title: Long-term lopinavir/ritonavir monotherapy in HIV-infected children.
abstract: 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.
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Pope
authors.initials: P
authors.lastname: Kosalaraksa
authors.forename: Jintanat
authors.initials: J
authors.lastname: Ananworanich
authors.forename: Thanyawee
authors.initials: T
authors.lastname: Puthanakit
authors.forename: Suteeraporn
authors.initials: S
authors.lastname: Pinyakorn
authors.forename: Pagakrong
authors.initials: P
authors.lastname: Lumbiganon
authors.forename: Thongsuai
authors.initials: T
authors.lastname: Chuanjaroen
authors.forename: Umaporn
authors.initials: U
authors.lastname: Chobkarjing
authors.forename: Praphan
authors.initials: P
authors.lastname: Phanuphak
authors.forename: Chitsanu
authors.initials: C
authors.lastname: Pancharoen
authors.forename: Torsak
authors.initials: T
authors.lastname: Bunupuradah
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D002648:Child; D005260:Female; D006678:HIV / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage*; D008297:Male; D019438:Ritonavir / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D061466:Lopinavir; D019438:Ritonavir