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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

doi: 10.1097/QAD.0b013e32834231f5
Clinical Science

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.

aThe HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand

bKhon Kaen University, Khon Kaen, Thailand

cChulalongkorn University, Bangkok, Thailand

dRadboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

eSouth East Asia Research Collaboration with Hawaii (SEARCH), Bangkok, Thailand.

Received 27 May, 2010

Revised 26 October, 2010

Accepted 1 November, 2010

Correspondence to Torsak Bunupuradah, MD, HIV-NAT, The Thai Red Cross AIDS Research Center, 104 Ratchadamri Road, Pathumwan, Bangkok 10330, Thailand. Tel: +66 2 652 3040; fax: +66 2 252 5779; e-mail:

© 2011 Lippincott Williams & Wilkins, Inc.