OBJECTIVES:Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). METHODS:We analysed a prospective cohort of patients who initiated either a TDF-containing highly active antiretroviral therapy (HAART) regimen [TDF-exposed (TDF+) group; n = 165] or a TDF-sparing HAART regimen [TDF-unexposed (TDF-) group; n = 90], and who had normal baseline phosphate and creatinine values. RESULTS:The TDF+ and TDF- groups had comparable median follow-up times (10.9 vs 8.8 months, respectively; P = 0.18) and number of phosphate measurements (median = 3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+vs 6.7% of TDF-patients developed grade 2 hypophosphataemia (2.0-2.4 mg/dL), and 2.4% of TDF+ patients vs 0% of TDF-patients developed grade 3 hypophosphataemia (1.0-1.9 mg/dL); none developed grade 4 hypophosphataemia (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+ patients vs 8.0 per 100 person-years among TDF-patients (P = 0.11). CONCLUSIONS:The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.

译文

目的:已经报道了接受替诺福韦二富马酸富马酸酯(TDF)感染HIV的患者发生低血磷的情况(通常与肾功能不全同时发生),但基线肾功能正常的HIV感染者的随机安慰剂对照试验发现TDF和安慰剂组的低磷血症。我们在HIV门诊研究(HOPS)中评估了2级和更高的低血磷的发生率。
方法:我们分析了开始采用含TDF的高活性抗逆转录病毒疗法(HAART)方案[TDF暴露(TDF)组)的患者的前瞻性队列研究。 n = 165]或保留TDF的HAART方案[未暴露TDF(TDF-)的组; n = 90],并且基线磷酸盐和肌酐值正常。
结果:TDF和TDF-组的中位随访时间(分别为10.9和8.8个月; P = 0.18)和磷酸盐测量次数(两者的中位数= 3)具有可比性,并且在大多数临床和人口统计学因素上相似。在随访期间,TDF的12.7%与TDF的患者的6.7%发生了2级低血磷(2.0-2.4 mg / dL),TDF的2.4%vs TDF的患者中出现了3级的低血磷(1.0-1.9 mg) / dL);没有一个发生4级低血磷(<1.0 mg / dL)。 TDF患者中2级或更高水平低血磷的发生率为每100人年16.7人,而TDF患者为每100人年8.0人(P = 0.11)。
结论:在观察的头1至2年中,与含TDF的HAART的HOPS患者相比,接受含TDF的HAART的HOPS患者的低磷酸盐血症发生率有所升高,但差异无统计学意义。需要对更大的人群进行更长时间的随访,以确定这种联系趋势是否达到统计学意义并评估低血磷的临床后果。

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