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2. Benefit of therapeutic drug monitoring of protease inhibitors in HIV-infected patients depends on PI used in HAART regimen--ANRS 111 trial

Author

Duval, Xavier, Mentré, France, Rey, Elisabeth, Auleley, Solange, Peytavin, Gilles, Biour, Michel, Métro, Annie, Goujard, Cecile, Taburet, Anne-Marie, Lascoux, Cecile, Panhard, Xaviere, Tréluyer, Jean-Marc, Salmon-Céron, Dominique, Study Group, The Cophar 2, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), Service des maladies infectieuses et tropicales, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Service de toxicologie, Centre de Recherche Saint-Antoine (UMRS893), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Agence Nationale de Recherches sur le Sida et les Hépatites Virales (ANRS), Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Hôpital Saint-Louis, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Comets, Emmanuelle, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UP7) - Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bichat - Claude Bernard - Université Paris Diderot - Paris 7 (UP7), Centre de Recherche Saint-Antoine (CR Saint-Antoine), Institut National de la Santé et de la Recherche Médicale (INSERM) - Université Pierre et Marie Curie - Paris 6 (UPMC), Agence Nationale de Recherche sur le Sida (ANRS), ANRS, Université Paris-Sud - Paris 11 (UP11) - Assistance publique - Hôpitaux de Paris (AP-HP) - Hôpital Bicêtre, Assistance publique - Hôpitaux de Paris (AP-HP) - Université Paris Diderot - Paris 7 (UP7), and CHU Cochin [APHP]

Subjects
Adult, Male, medicine.medical_specialty, HIV Infections, Pharmacology, 030226 pharmacology & pharmacy, Gastroenterology, Article, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Pharmacotherapy, Indinavir, immune system diseases, Internal medicine, Antiretroviral Therapy, Highly Active, Drug Resistance, Viral, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Adverse effect, [INFO.INFO-BI] Computer Science [cs]/Bioinformatics [q-bio.QM], [SDV.BIBS] Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], medicine.diagnostic_test, Dose-Response Relationship, Drug, business.industry, virus diseases, Lopinavir, HIV Protease Inhibitors, Middle Aged, [SDV.BIBS]Life Sciences [q-bio]/Quantitative Methods [q-bio.QM], 3. Good health, Regimen, Nelfinavir, Therapeutic drug monitoring, RNA, Viral, Ritonavir, Female, Drug Monitoring, [INFO.INFO-BI]Computer Science [cs]/Bioinformatics [q-bio.QM], business, medicine.drug, Follow-Up Studies
Abstract

International audience; As a result of high inter-patient variability, and efficacy-concentration and toxicity-concentration relationships, optimization of HIV-protease inhibitor (PI) doses based on plasma concentrations could be beneficial. During a 48-week open prospective non-randomized interventional study of 115 protease inhibitor-naïve patients initiating an indinavir/ritonavir- or lopinavir/ritonavir-, or nelfinavir-containing therapy, protease inhibitor dose was modified when plasma trough concentrations (C(trough)) at weeks 2, 8, 16 and 24 were outside predefined optimal concentration ranges. Failure of the strategy was defined as the proportions of patients with HIV-RNA above 200 copies/mL from weeks 24 to 48 and/or experiencing grades 2, 3 or 4 PI-related adverse events during the study; proportion of patients with last C(trough) measurement outside the concentration range was determined at each visit. Virological failure and/or occurrence of adverse event were observed in 37/94 assessable patients (39%; 95% CI: 29.4-50.0). In the on-treatment analysis, failure of the strategy was noted in 16% of indinavir/r- or lopinavir/r-treated patients (8/51; 95% CI: 7.0-28.6; virological failure: 2; adverse event: 6) but in 44% of nelfinavir-treated patients (11/25; 95% CI: 24.4-65.1; virological failure: 10; adverse event: 1); C(trough) concentrations outside the range were less frequent at the last measurement than at W2 (41% vs. 66%; P < 0.05), with proportions of 35% for indinavir/r- or lopinavir/r-treated patients, but 57% for nelfinavir-treated patients. The proposed strategy of therapeutic drug monitoring may be beneficial to indinavir/r- and lopinavir/r-treated patients, but failed to move concentrations into the predefined range and to produce the expected virological success for nelfinavir-treated patients.

Published
2009

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