在一项III期试验（ECHO）中，接受rilpivirine或依非韦伦治疗的初治HIV-1感染成年患者在48周内维生素D水平的变化及严重维生素D缺乏风险。

Change in vitamin D levels and risk of severe vitamin D deficiency over 48 weeks among HIV-1-infected, treatment-naive adults receiving rilpivirine or efavirenz in a Phase III trial (ECHO).

作者信息

Wohl David A, Orkin Chloe, Doroana Manuela, Pilotto José H, Sungkanuparph Somnuek, Yeni Patrick, Vanveggel Simon, Deckx Henri, Boven Katia

机构信息

The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

出版信息

Antivir Ther. 2014;19(2):191-200. doi: 10.3851/IMP2721. Epub 2014 Jan 16.

DOI:10.3851/IMP2721

PMID:24430534

Abstract

BACKGROUND

This analysis assessed changes in serum 25-hydroxyvitamin D (25[OH]D; the precursor form of active vitamin D) in antiretroviral-naive adults receiving rilpivirine or efavirenz over 48 weeks in a randomized, double-blind, Phase III trial (ECHO).

METHODS

ECHO included 690 patients randomized 1:1 to receive rilpivirine 25 mg once daily (n=346) or efavirenz 600 mg once daily (n=344), plus tenofovir disoproxil fumarate/emtricitabine. 25(OH)D was measured in stored serum samples collected at baseline, and weeks 24 and 48. Proportions of patients with optimal/sufficient (≥30 ng/ml), insufficient (21-29 ng/ml), deficient (10-20 ng/ml) and severely deficient (<10 ng/ml) 25(OH)D levels were determined. Data are presented for patients with paired baseline and week 48 25(OH)D data (rilpivirine, n=292; efavirenz, n=290).

RESULTS

After 48 weeks, mean 25(OH)D levels remained largely unchanged from baseline with rilpivirine (-0.2 ng/ml; P=0.57 versus no change), but were significantly reduced with efavirenz (-2.5 ng/ml; P<0.0001 versus no change). When adjusting for season of randomization and the combined variable of race (Black/African American, White/Caucasian, Asian, other race) and ethnicity (Hispanic or Latino and not Hispanic or not Latino), the conclusion about the treatment difference between the rilpivirine and efavirenz treatment groups remained valid. At baseline the proportion of patients with severe 25(OH)D deficiency was similar in both groups (5%) but was significantly lower with rilpivirine than efavirenz at week 48 (5% versus 9%, respectively; P=0.032). Furthermore, of the patients with 25(OH)D insufficiency/deficiency at baseline, the proportion who developed severe 25(OH)D deficiency at week 48 was significantly lower with rilpivirine than efavirenz (2% versus 8%, respectively; P=0.0079).

CONCLUSIONS

Rilpivirine had little effect on 25(OH)D, whereas efavirenz resulted in a significant reduction in 25(OH)D levels and an increase in the risk of severe 25(OH)D deficiency.

摘要

背景

本分析评估了在一项随机、双盲、III期试验（ECHO）中，未接受过抗逆转录病毒治疗的成年人在48周内接受利匹韦林或依非韦伦治疗时血清25-羟基维生素D（25[OH]D；活性维生素D的前体形式）的变化。

方法

ECHO纳入了690例患者，这些患者按1:1随机分组，分别接受每日一次25mg利匹韦林（n = 346）或每日一次600mg依非韦伦（n = 344），加用富马酸替诺福韦二吡呋酯/恩曲他滨。在基线、第24周和第48周采集的储存血清样本中检测25(OH)D。确定25(OH)D水平处于最佳/充足（≥30 ng/ml）、不足（21 - 29 ng/ml）、缺乏（10 - 20 ng/ml）和严重缺乏（<10 ng/ml）的患者比例。给出了具有配对的基线和第48周25(OH)D数据的患者的数据（利匹韦林组，n = 292；依非韦伦组，n = 290）。

结果

48周后，利匹韦林治疗组的平均25(OH)D水平与基线相比基本未变（-0.2 ng/ml；与无变化相比，P = 0.57），但依非韦伦治疗组显著降低（-2.5 ng/ml；与无变化相比，P < 0.0001）。在对随机分组季节以及种族（黑人/非裔美国人、白人/高加索人、亚洲人、其他种族）和族裔（西班牙裔或拉丁裔以及非西班牙裔或非拉丁裔）的综合变量进行校正后。利匹韦林和依非韦伦治疗组之间治疗差异的结论仍然有效。基线时，两组中严重25(OH)D缺乏患者的比例相似（5%），但在第48周时，利匹韦林组显著低于依非韦伦组（分别为5%和9%；P = 0.032）。此外，在基线时25(OH)D不足/缺乏的患者中，第48周时发展为严重25(OH)D缺乏的患者比例，利匹韦林组显著低于依非韦伦组（分别为2%和8%；P = 0.0079）。