TY - JOUR
T1 - Therapeutic drug monitoring of nelfinavir and indinavir in treatment-naive HIV-1-infected individuals
AU - Burger, David
AU - Hugen, Patricia
AU - Reiss, Peter
AU - Gyssens, Inge
AU - Schneider, Margriet
AU - Kroon, Frank
AU - Schreij, Gerrit
AU - Brinkman, Kees
AU - Richter, Clemens
AU - Prins, Jan
AU - Aarnoutse, Rob
AU - Lange, Joep
PY - 2003
Y1 - 2003
N2 - Background: Both virological failure and the toxicity of HIV protease inhibitors have been related to interindividual variability of plasma drug concentrations. Therapeutic drug monitoring (TDM) offers the possibility to detect patients with drug concentrations outside therapeutic ranges, who can subsequently benefit from dose modifications. Methods: ATHENA was a randomized controlled clinical trial. Subjects were randomly assigned to either a TDM group, in which the results of drug concentration measurements plus advice were reported to their treating physician, or to a control group for whom TDM results were not reported. This analysis refers to treatment-naive patients who started a regimen containing indinavir or nelfinavir before November 1999. Findings: A total of 147 patients were randomly assigned: 92 to nelfinavir, 55 to indinavir. After one year of follow-up significantly fewer patients in the TDM group had discontinued nelfinavir or indinavir than in the control group: 17.4 versus 39.7%. This was mainly driven by a significantly lower rate of discontinuation because of virological failure in nelfinavir patients: 2.4% in the TDM group versus 17.6% in the control group, and by a non-significant difference in the rate of discontinuation because of toxicity in indinavir patients: 14.3% in the TDM group versus 29.6% in the control group. in a non-completer equals failure analysis of all randomized patients, the TDM group showed a significantly higher proportion of patients with a viral load below 500 copies after 12 months of treatment (78.2 versus 55.1 %). Interpretation: TDM of nelfinavir and indinavir in treatment-naive patients improves treatment response. (C) 2003 Lippincott Williams Wilkins
AB - Background: Both virological failure and the toxicity of HIV protease inhibitors have been related to interindividual variability of plasma drug concentrations. Therapeutic drug monitoring (TDM) offers the possibility to detect patients with drug concentrations outside therapeutic ranges, who can subsequently benefit from dose modifications. Methods: ATHENA was a randomized controlled clinical trial. Subjects were randomly assigned to either a TDM group, in which the results of drug concentration measurements plus advice were reported to their treating physician, or to a control group for whom TDM results were not reported. This analysis refers to treatment-naive patients who started a regimen containing indinavir or nelfinavir before November 1999. Findings: A total of 147 patients were randomly assigned: 92 to nelfinavir, 55 to indinavir. After one year of follow-up significantly fewer patients in the TDM group had discontinued nelfinavir or indinavir than in the control group: 17.4 versus 39.7%. This was mainly driven by a significantly lower rate of discontinuation because of virological failure in nelfinavir patients: 2.4% in the TDM group versus 17.6% in the control group, and by a non-significant difference in the rate of discontinuation because of toxicity in indinavir patients: 14.3% in the TDM group versus 29.6% in the control group. in a non-completer equals failure analysis of all randomized patients, the TDM group showed a significantly higher proportion of patients with a viral load below 500 copies after 12 months of treatment (78.2 versus 55.1 %). Interpretation: TDM of nelfinavir and indinavir in treatment-naive patients improves treatment response. (C) 2003 Lippincott Williams Wilkins
U2 - https://doi.org/10.1097/00002030-200305230-00007
DO - https://doi.org/10.1097/00002030-200305230-00007
M3 - Article
C2 - 12819517
SN - 0269-9370
VL - 17
SP - 1157
EP - 1165
JO - AIDS (London, England)
JF - AIDS (London, England)
IS - 8
ER -