Safety and efficacy of a double-boosted protease inhibitor combination, saquinavir and lopinavir/ ritonavir, in pretreated children at 96 weeks

• Published in: Antiviral therapy 2009-01, Vol.14 (2), p.241-248
• Main Authors: BUNUPURADAH, Torsak, VAN DER LUGT, Jasper, BURGER, David, RUXRUNGTHAM, Kiat, ANANWORANICH, Jintanat, KOSALARAKSA, Pope, ENGCHANIL, Chulapan, BOONRAK, Pitch, PUTHANAKIT, Thanyawee, MENGTHAISONG, Tawan, MAHANONTHARIT, Apicha, LUMBIGANON, Pagakrong, TOMPKINS, Emily
• Format: Article
• Language: English
• Subjects: Adolescent; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Biological and medical sciences; Child; Drug Administration Schedule; Drug Monitoring; Female; HIV Infections - drug therapy; HIV Protease Inhibitors - administration & dosage; HIV Protease Inhibitors - adverse effects; HIV-1 - drug effects; Human immunodeficiency virus 1; Humans; Hypercholesterolemia - chemically induced; Lopinavir; Male; Medical sciences; Pharmacology. Drug treatments; Pyrimidinones - administration & dosage; Pyrimidinones - adverse effects; Ritonavir - administration & dosage; Ritonavir - adverse effects; Saquinavir - administration & dosage; Saquinavir - adverse effects; Thailand; Treatment Outcome
• ISSN: 1359-6535; 2040-2058
• DOI: 10.1177/135965350901400218

This study aimed to assess the long-term efficacy, safety and use of therapeutic drug monitoring (TDM) of a double-boosted protease inhibitor (PI) combination, saquinavir (SQV) and lopinavir/ritonavir (LPV/r), in Thai HIV type-1 (HIV-1)-infected children who had failed on reverse transcriptase inhibitors. In total, 50 children from two sites in Thailand were treated with standard dosing of SQV and LPV/r. CD4(+) T-cell count and percentage, viral load (VL; HIV-1 RNA), minimum plasma drug concentrations (C(min)) and drug safety laboratory evaluations were monitored. Virological failure was defined as having two consecutive VL measures >400 copies/ml after week 12. An intention-to-treat analysis was performed. Baseline data were a median age of 9.3 years (interquartile range [IQR] 7.1-11.2), VL 4.8 log(10) copies/ml (IQR 4.5-5.1) and CD4(+) T-cell percentage 7% (IQR 3.0-9.5). CDC classifications were N=4%, A=14%, B=68% and C=14% of participants. Median CD4(+) T-cell percentage and CD4(+) T-cell count increase were 14% (IQR 7-19) and 558 cells/mm(3) (IQR 308-782), respectively (both P