second half of 2006, but under some limited circumstances, patients may be able to access it now. For people who have lost all other options and start on TMC-114, it is unlikely that this or any other new drug will work very well by itself. Chances of success are greater if two new drugs can be started at the same time. Thus, Tibotec has been willing to make TMC-125 available to the most seriously advanced patients so they can get the chance to start two new drugs at the same time. To access this special, limited program, patients should have their doctor contact Lew Sibert at Tibotec at LSibert@tibus.jnj.com.

QUIETLY AVAILABLE NOW: Free Norvir. When the price of Norvir was suddenly increased dramatically last year, it made it particularly difficult for people using high doses of the drug to pay for it. Consequently, Abbott Labs started a program that supplies Norvir free of charge to anyone who uses or requires 400mg or more of the drug daily. This would apply to people who use "full dose" Norvir as a primary antiviral, and to people who use the new protease inhibitor Aptivus, which requires 400mg of Norvir daily. Access to free Norvir requires patients or their doctors to apply under the Abbott Patient Assistance program at www.rxabbott.com. Doctors and patients should know that they do not need to fill out the part of the form that asks for the patient's income level or the part that asks about any other insurance a patient may have.

COMING SOON: Merck integrase inhibitor, MK-0518. This new class of drug will be available under an expanded access program in the early fall of 2006. Web site and contact information are not yet available. Patients must have failed other classes of drugs.

COMING SOON: Pfizer entry inhibitor, maraviroc. This is another new class of drug that will be available via expanded access in the last quarter of 2006. Web site and contact information are not yet available. Entry criteria not yet determined.

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