alan@garp.mit.edu (Alan Shaw) (09/19/89)
The Treatment & Data Digest A Review of issues addressed by ACTUP's T&D committee during its past week of activities Number 13: September 18, 1989 ddI NOW AVAILABLE: Last Friday, the distribution of ddI through the Treatment IND protocol began, i.e. the drug started to be given away free to those wqho need it but who aren't in the official trials. However, Bristol Myers' program is currently only for people who are AZT intolerant. If you are AZT intolerant -- meaning your blood levels dropped to a dangerously low level while on AZT -- you should give Bristol Myers a call. The toll free number is (800) 662-7999. The distribution was timed to coincide with the start of the official phase II trial meant to determine how effective ddI actually is in AZT intolerant people. Trials to determine how effective ddI is for long term users of AZT, as well as the newly diagnosed, are set to begin soon as well. Once those trials begin, Bristol Myers will expand access to ddI through the Treatment IND program. A NEW CMV TREATMENT: Cytomegalovirus (CMV) can cause a variety of rather nasty problems, including retinitis (blindness) and colitis (diarrhea). The standard treatment is currently DHPG, while foscarnet is in testing and looks good. Now comes a new treatment, called Fiac, that was developed at Sloan-Kettering hospital. The drug has already been tested in 100 people at Kettering, and trials have now been expanded to four other sites. It's good to see another treatment being developed for CMV. One of the unfortunate problems with the AIDS drug development industry is the lack of attention paid to the opportunistic infections that people with HIV must deal with on a day to day basis. Too many researchers spend their time searching for s "cure" for HIV and ignore the opportunities available to improve the quality of life for PWAs. TROJAN HORSES AND MACROPHAGES: Most anti-retrovirals being developed are designed to interfere with HIV's attack on the T4 cell. Yet HIV also destroys other types of cells, particularly another important part of the immune system: macrophages. Macrophages "eat" bacteria and other particles not meant to be in the bloodstream and then hold those particles until other parts of the immune system arrive and destroy the invader. SCientists have recently begun to investigate how the macrophage's ability to swallow particles can be used int eh fight against HIV. One method is encapsulation: an anti-HIV drug is trapped within a small amount of liposome (fat). These liposome are then injected intravenously, and once in the bloodstream, they are swallowed up by the macrophages. Once inside the macrophage, the active drug comes out of the fat and can begin its anti-HIV work. This trojan horse effect is hoped to be quite effective. A drug called Gent-65 is one of the first to use this method. FLUCONAZOLE UPDATE: Fluconazole is an anti-fungal drug made by Pfizer which looks very promising for treatment and prevention of cryptococcal meningitis, candidiasis and other common fungal infections in PWAs. It is already in phase II and phase III trials in the U.S. and is approved in France, Britain, Denmark, Switzerland and several other European countries. The drug currently used to treat cryptococcal meningitis is amphotericin-B, which usually has extremely severe side effects. It is uncommon for fluconazole to cause serious side effects. However, fluconazole is extremely expensive, especially for use in meningitis prophylaxis (prevention): it must be used indefinitely, at a cost of as much as $700 per month. Even so, a large number of PWAs are paying out of their own pockets to import the drug from Europe. Pfizer and the FDA claim that there is wide availability of the drug through clinical trials and compassionate use. The reality is that fluconazole is not accessible to many PWAs who need it. Pfizer submitted its data to the FDA last winter -- and nothing has happened since. Pfizer claims to have tried to negotiate a wider release of fluconazole with the FDA several months ago, under Treatment IND, but says that the FDA wanted such restrictive terms that Pfizer felt it was better to continue its compassionate use policy; the FDA won't confirm that such negotiations occurred. (However, other officials at the FDA state that Pfizer is trying to get fluconazole approved for conditions that it hasn't yet shown fluconazole is effective intreating. These officials claim the FDA is ready to expand the compassionate use distribution of the drug, but that Pfizer won't agree to this because it is holding out and waiting for the FDA to expand the list of conditions for which fluconazole can be used.) Even if approved, the cost of fluconazole will be exorbitant. If our discussions with the FDA and Pfizer do not yield significantly wider availability and a major price decrease, it will be necessary to expand the scale and intensity of our actions. For more information, contact Scott Slutsky at (212) 535-2852. IMPORTANT NUMBERS: AIDS Treatment Registry: information about trials in the New York area: 212-268-4196. Project Inform: information on different experimental treatments: 800-822-7422. National Trial Hotline: information on trials throughout the United States: 800-TRIALSA. Bristol Myers ddI Hotline: information on how to get ddI through the parallel track: 800-662-7999.