As reported in the December 1, 2007 Journal of Acquired Immune Deficiency Syndromes, researchers conducted a study to determine the proportion of HIV patients with drug levels above or below target concentrations for protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI), as well as predictors of suboptimal levels.

In this 48-week, multicenter, open-label trial, 190 HIV patients were randomly assigned to receive TDM versus standard of care (no TDM). Serial pharmacokinetic measures were performed, and expert committee TDM recommendations were given to the clinicians treating participants in the TMD arm.

Results

Conclusion

“Most patients had non-target PI and/or NNRTI concentrations over 48 weeks,” the authors wrote. “TDM recommendations were well accepted and improved exposure. Patients below TDM targets trended toward worse virologic response.”

University of California, San Diego, CA; Harbor-University of California, Los Angeles (UCLA) Medical Center and Los Angeles Biomedical Research Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA; University of California, Irvine, CA; Santa Clara Valley Medical Center, San Jose, CA; University of Southern California, Los Angeles, CA; RAND Corporation, Santa Monica, CA.

12/11/07

Reference
BM Best, M Goicoechea, MD Witt, and others. A Randomized Controlled Trial of Therapeutic Drug Monitoring in Treatment-Naive and Experienced HIV-1-Infected Patients. Journal of Acquired Immune Deficiency Syndromes 46(4): 433-442. December 1, 2007.