Clarithromycin Therapy for Mycobacterium avium Complex Disease in Patients with AIDS: Potential and Problems
- Mark Goldberger, MD; and
- Henry Masur, MD
- Food and Drug Administration; Rockville, MD 20857 National Institutes of Health; Bethesda, MD 20892-1662 Disclaimer: This article represents the views of the authors and does not represent official policy of the National Institutes of Health or the Food and Drug Administration.
The quality and duration of survival for patients with human immunodeficiency virus (HIV) infection have improved substantially during the past decade. Much of this improvement has been because of better management of opportunistic infections. However, progress with Mycobacterium avium complex, a pathogen that ultimately infects 30% to 50% of patients with the acquired immunodeficiency syndrome (AIDS) in North America, has until recently been disappointing, especially in terms of prophylaxis and therapy.
The development of new rifamycin and macrolide antibiotics has increased optimism among health care providers and patients searching for remedies for disease caused by this Mycobacterium species. Rifabutin, a newer rifamycin, has been approved by the U.S. Food and Drug Administration for prophylaxis of M. avium complex based on two large, controlled trials [1]. Clarithromycin, a newer macrolide, is the only drug that has been approved to date for the acute treatment of disseminated M. avium complex disease. This approval was based largely on unpublished data (2, 3; Minutes of the Open Public Meeting of the Food and Drug Administration Antiviral Advisory Committee, 10 May 1993). For health care professionals and patients, an important question is, “Do we truly have therapy that can produce sustained clinical benefit?”
In this issue, Chaisson and colleagues [4] present some of the data that led to the approval of clarithromycin for treatment of disseminated M. avium complex infection. The data clearly show evidence for in vivo microbiological activity and for short-term clinical benefit. Are these data sufficient to establish clear-cut therapy recommendations, or, despite their promising nature, are there still gaps in our knowledge and some ominous issues that must be resolved?
Chaisson and colleagues [4] randomly assigned patients with M. avium complex bacteremia to receive twice-daily clarithromycin at doses of 500 mg, 1000 mg, …
This 100-word excerpt has been provided in the absence of an abstract.
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