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Skip Navigation LinksHome > January 28, 2011 - Volume 25 - Issue 3 > Monoboosted lopinavir/ritonavir as simplified second-line ma...
AIDS:
doi: 10.1097/QAD.0b013e32834231f5
Clinical Science

Monoboosted lopinavir/ritonavir as simplified second-line maintenance therapy in virologically suppressed children

Bunupuradah, Torsaka; Kosalaraksa, Popeb; Puthanakit, Thanyaweea,c; Mengthaisong, Tawana; Wongsabut, Jiratchayaa; Lumbiganon, Pagakrongb; Phanuphak, Praphana; Burger, Davidd; Pancharoen, Chitsanuc; Ananworanich, Jintanata,c,e; on behalf of the HIV-NAT 077 Study Team

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Abstract

Background: Monoboosted protease inhibitor is being evaluated as a strategy to simplify therapy in virologically suppressed patients who are on complex regimens.

Methods: Children with two consecutive HIV-RNA below 50 copies/ml at least 3 months apart while on double boosted protease inhibitor (dPI) were switched to monoboosted lopinavir/r (mLPV/r). The previous dPI regimen was resumed within 4 weeks in children who experienced virological failure defined as two HIV-RNA at least 500 or three HIV-RNA at least 50 copies/ml. Primary endpoint was the proportion of children still on mLPV/r and having HIV-RNA less than 50 copies/ml at week 48.

Results: Forty children on LPV/r + saquinavir (90%) or LPV/r + indinavir (10%) were enrolled, 50% were female, median [interquartile range (IQR)] age was 11.7 (10.2–13.5) years, and body weight was 29.4 (24.1–40.2 kg). The median (IQR) CD4% was 27 (23.5–29.5%). At 48 weeks, none had died or had HIV disease progression. Thirty-one children were on mLPV/r and 29 (72.5%) had HIV-RNA less than 50 copies/ml. Nine resumed dPI due to mLPV/r failure with four achieving undetectable HIV-RNA. Overall, 31 children (82.5%) had HIV-RNA suppression. Predicting factor for failing mLPV/r was baseline HIV-RNA at least 50 copies/ml. No major protease mutations were found.

Conclusion: By simplifying second-line treatment from dPI to mLPV/r, the majority of children had sustained viral suppression at 48 weeks. Randomized study of simplified mono protease inhibitor therapy in children is warranted.

© 2011 Lippincott Williams & Wilkins, Inc.

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