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Efficacy and tolerability of a double boosted protease inhibitor (lopinavir + saquinavir/ritonavir) regimen in HIV‐infected patients who failed treatment with nonnucleoside reverse transcriptase inhibitors
Author(s) -
Chetchotisakd P,
Anunnatsiri S,
Mootsikapun P,
Kiertiburanakul S,
Anekthana T,
Bowonwatanuwong C,
Kowadisaiburana B,
Supparatpinyo K,
Ruxrungtham K
Publication year - 2007
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2007.00506.x
Subject(s) - saquinavir , medicine , ritonavir , tolerability , regimen , lopinavir , indinavir , lopinavir/ritonavir , reverse transcriptase inhibitor , protease inhibitor (pharmacology) , nucleoside reverse transcriptase inhibitor , viral load , pharmacology , gastroenterology , interquartile range , virology , adverse effect , human immunodeficiency virus (hiv) , antiretroviral therapy
Objectives Long‐term nonnucleoside reverse transcriptase inhibitor (NNRTI)‐based antiretroviral treatment failure in most developing countries has led to broad cross‐resistance within NNRTI and nucleoside reverse transcriptase inhibitor (NRTI) classes. In this study, we investigated the efficacy and tolerability of a double boosted protease inhibitor (PI) regimen in this setting. Methods A total of 64 HIV‐infected patients who had failed NNRTI‐based regimens were randomized to receive either lopinavir/saquinavir/ritonavir [LPV/SQV/r; 400/1000/100 mg twice a day (bid)] alone or indinavir/ritonavir (IDV/r; 800/100 mg bid) plus two NRTIs optimized with genotypic drug resistance guidance. Patients who had no available optimized NRTI backbone were allocated to the LPV/SQV/r arm. Results At 48 weeks, the percentages of patients with plasma viral load<50 HIV‐1 RNA copies/mL were 60% (31 of 52 patients) in the LPV/SQV/r arm vs 50% (six of 12) in the IDV/r/2NRTIs arm in the intent‐to‐treat (ITT) analysis, and 61% (31 of 51) vs 71% (five of seven), respectively, in the as‐treated analysis. The median (interquartile range) increases in absolute CD4 cell count from baseline were 177 (91–269) and 100 (52–225) cells/μL in the LPV/SQV/r and IDV/r/2NRTIs groups, respectively ( P =0.32). Four of 12 patients (33%) in the IDV/r/2NRTIs group experienced severe nausea and vomiting and four patients (8%) in the LPV/SQV/r group had significant hepatitis. Conclusions LPV/SQV/r and high‐dose boosted IDV were not well tolerated and led to <65% ITT virological efficacy outcomes. A randomized larger scale study with new formulations and/or more tolerable boosted PIs in NNRTI‐based failure is warranted.