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Failure to Mention Fixed-Dose Drug Combinations in the ATS/CDC/IDSA Tuberculosis Control Statement

The recent American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America (ATS/CDC/IDSA) statement on the control of tuberculosis (TB) emphasized directly observed therapy (DOT) and included the word DOT 31 times, but failed to mention fixed-dose combinations (FDCs) of anti-TB drugs (1). By contrast, an earlier ATS/CDC/IDSA statement on treatment of TB recommended the use of FDCs when DOT is given daily or when DOT is not possible for three reasons: ease of administration; potential for reducing medication errors; and preventing the patient from taking a single drug (monotherapy) which, if taken, greatly increases the chance that drug resistance will develop (2). The importance of this treatment recommendation has been confirmed by the finding of very low rates of acquired drug resistance to Mycobacterium tuberculosis, less than 0.3%, among 4,000 HIV-negative patients taking self-supervised therapy (SST) in Los Angeles (3). FDCs of anti-TB drugs are not widely used in the United States. The ratio of money spent for FDCs containing rifampin to individual rifampin pills is approximately 10 to 1 (Mr. Joe Ware, Versapharm, Inc.).

Despite the emphasis on DOT by the ATS/CDC/IDSA, a significant proportion of patients are being treated with SST, since only 78% receive DOT alone or in combination with SST (1). Much of the SST is given in the non–health department private sector, which treats 22% of all patients for the entire duration of therapy plus 21.9% in the initial phase of therapy when the bacterial populations are large and the chance of developing drug resistance is high (4). Since use of DOT by private physicians is rare and not likely to change, use of FDCs in the private sector is particularly important to prevent acquired drug resistance. To correct this deficiency in the recent TB control statement, special directed efforts to promote the widespread use of FDCs need to be carefully considered and vigorously pursued.

Thomas Moulding

Harbor UCLA Medical Center, Torrance, California

FOOTNOTES

Conflict of Interest Statement: T.M. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript.

REFERENCES

1. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America. Controlling tuberculosis in the United States. Am J Respir Crit Care Med 2005;172:1169–1227.[Free Full Text]
2. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America. Treatment of tuberculosis. Am J Respir Crit Care Med 2003;167:603–662.[Free Full Text]
3. Moulding TS, Le HQ, Rickleen D, Davidson P. Preventing drug resistant tuberculosis with a fixed dose combination of isoniazid and rifampin. Int J Tuberc Lung Dis 2004;8:743–748.[Medline]
4. Centers for Disease Control and Prevention. Reported tuberculosis in the United States, 2004. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2005.

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