Gertrude H, Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY USA.
BMC Pediatr. 2014 Feb 12;14:39. doi: 10.1186/1471-2431-14-39.
While studies of HIV-infected adults on antiretroviral treatment (ART) report no sex differences in immune recovery and virologic response but more ART-associated complications in women, sex differences in disease progression and response to ART among children have not been well assessed. The objective of this study was to evaluate for sex differences in response to ART in South African HIV-infected children who were randomized to continue ritonavir-boosted lopinavir (LPV/r)-based ART or switch to nevirapine-based ART.
ART outcomes in HIV-infected boys and girls in Johannesburg, South Africa from 2005-2010 were compared. Children initiated ritonavir-boosted lopinavir (LPV/r)-based ART before 24 months of age and were randomized to remain on LPV/r or switch to nevirapine-based ART after achieving viral suppression. Children were followed for 76 weeks post-randomization and then long-term follow up continued for a minimum of 99 weeks and maximum of 245 weeks after randomization. Viral load, CD4 count, lipids, anthropometrics, drug concentrations, and adherence were measured at regular intervals. Outcomes were compared between sexes within treatment strata.
A total of 323 children (median age 8.8 months, IQR 5.1-13.5), including 168 boys and 155 girls, initiated LPV/r-based ART and 195 children were randomized. No sex differences in risk of virological failure (confirmed viral load >1000 copies/mL) by 156 weeks post-randomization were observed within either treatment group. Girls switched to nevirapine had more robust CD4 count improvement relative to boys in this group through 112 weeks post-randomization. In addition, girls remaining on LPV/r had higher plasma concentrations of ritonavir than boys during post-randomization visits. After a mean of 3.4 years post-randomization, girls remaining on LPV/r also had a higher total cholesterol:HDL ratio and lower mean HDL than boys on LPV/r.
Sex differences are noted in treated HIV-infected children even at a young age, and appear to depend on treatment regimen. Future studies are warranted to determine biological mechanisms and clinical significance of these differences.
ClinicalTrials.gov Identifier: NCT00117728.
虽然研究表明，接受抗逆转录病毒治疗（ART）的 HIV 感染成年人在免疫恢复和病毒学反应方面没有性别差异，但女性的 ART 相关并发症更多，但儿童疾病进展和对 ART 的反应方面的性别差异尚未得到很好的评估。本研究的目的是评估南非 HIV 感染儿童在接受利托那韦增强洛匹那韦（LPV/r）为基础的 ART 或转换为奈韦拉平为基础的 ART 后的治疗反应是否存在性别差异。
比较了 2005-2010 年约翰内斯堡 HIV 感染男孩和女孩的 ART 结果。儿童在 24 个月之前接受利托那韦增强洛匹那韦（LPV/r）为基础的 ART，并在病毒抑制后随机继续接受 LPV/r 或转换为奈韦拉平为基础的 ART。儿童在随机分组后随访 76 周，然后继续进行至少 99 周和最长 245 周的长期随访。定期测量病毒载量、CD4 计数、血脂、人体测量学、药物浓度和依从性。在治疗分层内比较性别之间的结果。
共有 323 名儿童（中位年龄 8.8 个月，IQR 5.1-13.5），包括 168 名男孩和 155 名女孩，开始接受 LPV/r 为基础的 ART，其中 195 名儿童被随机分组。在随机分组后 156 周内，未观察到任何性别的病毒学失败（确证病毒载量>1000 拷贝/ml）风险差异，无论在哪个治疗组中均如此。与该组中的男孩相比，转换为奈韦拉平的女孩在随机分组后 112 周时 CD4 计数的改善更为显著。此外，在随机分组后的就诊中，接受 LPV/r 的女孩的利托那韦血浆浓度高于男孩。在随机分组后平均 3.4 年，接受 LPV/r 的女孩的总胆固醇/高密度脂蛋白比值也高于男孩，而 HDL 则低于男孩。
即使在年幼时，接受治疗的 HIV 感染儿童中也存在性别差异，而且似乎取决于治疗方案。需要进一步研究以确定这些差异的生物学机制和临床意义。
ClinicalTrials.gov 标识符：NCT00117728。
