Centre for Clinical Research, Modelling and Epidemiology, Research Department of Infection and Population Health, Institute for Global Health, University College London Medical School, Royal Free Campus, London, UK.
Medical University Innsbruck, Innsbruck, Austria.
HIV Med. 2018 Feb;19(2):102-117. doi: 10.1111/hiv.12557. Epub 2017 Oct 6.
There are currently few data on the long-term risk of cancer and death in individuals taking raltegravir (RAL). The aim of this analysis was to evaluate whether there is evidence for an association.
The EuroSIDA cohort was divided into three groups: those starting RAL-based combination antiretroviral therapy (cART) on or after 21 December 2007 (RAL); a historical cohort (HIST) of individuals adding a new antiretroviral (ARV) drug (not RAL) to their cART between 1 January 2005 and 20 December 2007, and a concurrent cohort (CONC) of individuals adding a new ARV drug (not RAL) to their cART on or after 21 December 2007. Baseline characteristics were compared using logistic regression. The incidences of newly diagnosed malignancies and death were compared using Poisson regression.
The RAL cohort included 1470 individuals [with 4058 person-years of follow-up (PYFU)] compared with 3787 (4472 PYFU) and 4467 (10 691 PYFU) in the HIST and CONC cohorts, respectively. The prevalence of non-AIDS-related malignancies prior to baseline tended to be higher in the RAL cohort vs. the HIST cohort [adjusted odds ratio (aOR) 1.31; 95% confidence interval (CI) 0.95-1.80] and vs. the CONC cohort (aOR 1.89; 95% CI 1.37-2.61). In intention-to-treat (ITT) analysis (events: RAL, 50; HIST, 45; CONC, 127), the incidence of all new malignancies was 1.11 (95% CI 0.84-1.46) per 100 PYFU in the RAL cohort vs. 1.20 (95% CI 0.90-1.61) and 0.83 (95% CI 0.70-0.99) in the HIST and CONC cohorts, respectively. After adjustment, there was no evidence for a difference in the risk of malignancies [adjusted rate ratio (RR) 0.73; 95% CI 0.47-1.14 for RALvs. HIST; RR 0.95; 95% CI 0.65-1.39 for RALvs. CONC] or mortality (adjusted RR 0.87; 95% CI 0.53-1.43 for RALvs. HIST; RR 1.14; 95% CI 0.76-1.72 for RALvs. CONC).
We found no evidence for an oncogenic risk or poorer survival associated with using RAL compared with control groups.
目前关于接受拉替拉韦(RAL)治疗的个体癌症和死亡的长期风险数据较少。本分析的目的是评估是否有证据表明存在关联。
EuroSIDA 队列分为三组:2007 年 12 月 21 日或之后开始基于 RAL 的联合抗逆转录病毒疗法(cART)的患者(RAL 组);2005 年 1 月 1 日至 2007 年 12 月 20 日期间将新的抗逆转录病毒药物(非 RAL)添加到其 cART 中的历史队列(HIST 组),以及 2007 年 12 月 21 日或之后将新的抗逆转录病毒药物(非 RAL)添加到其 cART 的同期队列(CONC 组)。使用逻辑回归比较基线特征。使用泊松回归比较新发恶性肿瘤和死亡的发生率。
RAL 队列包括 1470 名患者[4058 人年随访(PYFU)],与 HIST 队列的 3787 名(4472 PYFU)和 CONC 队列的 4467 名(10691 PYFU)相比。与 HIST 队列相比,RAL 队列中基线前非艾滋病相关恶性肿瘤的患病率倾向于更高[调整后比值比(aOR)1.31;95%置信区间(CI)0.95-1.80],与 CONC 队列相比(aOR 1.89;95%CI 1.37-2.61)。在意向治疗(ITT)分析(事件:RAL,50;HIST,45;CONC,127)中,RAL 队列中所有新发恶性肿瘤的发生率为每 100 PYFU 1.11(95%CI 0.84-1.46),而 HIST 和 CONC 队列中分别为 1.20(95%CI 0.90-1.61)和 0.83(95%CI 0.70-0.99)。调整后,RAL 组与 HIST 组(RAL 与 HIST 相比,调整后的发病率比(RR)为 0.73;95%CI 0.47-1.14)或 CONC 组(RAL 与 HIST 相比,RR 为 0.95;95%CI 0.65-1.39)的恶性肿瘤风险或死亡率均无差异[调整后 RR(RAL 与 HIST 相比)为 0.87;95%CI 0.53-1.43;RAL 与 CONC 相比,RR 为 1.14;95%CI 0.76-1.72]。
我们没有发现与对照组相比,RAL 与致癌风险或生存较差相关的证据。