Logistics of TDM for Antiretrovirals

Gene D. Morse, Pharm.D., BCPS, FCCP Associate Dean, Clinical Education and Research Professor and Chair, Department of Pharmacy Practice School of Pharmacy and Pharmaceutical Sciences University at Buffalo E-mail: emorse@buffalo.edu Concepta A. Merry, Ph.D., M.S. National Pharmacoeconomics Center, St. James Hospital Dublin, Ireland E-mail: Not Available Judianne C. Slish, Pharm.D. Clinical Assistant Professor Department of Pharmacy Practice University at Buffalo ECMC - Department of Medicine Division of Infectious Diseases 315 Cooke Hall, Buffalo NY, 14260 E-mail: slish@buffalo.edu

Theraputic Drug Monitoring Therapeutic Drug Monitoring (TDM) SUNY Lab for Antiviral Research Clinical Significance of Antiretroviral Drug Levels

Logistics of TDM for Antiretrovirals

In comparison to TDM for many common drugs that occurs in an acute care setting (e.g. vancomycin, gentamicin) or with drugs that have long-half-lives (phenytoin), antiretroviral therapy with PIs poses a number of challenges to successful application of plasma concentration monitoring. These factors are as follows:

• Documenting patient adherence for 3-4 days prior to the TDM plasma sample collection.
  
  
• Accurate collection of plasma samples.
  
  
• Timely processing, storage and shipping of plasma.
  
  
• Rapid, overnight shipping to assay lab.
  
  
• Rapid assay turnaround with accurate results.
  
  
• Communication of assay result to clinical site.
  
  
• Successful dosage adjustment of ARV documented.
  
  
• Confirmation that dosage adjustment changes plasma ARV concentration.

Despite these obstacles, a number of clinical trials have demonstrated that with a diligent clinical staff and a dedicated pharmacology laboratory, TDM can be performed in a reliable fashion and provide important data to assess the possible contributions of TDM for HIV-infected patients.

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