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.
From the *Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen; †The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Centre; ‡Department of Medicine, Faculty of Medicine, Chulalongkorn University; §SEARCH, the Thai Red Cross AIDS Research Centre; and ¶Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Accepted for publication October 25, 2012.
This study was presented as poster presentation (Poster 962) at 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012), March 5–8, 2012, at the Washington State Convention Center in Seattle, WA.
T.B. and P.K. had received educational grants, travel grants and/or speakers’ honoraria from Roche and Abbott. J.A. has received consultation fees and/or speakers’ honoraria from ViiV Healthcare, Gilead and Abbott. T.P. has received speaker’s honoraria from Abbott. The authors have no other funding or conflicts of interest to disclose.
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Address for correspondence: Torsak Bunupuradah, MD, HIV-NAT, The Thai Red Cross AIDS Research Center, 104 Ratchadamri Road, Pathumwan, Bangkok, Thailand 10330. E-mail: firstname.lastname@example.org.