Jonathan M. Schapiro, MD

Disclosures

November 11, 2003

Question

In contrast to practices in the European Union, therapeutic drug monitoring (TDM) is not widely used in the United States. What are the current recommendations for US HIV clinicians for use of this technique, and do you think utilization of TDM will soon parallel that in Europe?

Response from Jonathan M. Schapiro, MD

Therapeutic drug monitoring (TDM) is being performed on a widespread basis in a number of European countries, such as The Netherlands, the United Kingdom, and France. It is used most commonly in management of protease inhibitor (PI) therapy and to a somewhat lesser degree with nonnucleoside reverse transcriptase inhibitors (NNRTIs). However, TDM is not routinely used for guiding NRTI therapy. The degree to which this diagnostic tool is being used in different countries varies widely. Some European Union countries, such as Spain, are not using TDM on a widespread basis, and the same is true for the United States.

The relationship between drug levels and efficacy, and in some cases toxicity, has been well documented for several antiretroviral agents. What is still very much in evolution is our understanding about how best to utilize this test and the degree to which it will provide benefit in common clinical situations. The current US Department of Health and Human Services guidelines for the treatment of HIV-infected patients view TDM as an investigational test that is not recommended for routine use.[1,2] There is, however, a clear suggestion that TDM should be evaluated further in clinical trials and other studies. In addition, the guidelines provide specific suggestions for clinicians who currently use TDM. Many aspects of TDM remain controversial, but some degree of consensus on specific indications appears to be evolving in the scientific community.

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