Hepatoxicity monitoring: Study offers best data
Is more frequent testing warranted?
To get a better handle on the impact of monitoring patients at risk for isoniazid-induced hepatitis, the Centers for Disease Control and Prevention is working on a look-back study with the New York City Bureau of TB Control involving 3,000 patients in methadone treatment who received isoniazid preventive therapy and were given monthly serum enzyme tests.
The study, however, faces some difficulties. First, about 7% of the patients have been lost to follow-up in the treatment program a rate that could confound the study findings. Second, strict confidentiality guidelines for the methadone program prevent thorough searching of medical records outside of the program. Without searching for evidence of hepatitis diagnosis outside the program, the study would not be as valid, notes John Jereb, MD, medical epidemiologist in the CDC’s division of TB elimination.
Meanwhile, the CDC has developed a model to predict how often monitoring would be necessary to further reduce the risk of hepatitis. By monitoring patients every 10 days, providers theoretically should be able to detect and prevent all cases of isoniazid hepatitis, while monitoring every 30 days would prevent only about 30% of cases, Jereb says.
What health consultants must confront is whether an increase in monitoring would make sound public health policy in terms of cost, feasibility, and effectiveness. "The CDC doesn’t often enter into that kind of debate," he adds. "On the other hand, other advisory bodies, like the American Thoracic Society, have to consider that very heavily."
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