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Isoniazid Hepatotoxicity Associated With Treatment of Latent Tuberculosis Infection^*

A 7-Year Evaluation From a Public Health Tuberculosis Clinic

^* From the Tuberculosis Clinic (Dr. Fountain), Memphis and Shelby County Health Department, Memphis; Department of Preventive Medicine, (Dr. Tolley), University of Tennessee Health Science Center, Memphis; Methodist Medical Center of Oak Ridge (Dr. Chrisman), Oak Ridge; and College of Pharmacy (Dr. Self), University of Tennessee Health Science Center, Memphis, TN.

Correspondence to: Timothy Self, PharmD, Professor, College of Pharmacy, University of Tennessee Health Science Center, 910 Madison Ave, Room 308, Memphis, TN 38163; e-mail: tself{at}utmem.edu

Objectives: To determine the overall incidence of isoniazid (INH) hepatotoxicity in a public health tuberculosis clinic over a 7-year period, and to determine if systematic, limited aspartate aminotransferase (AST) monitoring would be of benefit in detecting INH hepatotoxicity.

Methods: Evaluation of INH hepatotoxicity in adults aged 25 years from a database maintained from fall 1996 to 2003 in a public health department clinic. Hepatotoxicity was defined as AST levels more than five times the upper limit of normal (ULN).

Results: Among 3,377 patients started on INH therapy, 19 patients had AST levels more than five times the ULN, or a rate of 5.6 per 1,000 patients. Only 1 of 19 patients had prodromal symptoms associated with hepatotoxicity. After 1 month, 3 months, and 6 months of therapy, the numbers of hepatotoxic events per 1,000 patients were 2.75, 7.20, and 4.10. The age-specific numbers of hepatotoxic events per 1,000 patients were 4.40 for those from 25 to 34 years of age, inclusive; 8.54 for those between 35 to 49 years of age, inclusive; and 20.83 for those 50 years old. Age > 49 years (p < 0.02) and baseline AST greater than ULN (p < 0.0003) were risk factors for hepatotoxicity.

Conclusions: Consistent with earlier trials, INH hepatoxicity is age related. Our results suggest hepatotoxicity is also related to baseline AST greater than ULN. Moderate-to-severe hepatotoxicity frequently occurs without symptoms, suggesting the value of more widespread AST monitoring.

Key Words: aspartate aminotransferase • hepatotoxicity • isoniazid

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