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

Long-term Lopinavir/Ritonavir Monotherapy in HIV-infected Children
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DOI:
10.1097/inf.0b013e31827b1bd3
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发表时间:
2013-04-01
影响因子:
3.6
通讯作者:
Bunupuradah, Torsak
Bunupuradah, Torsak
中科院分区:
医学4区
文献类型:
--
作者:
Kosalaraksa, Pope;Ananworanich, Jintanat;Bunupuradah, Torsak

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背景:关于洛匹那韦/利托那韦单药治疗 (mLPV/r) 作为病毒学抑制儿童的治疗简化策略的长期数据有限。方法:确认血浆 HIV 病毒载量 (VL) = 500 或 3 个连续 VL >= 50 拷贝/mL 的儿童。 VF 儿童的 dPI 在 4 周内恢复。主要终点是在第 144 周仍接受 mLPV/r 时 VL < 50 拷贝/mL 的儿童比例。 结果: 40 名儿童入组; 90% 的患者接受 LPV/r + 沙奎那韦治疗,10% 的患者接受 LPV/r + 茚地那韦治疗,然后简化为 mLPV/r。中位年龄为 11.7 岁; 50%是女性。 CD4% 中位数为 27%。四人 (10%) 在进入时 VL > 50 拷贝/mL。第 144 周时,仍在接受 mLPV/r 且 VL < 50 拷贝/mL 的儿童比例为 40 人中的 22 人 (55%)。第 144 周时,所有 VL < 50 拷贝/mL 的儿童比例为 40 名中的 33 名 (82.5%)。在 16 名患有 VF 并恢复 dPI 的儿童中,11 名 (69%) 在第 144 周时达到 VL < 50 拷贝/mL。没有 VF 儿童出现主要 LPV/r 突变。在研究期间的任何访视中,入院时可检测到的 VL 和服药计数 < 95% 且连续 > 3 次的依从性可显着预测 mLPV/r 上的 VF(均 P = 0.025)。总胆固醇升高 (>200 mg/dL) 的儿童比例从基线时的 65% 降至第 144 周时的 40% (P = 0.007)。结论:大约一半的儿童在 mLPV/r 上维持病毒学抑制近 3 年。 VF 很常见,但大多数人在恢复 dPI 后实现了抑制,并且没有人出现主要的 LPV/r 突变。如果可以进行频繁的 VL 监测来检测 VF,则仅应考虑将 mLPV/r 用于简化的维持治疗。
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) = 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.