Important note: Information in this article was accurate in 1992. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - December 23, 1992
Monica Revelle - (301) 443-4177
Rifabutin is the first drug approved for the prevention of MAC disease. Individuals with MAC infection experience chronic debilitating symptoms including fever, night sweats, weight loss, fatigue, abdominal pain, severe anemia and liver dysfunction. Estimates of its prevalence in patients with advanced HIV infection range from 30 to 50 percent. In people with AIDS, this infection can contribute to death.
"As the first product approved for the prevention of MAC disease, this drug will provide significant benefits for AIDS patients," said FDA Commissioner David A. Kessler, M.D. "It is a welcome addition to the growing number of products used to fight AIDS and diseases that can accompany it."
Patients enrolled in clinical trials who received rifabutin were one-third to one-half as likely to develop MAC as were patients who received a placebo.
The most common adverse reactions associated with rifabutin are rash, gastrointestinal symptoms, muscle and joint aches and discolored urine. In the trials, a decrease in certain infection-fighting white blood cells was the only serious adverse reaction that occurred in more patients who received rifabutin than patients who received a placebo.
Rifabutin was made available in February under a Treatment Investigational New Drug (IND) protocol, under which FDA allows drug developers to provide pre-approval access to experimental drugs that are intended to treat serious and life-threatening conditions for which there are no satisfactory treatments. Drugs that are granted Treatment IND status must have demonstrated through clinical testing that they may be efficacious.
This is the first drug whose approval was based on research from multi-center clinical trials conducted in community-based research groups, according to David W. Feigal, Jr., M.D., director of the Division of Anti-Viral Drug Products, which is responsible for reviewing rifabutin. "The approval of rifabutin marks an important medical advancement for AIDS patients," said Dr. Feigal.
In September, FDA's Antiviral Drug Products Advisory Committee recommended approval of rifabutin. The committee reviewed data from two clinical trials involving 1,146 AIDS patients whose white blood cells or CD4 helper cell counts were 200 or less. CD4 helper cells are white blood cells important in the immune system that are destroyed by the AIDS virus.
Rifabutin is manufactured by Adria Laboratories, Columbus, Ohio, and will be sold under the brand name Mycobutin.
921223
FD921202
SOURCE: Food and Drug Administration (FDA).
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, the Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.
Always watch for outdated information. This article first appeared in 1992. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 1992. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .