BackgroundHIV 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.MethodsThis 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.ResultsParticipants 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.ConclusionLipid 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.

中文翻译：

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96 周抗逆转录病毒治疗后的血脂水平、胰岛素抵抗和心血管风险：一项比较低剂量司他夫定和替诺福韦的随机对照试验

背景 HIV 感染和抗逆转录病毒治疗与血脂水平、胰岛素抵抗和心血管疾病 (CVD) 风险的变化有关。我们调查了在使用低剂量司他夫定或替诺福韦方案治疗的前 96 周内的这些变化。方法这是对在南非、乌干达和印度进行的一项双盲、随机对照试验的二次分析，比较低剂量司他夫定（20 mg每日两次）与替诺福韦联合依法韦仑和拉米夫定用于未接受抗逆转录病毒治疗的成人（n = 1067）（Clinicaltrials.gov，NCT02670772）。在 96 周内，收集了空腹血脂、葡萄糖和胰岛素的数据。胰岛素抵抗用 HOMA-IR 指数和 10 年 CVD 风险用弗雷明汉风险评分 (FRS) 进行评估。使用广义线性混合模型来估计随时间的趋势。结果参与者平均年龄为 35.3 岁，女性占 57.6%，非洲黑人占 91.8%。所有脂质水平在治疗开始后都增加，在治疗的前 24 周增加最显着。在 96 周内，司他夫定组中所有脂质亚成分的增加高于替诺福韦组。胰岛素抵抗稳步增加，研究组之间没有检测到差异。整个组的 FRS 从基线时的 1.90% (1.84–1.98%) 上升到第 96 周的 2.06 (1.98–2.15%)，治疗组之间没有差异 (p = 0.144)。印度参与者的脂质变化比非洲参与者更显着。结论两组的脂质水平均增加，与替诺福韦相比，低剂量司他夫定导致更差的脂质特征。胰岛素抵抗增加，方案之间没有差异。CVD 风险随着时间的推移而增加，并且在司他夫定组中增加更多。在没有其他 CVD 风险因素的情况下，两组的 CVD 风险均较低，因此反对常规血脂和血糖监测。在高危患者中，监测可能仅在治疗开始后至少一年才合适。