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
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 an...
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th-cmuir.6653943832-612462018-09-10T04:07:25Z 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 P. Chetchotisakd S. Anunnatsiri P. Mootsikapun S. Kiertiburanakul T. Anekthananon C. Bowonwatanuwong B. Kowadisaiburana K. Supparatpinyo K. Ruxrungtham Medicine 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. © 2007 British HIV Association. 2018-09-10T04:07:25Z 2018-09-10T04:07:25Z 2007-11-01 Journal 14681293 14642662 2-s2.0-35448967037 10.1111/j.1468-1293.2007.00506.x https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=35448967037&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/61246 |
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Medicine P. Chetchotisakd S. Anunnatsiri P. Mootsikapun S. Kiertiburanakul T. Anekthananon C. Bowonwatanuwong B. Kowadisaiburana K. Supparatpinyo K. Ruxrungtham 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 |
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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. © 2007 British HIV Association. |
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P. Chetchotisakd S. Anunnatsiri P. Mootsikapun S. Kiertiburanakul T. Anekthananon C. Bowonwatanuwong B. Kowadisaiburana K. Supparatpinyo K. Ruxrungtham |
author_facet |
P. Chetchotisakd S. Anunnatsiri P. Mootsikapun S. Kiertiburanakul T. Anekthananon C. Bowonwatanuwong B. Kowadisaiburana K. Supparatpinyo K. Ruxrungtham |
author_sort |
P. Chetchotisakd |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publishDate |
2018 |
url |
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=35448967037&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/61246 |
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1681425584945627136 |