Background: Highly active antiretroviral therapy (HAART) can suppress viral replication and prolong patient life substantially. However, HAART can fail for a number of reasons, including incomplete adherence, pharmacokinetic factors and the emergence of resistance. Because the number of possible antiretroviral combinations is limited, the use of existing treatment options must be optimized. Whether the application of therapeutic drug monitoring (TDM) in routine clinical practice may help with this purpose remains a subject of debate. However, TDM has been introduced in some centres despite the lack of guidelines for optimal use of this test.
Objective: In October 2000, a panel of experts met in Perugia, Italy, to discuss the key issues surrounding the introduction of TDM into routine clinical practice. The purpose of the meeting was to achieve a consensus among panel members on the following issues: (i) validity of data suggesting the utility of TDM in HAART; (ii) patient categories and clinical settings in which TDM may be of most benefit; (iii) target levels of antiretroviral agents; (iv) influence of covariables on target levels of drugs; (v) blood sampling and dosage adjustment strategies; and (vi) future research steps needed to elucidate issues regarding the applicability of TDM in clinical practice.
Outcome: This report, which has been updated to include data published or presented at conferences up to the end of August 2001, summarizes the data presented and issues discussed at the meeting. This article will guide the reader through the data and discussions that have allowed the panel to formulate a series of position statements regarding the current status and future applications of TDM in antiretroviral therapy. These statements have been formulated to provide suggestions for the design of future TDM clinical trials, as well as to provide useful points of reflection for centres in which TDM is already in use.