AIDS TREATMENT NEWS #139, November 22, 1991
John S. James
The data now available suggests Septra may be the more effective pneumocystis treatment, but it is also more toxic. (About 25 percent of patients had to discontinue Septra because of side effects, compared to less than 10 percent who had to discontinue 566C80 for this reason, in a phase II/III trial.) 566C80 may have another important advantage in that, in animal tests, it can kill the cysts of pneumocystis, potentially eradicating the disease; however, it is not known if it will do so in humans.
Burroughs Wellcome will run two 566C80 programs through the same phone number given above. One, the treatment IND, will provide the drug for those with mild to moderate pneumocystis. The other, an open-label protocol, is for those with severe disease. The reason for the difference is that the drug has only been in trials for mild to moderate illness; those more severely ill who need to use 566C80 because they have no other options will get it through a study designed to learn whether the drug can be effective in that case.
566C80 is given orally. (An intravenous form is now being developed; it might be useful for more severe illness.) The current oral formulation should be taken with food when possible.
According to David Peck of ACT UP/Boston, who led the activist efforts for access to 566C80, the drug is easy to obtain and the paperwork is not a problem. The FDA requires local IRB approval when possible; exceptions include unavailability of an IRB, or an immediately life-threatening event.
In exceptional circumstances, the drug might be released for toxoplasmosis on an individual basis. However, there is no formal program for toxoplasmosis at this time. Studies for this infection are ongoing. 566C80 is also being studied for cryptosporidiosis.
Note: ACT UP/Boston, ACT UP/New York, and Project Inform have been most closely involved in working with Burroughs Wellcome to develop this 566C80 distribution program. Last July over 50 organizations formed a national coalition seeking access to this drug.
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