Plasma concentrations of generic lopinavir/ritonavir in HIV type-1-infected individuals

Antiviral Therapy
Jasper van der LugtKiat Ruxrungtham

Abstract

Generic drugs can contribute to access to treatment for HIV-infected patients. However quality and safety remains an issue of concern. Therefore, we evaluated minimal plasma concentrations and short-term safety of a generic lopinavir/ritonavir 200/50 mg tablet formulation. In a single-centre prospective pilot study, patients receiving protease-inhibitor-based antiretroviral treatment were switched to a generic lopinavir/ritonavir tablet at the standard dose (400/100 mg twice daily). Minimum drug concentrations (C(min)) of lopinavir and ritonavir were performed before switching (in 16 patients who were on Kaletra((R)) soft-gel capsules) and after 4 weeks (in all patients). Plasma levels of lopinavir and ritonavir were determined by a validated HPLC method. Either the Wilcoxon signed-rank or Mann-Whitney U test was used to compare the groups. A total of 37 patients (18 females) were included in the study. Two stopped their study medications prematurely because of intolerance. The median (interquartile range) lopinavir C(min) was 7.2 mg/l (5.8-8.3) and no patients had subtherapeutic levels <1.0 mg/l. No significant difference of lopinavir C(min) levels was found between Kaletra((R)), and the generic product (P=0.224). By contrast,...Continue Reading

Associated Clinical Trials

Citations

Nov 20, 2012·Current Opinion in Obstetrics & Gynecology·Jorge SeniseAdauto Castelo
Oct 27, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Reshmie A RamautarsingAnchalee Avihingsanon
Dec 21, 2013·The Pediatric Infectious Disease Journal·Diane E T BastiaansUNKNOWN PENTA 18KONCERT Study Group
Jun 1, 2014·Expert Opinion on Drug Metabolism & Toxicology·Diane E T BastiaansDavid M Burger
Oct 30, 2015·Journal of Virology·Angelica N MartinsEric O Freed
Feb 2, 2011·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Mark MirochnickUNKNOWN IMPAACT 1026s Study Team
Aug 15, 2014·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Jintanat Ananworanich, Anchalee Avihingsanon
Jan 15, 2013·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Michelle S CespedesJudith A Aberg
Nov 23, 2011·Therapeutic Drug Monitoring·Maria Martinez-RebollarJosep Mallolas
Apr 5, 2020·Pharmaceuticals·Martin D Bleasel, Gregory M Peterson
Oct 6, 2020·EMBO Molecular Medicine·Alexander SimonisJakob J Malin
Nov 28, 2020·Virology Journal·Mohamed MahdiJózsef Tőzsér

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