AIDS TREATMENT NEWS Issue #209, October 21, 1994
John S. James
For several years there have been small studies of human growth hormone as a treatment for AIDS-related wasting syndrome. The first results of a large trial (178 volunteers) were released in August 1994 at the Tenth International Conference on AIDS in Yokohama, Japan (see AIDS TREATMENT NEWS #205, August 19, 1994, for a summary of this report). The same information was reported in THE NEW YORK TIMES, October 16, 1994 (page 16 of the national edition); both articles may help in fighting for reimbursement for the treatment. Wasting syndrome is a major cause of death in persons with AIDS.
The study reported in Yokohama was sponsored by Serono Laboratories Inc. of Norwell, Massachusetts. The Serono product, brand name Serostim(TM), which is produced by genetically engineered mammalian cells, has been approved in about 50 countries (but not in the U.S.) for treating growth- hormone deficiency in children. In the U.S., two other brands of recombinant human growth hormone have been approved for the same purpose: Protropin (sold by Genentech Inc.) and Humatrope (sold by Eli Lilly and Company). The three products are not identical, however; the small differences in the molecule might or might not be important.
In the U.S., although human growth hormone is available as a prescription drug, supplies are carefully controlled to prevent abuse by athletes. Although these controls are not intended to block legitimate medical use for treating life- threatening conditions, we have heard that physicians have been unable to obtain Protropin for persons with AIDS. We have not yet heard from anyone trying to obtain Humatrope. Even with Serostim available through Canada, U.S. patients may want to get the U.S. product in hope of reimbursement (although its use is still "off label," pending FDA approval of one of the products for wasting syndrome).
One of the sites for the Serono study was San Francisco, and about 50 people here received Serostim in the Serono trial. Two activists in ACT UP/Golden Gate were in that trial, and no one who knew them had any doubt that the drug was helpful. ACT UP/Golden Gate had already been involved in changing the design of the trial so that it could accrue enough volunteers, and has continued to assist as the drug moves closer to routine availability.
To obtain Serostim for treatment of AIDS-related wasting, a physician must call the Serono Canada Information Line for Human Growth Hormone in HIV-Associated Wasting, 800/935-8853, 8:30 to 5:00 Eastern time Monday through Friday. The physician will need to send a prescription, and a personal- use statement for U.S. customs. According to ACT UP/Golden Gate, both documents must include the two names of the product: "Serostim," and "recombinant human growth hormone."
The dose used in the Serono trials has averaged 6 mg per day (1/10 mg per kilogram of body weight per day). The Canadian price is $25 per mg., meaning that for the average person, the drug will cost over $1,000 per week. No one knows if this high dose needs to be maintained; one ongoing study is testing lower doses, by giving physicians the option to reduce the dose from daily to twice a week, after three to six months of the daily dose.
One of the activists working on the issue, who is also using the drug himself, distributed an October 4 press release suggesting:
* Stocking up on food and planning four meals a day, at least when starting the drug;
* Weight lifting to help build muscle;
* Considering reducing the dose to once or twice per week after two weeks at the daily dose, and combining human growth hormone with other treatments for wasting syndrome during this time. He said the hormone "helped other therapies work anew for me." Presumably one could return to the higher dose if necessary. This regimen has not been tested, however, so there is no way to know whether or not it will be effective.
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