A Randomized Controlled Trial of Therapeutic Drug Monitoring in Treatment-Naive and -Experienced HIV-1-Infected Patients

• DOI: 10.1097/qai.0b013e318156f029
• Publication Date: 2009-03-03T23:43:42Z
• Authors: Brookie M Best; Miguel Goicoechea; Mallory D Witt; Loren Miller; Eric S Daar; Catherine Diamond; Jeremiah G Tilles; Carol A Kemper; Robert Larsen; Diane T Holland; Shelly Sun; Sonia Jain; Glenn Wagner; Edmund V Capparelli; J Allen McCutchan; Richard H Haubrich
• Keywords: Lopinavir; Therapeutic Drug Monitoring; Efavirenz; Ritonavir

Objective: To improve the utility of therapeutic drug monitoring (TDM) by defining proportion patients with and predictors above or below target protease inhibitor (PI) nonnucleoside reverse transcriptase (NNRTI) concentrations. Methods: This 48-week, multicenter, open-label clinical trial randomized to TDM versus standard care (SOC). Serial pharmacokinetics, including a week-2 3-sample sparse collection, expert committee recommendations were given TDM-arm patients' providers. Results: Seventy-four (39%) 190 had concentrations outside targets 122 (64%) nontarget exposure at least once over 48 weeks. Providers accepted 75% recommendations. Among below-target concentrations, more than SOC-arm achieved (65% vs. 45%; P = 0.09). Increased body weight efavirenz lopinavir/ritonavir use significant Patients who after TDM-directed dose modifications trended toward greater viral load reductions week exposures (HIV RNA reductions: 2.4, 2.3, 1.9 log10 copies/mL, respectively; Conclusions: Most PI and/or NNRTI well improved exposure. worse virologic response.