Norwich Medical School, University of East Anglia, Norwich.
Oxford University Clinical Academic Graduate School, University of Oxford.
AIDS. 2021 Dec 15;35(Suppl 2):S189-S195. doi: 10.1097/QAD.0000000000003083.
Recent clinical trials have shown weight gain associated with newer antiretrovirals. It is unclear how the nucleoside reverse transcriptase inhibitor backbone affects weight. Recent evidence suggests greater weight gain with tenofovir alafenamide (TAF) compared with tenofovir disoproxil fumarate (TDF). However, it is not fully understood whether TDF contributes to weight suppression.
A systematic search of PubMed, Embase and clinicaltrials.gov was conducted to identify all randomized control trials comparing TDF/FTC or TDF to control in HIV-negative individuals. The primary endpoint included the number of events of 5% weight loss. Mantel-Haenszel test with random-effects modelling was used to calculate the odds ratio (OR) and 95% confidence intervals (95% CI). Further analyses of gastrointestinal (GI) adverse events were also undertaken.
Seven PrEP trials: PARTNERS, VOICE, TDF-2, Bangkok PrEP, iPrEX, FEM-PrEP and HPTN 084 were included in the analysis of weight loss, with a total sample size of 19 359. One study (HPTN 084) compared TDF/FTC to cabotegravir (CAB). HIV-negative individuals taking TDF were more likely to experience weight loss compared with control [odds ratio (OR) 1.44; 95% CI 1.12-1.85; P = 0.005). Exposure to TDF was also linked to greater odds of vomiting (OR 1.81; 95% CI 1.20-2.73; P < 0.005). There were no increased odds of nausea, diarrhoea or loss of appetite.
There is evidence in HIV-negative individuals that TDF may be associated with weight loss. Further research should be carried out in HIV-positive individuals, and clinical trials of TDF/FTC should publish weight data to widen the evidence base.
最近的临床试验表明，新型抗逆转录病毒药物会导致体重增加。核苷类逆转录酶抑制剂骨架如何影响体重尚不清楚。最近的证据表明，与富马酸替诺福韦二吡呋酯（TDF）相比，替诺福韦艾拉酚胺（TAF）会导致更大的体重增加。然而，尚不完全清楚 TDF 是否有助于抑制体重。
系统检索了 PubMed、Embase 和 clinicaltrials.gov，以确定所有比较 TDF/FTC 或 TDF 与 HIV 阴性个体对照的随机对照试验。主要终点包括体重下降 5%的事件数。采用 Mantel-Haenszel 检验和随机效应模型计算比值比（OR）和 95%置信区间（95%CI）。还对胃肠道（GI）不良事件进行了进一步分析。
纳入了 7 项 PrEP 试验：PARTNERS、VOICE、TDF-2、曼谷 PrEP、iPrEX、FEM-PrEP 和 HPTN 084，共分析了 19359 名个体的体重减轻情况。一项研究（HPTN 084）比较了 TDF/FTC 与卡替拉韦（CAB）。与对照组相比，服用 TDF 的 HIV 阴性个体更有可能出现体重减轻[比值比（OR）1.44；95%CI 1.12-1.85；P=0.005]。TDF 暴露也与更高的呕吐几率相关（OR 1.81；95%CI 1.20-2.73；P<0.005）。恶心、腹泻或食欲不振的几率没有增加。
在 HIV 阴性个体中，有证据表明 TDF 可能与体重减轻有关。应在 HIV 阳性个体中进行进一步研究，并且 TDF/FTC 的临床试验应公布体重数据，以扩大证据基础。
