Young Laura, Wohl David A, Hyslop William B, Lee Yueh Z, Napravnik Sonia, Wilkin Aimee
HIV Clin Trials. 2015 Oct;16(5):163-9. doi: 10.1179/1945577115Y.0000000002. Epub 2015 Aug 7.
Raltegravir (RAL) plus tenofovir/emtricitabine (TDF/FTC) is a recommended initial antiretroviral regimen. A substantial proportion of persons diagnosed with HIV infection and starting antiretrovirals in the U.S. are African-American (AA); however, the effects of this regimen on metabolic parameters have largely been studied in white patients.
Single-arm, open-label study of untreated AA HIV-infected patients administered RAL with TDF/FTC for 104 weeks. Changes in fasting lipids, insulin resistance, visceral adipose tissue (VAT), abdominal subcutaneous adipose tissue (SAT), limb and trunk fat, and bone mineral density (BMD) were assessed at weeks 56 and 104.
Thirty (85% men) participants were included. Median entry characteristics included age of 38 years, CD4 323 cells/mm3, HIV RNA level 29,245 copies/ml, and body mass index 28.1 kg/m2. At 56 and 104 weeks, significant increases in VAT, trunk fat, limb fat, and overall fat were observed. Bone mineral density decreased by 1.5% by week 104.There were no significant changes in non-HDL-cholesterol, fasting triglycerides, or insulin resistance. A median CD4 cell count increase of 318 cells/mm3 (IQR 179, 403; full range 40, 749) (P<0.001) was observed. Assuming missing=failure, 78 and 70% had HIV RNA levels<40 copies/ml at weeks 56 and 104, respectively. There were no treatment-related discontinuations and no new antiretroviral resistance mutations were detected.
In this cohort of AAs, initiation of RAL with TDF/FTC was associated with significant general increases in fat. Significant changes in lipids or insulin resistance were not observed and there was a small decline in BMD. Therapy was well tolerated and effective. These results are consistent with findings of studies of initial antiretroviral therapy in racially diverse cohorts and inform treatment selection for AA patients starting therapy for HIV infection.
拉替拉韦（RAL）联合替诺福韦/恩曲他滨（TDF/FTC）是推荐的初始抗逆转录病毒治疗方案。在美国，相当一部分被诊断为HIV感染并开始接受抗逆转录病毒治疗的人是非裔美国人（AA）；然而，该方案对代谢参数的影响主要是在白人患者中进行研究的。
对未接受治疗的AA HIV感染患者进行单臂、开放标签研究，给予RAL联合TDF/FTC治疗104周。在第56周和第104周评估空腹血脂、胰岛素抵抗、内脏脂肪组织（VAT）、腹部皮下脂肪组织（SAT）、肢体和躯干脂肪以及骨密度（BMD）的变化。
纳入了30名参与者（85%为男性）。入组时的中位特征包括年龄38岁、CD4细胞计数323个/mm³、HIV RNA水平29245拷贝/ml以及体重指数28.1kg/m²。在第56周和第104周时，观察到VAT、躯干脂肪、肢体脂肪和总体脂肪显著增加。到第104周时骨密度下降了1.5%。非高密度脂蛋白胆固醇、空腹甘油三酯或胰岛素抵抗无显著变化。观察到CD4细胞计数中位数增加318个/mm³（四分位间距179,403；范围40,749）（P<0.001）。假设缺失=失败，在第56周和第104周时分别有78%和70%的患者HIV RNA水平<40拷贝/ml。没有与治疗相关的停药情况，也未检测到新的抗逆转录病毒耐药突变。
在这个AA队列中，开始使用RAL联合TDF/FTC治疗与脂肪普遍显著增加有关。未观察到血脂或胰岛素抵抗的显著变化，骨密度有小幅下降。治疗耐受性良好且有效。这些结果与在不同种族队列中进行的初始抗逆转录病毒治疗研究结果一致，并为开始HIV感染治疗的AA患者的治疗选择提供了参考。
