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Published on: April 9, 2014
Long-term lopinavir/ritonavir monotherapy in HIV-infected children
Pope Kosalaraksa1, Jintanat Ananworanich, Thanyawee Puthanakit
1Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Insights
Lopinavir/ritonavir monotherapy (mLPV/r) in children maintained virologic suppression in 55% at 144 weeks. While virologic failure was common, resuming double protease inhibitors (dPI) restored viral load suppression in most cases.
Area of Science:
- Pediatric infectious diseases
- HIV/AIDS treatment
- Pharmacology
Background:
- Limited long-term data exist for lopinavir/ritonavir monotherapy (mLPV/r) as a simplification strategy in virologically suppressed children.
- Evaluating mLPV/r requires understanding its efficacy and safety in this specific pediatric population.
Purpose of the Study:
- To assess the long-term efficacy of lopinavir/ritonavir monotherapy (mLPV/r) for treatment simplification in HIV-infected children.
- To determine the proportion of children maintaining viral load <50 copies/mL at 144 weeks on mLPV/r therapy.
Main Methods:
- Children with viral load (VL) <50 copies/mL on double protease inhibitors (dPI) were switched to mLPV/r.
- Virologic failure (VF) was defined as 2 consecutive VL ≥ 500 or 3 consecutive VL ≥ 50 copies/mL.
- Primary endpoint: proportion of children with VL < 50 copies/mL at week 144 while on mLPV/r.
Main Results:
- 55% of children maintained VL <50 copies/mL at week 144 on mLPV/r; 82.5% achieved VL <50 copies/mL overall.
- Virologic failure occurred in some children, but 69% achieved viral suppression after resuming dPI.
- No major lopinavir/ritonavir mutations were detected in children with VF. Detectable VL at entry and poor adherence predicted VF.
Conclusions:
- Lopinavir/ritonavir monotherapy (mLPV/r) can maintain virologic suppression in about half of children for nearly 3 years.
- Virologic failure is possible but manageable by resuming dPI, with no major resistance mutations observed.
- mLPV/r may be considered for simplified therapy if frequent viral load monitoring is implemented to detect virologic failure early.
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.
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