(ATN) MEGACE Now Approved for AIDS: New Formulation

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(ATN) MEGACE Now Approved for AIDS: New Formulation

AIDS TREATMENT NEWS Issue #183, September 17, 1993
John S. James


MEGACE (megestrol acetate), a drug long approved as a palliative treatment for certain cancers, was approved by the FDA on September 10 for treatment of unexplained significant weight loss, or loss of appetite, in persons with AIDS. Because of the large doses used with AIDS (which are inconvenient to take with the MEGACE tablets previously approved), a new oral suspension form was also approved on September 10. It should be in pharmacies within the next few weeks.

In controlled studies, weight increased by an average of 7.8 to 11.2 pounds in high-dose groups, and 4.2 pounds with a lower dose, compared to a weight loss of about two pounds with placebo. Also improved were appetite, caloric intake, and sense of well being. The weight gain was shown to include lean body weight and muscle mass, not just water.

However, a followup study a year later found no difference in survival between the treatment and placebo groups. And impotence occurred in as many as 12 percent of the patients at the highest dose; it appears to be reversible when the drug is discontinued.

A suggested starting dose for most patients is 800 mg per day, reduced to 400 mg after one month. In practice, according to Jamie Von Roenn, M.D., lead investigator of a MEGACE trial, patients are likely to start with the high dose until they gain weight, then reduce the dose to maintain the weight.

According to Bristol-Myers Squibb, the price to wholesalers will be $4.15 per day or less; we do not know what dose was used for this computation. For patients who need the drug but cannot pay, physicians can call 800/788-0123 to apply for free drug when no third-party options are available.


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