Skip Navigation LinksHome > April 2013 - Volume 32 - Issue 4 > Long-term Lopinavir/Ritonavir Monotherapy in HIV-infected Ch...
Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e31827b1bd3
HIV Reports

Long-term Lopinavir/Ritonavir Monotherapy in HIV-infected Children

Kosalaraksa, Pope MD*; Ananworanich, Jintanat MD, PhD†‡§; Puthanakit, Thanyawee MD†¶; Pinyakorn, Suteeraporn MSc†§; Lumbiganon, Pagakrong MD*; Chuanjaroen, Thongsuai BNS; Chobkarjing, Umaporn MSc; Phanuphak, Praphan MD, PhD; Pancharoen, Chitsanu MD; Bunupuradah, Torsak MD; on behalf of the HIV-NAT 077 Study Team

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Background: Long-term data are limited on lopinavir/ritonavir monotherapy (mLPV/r) as a treatment simplification strategy in virologically suppressed children.

Methods: Children with confirmed plasma HIV viral load (VL) <50 copies/mL while receiving double protease inhibitors (dPI) were switched to mLPV/r therapy. Virologic failure (VF) was defined as 2 consecutive VL ≥ 500 or 3 consecutive VL ≥ 50 copies/mL. dPI was resumed within 4 weeks in children with VF. Primary endpoint was the proportion of children with VL < 50 copies/mL while still receiving mLPV/r at week 144.

Results: Forty children were enrolled; 90% were receiving LPV/r + saquinavir and 10% LPV/r + indinavir before simplifying to mLPV/r. Median age was 11.7 years; 50% were female. Median CD4% was 27%. Four (10%) had VL > 50 copies/mL at entry. At week 144, the proportion of children still receiving mLPV/r who had VL < 50 copies/mL was 22 of 40 (55%). The proportion of all children with VL < 50 copies/mL at week 144 was 33 of 40 (82.5%). Among 16 children who had VF and resumed dPI, 11 (69%) achieved VL < 50 copies/mL at week 144. No children with VF had major LPV/r mutations. Having detectable VL at entry and adherence by pill count <95% for >3 times at any visits during the study period significantly predicted VF on mLPV/r (both P = 0.025). The proportion of children with elevated total cholesterol (>200 mg/dL) decreased from 65% at baseline to 40% at week 144 (P = 0.007).

Conclusions: About half of children maintained virologic suppression on mLPV/r for almost 3 years. VF was common but the majority achieved suppression after resuming dPI and none had major LPV/r mutations. mLPV/r should only be considered for simplified maintenance therapy if frequent VL monitoring to detect VF is available.

© 2013 Lippincott Williams & Wilkins, Inc.


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