Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Retrovirology. 2018 Dec 14;15(1):77. doi: 10.1186/s12977-018-0460-z.
HIV infection and antiretroviral treatment are associated with changes in lipid levels, insulin resistance and risk of cardiovascular disease (CVD). We investigated these changes in the first 96 weeks of treatment with low-dose stavudine or tenofovir regimens.
This is a secondary analysis of a double blind, randomised controlled trial performed in South-Africa, Uganda and India comparing low-dose stavudine (20 mg twice daily) with tenofovir in combination with efavirenz and lamivudine in antiretroviral-naïve adults (n = 1067) (Clinicaltrials.gov, NCT02670772). Over 96 weeks, data were collected on fasting lipids, glucose and insulin. Insulin resistance was assessed with the HOMA-IR index and 10-year CVD risk with the Framingham risk score (FRS). A generalized linear mixed model was used to estimate trends over time.
Participants were on average 35.3 years old, 57.6% female and 91.8% Black African. All lipid levels increased following treatment initiation, with the sharpest increase in the first 24 weeks of treatment. The increase in all lipid subcomponents over 96 weeks was higher among those in the stavudine than the tenofovir group. Insulin resistance increased steadily with no difference detected between study groups. FRS rose from 1.90% (1.84-1.98%) at baseline to 2.06 (1.98-2.15%) at week 96 for the total group, with no difference between treatment arms (p = 0.144). Lipid changes were more marked in Indian than African participants.
Lipid levels increased in both groups, with low-dose stavudine resulting in a worse lipid profile compared to tenofovir. Insulin resistance increased, with no difference between regimens. CVD risk increased over time and tended to increase more in the group on stavudine. The low CVD risk across both arms argues against routine lipid and glucose monitoring in the absence of other CVD risk factors. In high risk patients, monitoring may only be appropriate at least a year after treatment initiation.
HIV 感染和抗逆转录病毒治疗会导致血脂水平、胰岛素抵抗和心血管疾病（CVD）风险发生变化。我们研究了在接受低剂量司他夫定或替诺福韦方案治疗的前 96 周内这些变化。
这是在南非、乌干达和印度进行的一项双盲、随机对照试验的二次分析，比较了低剂量司他夫定（20mg，每日两次）与替诺福韦联合依非韦伦和拉米夫定在抗逆转录病毒初治成人中的效果（n=1067）（Clinicaltrials.gov，NCT02670772）。在 96 周内，收集空腹血脂、血糖和胰岛素数据。使用 HOMA-IR 指数评估胰岛素抵抗，使用 Framingham 风险评分（FRS）评估 10 年 CVD 风险。使用广义线性混合模型估计随时间的趋势。
参与者的平均年龄为 35.3 岁，57.6%为女性，91.8%为黑非洲人。所有血脂水平在治疗开始后均升高，治疗开始后的前 24 周内升高最明显。在 96 周内，司他夫定组的所有血脂亚组分升高幅度均高于替诺福韦组。胰岛素抵抗稳步上升，两组之间无差异。FRS 从基线时的 1.90%（1.84-1.98%）上升至 96 周时的 2.06%（1.98-2.15%），两组之间无差异（p=0.144）。脂质变化在印度参与者中比非洲参与者更为明显。
两组的血脂水平均升高，与替诺福韦相比，低剂量司他夫定导致的血脂谱更差。胰岛素抵抗增加，但方案之间无差异。随着时间的推移，CVD 风险增加，在使用司他夫定的组中风险增加趋势更大。由于缺乏其他 CVD 风险因素，两种方案的 CVD 风险均较低，不支持常规进行血脂和血糖监测。在高危患者中，至少在治疗开始一年后才需要进行监测。
